Unresolved Conflicts of Interest in University Human Subject Research – OLD

01.27.2017  |  Comments Off on Unresolved Conflicts of Interest in University Human Subject Research – OLD

By Gabriela A. Weigel*

“They are not ignorant men. Most of them are trained physicians and some of them are distinguished scientists. Yet these defendants, all of whom were fully able to comprehend the nature of their acts, and most of whom were exceptionally qualified to form a moral and professional judgment in this respect, are responsible for wholesale murder and unspeakably cruel tortures.

It is our deep obligation to all peoples of the world to show why and how these things happened. It is incumbent upon us to set forth with conspicuous clarity the ideas and motives which moved these defendants to treat their fellow men as less than beasts. The perverse thoughts and distorted concepts which brought about these savageries are not dead. They cannot be killed by force of arms. They must not become a spreading cancer in the breast of humanity. They must be cut out and exposed for the reason so well stated by Mr. Justice Jackson in this courtroom a year ago–

‘The wrongs which we seek to condemn and punish have been so calculated, so malignant, and so devastating, that civilization cannot tolerate their being ignored because it cannot survive their being repeated.’”

Opening Statement in the Doctors Trial at Nuremberg by Brig. General Telford Taylor
(December 9, 1946)[1]

I. Introduction

It is almost unnecessary to say that with the advancement of science there has come a plethora of ethical dilemmas – dilemmas which lay bare questions about the boundaries of our human interaction. The drive for “progress” and knowledge for the “good of society,” as well as the age old desire for profit and power, continually create a conflict between the further advancement of the human race and respecting whatever meaning and value we ascribe to ourselves individually by virtue of our humanity. We only have to turn to this last century to find case after case – the horrors of the Nazi medical experiments, the shocking revelations by Henry Knowles Beecher of postwar abuses in the United States[2], the Tuskegee Syphilis Study (1932-1972)[3], the Jewish Chronic Disease Hospital study, the Japanese Army’s “Unit 731,” etc.[4] – of cringe-worthy experiments involving human subjects.

Each of these cases elicited a societal backlash and together they have prompted the creation of ethical codes which address and clarify the boundaries of research involving human subjects. In 1948, the Nuremberg Code gave an absolutist, natural law based condemnation of the Nazi experiments. The World Medical Association later issued the Declaration of Helsinki in 1964 and just over a decade later, in 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report. The “Common Rule” eventually evolved from the Belmont Report and currently governs the regulation of human subject research in the United States. Embedded in each of these ethical codes is the principle of autonomy, primarily safeguarded through the application of informed consent.

However, the application of these ethical codes has been, needless to say, less than easy. Given the inherent conflicts of interest involved in human subjects research (the pursuit of knowledge and profit at the risk of undermining human rights, and by extension, dignity) and the speedy evolution of the nature of clinical research,[5] violations and problems in application still occur.[6] One particular arena affected by these conflicts of interest is the university system, which since the 1950’s has been the locus of federally funded research, particularly in the biomedical sciences.[7] Many of the most notable, and deadly, human subject research studies in the last 60 years have been located in university health and research centers and affiliates.[8] Though initially charged with the academic education of its students, since the advent of the research university system, universities have also been expected to be producers of cutting edge technology as partners working in close relationship with or in easy transferability to industry.[9] These expectations have magnified the conflicts of interest already inherent in human subject research and have raised additional questions about licensing, patents, and the meaning of a university’s academic mission.

This paper seeks to further explore the conflicts of interest inherent in the human subject research situation, particularly in light of the university context. To begin, it relays the historical development of the Common Rule and its emphasis on informed consent in greater detail. Additionally, the historical development of the American research university and its relationship to federal and industrial funding is further fleshed out. The current status of the Common Rule is then evaluated for possible deficiencies in regulating human subject research, particularly in the university setting. Examples of recent ethical violations help to exemplify these deficiencies. Finally, the recent Notice of Proposed Rulemaking issued by the Department of Health and Human Services is examined for what resolutions to the stated issues are proposed and what resolutions are still missing. This paper concludes that though the Notice of Proposed Rulemaking may close some gaps in the coverage of regulation, the focus of the Common Rule and the Notice of Proposed Rulemaking are still behind not only in adapting to the changing nature of clinical research, but more importantly in their premises and focus.

II. History and Context

A. The development of human subjects research regulation

The 20th century ushered in a new type of government regulation, focusing on the ethical use of human subjects in research. The Food and Drug Administration’s (FDA) modern regulatory functions began with the passage of the Pure Food and Drug Act in 1906 (by 1991, the FDA would become a key player in the development and adoption of the Common Rule for regulating their own clinical drug trials and research[10]). Forty years later, an American military tribunal opened criminal proceedings against German physicians and administrators for their participation in war crimes and crimes against humanity. The atrocities of the Nazi experiments, conducted with unwilling human subjects, rocked the world, and the military tribunal responded with the well-known Nuremberg Code, outlining what the tribunal saw as ten basic principles necessary for ethical human subjects research: voluntary consent, fruitful results for the good of society, a basis in animal experimentation, avoidance of unnecessary physical and mental suffering and injury, avoidance of a priori reason to believe death and disabling injury will occur, reasonable degree of risk, proper preparation and adequate facility, limitation to scientifically qualified personnel, human subjects liberty to rescind consent and end the experiment, and the duty of the scientist to rescind an experiment that becomes excessively dangerous.[11]

Despite the American issuance of the Nuremberg Code in 1948, the U.S. Public Health Service conducted the infamous Tuskagee Syphilis Study from 1933-1972, until publicity surrounding the experiment forced the U.S. Department of Health, Education, and Welfare to end it.[12] Within that same timeframe, the Office of Scientific Research and Development (created by President Roosevelt in 1941) conducted dangerous dysentery vaccine experiments on mentally disabled children through the Committee on Medical Research in 1943-44.[13] In addition to these, multiple other U.S. agencies conducted highly hazardous plutonium experiments on unwitting human subjects.[14] Henry Knowles Beecher, in his 1966 article in the New England Journal of Medicine, further showed that much had not changed with regards to research abuses after the war.[15] It was clear that, as the historian David Rotham concluded, “Well into the 1960’s, the American research community considered the Nuremberg findings, and the Nuremberg Code, irrelevant to its own work.”[16]

At the same time, the World Medical Association reacted to growing awareness about the continuing problem of research abuse by developing the Helsinki Codes, I and II, in 1964 and 1975, respectively. These documents reiterated some of the basic tenants laid out in Nuremberg, but called for more specifics. They proposed that consent should be preserved in writing, that clinical research for patient care should be distinguished from clinical research for non-therapeutic purposes, and required that an ethical review committee monitor all research with human subjects.[17] The National Research Act of 1974 also stepped in just before the revision of the Helsinki Code in 1975, responding directly to the publicity surrounding the Tuskagee Syphilis Study by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, who in turn created the Belmont Report.[18] The Belmont Report would become “the foundational document for the ethics of human subject research in the United States.”[19]

The bedrock principle that can be found in each of these ethical codes is a respect for autonomy, verified through the use of consent. The Nuremberg Code states that “The voluntary consent of the human subjects is absolutely essential,”[20] and although it did not carry the force of law, the Nuremberg Code was the first international document which advocated for voluntary participation and informed consent in human subject research.[21] The World Medical Association followed with the Declaration of Helsinki in 1964[22], outlining recommendations for medical doctors involved in human subjects “research combined with clinical care” and “non-therapeutic [human subjects] research,” reiterating the necessity of informed, voluntary consent.[23] The National Commission for the Protection of Human subjects of Biomedical and Behavioral Research, in issuing the Belmont Report in 1979, outlined three basic ethical principles that should undergird all human subject research conduct: respect for persons (autonomy), beneficence, and justice.[24] Corresponding to each principle was the application of informed consent, assessment of risks and benefits involved in the research, and proper selection of research subjects.[25] A series of regulations following the issuance of the Belmont Report were eventually formally adopted by 17 agencies and the FDA in 1991 as the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”[26] The Common Rule entails the current federal regulations for human subject research, requiring entities receiving federal funding to establish Institutional Review Boards to monitor and approve proper and ethical research and procedures.[27]

Since its inception in 1991, the Common Rule has been subject to little change. It was not until July 2011, after President Obama had issued an Executive Order requiring federal agencies to review and revise burdensome and ineffective significant regulations,[28] that the Department of Health and Human Services (HHS) issued an Advanced Notice of Proposed Rule Making (ANPRM).[29] Researchers welcomed the ANPRM, titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” as a much needed address to the growth and change in the nature of clinical research that had developed since the Common Rule’s inception.[30] After much anticipation, the ANPRM has finally translated into the Notice of Proposed Rulemaking, as proposed by the HHS on September 8, 2015.

B. The history of the American research university

The concept of the research university is barely older than the development of human research ethics and regulation. Beginning in the nineteenth century and notably guided by the ideas of Alexander Von Humboldt, “Research, as an experimental procedure conducted in a spirit of discovery, first appeared in German universities.”[31] By the end of the nineteenth century, the Humboltian model of the research university faced multiple hurdles, including how to properly integrate research and teaching under the same roof, resulting in the delegation by many universities of experimental research activities to in-house institutes of basic research under the aegis of individual professors.[32] However, by the beginning of the twentieth century, North American universities once again took up the ideal of combining and integrating teaching and research, with several institutions successfully asserting themselves as distinguished research universities.[33] One of the most notable of these institutions is Johns Hopkins University, which prides itself on being “America’s first research university.”

The experimental approach now integrated into the university system played a major role in the development of new scientific knowledge and technologies. In realizing this value of the new research university model, and prompted primarily by the post-World War II era concerns, the federal government established a comprehensive policy on the role of the federal government in supporting research.[34] This policy was initialized in Vannevar Bush’s Science, The Endless Frontier in 1945, building an overarching objective of cultivating a “steady stream of scientific knowledge to ensure economic growth.”[35] By 1950, Congress had established the National Science Foundation (NSF) as an agency devoted to the support of basic research and education in all scientific and engineering disciplines. The 1958 launch of Sputnik and the beginning of the space race further propelled U.S. investment in its research universities. Since the end of the Cold War, federal research policies expanded beyond defense-specific research and continued to increase funding for university based research.[36] Expansion included health-related research and basic research in a wide range of other disciplines, with total funding jumping from $31 million in 1940 to $3 billion in fiscal year 1979.[37] However, federal funding began to stagnate around the 1970’s and industry struggles with increasing competition from abroad and slowing productivity at home fostered interest in possible benefits from closer cooperation with universities.[38] The federal government encouraged such cooperation,[39] notably through the Bayh-Dole Act of the Patent and Trademark Amendments of 1980 which invigorated technology transfer from universities to business and industry by transferring federal government patent rights from the results of federally funded research to universities.[40] The Bayh-Dole legislation had a “significant impact,” creating a “compelling incentive for universities and industry to partner in the commercialization of scientific discoveries” and resulting in the number or patents awarded to university faculty to increase fourfold from 1988-2003.[41] Though the federal government remained the dominant source of funds for university research, the amount provided by industries rose since the 1970’s and into the 80’s, focusing especially in the fields of biology, chemistry, and engineering.[42] In recent years, funding has diminished, with funding through the National Institute of Health (NIH) and the National Science Foundation (NSF) being cut by 5% for the 2013 fiscal year[43] and industry funding slowing due to recent economic crisis.[44]

III. Conflicts of Interest and the Limits of the Common Rule

A. The basic conflict

The diminishment of funding sources poses an age old problem for researchers in the university setting: money. A criterion for being called a research university is the significant amount of basic research that must be conducted there, with the measure of that effort being “the magnitude of research grants received by its professional research staff from funding agencies.”[45] It is common knowledge that drawing in an adequate amount of funding is a tenure requirement for many professors in the sciences. The pressure to develop and produce successfully is only intensified by the limitation of resources.

However, the funding issue simply exacerbates what is already an issue in the field of human subject research. Inherent in the relationship between researchers and their subjects is a tension between the goals of the researchers – be it knowledge and the good of society, profit, or merely job security – and the dignity and autonomy of the subject. The Common Rule attempts to regulate these tensions by outlining the primacy and necessity of obtaining and documenting informed consent, establishing requirements for Institutional Review Boards (IRBs) and their analyses, adding protections for specified “vulnerable” classes, and including requirements for assuring compliance by research institutions.[46] Crafting an adequate regulatory scheme is no easy feat, particularly in an area as large and diverse as human subject research, but it is an absolute necessity. Unfortunately, the laws currently in place fall short of the task.

B. Experiments gone awry

The ineffectiveness of IRBs and the current Common Rule system is most starkly felt when death is the result, and particularly when death is the result at a highly regarded institution, expected to be the hallmark of not only successful, but also ethical research. The unfortunate reality is that every experiment involving human subjects will involve some level of risk of death, but when the regulatory system designed to protect against unacceptably high levels of that risk fails to do so, the results can be tragic.

Notable recent examples include Johns Hopkins University and the University of Minnesota. In 2011, Johns Hopkins, who received at the time more federal research money than any other research university at a hefty $310 million in 2010, had almost all of its federally financed medical research suspended after a federal oversight committee investigated the death of young volunteer in a research study at the university.[47] The agency cited a failure by the university’s IRB to take proper precautions to protect the research subjects and required the university to structure a new program to ensure their IRB was properly educated on federal human subject research regulations.[48] The young volunteer died a month after inhaling hexamethonium, an unapproved drug being used to test the causes of asthma.[49]

In an even more disastrous experiment, the University of Minnesota became the subject of public scrutiny after the violent death of a young man taking part in a clinical study at the university became widely publicized. Dan Markingson was a psychotic patient enrolled into a university led study of the drug Seroquel after having been involuntarily committed as a violent threat to himself and others in 2004. Despite his mother’s protests and a previous determination that Dan was incapable of consent, Dan was made to partake in the study for five months until he committed a bloody suicide with a box-cutter.[50] The case of Dan Markingon was particularly egregious not only for concerns with informed consent, but also for the relationship between the university researcher in charge of Dan’s case and AzraZeneca, the drug company seeking to promote Seroquel. It was only after several years of intense prompting by Markingon’s mother and others that the case came to light after having been successfully hushed and hidden from the public, reportedly by university officials.[51] Such an instance more potently demonstrates the conflict of interest that can arise where both the researcher and an industry stand to make a profit.

In less death-ridden cases, the courts have attempted to address the issue of informed consent, though the amount of case law in this area is very limited.[52] (Dan Markingon’s case was dismissed on the grounds of immunity.[53]) In the 2001 case Grimes v. Kennedy, the court addressed the issue of children being enrolled in clinical trials after parents filed suit for negligence in a study conducted by a “prestigious research institute, associated with Johns Hopkins University.”[54] The study was a non-therapeutic research program investigating the effect of different lead abatement procedures for apartments containing lead dust and paint which required children to be exposed to varying levels of lead dust. After the study had been ongoing for some time, several of the children were found to have accumulated hazardously high levels of lead in their blood to the knowledge of the researchers who then failed to notify parents. The Maryland court concluded that parents or other surrogates could not consent to the participation of a child in nontherapeutic research where there is any risk of injury or damage to the health of the subject.[55]

In a 2014 class action against members of the University of Alabama Institutional Review Board, children who had been members of a clinical trial involving research on premature infants with extremely low birth weights filed suit for injury as a result of the study. The clinical trial had two aspects: 1) “exploring treatment with continuous positive airway pressure”; and 2) “determining the appropriate levels of oxygen saturation in extremely low-birth-weight infants by comparing a lower versus higher range of levels of oxygen saturation in such infants.”[56] The plaintiff’s parents contended that they “would not have enrolled the Plaintiffs [in the study] had they been informed of the true risks, benefits, and nature of the [Trial] [sic].”[57] This case granted defendants a motion to dismiss, again highlighting the lack of solid case law dealing with Common Rule violations and also emphasizing issues with the accountability of IRBs, who are often guarded on the grounds of immunity.[58] Where it can be difficult to hold IRBs accountable for failing to adequately safeguard human subjects, a stronger regulatory system is needed upfront.

Some research studies involve bodily harm, but others can be less threatening physically while still giving pause to the conflict of interest at hand. A more recent case involved the University of Maryland and chocolate milk. The University collaborated with industry partners through a program called the Maryland Industrial Partnerships Program, the goal of this collaboration being to foster job creation. The milk manufacturer whose chocolate milk was being tested funded approximately ten percent of the study, which proved to be favorable in showing the manufacturer’s brand of chocolate milk as contributing to improvement in concussion related injuries. Several have called out the University’s study for being “shoddy” and unscientific as the study was released in 2015 without having been published or peer reviewed first. Others point to it as yet another example of the “commercialization” of university research. As one review in BioMed Central put it, “The growing emphasis on commercialization of university research may be exerting unfound pressure on researchers and misrepresenting scientific research realities, prospects and outcomes.”[59]

C. Important tenants of the Common Rule and their limitations

Designed to prevent against disastrous cases, the two most impactful tenants of the Common Rule are the establishment of the IRB and the use of informed consent. In application, however, the Common Rule seems to have collapsed into a system where the IRBs focus primarily on consent forms and significantly less on the other elements highlighted.

The Common Rule specifies that IRB’s focus on seven elements: risk minimization, risk/benefit comparison, equitable subject selection, informed consent, data monitoring to ensure safety, privacy protection and confidentiality, and protection of vulnerable subjects.[60] However, one study of 20 IRB meetings across 10 leading academic medical centers showed that on the low end, only 40% of the IRBs discussed equitable subject selection, whereas on the high end, 98% of IRBs discussed informed consent extensively.[61] The second highest after informed consent was 87% of IRBs having discussed protection of vulnerable populations, with the remaining Common Rule criteria falling between the 40% and 87% discussion rates, the result being a lack of uniformity in application of essential elements of human subjects protection across IRBs.[62]

In addition to problem of inconsistent IRB coverage of the basic protections required in the Common Rule, the adequacy of informed consent has been called into question. Some would say using informed consent as “anything goes so long as there is consent” is a flawed basis[63] and others discuss the difficulty in establishing exactly what informed consent means. While the Common Rule calls for the inclusion of pertinent information,[64] it has regularly been the case that researchers bury important aspects of the research experiment within lengthy and convoluted documents, difficult for the lay person, who is in many cases the research subject, to understand.[65] Also, questions of whether certain classes of persons can consent at all, including children, the mentally disabled, and those particularly vulnerable to coercion, such as prisoners, remain, as do questions about whether it is ethical for such vulnerable persons to have others consent for them.

Essentially, the current limitations of the Common Rule come from the internal nature of the IRBs, their lack of uniformity due to a lack of resources and education, and the inadequacy of informed consent. While ideally human subject research will occur between educated and aware subjects who are given full access to all necessary information to make a legitimately consenting decision, the reality is that informed consent documents are often dense and hide necessary information. This issue is further exacerbated by the fact that IRBs focus entirely too much on informed consent alone and hardly enough on the ethical quality of the research experiment itself and the vulnerability of the subjects taking part in the study. Furthermore, they are often swamped with reviewing a multitude of research projects ongoing at their own institutions. Unfortunately, though, informed consent standing alone, especially as it is currently applied, can hardly safeguard persons from the often deadly risks associated with poorly regulated clinical trials.

IV. The Common Rule Going Forward

A. The Notice of Proposed Rulemaking

On July 2011, the U.S. Department of Health and Human Services (HHS) took a giant step towards the first general overhaul of the Common Rule since it was first issued in 1991 by publishing the Advanced Notice of Proposed Rulemaking (ANPRM).[66] The ANPRM was much awaited by many who believe modernization of the Common Rule is desperately needed but it did not advance anywhere until four years later, on September 8, 2015, when the Notice of Proposed Rule Making (NPRM) made its debut. The Office of Human Research Protections stated that the focus of the NPRM was to elaborate particularly on two of the three key concepts upheld in the Belmont Report, autonomy and beneficence,[67] in addition to the last of the concepts, justice.[68]

In order to achieve this, eight major proposals have been included in the NPRM, some new and some adapted from the ANPRM, which hope to streamline the entire process and give greater protection and control to participating human subjects. The NPRM “sets forth proposals to modify informed consent for biospecimen research, improve the understandability of consent forms, mandate single institutional review board (IRB) oversight of research, and establish data security safeguards.”[69] In addition, the NPRM seeks to extend the scope of the policy to cover all clinical trials conducted as an institution that received federal funding for human subjects research, regardless of their particular funding source.[70] Finally, the NPRM adds exemption and exclusion categories, as well as categories for which continued IRB review throughout the life of the research experiment can be eliminated.[71]

Four of these proposals particularly impact the situation of the research university. The most major (logistically speaking) proposed change has been to almost always require informed consent for the secondary use of biospecimens,[72] regardless of their identifiability.[73] Essentially, the proposal would expand the definition of a human subject to include biospecimens.[74] Previously the definition of human subject for purposes of the common rule only included a living person about whom a researcher obtains personal data or private information that can be connected to the person;[75] de-identified biospecimens were not included. Two alternative proposals call for expanding the definition to either include whole human genome sequencing or to include only certain biospecimens used in particular technologies.[76] Under the NPRM, consent will almost always be needed to conduct research with even de-identified biospecimens. In order to help cover the magnitude of specimens this change would include, the NPRM allows for “broad consent” to be given for the unspecified future use of biospecimens in research, as opposed to specific consent for a specific study. Additionally, the IRB’s ability to waive the consent requirement for the use of biospecimens is further limited under the NPRM.[77] These changes are designed to further the Belmont goal of autonomy, giving persons control over the use of their biospecimens.[78]

The second major proposal the NPRM makes is to simplify the informed consent document. Also in keeping with the goal of enhancing autonomy, the NPRM calls for information to be presented in sufficient detail and organized and presented in a way that facilitates prospective subject’s understanding of the reasons why one might or might not want to participate.[79] One key new feature is the addition of the reasonable person standard, designed to be akin to the legal understanding of the reasonable person.[80] The NPRM emphasizes that essential information that a reasonable person would want to know should be given to prospective participants upfront in consent documents before any other supplemental information is provided.[81] Additionally, supplemental information is encouraged to be organized into an Appendix to further organize and clarify the informed consent document. Finally, to achieve greater transparency, the NPRM calls for a one-time requirement that consent forms of clinical trials be posted on a designated government website sixty days after the recruitment process for the study closes, making the forms accessible to the public eye.[82]

Particularly of interest to university researchers, a third major proposal seeks to bring more clinical research under the Common Rule regulations. It requires U.S. institutions which receive any sort of federal funding for non-excluded, non-exempt human subject research to subject all of their clinical trials to the Common Rule, regardless of any other funding sources. The only exception for this proposal would be clinical trials already subject to FDA regulation.[83] This proposal thus impact not only the universities conducting the research, but also the sponsors who partner with university researchers to conduct clinical trials.

Finally, advantageous to researchers moving between universities, the NPRM calls for only one IRB to review multi-site research conducted at U.S. institutions. Previously, the IRB from each location where the research was being conducted had to independently review the research project. Exceptions to this proposal are made where more than one IRB is required by law or where a federal department or agency determines more than one IRB is needed. As a part of this proposal, independent IRBs will be held directly accountable for compliance with the Common Rule.[84]

B. Analyzing the changes in light of university conflicts

The NPRM is over 130 pages of dense and sometimes vague proposals – covering about eighty-eight different issues within eight major changes – making it difficult even for experts to digest and understand the changes and what impacts they will have.[85] From what can be discerned, four of the eight proposed changes included in the NPRM are specifically related to the issues highlighted in this paper. In sum, they are the proposal to sometimes require consent for certain biospecimens, the proposed reorganization of the informed consent document, the proposal to require only one IRB review research taking place at multiple different U.S. locations, and the proposed expansion of the Common Rule’s coverage regardless of funding source.

The proposal to require consent for the use of certain biospecimens poses a massive logistical problem for researchers everywhere, including at universities. The vast majority of biospecimens are collected during clinical service, rather than specifically for the cause of research. Broad consent upfront helps to blanket all of the biospecimens moving from collection in clinical service to the research arena, but in practice it will make the process more expensive, requiring researchers to track the type of consent and which biospecimen it is linked to.[86] This tracking is key particularly where consent waivers are involved. IRBs have the authority to waive the consent requirements where there is compelling scientific reasons for the use of the biospecimens and the research cannot be conducted with other biospecimens for which consent can be or was obtained. However, IRBs will not be permitted to waive the consent requirement if the individuals providing the biospecimens were asked to give broad consent and declined.[87] Adding additional cost burdens such as these tracking requirements will impose can only contribute to the funding burdens of university researchers.

Next, the proposals look to the consent document to attempt to give human subject participants greater awareness and control over their involvement in the human subject research. The NPRM added the reasonable person standard, stated that information important to the reasonable person should be placed upfront and in a clearly organized manner in the consent document, encouraged that other supplemental information be organized neatly in an appendix, and required that the consent document be posted on a government website once the recruitment period closes. However, these changes not only minimally improve the issue of informed consent, but also create new problems. Nowhere in the NPRM is the definition of the reasonable person expounded upon,[88] causing confusion about what information and even what reading levels satisfy that standard, particularly among different demographics of human subject populations.[89] The Common Rule and the NPRM provide mandatory elements which should be included in the consent form,[90] but some argue not all of these elements are pertinent to different subject populations.[91] Secondly, no templates or specific guidelines are given for what constitutes “clearly organized,” other than a general suggestion to include important elements upfront and supplemental information in an appendix. Finally, the posting requirement is expected to be burdensome without providing any clear benefit. It is a one-time posting requirement, taking place after the recruitment process concludes, meaning it neither benefits those interested in being recruited to participate in the study nor does it provide up to date information once the study commences as the study may be changed or updated as it progresses.[92]

Moreover, some experts complain that the protections of informed consent should not be focused on the document but rather on the process.[93] While some would argue that the move to streamline the document is an effort to reduce paternalistic attitudes in how researchers deal with participants, others would say the move actually enhances those paternalistic notions because ultimately the IRB will still be the only entity to fully review consent documents.[94] Dr. Ross McKinney, Director of Bioethics at the Trent Center, said in response to the NPRM consent form proposals that, “what we were urged to do in Belmont was respect for persons, and autonomy is one element of that respect, but when you present information to people that they cannot understand in a format that they will not bother to go through, you are not respecting persons. The NPRM as best I can see it does nothing to further our respect for persons.” In addition, this development still misses a major factor relating to informed consent, and that is the effectiveness of the IRB’s reviewing the study itself for inherent ethical dilemmas.[95] If the IRBs do not effectively review the consent process in the first place, even the supposed protection of a paternalistic method falls flat.

Furthermore, the NPRM does not discuss who has the final say with regards to the consent documents. This is a major problem for the legitimacy of the consent process because sponsors can and do use this gap to push for the inclusion and exclusion of certain information and formats.[96] Particularly where an IRB is attached to a certain organization rather than functioning independently, they are often placed under enormous pressure to compromise lest the industry sponsor bows out and the researchers are left with inadequate resources and funding.[97] Currently the NPRM and Common Rule do nothing to hold sponsors accountable in the consent process, including having no requiring that sponsors be divulged.[98] This harkens to the NPRM sub-proposal to hold independent IRBs directly accountable for compliance with the Common Rule. The overall proposal to streamline the process for multi-site research by allowing for only one IRB to review is a welcome change because it reduces the existence of conflicting IRB opinions about one research project. Unfortunately, however, the sub-point holding IRBs directly accountable moves the Common Rule further from addressing the real culprit: the sponsors.

Despite this gap, the last of these four proposals, namely the proposal to expand the Common Rule’s impact by subjecting all research at a federally funded institution to the federal regulation, does help to address previously untouched problems. The inherent conflict in human subject research is success and profit versus individual human dignity and safety. Where human subject research is conducted in a competitive market system, the drive for success and profit can easily begin to overcome the rights of the individual human person involved as a human subject. Given that many universities and other research institutions receive at least some portion of their funding from the federal government, this proposal would very quickly expand the scope of the Common Rule to almost all areas of human subject research conducted in the U.S.

C. Going Forward

The period for notice and comment regarding the NPRM closed, after an extension, on January 1, 2016.[99] 2,189 comments have been filed concerning the NPRM, up from the roughly 1,000 comments that were received concerning the ANPRM.[100] From this point, the comments will be addressed by the Department of Health and Human Resources before the release of a final rule which will officially update the Common Rule for the first time since 1991. The final rule is expected to be released sometime in the year 2016.[101]

V. The Unresolved Conflicts of Interest

The unfortunate reality is the NPRM as it stands is a hugely lost opportunity. Technology has been progressing at unprecedented rates, but the Common Rule needs to address more than just the security and privacy issues that have evolved with technology.[102] As one commenter put it, the “Henrietta Lacks concern over commercialization” is being overblown,[103] and the real issues at hand are not being addressed.

Much of the inherent conflicts of interest embedded in human subject research surrounds the idea and implementation of informed consent. Informed consent has positioned itself as the hallmark principle of each of the major ethical codes; Nuremberg, Helsinki, Belmont, and now the Common Rule. As one critic[104] of informed consent noted, consent “is intimately connected to our ideas of ‘liberty’ (I may do what I choose to do, and may refuse to consent to actions in which I do not wish to be involved); ‘equality’ (we all get to consent); ‘autonomy’ (I and only I may make these choices and decisions); and ‘dignity’ (I may make these decisions because of who and what I am).”[105] He continues, “Perhaps because consent is so embedded in our moral thinking, we put it to at least two different tasks. First, consent is a basic fundamental prerequisite of our political and social institutions and of our dealings with one another. We have lost the premodern vision of the world as an organic whole, and so consent, rather than nature or design, structures the coming together, binding together, and living together of modern master-less men. This side of consent animates the political ‘consent theory’ and permeates the rhetoric of the American founding. It is a necessary first condition for the legitimacy of the institution or end-state that proceeds from the act of consenting.”[106] Without proper conducted and adequately informed consent, the validity of researcher actions is highly suspect, and society cries injustice.

Despite our recognition that informed consent is a defining principle in valid human subject research, we have yet to agree on what informed consent exactly is or what it should look like. Currently, the Common Rule places great emphasis on the actual consent document itself, much to the dismay of many well-meaning practitioners in the research field.[107] However, there is little to no empirical research on informed consent and what constitutes an effective method of ensuring the participants in the research study have actual comprehension of the study and the ramifications of being a part of it.[108] Lists of required elements, like the one contained in the Common Rule (which is being added to by the NPRM) are only minimally effective since the focus for IRBs and researcher potentially becomes meeting data requirements rather than improving understanding. What instead needs to be done is to look at informed consent as a process rather than a single document with a signature. The objective, after all, is “to provide adequate information in a dispassionate style so that a reasoned decision about participation can be made.”[109] Ultimately, the informed consent process should be about making sure the participant is fully aware, autonomous, and competent to ensure they can give an authentic response about their desire to participate or not participate in a research study.

Sponsors or industry partners, however, can destroy the validity of informed consent in two ways: by cloaking or omitting certain information from a participant in order to obtain human subjects for their research, or by designing studies that are inherently wrong. Given that the Common Rule and NPRM are silent as to who has the final say in the consent documents, the former is still a very real issue. The latter, however, has been untouched by the NPRM and only minimally discussed by the Common Rule or the researchers who function under it. “The first and most important question is whether the experiment should be done at all.”[110] Richard W. Garnett writes that in every case of human subject experimentation, there are three interests, and not just the two of the researcher and the human subject. That third interest is our interest in preserving human dignity in our community. We as humans, though not necessarily the human subject of the moment, either suffer or benefit from the performance or non-performance of certain experiments.[111]

The Common Rule does seek to protect human subjects from studies that could be seen as inherently wrong or dangerous through the use of the IRB. As we have seen, however, IRBs have not been effective in implementing a holistic understanding of the Common Rule and instead tend to zero in on the informed consent documents.[112] The reality is, responsibility should extend beyond IRB. Sponsors who provide funding, as well as often unwanted pressure to increase chances of success for marketing purposes, must be held accountable, as well as the researchers themselves. The remarkable lack of case law concerning human subject research, contrasted with the relatively high number of even just recent cases of death and injury from poorly run clinical trials, is a testament to the lack of accountability currently in the system.

If anything, the Common Rule should be updated to deal with the changing nature of research relationships, particularly on university campuses. The pressures of funding and achieving success only add to the tension that already exists between the researcher and the human subject, and it is utterly unacceptable that sponsors to human research projects can maintain such a level of power and authority over the consent process – a process which plays such a vital role in the Common Rule’s scheme for the protection of human subjects. Unfortunately, the Common Rule has thus far seemed to limit itself, first by waiting so long to update its regulatory scheme, and second, because the NPRM only adds to already cumbersome and often complicated regulations, rather than providing any guidance to harken back to its roots in the Belmont Report. The principles of justice, beneficence, and respect for persons (or autonomy) have found their place, for good or ill, as the bedrock principles of the United States’ ethical understanding for dealing with human persons, and if they are to remain as such they must be couched in a regulatory system that enhances their understanding and effect rather than diminishing it.

VI. Conclusion

The arena of human subject research is nothing short of complicated, both in the rapidly ever-changing nature of the research conducted and the application of ethical principles to such a fluid field. Isaac Asimov succinctly described this issue when he wrote, “The saddest aspect of life right now is that science gathers knowledge faster than society gathers wisdom.”[113] History has showed us the high stakes that can come with advancing the cause of science through human subject research, from atrocities in Nazi war camps to seemingly preventable deaths in modern clinical trials at prestigious universities like Johns Hopkins. The Common Rule and the most recent NPRM work to prevent some of the negative ramifications of poorly conducted human subject research through outlining new procedures that should further guide the actions of researchers. However, the NPRM is already long overdue and as of yet, is still missing some key components to adequate protection of human subjects in research. A strong, core understanding of the meaning of the informed consent process and a robust structure to deal with the tensions between funding sources and the goodwill of researchers is desperately needed. Without either of these core principles, the conflict inherent in human subject research is hardly dealt with and abuses are sure to continue with more frequency than is acceptable.

The research university is uniquely positioned concerning these issues, not only because it has become the host of a large quantity of modern research, including human subject research, but because it also has always been a place of advancing human wisdom and not just human knowledge. The university campus is where we frequently challenge our notions of human existence, of human trial and suffering, of human joy and prosperity. Where we see the university advancing towards the goals of consumerism and the marketplace rather than the higher goods of man’s dignity and identity, we must build a firm wall. The advancement of human knowledge should not come at the price of human life or human dignity, and universities are distinctively suited to guard those goods as they have always done.



*J.D. Candidate, Notre Dame Law School, 2017

[1] Brig. General Telford Taylor, Opening Statement in the Doctors Trial (1946), http://law2.umkc.edu/faculty/projects/ftrials/nuremberg/doctoropen.html.

[2] Daniel Callahan, What Price Better Health? Hazards of the Research Imperative at 135 (Univ. of Cal. Press 2006).

[3] Mary Faith Marshall, Born in Scandal: The Evolution of Clinical Research Ethics, Sci., Apr. 26, 2002 at, http://goo.gl/rV8Qhv.

[4] Richard W. Garnett, Why Informed Consent? Human Experimentation and the Ethics of Autonomy, 36 Cath. Law. (1996) at 465

[5] Leslie Meltzer Henry, Revising the Common Rule: Prospects and Challenges, 41 J. of Law, Med. & Ethics 386, 386-389 (2013).

[6] Steinbrook R. , Protecting Research Subjects – the Crisis at Johns Hopkins, 2002 New Eng. J. Med. 716-720 (2002); Carl Elliot, Why the University of Minnesota Psychiatric Research Scandal Must Be Investigated, MinnPost, Mar. 28, 2013 at, https://goo.gl/YxD3gI.

[7] Robert LaCroix & Louis Maheu, The Emergence of the Research University, in Leading Research Universities in a Competitive World 3-11 (McGill-Queen’s Univ. Press 2015).

[8] Supra note 6

[9] Michael M. Crow & Christopher Tucker, The American Research University System As America’s De Facto Technology Policy, 1999 (1999).

[10] U.S. Department of Health & Human Services, Federal Policy for the Protection of Human Subjects (‘Common Rule’), http://www.hhs.gov/ohrp/humansubjects/commonrule/

[11] The ten principles of the Nuremberg Code, infra, in full are as follows:

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehensions of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be constructed; all inconveniences an hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the diseases or other problem under study that the anticipated results        will justify the performance of the experiment.
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as          subjects.
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance o the problem to be solved by the experiment.
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities o injure, disability, or death.
  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the      experiment.
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him            to be impossible.
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of good faith, superior skill, and careful judgement required of him, that a continuation of the experiment is likely to result in injury,     disability, or death to the experimental subject.

Reprinted in Wendy K. Mariner, AIDS Research and the Nuremberg Code, in The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation 286-304 (George J. Annas & Michael A Grodin eds., 1992).

[12] Office of the Vice Chancellor, Research and Economic Development, 2015 (2015), http://ors.umkc.edu/research-compliance-%28iacuc-ibc-irb-rsc%29/institutional-review-board-%28irb%29/history-of-research-ethics.

[13] Supra note 2, at 139

[14] Id. 140

[15] Id. 142

[16] Supra note 2, at 140

[17] Id. 142

[18] Supra note 12

[19] Id.

[20] The Nuremberg Code, in 2 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10 at 181-182 (U.S. Gov’t Printing Office 1949), http://www.hhs.gov/ohrp/archive/nurcode.html.

[21] Supra note 12

[22] WMA Gen. Assembly, WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (1964), http://www.wma.net/en/30publications/10policies/b3/.

[23] Id.

[24] The Nat’l Comm’n for the Prot. of Human Subjects of Biomedical & Behavioral Research & U.S. Dep’t of Health & Human Services, Office of the Sec’y, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

[25] Id.

[26] Called the “Common Rule” because it is common to 18 departments and agencies, namely the Department of Commerce (15 CFR 27), The Department of Defense (32 CFR 219), the Department of Education (34 CFR 97), the Department of Energy (50 CFR 745), the Department of Health and Human Services (45 CFR 46), the Central Intelligence Agency (45 CFR 46), the Department of Homeland Security (45 CFR 46), the Social Security Administration (45 CFR 46), the Food and Drug Administration (45 CFR 46), the Department of Housing and Urban Development (24 CFR 60), the Department of Justice (28 CFR 60), the Department of Transportation (49 CFR 11), the Department of Veterans Affairs (38 CFR 16), the Consumer Product Safety Commission (16 CFR 1028, the Environmental Protection Agency (40 CFR 26), the Agency for International Development (22 CFR 225), the National Aeronautics and Space Administrations (14 CFR 1230), the National Science Foundation (45 CFR 690) and the Department of Agriculture (7 CFR 1c); The Department of Labor will join for first time under the NPRM.

[27] “The Common Rule,” 45 C.F.R. § 46 (2009).

[28] Supra note 5

[29] Id.; Summary, Doug Lederman, Updating the Common Rule, 2011 Inside Higher Ed (2011) at, https://goo.gl/EvUYpU.

[30] Supra note 5

[31] Supra note 7, at 1

[32] Id. at 4

[33] Supra note 7, at 5

[34] Arden L. Bement Jr. & Angela Phillips Diaz, U.S. Public Research Universitites: A Historical Perspective, Purdue Univ. (2011), at 1.

[35] Id. at 2.

[36] Id. at 4; Judith Jarvis Thomson et al., Academic Freedom and Tenure: Corporate Funding of Academic Research, 69 Academe 18a (1983) available at http://www.jstor.org/stable/40249083.

[37] Academic Freedom and Tenure, supra note 36.

[38] Supra note 37.

[39] Supra note 37.

[40] Supra note 34, at 4

[41] Id. at 5; Jerry G. Thursby & Marie C. Thursby, Faculty Participation in Licensing: Implications for Research, 40 Res. Pol’y 20, 20-29 (2011).

[42] Supra note 37.

[43] Michael Price, Funding Cuts Ravage Academic Laboratories, 2013 Sci. Careers: The Job Market (2013), http://www.sciencemag.org/careers/2013/09/funding-cuts-ravage-academic-laboratories.

[44] Yudhijit Bhattacharjee, Industry Shrinks Academic Support, 312 Sci. (2006), http://www.sciencemag.org.

[45] Supra note 7, at 8

[46] Supra note 27; Supra note 12; Carl H. Coleman, Vulnerability as a Regulatory Category in Human Subject Research, 2009 J. of Law, Med. & Ethics (2009).

[47] G. Kolata, Johns Hopkins Death Brings Halt to U.S.-financed Human Studies, 2001 N.Y. Times A1 (2001).

[48] Id.

[49] Id.

[50] Carl Elliot, “I Was Just Following Orders”: A Seroquel Suicide, a Study Coordinator, and a “Corrective Action”, 2012 Mad in America Science, Psychiatry & Community (2012) at, https://goo.gl/QdWVCU; Carl Elliot, University of Minnesota Blasted for Deadly Clinical Trial, Mother Jones, Apr. 3, 2015 at, http://goo.gl/9aobJb.

[51] Carl Elliot, Why the University of Minnesota Psychiatric Research Scandal Must Be Investigated, MinnPost, Mar. 28, 2013 at, https://goo.gl/YxD3gI.

[52] Grimes v. Kennedy Krieger, 782 A.2d 807 (Md. 2001), see footnote 1.

[53] Supra note 50.

[54] Grimes v. Kennedy, supra note 51.

[55] Grimes v. Kennedy, supra note 51.

[56] Looney v. Moore, (2014), (slip Copy).

[57] Id.

[58] Id.

[59] Julia Belluz, The Incredible Tale of Irresponsible Chocolate Milk Research at the University of Maryland, 2016 Vox, Jan. 16, 2016 at (2016), http://www.vox.com/2016/1/16/10777050/university-of-maryland-chocolate-milk; (citing 2015 review in BioMed Central at http://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-015-0064-2).

[60] Supra note 27, Charles W. Lidz et al., How Closely Do Institutional Review Boards Follow the Common Rule?, 87 Acad. Med., May 22 (2012).

[61] How Closely, supra note 60.

[62] Supra note 61.

[63] See generally, Richard W. Garnett, Why Informed Consent? Human Experimentation and the Ethics of Autonomy, 36 Cath. Law. (1996) at 465

[64] Supra note 37.

[65] Grimes v. Kennedy, supra note 51.

[66] U.S. Department of Health & Human Services, NPRM 2015 – Summary, http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html.

[67] Video: Office of Human Research Protections: Webinars on the Notice of Proposed Rulemaking (NPRM) (Sept. 30, 2015) at, https://www.youtube.com/watch?v=ykxT25ze-rg&list=PLrl7E8KABz1FtLMpK2zPa8nqV-F-xhW2C&index=1.

[68] Proposed Rules, Fed. Reg. (Sept. 8, 2015) (to be codified at 45 C.F.R.) at 11.

[69] Ropes & Gray, Alert: HHS Proposes Major Overhaul of the Common Rule, , Sept. 8, 2015 at https://www.ropesgray.com/newsroom/alerts/2015/September/HHS-Proposes-Major-Overhaul-of-the-Common-Rule.aspx

[70] Sweeping Changes Proposed to Common Rule Governing Human Subjects Research, Quorum Blog, Sept. 4, 2015 at, http://www.quorumreview.com/2015/09/04/nprm-2015-summary-post/.

[71] Supra note 67.

[72] Id.; Video: Research Match, Enhancing and Clarifying Consent Forms and Establishing Standard Safeguards (Streamed Live Nov. 18, 2015) at, https://www.youtube.com/watch?v=FBTHKkkOP5E.

[73] Supra note 67.

[74] “Biospecimens are materials taken from the human body, such as tissue, blood, plasma, and urine that can be used for cancer diagnosis and analysis. When patients have a biopsy, surgery, or other procedure, often a small amount of the specimen removed can be stored and used for later research. Once these samples have been properly processed and stored they are known as human biospecimens.” National Cancer Institute, Patient Corner: What Are Biospecimens and Biorepositories?, Biorepositories & Biospecimens Res. Branch, July 28, 2014 at http://biospecimens.cancer.gov/patientcorner/.

[75] Research Match, supra note 72.

[76] Supra note 68, at 15.

[77] Supra note 67.

[78] Id.

[79] Id.

[80] Id.

[81] Supra note 68, at 6.

[82] Id.

[83] Supra note 67

[84] Supra note 68, at 51.

[85] Research Match, supra note 72 (citing Maureen Smith).

[86] Id. (citing Dr. Mark Schreiner).

[87] Supra note 67.

[88] Research Match, supra note 72; Supra note 67 (Only mentioned in this video that it is akin to the legal standard).

[89] Research Match, supra note 72 (citing Jeri Burtchell).

[90] The eight elements currently required in the Common Rule are as follows:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and       identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subject’ rights, and whom to contact in the event of a research-related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitles, and the subject may discontinue participation at any           time without penalty or loss of benefits to which the subject is otherwise entitled.

Supra note 27.

Elements to be added or changed by the NPRM are as follows:

  1. The number of subjects to be included in the trial
  2. Prospective subjects are to be informed that their biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  3. Prospective subjects are to be informed of whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
  4. Provide subjects or their legally authorized representatives with an option to consent, or refuse to consent, to investigators re-contacting the subject to seek additional information or biospecimens or to   discuss participation in another research study.

Research Match, supra note 72 (citing Carson Reider and Dr. Ross McKinney).

[91] Research Match, supra note 72. (For example, a patient population with diabetes would not necessarily need additional information about diabetes treatment or simplified language concerning diabetes since they are already familiar with the disease).

[92] Id. (citing Amy Schwarzhoff).

[93] Id. (citing Dr. Ross McKinney and Dr. Mark Schreiner).

[94] Id.(citing Carson Reider, Dr. Ross McKinney, and Amy Schwarzhoff).

[95] Supra note 60.

[96] Research Match, supra note 72 (citing Carson Reider and Dr. Mark Schreiner, etc.)

[97] Id. (citing Amy Schwarzhoff).

[98] Id. (citing Dr. Ross McKinney).

[99] U.S. Department of Health & Human Services, Federal Policy for the Protection of Human Subjects (2016) (docket Folder), http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2015-0008.

[100] Supra note 67.

[101] Id.; Research Match, supra note 72/

[102] Supra note 68, at 25, 35, 45.

[103] Research Match, supra note 72 (citing Dr. Ross McKinney)

[104] Richard W. Garnett gives an interesting discussion concerning whether informed consent is sufficient as a regulatory tool and safeguarding principle in the area of human interaction. He writes, “We might block the consented-to action, but we pay lip service to consent’s justifying role by assuring ourselves that had the consent been untainted, had it been ‘informed,’ it would have ha moral force. In fact, we pay lip service precisely because we often slightly suspect that consent cannot and foes not always justify. Therefore, in difficult situation, we declare that the decision maker did not or could not really consent, that the consent was not ‘informed’ or ‘knowing’ or ‘voluntary.’ Rather than admit that the consent does not and could not justify the act, we denigrate the consent and, necessarily, the consenter as well.

“This is cheating; it is a subterfuge designed to hide our unease and to allow us to profess simultaneous commitment to values that often conflict.”

Supra note 4, at 460 (citing Robin West, Colloquy, Submission, Choice, and Ethics: A Rejoinder to Judge Posner, 99 Harv. L. Rev. 1449, 1449-50 (1986)(arguing that readers would not believe that people should be allowed to sell themselves into slavery or prostitution) and Guido Calabresi & Philip Bobbitt, Tragic Choices 195-199 (1978)).

[105] Id. at 457.

[106] Id. at 458.

[107] Research Match, supra note 72.

[108] Cognitive scientists have shown in numerous experiments that the “phrasing” and the way that information is presented can severely affect the decision the human subject makes. A classic example is the consent for becoming an organ donor, which was given to patients before surgery. By changing the wording from “Check here if you want to become an organ donor” to “Check here is you do NOT want to become an organ donor,” scientists were able to get a much higher consent rate. However, there is little data on this with regards to informed consent in human subject research; an area arguably more complex than checking a box to become or not become an organ donor. The Common Rule provides no such data on the issue with regards to clinical trial informed consent documents, much less whether or not an informed consent document is the most apt method for ensuring proper informed consent.

[109] Research Match, supra note 72 (citing Dr. Ross McKinney)

[110] Supra note 4, at 493

[111] Id. at 498

[112] How Closely, supra note 60.

[113] Isaac Asimov & Jason A. Shulman, Isaac Asimov’s Book of Science and Nature Questions 281 (Weidenfeld & Nicolson 1988).

Reconsidering Graduate Student Unionization After Brown University – OLD

01.31.2017  |  Comments Off on Reconsidering Graduate Student Unionization After Brown University – OLD

Matthew Wesley[1]

I. Introduction

Graduate students at Brown University, Cornell University, The New School, Yale University, and Columbia University have initiated unionization drives within the last year. At Columbia, the student group who initiated the unionization drive claimed that it had gotten 1,700 of Columbia’s 2,800 graduate teaching and research assistants to sign forms declaring that they wanted a union to represent them and had petitioned the regional office of the National Labor Relations Board for an election.[2] However, despite a majority of Columbia’s graduate students expressing a desire to be represented by a union, the regional office refused to recognize the bargaining unit because of National Labor Relations Board precedent holding that graduate students are not employees under the National Labor Relations Act, and therefore cannot unionize.[3]

Graduate students often take on multiple roles while enrolled in their programs of study. In addition to completing the required coursework and writing, graduate students are often asked to carry out a significant portion of the teaching and research load for their universities. As teaching assistants, graduate students typically teach lecture courses for a professor or preside over smaller discussion sections, whereas research assistants conduct field and laboratory research under the supervision of a professor and aid in furthering that particular professor’s research.[4] Graduate students generally receive some form of compensation, tuition remission or both in return for performing these duties.[5]

Similar to other workers, graduate students are concerned about wages, hours, and other working conditions and have sought to engage in collective bargaining under the National Labor Relations Act (“NLRA”) in order to address these concerns. [6] Efforts by graduate students to gain union representation under the NLRA are complicated due to the employee status issue – specifically, whether an individual can simultaneously be a student and employee and therefore covered under the NLRA.[7] While the issue of whether a graduate student can be both a student and an employee is not new,[8] it has taken on greater significance as universities are increasingly relying on graduate students as a cost effective way of avoiding the higher wages demanded by full-time faculty.[9]

For much of the National Labor Relations Board’s history, it has either side-stepped the issue of whether graduate students at private universities were employees under the National Labor Relations Act or has ruled for one reason or another that graduate students could not simultaneously be employees. However, in 2000, the National Labor Relations Board (“NLRB” or “the Board”) reversed nearly three decades of precedent regarding graduate student status when it addressed the issue in New York University.[10] There, the Board determined that graduate students were employees under the NLRA. The New York University decision had the effect of allowing graduate students at all private universities the possibility of forming a union in order to engage in collective bargaining. However, the New York University decision was short-lived. Four years later, the Board reverted to its prior doctrine in Brown University, denying graduate students the right to unionize on the rationale that they were primarily students and not employees.[11] Currently, the holding articulated in Brown remains good case law and the precedent by which all graduate student unionization efforts are evaluated.

This note begins with an overview of the Board’s history and structure. Part III discusses a series of cases in which the Board gradually adopted jurisdiction over private universities and incrementally developed its community of interest doctrine as that doctrine relates to graduate students. Part IV provides an in-depth history of the NLRB’s jurisprudence as it grappled with whether graduate students were employees under the meaning of the NLRA. Part V addresses the Board’s turnaround in New York University and Part VI examines the Board’s most recent decision in Brown. Part VII entertains criticisms of Brown and argues that Brown was wrongly decided because it deviated from prior interpretations of the statute and previous Board precedent.

II. The National Labor Relations Board’s History, Structure, and Jurisdiction

A. History

With the passage of the National Labor Relations Act in 1935, Congress created the National Labor Relations Board.[12] The NLRA was the second attempt by the Roosevelt administration to create a nationwide uniform right to organize. It displaced a complex body of state common law governing labor relations which emanated from judicial doctrines of conspiracy and tortious conduct.[13] The previous legislation, the National Industrial Recovery Act, had been struck down by the Supreme Court the preceding year holding it exceeded Congress’ authority under the Commerce Clause.[14] The constitutionality of the NLRA was also challenged, but this time the Court upheld the law as a legitimate exercise of Congressional authority under the Commerce Clause.[15]

The NLRA delegated to the NLRB two distinct functions: the prevention and remedying of unfair labor practices[16] and the determination of questions concerning representation.[17] In both kinds of cases, the processes of the NLRB are begun only when requested. These requests must be made in writing and filed with the proper Regional Office. Further, while performing these functions, the NLRB is to represent the public rather than any particular private right or interest.[18] In enacting the NLRA, Congress sought to “obtain ‘uniform application’ of its substantive rules and to avoid the ‘diversities and conflicts [which were] likely to result from a variety of local procedures and attitudes toward labor controversies.’”[19] Therefore, Congress submitted NLRB actions and decisions to judicial review by federal courts of appeal only.[20] When reviewing Board decisions on appeal, the Supreme Court has articulated that appellate courts should give the Board’s decisions great deference.[21] This deference is due in large part to the Board’s composition of experts who have specialized knowledge of labor law.[22]

B. Structure

The National Labor Relations Board includes the Board, the General Counsel, and the regional and sub-regional offices. The NLRB has a bifurcated structure consisting of the General Counsel and the Board. The General Counsel is responsible for the investigation and prosecution of unfair labor practice cases and for the general supervision of the thirty-three NLRB field offices.[23] The General Counsel is appointed by the President, with consent of the Senate, to a four-year term. The Board is the NLRB’s judicial branch and is comprised of five members who serve five-year terms and are nominated by the President and confirmed by the Senate.[24] Each member is appointed to a staggered, five-year term.[25] The process allows each administration to have the opportunity within one term to almost entirely reshape the membership of the Board and to align the Board’s views on labor relations policy with that of the administration.[26] Consequently, the nomination process has taken on enormous significance and has become increasingly politicized.[27] This process, coupled with a high turnover rate of the Board, makes decisions unpredictable and may help to explain why the Board recently has reversed itself within short periods of time.

The Board hears appeals from unfair labor practice cases and challenges pertaining to the elections process. These appeals are derived from decisions in representation cases by Regional Directors and cases prosecuted by NLRB regional field office attorneys around the country and adjudicated in front of an NLRB administrative law judge.[28] In order for the Regional Office to process a representation petition for an election, workers must establish that at least thirty percent[29] of the individuals within an appropriate bargaining unit[30][31] have signed authorization cards or some other indicia which proves that the employees have an interest in having a particular entity serve as the employees’ sole representative for purposes of collective bargaining. If there is a thirty percent showing of interest, the NLRB Regional Director will process the petition and determine issues which may arise concerning the election process. In order to become the bargaining unit’s sole representative, the union must receive a majority of the votes cast from an appropriate bargaining unit. If the union obtains such a majority and there are no valid objections to the conduct of the election, the Regional Director will certify the union as the unit’s representative.[32] Following certification, the employer and union are required to meet and confer and to bargain in good faith over wages, hours, and other terms and conditions of employment.[33] The failure to bargain with the union at this point would constitute an unfair labor practice.[34]

C. Jurisdiction

As noted above, Congress legitimized its authority to enact the NLRA under its commerce power. In order for an employer to fall under the purview of the NLRB, it must be demonstrated that the employer engages in a minimum amount of interstate commerce.[35] The NLRB’s jurisdiction is very broad and covers a great majority of non-government employees within the workplace. Thus, in the college and university setting, the ability of graduate students to organize will depend on whether the university is engaged in interstate commerce and is public or private. The NLRA regulates only private sector employers; state law governs the organizational rights of graduate students at public universities.[36]

State labor laws vary greatly in their permissibility of collective action by employees. Some states have recognized graduate student as employees as well as their right to organize and negotiate collective bargaining agreements.[37] Currently, approximately fourteen states permit public university graduate students to engage in collective bargaining.[38] In approximately eleven states, public university employees are allowed to collectively bargain, but the eligibility of graduate students has yet to be determined.[39] In these instances, state statutes are usually silent and the determination of whether graduate students are employees eligible to unionize has been left to the courts and state labor boards.[40] In another twenty-three states, collective bargaining rights are denied to all university employees, including graduate students.[41] Given the significant variation among state labor laws, graduate students must look to the specific statutory scheme of the state where their institution is located in order to determine which policies and procedures govern their right to organize for purposes of collective bargaining.

Unlike public universities which are governed by their state labor laws, private universities fall under the domain of the NLRB. However, the NLRB has historically refused to recognize graduate students at private universities as employees.[42] As the following cases demonstrate, the NLRB was slow to extend its jurisdiction to include private universities per se, much less students at such universities.

1.Columbia University

In the decades following its enactment, the NLRB refused to extend collective bargaining rights to anyone employed by private universities under the theory that colleges and universities were not engaged in interstate commerce, and therefore were beyond the reach of the Board. This view was first expressed in 1951 concerning Columbia University. In Columbia University, a group of clerical employees for the various libraries at the university sought recognition as a unit. The Board acknowledged that the activities of the university sufficiently affected commerce “to satisfy the requirements of the statute and the standards established by the Board for normal exercise of its jurisdiction. . . .”, however, it was deeply concerned about extending jurisdiction to a not-for-profit educational institution.[43] The Board had identified a Senate Committee Conference Report which explained that not-for-profit corporations and associations operating as hospitals were not meant to be covered by the NLRA.[44] It reasoned that extending jurisdiction to a not-for-profit university would not effectuate the policies of the NLRA, “where the activities involved are not commercial in nature and intimately connected with the charitable purposes and educational activities of the institution.”[45]

2. Cornell University

This doctrine persisted for nearly twenty years until the Board revisited the issue in Cornell University. In Cornell University, the Board reversed its holding in Columbia University and extended the NLRB’s jurisdiction to include private universities. Similar to Columbia University, Cornell did not involve graduate students, but rather was an attempt by Cornell and Syracuse University employees to obtain bargaining rights under the NLRA. The Board began its opinion by noting the aggregate operating budget of each institution, its expenditures, government appropriations, and profits from ancillary services provided by the University – each exceeded hundreds of thousands or millions of dollars. It also noted each universities’ significant interactions outside the state. The Board then acknowledged its previous holding in Columbia, but asserted that “the Board’s discretionary standards for asserting jurisdiction [are] not fixed. . . . ”[46] Congress was content to “leave to the Board’s informed discretion . . . when to assert jurisdiction over nonprofit organizations whose operations have a substantial impact on interstate commerce.”[47]

The Board explained that the dividing line between purely commercial and noncommercial activity, as it related to university activity, had not been easily defined. While universities’ primary goals were still educational in nature, in order to carry out their educational functions, universities had “become involved in a host of activities which [were] commercial in character.”[48] Consequently, it was no longer appropriate to extend universities the same exemptions as not-for-profit hospitals. Despite determining that the universities had engaged in commercial activity affecting interstate commerce, the Board refused to establish a precise threshold for when it would exercise jurisdiction and left such a determination for a later date.[49]

With their newly expanded jurisdiction, the NLRB was now able to hear challenges from graduate students at private universities seeking to unionize.

3. Adelphi University

Two years after Cornell, the Board decided a case involving graduate students in Garden City, New York, who attempted to join a faculty union in order to collectively negotiate their working conditions. The Board began its analysis in the same way it began its Cornell opinion, by noting that the University had gross revenues exceeding $1 million and had purchased materials valued in excess of $50,000 from sources outside the State of New York. Given these factors, the Board concluded that the university had “engaged in commerce within the meaning of the Act. . . [and] it [would] effectuate the purpose[] of the Act to assert jurisdiction.”

The Adelphi University graduate students received free tuition in addition to receiving a stipend, which ranged from $1,200-$2,900. In exchange for the stipend, the graduate students were required to perform various duties for approximately twenty hours per week which included teaching classes, preparing examinations, and grading.[51] Because the graduate students sought to join the same bargaining unit as faculty, the Board performed a “community of interest” analysis in which it highlighted the differences between faculty and graduate students.

The graduate assistants are graduate students working toward their own advanced academic degrees, and their employment depends entirely on their continued status as such. They do not have faculty rank, are not listed in the university’s catalogs as faculty members, have no vote at faculty meetings, are not eligible for promotion or tenure, are not covered by the University personnel plan, have no standing before the University’s grievance committee. . . Unlike faculty members, graduate assistants are guided, instructed, assisted, and corrected in the performance of their assistantship duties by the regular faculty members to whom they are assigned.[52]

Thus, the Board determined that there were significant differences between the type of work and functions performed by graduate students and faculty. These disparities were significant enough that a bargaining unit comprised of graduate students and faculty would not share a similar “community of interest”, but rather they would likely have divergent interests, making it nearly impossible for a single labor organization to represent the interests of both faculty and graduate students in one unit. These divergent interests existed because the Board determined that the graduate students were “primarily students” and therefore it was inconceivable that they could have a sufficient community of interest with the regular faculty.[53]

III. Refinement of the NLRB’s Jurisdiction and the Community of Interest Doctrine

The decisions in Cornell and Adelphi firmly established the NLRB’s jurisdiction over private universities as it relates to collective bargaining. In a series of early 1970’s decisions, the Board began to articulate which members performing which job functions qualified as workers under the NLRA for purposes of joining a faculty union. At the conclusion of these cases, one thing was apparent – all students were excluded for purposes of collective bargaining.

C.W. Post Center was the first case in the series to address graduate students’ ability to be included in a collective bargaining unit.[54] In that case, the Board had to determine the appropriate bargaining units for a number of traditional employees within the university system, including: full-time faculty, associate and adjunct professors, librarians, a research associate, laboratory personnel, and guidance and admissions counselors. The Board ultimately found that all professional employees constituted an appropriate bargaining unit but explicitly excluded “student assistants” and “graduate students”.[55] However, the Board’s rationale for permitting the lone “research associate” to join the collective bargaining unit was most telling. The research associate position was distinct from that of graduate students because he had already obtained a doctoral degree and did not teach classes. Rather, he conducted research supported by a grant given to the university. The position was similar to faculty in that he was able to receive tenure and therefore had a sufficient community of interest with other faculty members.[56] C.W. Post Center solidified the distinction between graduate students and faculty for purposes of joining the same bargaining unit – they had different qualifications and different interests in pursuing collective-bargaining, which meant that the two groups would never have a sufficient community of interests.

College of Pharmaceutical Sciences in New York was the second case in the early 1970s in which the Board fleetingly addressed graduate students’ ability to join a faculty union.[57] The bulk of the Board’s opinion addressed the appropriateness of including extended faculty, instructors in the institutional and clinical programs, and laboratory assistants to join a full-time faculty bargaining unit. In the course of that opinion, the Board did take time to refute the notion that graduate students would share the same community of interests as faculty because “their continued employment depends upon satisfactory academic progress toward their respective degrees.”[58] It conceded they received a stipend and worked approximately sixteen to twenty hours a week, but made a distinction that the graduate students were “primarily students” and therefore did not “share sufficient community of interest with faculty members to warrant their inclusion in the unit.”[59] In making a determination that the graduate students were primarily students, the Board was not making a ruling on their status as employees under the Act, but rather was making a distinction for purposes of evaluating a community of interests.

The following year the Board found yet another distinction between teaching assistants and a university-wide union which represented part-time employees. Teaching assistants at Georgetown University attempted to join a collective bargaining unit which included clerical, technical, and hospital employees.[60] The Board noted that student employees were paid differently from regular part-time employees because their pay was diminished by the amount of financial aid each received via academic grants and federal aid.[61] The Board also noted that student employees typically only worked for nine months out of the year and therefore were unlike traditional part-time employees who worked year-round.[62] Thus, the students had “many facts particular to themselves, and [did] not appear to have a community of interests with other regular part-time employees.”[63]

Just a year later in Barnard College, the Board held that ten students – eight graduate students and two undergraduate students – who were employed as resident assistants and bowling alley operators could not be included in the collective bargaining unit of office clerical and other nonprofessional administrative staff employees.[64] The Board again distinguished between traditional university employees and student employees in determining that there was no community of interest. The Board reasoned that student employees are not permitted to remain permanently in their position of employment. However, the largest factor appeared to be that the students’ employment was “only incidental to their educational objectives.”[65] Also notable in Barnard College was the Board’s recognition of an emerging question of whether students who worked at the university were employees under Section 2(3) of the NLRA.[66] The Board did not address the issue of students being both students and employees because the students lacked a sufficient community of interest and therefore the question was moot. However, it was the first time the Board acknowledged the possibility of such an argument and one the Board would repeatedly have to address in the future.

The primary lesson learned from the preceding cases was that graduate students, or even students for that matter, could never share the same community of interests as faculty members or other university employees. Notable differences in their job description, their qualifications, and pay prevented graduate students from sharing a sufficient community of interests with lifelong academics who had obtained terminal degrees and occupied tenured positions at their institutions or with other university employees. If graduate students were going to establish an appropriate collective bargaining unit, with a sufficient community of interest, they would have to stop looking beyond their own ranks. They could avoid problems of community of interest only by forming their own unit.

IV. Graduate Students As Employees under the NLRA

In the mid-1970s, after years of unsuccessfully seeking recognition in units which included faculty or other university staff, graduate students sought employee status and recognition exclusively as graduate students. Because graduate students generally encounter similar working conditions within the university, employers were unable to challenge the request for recognition on community of interest grounds. Rather, the Board had to address whether a student could in fact be an employee under the Act.

A. Leland Stanford University

In 1974, eighty-four graduate students in Stanford University’s physics department sought recognition as employees and the right to form a union.[67] They did not seek to join a faculty union, but rather planned to start their own. The community of interest test as applied in the previous cases was not applicable; not only were all of the members within the unit graduate students, but they also were in the same course of study and therefore distinctions based on academic discipline were also out of the question.

The graduate students claimed that they were student-employees. In support of that statement, they noted that they were paid through Stanford’s normal payroll machinery for their work and as such were employees under the NLRA.[68] However, Stanford insisted, and the Board agreed, that the physics graduate students were not employees. There were several notable characteristics of a traditional employer-employee relationship absent in the relationship between the graduate student research assistants and the university.

First, the research that the graduate students were required to engage in was a necessary part of the PhD program because it helped prepare the students to select a topic for their dissertation and they received academic credit for this work which counted towards their degree.[69] Second, the money received by the students was a stipend which was meant to make the pursuit of an advanced degree possible.[70] While it is true that the graduate research assistants received their stipend through Stanford’s payroll machinery, the actual source of the funding was obtained through contracts or grants by government agencies or third parties. Research assistants did receive some benefits such as health care. They were not, however, extended traditional fringe benefits such as sick leave, vacation, or retirement benefits. Third, because the money received was a stipend, there was no correlation between the type of research done and the amount received by the student, nor was there a correlation between the hours spent conducting research and the amount received.[71] Finally, because the source of the stipend was from government contracts or grants, it was not taxed as part of the research assistants’ income, but rather was tax-exempt.

Each of the above-described factors lent credence to the Board’s conclusion that the research assistants were “primarily students” and “not employees within the meaning” of the Act.[72] In subsequent cases, these factors would form the basis of the “primary purpose” test. The primary purpose test would be used to determine whether the individual had achieved employee status under the Act or whether they were primarily a student.

B. Cedars-Sinai Medical Center

In 1976, the Board dismissed a petition for an election among interns, residents, and clinical fellows at Cedars-Sinai Medical Center in Los Angeles, California.[73] While these individuals were not students per se, they were similar to graduate students because they were enrolled in programs which had a practical element which was required to obtain professional status. The interns, residents, and fellows had already completed the classroom portion of their medical degree requirements and were now engaged in the hands-on, or internship, component of their graduate degree. The internships, residencies, and clinical fellowships ranged from one year to five years, with an average length of less than two years. Upon completion of these programs, the majority left the training hospital and entered into practice elsewhere.[74]

The individuals enrolled in these programs received a stipend of $20,000. The Board determined that they did not participate in these programs in order to earn a living, but rather for the primary purpose of pursuing a graduate medical education, of which internships, residencies, and fellowships were a requirement.[75] Similar to graduate students in Stanford University, the number of hours worked or the quality of the work rendered had no bearing on the monetary compensation paid in the form of a stipend.[76] While the students did receive fringe benefits such as health care and vacation, they were not eligible for the employee retirement plan.[77] Finally, the Board determined that these programs were not designed for the purpose of meeting the hospital’s staffing needs, but rather to allow the students to develop the skills necessary to practice medicine in the area of the student’s choosing.[78] These factors, the Board believed, highlighted the “fundamental difference[s] between an educational and employment relationship.”[79]

The stinging dissent written by member Fanning accused the majority of “exploit[ing] semantic distinctions between the terms ‘students’ and ‘employees.’”[80] Fanning argued that the NLRA did not require the relationship between student and employee to be mutually exclusive. Rather, the NLRA was meant to include any employee, unless explicitly excluded by the statute. Students, moreover, were not meant to be among those groups excluded from the statute. In rejecting the majority’s primary purpose test, he noted that an individual could be “’primarily a carpenter’ or ‘primarily a student’, but “nevertheless, an ‘employee’ under the Act.”[81]

Fanning believed that the students were undoubtedly employees under the Act. He argued that the term “employee” was at least as broad as it was understood under the common law.[82] Moreover, the conventional meaning of the word implied “someone who works or performs a service for another from whom he or she receives compensation.”[83] Fanning also noted that the hospital would be vicariously liable for the conduct of the students. For Fanning, this was indicative of an employee-employeer relationship. Fanning also tried to diminish the majority’s classification as a student by emphasizing that they spent the majority of their time providing care for the hospital’s patients and received no grades. He further argued that the mere fact that an individual is learning while performing a service could not possibly serve as a justification for classifying the individual primarily as a student and not an employee.[84]

C. St. Clare’s Hospital

The following year, the Board addressed the ability of graduate students working in a teaching hospital to organize for the purpose of collective bargaining. Realizing that some considered CedarsSinai to be an aberration in national labor policy, the St. Clare’s Hospital decision began by reaffirming the holding in Cedars-Sinai as consistent with prior precedent.[85] The Board sought to clarify that Cedars-Sinai was not primarily a decision about the health care industry and therefore only applicable in that setting, but rather Cedars-Sinai was much broader in its application and was primarily a decision about students.[86]

Summarizing its previous case law, the Board noted that student employment can be classified into four general categories. The first category consists of students employed by a commercial employer in a capacity unrelated to the students’ course of study. In this category, the status of individuals as students is sufficiently remote from their employment interests and therefore the distinction between employee and student is inconsequential for purposes of determining the appropriate bargaining unit.[87] The second category involves students who are employed by their own educational institution in a capacity unrelated to their course of study. The Board has excluded students from units which include nonstudent employees and has not afforded them the privilege of being represented separately because in these situations employment is incidental to the student’s primary interest of acquiring an education. In this category, the student’s employment is directly related to their continued enrollment at the educational institution and their transitory status excludes them from being included in bargaining units with full-time employees.[88] The third category consists of students employed by a commercial employer in a capacity related to the student’s course of study. The Board has concluded that the student shall be excluded from a bargaining unit of full-time nonstudent employees because in this instance, the commercial employer is acting as a surrogate for the educational institution, and thus, the student’s interests in their employment is primarily educational in nature. The final category consisted of students performing services at their educational institutions which are directly related to their educational program. In such instances, the Board has excluded students from units which include nonstudent employees and has denied their right to be represented separately.[90]

The majority concluded that the situation at St. Clare’s Hospital was directly analogous to the fourth category. There, graduate students were rendering services which were directly related to and constituted an integral part of their educational program. The services performed by the graduate students were therefore predominantly academic in nature and unsuitable for the collective bargaining process which is fundamentally economic.[91]

The Board was particularly concerned that academic matters, such as curriculum and teaching methods, would become the subject of collective bargaining. The Board feared that there would be a change in emphasis from the quality of education to economic concerns and that this shift would ultimately have a detrimental effect on both labor and education. The detrimental effects were particularly relevant in the educational setting because graduate education consists of largely personal relationships between the student and instructor.[92] Collective bargaining does not result in personalized treatment, but rather implies collective treatment for all those represented, and therefore permitting collective bargaining at the graduate level would be “the very antithesis of personal individualized education.”[93] Furthermore, the superior knowledge and experience possessed by the instructors places them in the best position to determine the most appropriate course of instruction. Thus, the Board reasoned that the instructional methods and, by implication, graduate education in general, should not be the subject of collective bargaining.

D. Boston Medical Center

The precedents established in Cedars-Sinai and St. Clare’s Hospital were expressly overruled in Boston Medical Center.[94] The facts of Boston Medical Center were nearly identical to Cedars-Sinai and St. Clare’s Hospital – a unit of interns and residents in a teaching hospital sought representation. In reaching its conclusion, the Board was persuaded by Member Fanning’s definition of employee advocated in Cedars-Sinai and St. Clare’s Hospital which was rooted in the common law concept of servant.[95] The Board, relying on a recent Supreme Court decision, stated that Section 2(3) created a “’broad statutory definition of employee.’”[96] The fact that the interns may also be students has no bearing on their employee status because “nothing in the statute suggests that persons who are students but also employees should be exempted from the coverage and protection of the Act.”[97] All of the essential elements necessary to define an employer-employee relationship were present in the relationship between the housestaff (interns and residents) and the hospital.

In support of the conclusion that the housestaff could simultaneously be students and employees, the majority pointed to the fact that the housestaff worked for a statutorily covered employer and were compensated for their services in the form of the stipend. Additionally, the hospital withheld federal and state taxes on the stipend and provided an array of fringe benefits, including: worker’s compensation, paid vacation, sick leave, health, dental, life and malpractice insurance. These were the same benefits that other hospital employees received. Further, the majority observed that housestaff spend nearly eighty percent of their time at the hospital engaged in direct patient care. The fact that housestaff “also obtained educational benefits from their employment does not detract” from their status as employees because their “status as students is not mutually exclusive of a finding that they are employees.”[98] Thus, the Board concluded that the housestaff held positions more closely similar to an apprentice, rather than a student, and fell within the definition of employee under Section 2(3) of the NLRA.

This more expansive reading of the NLRA overturned precedent, at least as it pertained to medical interns and residents. The Boston Medical Center decision enabled, at least for the time, these types of students to occupy a position in which they were both a student and employee. The decision, however, was unclear in its application to teaching assistants and research assistants at research universities. Such uncertainty regarding the application of the NLRA set the stage for a further shift in the Board’s jurisprudence.

V. New York University

Just months after its decision in Boston Medical Center, the Board sought to clarify whether all students or only medical interns and residents could be employees under the NLRA. New York University involved a subset of graduate students who served as graduate assistants, graders, and tutors.[99] Within this subset of graduate students, more than a majority sought recognition as employees under the NLRA. As in other cases, the university took the opposite position. The University also argued that there were a number of policy concerns which should prevent the Board from certifying the graduate students as a unit.

Similar to Boston Medical Center, the Board began by applying the common law master-servant test. That doctrine states that the master-servant relationship exists when a servant performs services for another, under the other’s control or right of control, and in return for payment.[100] Adopting the same broad interpretation of Section 2(3) of the NLRA as in Sure-Tan and Boston Medical Center, the Board explained graduate assistants are not in a category of worker who are excluded from the definition provided in that section. Rather, they perform services under the control and direction of the university, for which they are compensated by the university and are carried on the university’s payroll.[101] Thus, the graduate assistants’ relationship with the university was “indistinguishable from a traditional master-servant relationship.”[102] The Board rejected NYU’s attempt to distinguish this case from Boston Medical Center on the basis that the graduate students here only spent approximately fifteen percent of their time performing graduate assistants’ duties for the university. The Board also declined to adopt NYU’s argument that graduate assistants receive only financial aid and not compensation for their services. NYU also attempted to distinguish Boston Medical Center by noting that the housestaff had already obtained their degree which was unlike the graduate students here who performed the work in furtherance of their degree. Rather, the Board concluded that the graduate assistants who spent fifteen percent of their time performing services for the university were no less employees than part-time employees would be under the NLRA. In rejecting the argument that graduate students were not compensated for their work, the Board stated:

It is indisputable, however, that the graduate assistants, unlike the students receiving financial aid, perform work, or provide services, for the Employer under terms and conditions. . . controlled by the Employer. That this is work in exchange for pay, and not solely the pursuit of education, is highlighted by the absence of any academic credit for virtually all graduate assistant work. . . Thus, however the Employer may wish to characterize a graduate assistant position, the fulfillment of the duties of a graduate assistant requires the performance of work, controlled by the Employer, in exchange for consideration. . . .

[W]e disagree with the Employer’s argument that graduate assistant work is primarily educational. . . We recognize that working as a graduate assistant may yield an educational benefit, such as learning to teach or research. But . . . [that] is not inconsistent with employee status. . . Therefore, notwithstanding any educational benefit derived from the graduate assistants’ employment, we reject the premise of the Employer’s argument that graduate assistants should be denied collective bargaining rights because their work is primarily educational.[103]

By applying the common law tests for employee status, the traditional arguments against graduate student unionization would no longer succeed. The Board refused to accept NYU’s policy arguments concerning the collective-bargaining process’ potential chilling effect on academic freedom. Concerns over the chilling effect that collective bargaining could have on academic freedom were used to bolster many pre-Boston Medical Center cases, particularly St. Clair’s Hospital.[104] The Board classified NYU’s fears regarding academic freedom as speculative and noted that faculty members had been permitted to engage in collective bargaining for over thirty years. The parties could “’confront any issues of academic freedom as they would any other issue in collective bargaining.’”[105] The Board concluded by reminding those concerned about any potential infringements upon academic freedom that the NLRA did “not compel agreements between employers and employees,” rather it provides a forum to bring about adjustments or agreements concerning issues but the Act did not compel such agreement.[106]

VI. Brown University

The NYU decision was seen by many as a victory for graduate students across the country.[107] As graduate students were now employees under Section 2(3) of the NLRA, they could now hold elections and vote to bargain collectively with a particular university. The wages, hours, and terms and conditions of employment which had previously been negotiated on an individual basis, if at all, would now be subjected to collective bargaining. The right to unionize lasted for nearly four years until Brown University. The Brown decision was a 3-2 split decision decided along party lines.[108]

Graduate students at Brown University sought to exercise their statutory rights extended in NYU. However, the university argued that the current situation was factually distinguishable from NYU because the majority of the university’s departments at Brown required a student to serve as a teaching assistant or a research assistant in order to obtain his or her degree.[109] The Board, in rendering its decision, did not stop at merely analyzing the factual distinctions between NYU and Brown, but rather concluded that NYU was wrongly decided and that graduate students were not employees under the NLRA.[110]

The Board reverted to its pre-NYU decisions and readopted the primary purpose test articulated in Adelphi University.[111] To support its conclusion that these individuals were primarily students rather than employees, the Board noted that all of the individuals needed to be enrolled at Brown in order to be awarded a teaching assistant, research assistant, or proctor position. Only those enrolled at Brown could be eligible for the position. Also of significance to the Board was the fact that only a limited number of hours were spent performing these duties; their principal time commitment was the pursuit of their degree.[112] However, some of the most persuasive evidence indicating that these positions were primarily educational was the fact that completing a teaching assistant or research assistant position was a necessary component in twenty-one of the thirty-two departments which offered PhD degrees. This constituted sixty-nine percent of all graduate students enrolled.[113] Therefore, the Board determined that being a graduate student assistant and pursuing a PhD were “inextricably linked, and thus, that relationship. . . clearly educational.”[114]

The Board also rejected the argument put forth by the graduate students that the financial support they received was a form of compensation for work performed. Rather, the Board rationalized the financial support as a means to help defray the cost of graduate education. The Board noted that nearly eighty-five percent of continuing graduate students received this assistance and that the amount received was comparable to those students who received funds for a fellowship, which did not require any teaching or research.[115] Reaffirming the rationale espoused in St. Clare’s Hospital, the Board explained that collective bargaining rights could not be extended to students who perform services at their educational institutions that are “directly related to their educational program.”[116]

Because the majority viewed the relationship between students and the university as primarily educational rather than economic, the traditional employer-employee framework was inappropriate.[117] Following the line of reasoning adopted in St. Clare’s Hospital, the NLRB concluded that the collective-bargaining process – a fundamentally economic process – would be of “dubious value” because educational concerns were largely irrelevant to the traditional mandatory bargaining subjects of wages, hours, and working conditions.[118]

The NLRB also addressed the issue of academic freedom in the context of collective bargaining. Permitting graduate students to engage in collective bargaining, the Board thought, would devolve from a discussion of wages, hours, and working conditions into an attempt to bargain over fundamental academic decisions traditionally left to the university and its faculty; these included course length and content, standards for advancement, administration of examinations, and other administrative concerns.[119] Allowing such a discussion would “have a deleterious impact on the overall educational decisions by the Brown faculty and administration. . . [because it] would intrude upon decisions over who, what, and where to teach or research – the principal prerogatives of an educational institution like Brown.”[120]

The dissent in Brown argued that the Board should continue to follow the precedent established only four years prior in NYU. To that end, they believed that graduate assistants in Brown were statutorily employees under the NLRA, to whom collective bargaining rights should be extended.[121] The dissent also argued that the majority had “minimiz[ed] the economic relationship between graduate assistants and their universities. . . [and that their holding] rest[ed] on fundamental misunderstandings of contemporary higher education.”[122] In responding to the minority’s criticism, the majority asserted that “the ‘academic reality’ for graduate student assistants has not changed, in relevant respects, since our decisions over twenty-five years ago.”[123]

In sum, the Board determined that students could not be both students and employees if their work was related to, or a necessary component to, obtaining their degree. In making this determination, the Board acknowledged a number of policy considerations. Among these considerations was the unsuitability of collective bargaining in the educational setting and the effects that collective bargaining could have on academic freedom.

VII. Reconsidering Brown

More than a decade after Brown was decided, it remains binding precedent and all Regional Offices, when confronted with requests for recognition by graduate students, have acknowledged Brown’s constraint.[124] This reliance on precedent is problematic because the Brown decision was premised on the misunderstanding that academic realities for graduate students had remained constant for more than twenty-five years. Further, its holding cannot be reconciled with the language or intent of the statute, and is inconsistent with relevant Board and Court decisions. Given these flaws and shortcomings, Brown needs to be reconsidered.

1. Misunderstanding of Academic Realities

In its departing words, the majority in Brown determined that its analysis should remain faithful to the primary purpose test first articulated in Cedars-Sinai Medical Center because the academic realities for graduate students had not changed since its decision in Cedars-Sinai and therefore there was no justification for upholding NYU.[125] This conclusion, however, was made on a faulty understanding of the current state of higher education. From the time of the Cedars-Sinai decision in the 1970s, to the Brown decision in 2004, there had been a significant upheaval in the way that colleges and universities were managed, and as a result how graduate students were treated and utilized within the university setting.

In the time spanning the two decisions, tuition costs had risen significantly. The National Center for Education Statistics indicates that during that time there was greater than a fivefold increase in college attendance costs.[126] Consequently, colleges and universities had received increased criticism and resistance on the part of consumers and were forced to find ways to increase efficiency and reduce expenses – to operate like a business.[127] One of the means used to constrain costs has been the increased reliance by colleges and universities on graduate students and non-tenure-track instructors. By the late 1990s, the presence of graduate students and adjunct professors had grown to comprise more than forty percent of the teaching force in post-secondary education.[128] This number was significantly higher at some institutions, where graduate assistants and adjuncts can handle over seventy percent of undergraduate classroom hours.[129] Thus, unlike the situation in Cedars-Sinai where the Board indicated that the hospital’s use of student interns was not designed to meet staffing needs, the modern university is using graduate students to meet the instructional staffing needs.

For universities operating on businesslike models and looking to become increasingly more financially efficient, graduate students and adjunct faculty are an attractive alternative to higher paid faculty members because they generally receive lower pay and sub-par benefits.[130] For example, part-time faculty receive about a third of what a full-time faculty member earns per course taught. Further, only seventeen percent of part-time faculty received employer subsidized health insurance as compared to ninety-seven percent for full-time faculty.[131] These figures are likely even lower for graduate students.[132] Thus, for the majority in Brown to argue that there had been no significant changes in the realities of graduate students’ situation since the 1970s was to ignore the modern trends in higher education which had increasingly begun to rely on graduate students and adjunct faculty to meet their employment needs and to reduce their operating costs.

2. Inconsistent With Statutory Definition

The statutory definition of employee provided in Section 2(3) of the National Labor Relations Act is broad in its application. An employee for purposes of the NLRA is defined as “any employee”.[133] In interpreting the Act, the Supreme Court has repeatedly held that that phrase is to be read broadly. For example, in Sure-Tan, Inc. v. NLRB, the Supreme Court wrote that the “breadth of §2(3)’s definition is striking: the Act squarely applies to ‘any employee.’” [134] A unanimous Court in NLRB v. Town & Country stated “[t]he ordinary dictionary definition of ‘employee’ includes any ‘person who works for another in return for financial or other compensation.’”[135] In that decision, the Court looked at congressional reports and floor statements in order to determine the purpose of the NLRA. The Court noted that it was “fairly easy to find statements to the effect that an ‘employee’ simply ‘means someone who works for another for hire’[136] and includes ‘every man on a payroll.’”[137] Statements to the contrary, or statements suggesting a narrow or qualified view of the word are “scarce or nonexistent-except, of course, those made in respect to the specific exclusions written into the statute.”[138] These exceptions include: agricultural laborers, domestic workers, individuals supervised by their spouses or parents, individuals employed as independent contractors or supervisors, and individuals employed by a person who is not an employer under the NLRA.[139] Notably absent from the exemptions listed are students; there is no exception in the statute for employees who also happen to be students or are primarily students.

Prior Board decisions have been consistent with this broad reading of the definition of an employee authorized by the statute and approved by the Supreme Court. For example, in Sundlund Construction Co., the Board held that paid union organizers were employees when they attempted to obtain jobs to try to organize other employees. In so holding, the Board noted the absence of an express exclusion. “Under the well-settled principle of statutory construction – expressio unius est exclusio alterius – only these enumerated classifications are excluded from the definition of employee.”[140] The Board also gave a broad reading to the statutory definition of employee in Seattle Opera Association by permitting auxiliary choristers at a nonprofit opera company to be included in the Act.[141] In adopting the Supreme Court and the Board’s earlier broad reading of the statute and the common law master servant relationship test, the DC Circuit stated:

[I]t is clear that – where he is not specifically excluded from coverage by one of Section 152(3)’s enumerated exemptions – the person asserting statutory employee status does have such a status if (1) he works for a statutory employer in return for financial or other compensation; and (2) the statutory employer has the power or right to control and direct the person in the material details of how such work is to be performed.[142]

Thus, Brown is inconsistent with Supreme Court and Board precedent that has interpreted the meaning of employee to be broad and all-encompassing. Instead, the Board has crafted an exclusion that does not appear in the statute. This is an aberration from its own precedent and a departure from congressional intent which was meant to exclude from the statute only those who are expressly listed.

3. Inconsistent with Prior Court Cases and Board Decisions

Finally Brown’s holding, that an individual cannot be both a student and an employee, is irreconcilable with the long history of cases holding to the contrary. An apprentice, by its very definition, is simultaneously a student and employee.[143] As part of their training, apprentices work for an employer while receiving instructions in their craft. This type of on-the-job training is vital to learning the craft and nearly always accompanied by classroom training. The Board has repeatedly treated apprentices as employees, despite the fact that the work is part of their training for a career. As early as 1944, the Board held that apprentices who attended a school as part of the four or five year training program and worked under the supervision of training supervisors for two and a half years while learning shipbuilding skills were employees under the NLRA.[144] In General Motors Corp., the Board also found apprentices who are required to complete a set number of hours of on-the-job training, combined with the related classroom work necessary to achieve journeyman status, were also employees under the NLRA.[145] Similarly, in Boston Medical Center, the Board found that medical interns, residents and fellows were “employees,” despite also being students.[146] The Board explained that “their status as students is not mutually exclusive of a finding that they are employees.” The fact that students engaged in “long-term programs intended to impart and improve skills and knowledge,” did not jeopardize their status as employees.[147]

In each of these cases, the apprentices were simultaneously students and employees. They engaged in work that was related to their schooling. The Board has never suggested that the work of an apprentice was “primarily educational” and therefore incapable of achieving employee status. Thus, given the striking similarities between apprentices and the work of graduate students, the Board’s distinction that the work of the graduate student is “primarily educational” is a departure from its own precedent established for apprentices.[148]

The Board in Brown purported to substantiate its decision on Adelphi University and Leland Stanford Junior University. However, these cases do not support the proposition that graduate students cannot simultaneously be employees. In Adelphi the Board held that graduate teaching and research assistants were “primarily students.”[149] This determination does not indicate that the Board believed that the graduate students could not also be employees under the NLRA. Rather, the Board had distinguished teaching assistants from regular faculty members for purposes of determining a community of interests. Because the graduate students were primarily students, they did not share a sufficient community of interest with full-time faculty to “warrant their inclusion in the unit.”[150] The Board in Brown did not return to the holding in Adelphi, but instead distorted the holding of that case. At a minimum, Adephi held that graduate students and faculty have different community of interests, but it does not preclude a finding that graduate students are also employees; it simply was not addressed in the decision.

In the same vein, Leland Stanford did not hold that a graduate student could not be simultaneously a student and an employee. The Board found that the graduate students were not employees based on the particular facts of the case. There, the graduate students received academic credit for their work and such work was needed in order to help the student explore potential thesis options. However, the most significant factor was that the students received the tax-exempt stipends from outside funding agencies, not from the university. The Board concluded on these facts, that “the relationship of RA’s and Stanford is not grounded on the performance of a given task where both the task and the time of its performance is designated and controlled by the employer.”[151] Leland Stanford’s holding does not support Brown’s holding that a graduate student cannot be an employee when he or she performs a task under the direction of, and for the benefit of, the university.

To support its finding that student employees are not covered under the NLRA because their relationship to the university was “primarily educational,” the Board relied heavily on St. Clare’s Hospital. This is because there was nothing in Adelphi or Leland Stanford to support a conclusion that one cannot be simultaneously a student and an employee. This line of reasoning had been rejected by Boston Medical Center and decades of case law finding apprentices to be employees under the Act. Because the Board could not find precedent within its jurisprudence to support its conclusion in Brown, it had to rely on St. Clare’s Hospital; this decision, however, had been overruled by Boston Medical Center and thus the Board in Brown relied upon bad case law in order to substantiate its decision.[152]

VIII. Conclusion

The recent efforts by graduate students at Brown, Cornell, The New School, Yale, and Columbia University indicate that the desire for graduate students to be represented for purposes of collective bargaining is still present, despite the ruling in Brown. As colleges and universities continue to use graduate students as a means to defray ever-increasing costs, it is unlikely that their requests for recognition are going to cease any time soon. Because graduate students’ working conditions are unilaterally dictated to them by their employer, they seek a unified voice in order to engage with the employer concerning a discussion over wages, hours, and other terms and conditions of employment. As the reliance on graduate students increases, it is likely that the number of classes that they are required to teach or the number of exams they are required to grade will increase, while their compensation in the form of stipends and other financial aid will remain stagnant.

For those sympathetic to the graduate students’ cause, there is hope. President Barack Obama, during his tenure, has had the ability to replace Board members with those more likely to favor a reversal of Brown. Consequently, as graduate students at Columbia, The New School, and other universities appeal their regional office decisions, they are likely to encounter a Board much more favorable to their plight and willing to reconsider Brown. Those who favor Brown’s holding are likely to argue that constant reversals and overturnings will undermine the Board’s integrity and lead to further unpredictability in the Board’s jurisprudence. However, a Board willing to overturn Brown can support its decision on more than partisan politics. The need to reconsider and overturn Brown can be substantiated on the basis that the Board failed to follow Congress’s intent by declining to read Section 2(3) broadly. A broad reading of the definition of employee is supported both by Supreme Court decisions and prior Board precedent. Additionally, the cases cited in Brown for the proposition that there is some inconsistency between being simultaneously a student and an employee do not support that conclusion. Rather, Adelphi and Leland Stanford reach their conclusions because the graduate students did not share an appropriate community of interest with other unit members and did not directly receive their compensation from the university. Moreover, the Board’s decision completely ignores its previous history of finding apprentices to be employees under the Act. Finally, the Board relied on a decision which had been expressly overruled just a few years prior. Thus, there are compelling reasons to reconsider Brown.




[1] J.D. Candidate, Notre Dame Law School, 2017; B.A. Political Science, Purdue University Northwest, 2014. This note is dedicated to my parents and family who have given me their unyielding support throughout law school and in all of my endeavors. I also wish to thank Professor Barbara Fick for her editorial assistance.

[2] Steven Greenhouse, Columbia Graduate Students Push for a Labor Union, N.Y. Times, March 4, 2015, at A23.

[3] Columbia Univ., 02-RC-14301 (2015).

[4] Adelphi Univ. 195 NLRB 639, 640 [(1972) (categorizing graduate students into teaching assistants and research assistants and differentiating their respective roles).

[5] For example, graduate students at Columbia University receive stipends varying between $20,000-$40,000 depending on the department. Greenhouse, supra note 1.

[6] Grant M. Hayden, “The University Works Because We Do”: Collective Bargaining Rights for Graduate Assistants, 69 Fordham L. Rev. 1233, 1237 (2001).

[7] Robert A. Epstein, Note, Breaking Down the Ivory Tower Sweatshops: Graduate Student Assistants and Their Elusive Search for Employee Status on the Private University Campus. 20 St. John’s J. Legal Comment. 157, 162 (2005); Brown Univ., 342 NLRB 483, 483 (2004) (declaring that the issue to be decided was whether or not graduate student assistants must be treated as employees for purposes of collective bargaining).

[8] Graduate student unionization was first addressed in Adelphi University in 1972. Adelphi Univ., 195 NLRB 639 (1972).

[9] Epstein, supra note 6 at 181.

[10] New York Univ., 332 NLRB 1205 (2000).

[11] Brown Univ., 342 NLRB 483 (2004).

[12] Modjeska ET AL, Federal Labor Law: NLRB Practice §1:1 (2015).

[13] Raymond L. Hogler, The Historical Misconception of Right to Work Laws in the United States: Senator Robert Wagner, Legal Policy, and the Decline of American Unions, 23 Hofstra Lab. & Emp. L.J. 101, 104 (2005).

[14] A.L.A. Schlechter Poultry Corp. v. United States, 295 U.S. 495 (U. S. 1935).

[15] NLRB v. Jones & Laughlin Steel Corp., 301 U. S. 1 (U. S. 1937).

[16] “Congress ensured that collective bargaining would go forward by creating the Board and giving it the power to condemn as unfair labor practices certain conduct by unions and employer that it deemed deleterious to the process. . . .” First Nat’l Maint. Corp. v. NLRB, 452 U.S. 666, 674 (U. S. 1981).

[17] Modjeska, supra note 11.

[18] Id.

[19] NLRB v. Nash-Finch Co., 404 U.S. 138, 144 (U. S. 1971) (quoting Garner v. Teamsters, Chauffeurs and Helpers Local Union No. 776 (A.F.L.), 346 U.S. 485, 491 (U. S. 1953)).

[20] Modjeska, supra note 11.

[21] See, e.g., NLRB v. Curtin Matheson Scientific, Inc., 494 U.S. 775 (U. S. 1990); NLRB v. J Weingarten, Inc., 420 U.S. 251, 266 (U. S. 1975) (stating the Board’s “special competence in this field is the justification for the deference accorded its determination.”).

[22] Modjeska, supra note 11; Lechner, Inc. v. NLRB, 502 U.S. 527, 536 (U. S. 1992).

[23] National Labor Relations Board, General Counsel, https://www.nlrb.gov/who-we-are/general-counsel (last visited Nov. 5, 2015).

[24] 29 U.S.C. §153 (2015).

[25] Modjeska ET AL, Federal Labor Law: NLRB Practice §2:1 (2015).

[26] Ryan Patrick Dunn, Comment, Get a Real Job! The National Labor Relations Board Decides Graduate Student Workers at Private Universities Are Not “Employees” under the National Labor Relations Act, 40 New Eng. L. Rev. 851, 861 (2006).

[27] See, e.g., NLRB v. Noel Canning, 134 S.Ct. 2550 (U. S. 2014), in which an employer challenged a ruling by the Board which consisted of three members who had been appointed by the President using his recess appointment powers. The employer challenged the ruling on grounds that the Board lacked a quorum because the three members were inappropriately appointed. The Senate had met in pro forma sessions in order thwart the appointment process.

[28] National Labor Relations Board, The NLRB Process, https://www.nlrb.gov/resources/nlrb-process (last visited Nov. 5, 2015).

[29] 29 U.S.C. §159(e)(1) (2015).

[30] 29 U.S.C. §159(b) (2015).

[31] In determining the appropriate bargaining unit, the Board often looks at whether the employees have a “community of interests.” A community of interests analysis will look at whether the employees in the proposed bargaining unit share: similarity in the scale and manner of determining earnings; similarity of employment benefits, hours of work and other terms and condition of employment; similarity in the kind of work performed; similarity in the qualifications, skills and training of the employees; frequency of contact or interchange among the employees; geographic proximity; continuity or integration of production process; common supervision and determination of labor relations policy; relationship to the administrative organization of the employer; history of collective bargaining; desires of the affected employees; extent of union organization. NLRB v. St. Francis Coll., 562 F.2d 246, 249 (3d Cir. 1977).

[32] National Labor Relations Board, Conduct Elections, https://www.nlrb.gov/what-we-do/conduct-elections (last visited Nov. 12, 2015).

[33] 29 U.S.C. §158(d) (2015).

[34] See National Labor Relations Board, supra note 21.

[35] There are varying dollar thresholds depending on the type of business the employer engages in. For example, retailers must have an annual gross volume greater than $500,000 and non-retailers’ inflow and outflow of goods across state lines must exceed $50,000 in order for the Board to have jurisdiction; the NLRB also has a “special categories” which includes transportation, health care, and child care facilities. The threshold for colleges, universities, other schools, museums, or symphony orchestras is $1 million annually. National Labor Relations Board, Jurisdictional Standards, https://www.nlrb.gov/rights-we-protect/jurisdictional-standards (last visited Nov. 12, 2015).

[36] The NLRA excludes from its coverage employees of the United States and of any State or political division. 29 U.S.C. §152(2); see also Neal Hutchens & Melissa Hutchens, Catching the Union Bug: Graduate Student Employees and Unionization, 39 Gonzaga L. Rev. 105, 108 (2004).

[37] Id.

[38] Id. at 108.

[39] Id.

[40] Hayden, supra note 5 at 1243.

[41] Hutchens, supra note 24 at 108.

[42] Rogers ET AL, Effects of Unionization on Graduate Student Employees: Faculty-Student Relations, Academic Freedom and Pay, 66 Indus. & Lab. Rel. Rev. 487, 488 (2013).

[43] Trustees of Columbia Univ., 97 NLRB 424, 425 (1951).

[44] Id. at 427.

[45] Id.

[46] Cornell Univ., 183 NLRB 329, 331 (1970).

[47] Id.

[48] Id.

[49] Id. at 334.

[50] Adelphi Univ., 195 NLRB 639, 639 (1972). See 29 C.F.R. §103.1: “The Board will assert jurisdiction in any proceedings. . .involving any private nonprofit college or university which has a gross annual revenue from all sources (excluding only contributions which, because of limitation by the grantor, are not available for use for operating expenses) of not less than $1 million.”

[51] Id. at 640.

[52] Id.

[53] Id.

[54] Long Island Univ., C.W. Post Ctr., 189 NLRB 904 (1971).

[55] Id. at 908.

[56] Id. at 907.

[57] Coll. of Pharm. Sci. in the City of New York, 197 NLRB 959 (1972).

[58] Id.

[59] Id. at 960.

[60] Georgetown Univ., 200 NLRB 215, 215 (1972).

[61] Id. at 216.

[62] Id.

[63] Id.

[64] Barnard Coll., 204 NLRB 1134 (1973).

[65] Id. at 1135.

[66] Id. at n. 5.

[67] The Leland Stanford Junior Univ., 214 NLRB 621 (1974).

[68] Id.

[69] Id. at 622.

[70] Id. at 621.

[71] Id.

[72] Id. at 623.

[73] Cedars-Sinai Med. Ctr., 223 NLRB 251 (1976).

[74] Id. at 253.

[75] Id.

[76] Id.

[77] Id. at 252.

[78] Id. at 253.

[79] Id. at 254 (Fanning, dissenting).

[80] Id.

[81] (emphasis in original) Id.

[82] Id.

[83] Id.

[84] Id. at 256.

[85] St. Clare’s Hosp. & Health Ctr., 229 NLRB 1000, 1000 (1977).

[86] Id.

[87] Id. at 1001.

[88] Id. See, e.g., the discussion of Georgetown Univ., supra.

[89] St. Clare’s Hosp., 229 NLRB at 1001. This would likely to arise in an external internship situation.

[90] Id. at 1002. See, e.g., the discussion of CW Post and Stanford, supra.

[91] St. Clare’s Hosp., 229 NLRB at 1002.

[92] The Board attempted to provide context by noting that the subject of hours is a mandatory bargaining subject under the NLRA. Part of a graduate education in medicine includes working as a resident or intern. These positions are necessary to provide the student with a broad educational experience and such experiences do not necessarily occur during ideal working hours. Permitting students to bargain over these hours could result in decreased educational opportunities. Id.

[93] Id.

[94] Boston Med. Ctr. Corp., 330 NLRB 152 (1999).

[95] Id.

[96] Id. at 160, quoting Sure-Tan, Inc. v. NLRB, 467 U.S. 883, 891-892 (U. S. 1984).

[97] Boston Med. Ctr., 330 NLRB at 160.

[98] Id. at 161.

[99] New York Univ., 332 NLRB 1205 (2000).

[100] Id. at 1206 citing NLRB v. Town & Country, 516 U.S. 85, 90-91, 93-95 (U. S. 1995).

[101] New York Univ., 332 NLRB at 1206.

[102] Id.

[103] Id. at 1207.

[104] See supra notes 94-96.

[105] New York Univ., 332 NLRB at 1208 , quoting Univ. of Pa. v. EEOC, 493 U.S. 182, 195-202 (U. S. 1990).

[106] New York Univ., 332 NLRB at 1208.

[107] Gerilynn Falasco & William J. Jackson, Note, The Graduate Assistant Labor Movement, NYU and Its Aftermath: a Study of Attitudes of Graduate Teaching and Research Assistants at Seven Universities, 21 Hofstra Lab. & Emp. Law J. 753, 753 (2004).

[108] At the time of the Brown decision, President George W. Bush had been in office for three years and had appointed three members to the board – the three-member majority. The two members of the minority had been appointed by President Bill Clinton and voted in the majority in the NYU decision.

[109] Brown Univ., 342 NLRB 483, 484 (2004).

[110] Id. at 486.

[111] “[The] principles developed for use in the industrial setting cannot be imposed blindly on the academic world. . . It is clear to us that graduate student assistants. .. are clearly students and have a primarily educational, not economic relationship with their university .” Id. at 487 (internal quotes omitted).

[112] Id. at 488.

[113] Id.

[114] Id. at 489.

[115] Id.

[116] Id., citing St. Clare’s Hosp., 229 NLRB 1000, 1002 (1977).

[117] “[It] ‘is important to recognize that the student-teacher relationship is not at all analogous to the employer-employee relationship.'” Brown Univ., 342 NLRB at 489.

[118] Id.

[119] Id. at 490.

[120] Id. In the most recent NLRB decision regarding university students, the NLRB refused to assert jurisdiction over Northwestern University football players who sought collective bargaining rights. The Board did not determine whether the players were statutory employees under the NLRA, but rather held that asserting jurisdiction over a single team would not promote stability in labor relations across the NCAA. The overwhelming majority of college football teams in Division I football (108 of 125 teams) are state-run institutions and therefore collective bargaining rights are determined at the state level. Moreover, Northwestern is the only private institution in its athletic conference, the Big Ten. Northwestern Univ., Case 13-RC-121359 (2015).


[121] Brown Univ., 342 NLRB 483, 497 (2004).

[122] Id.

[123] Id. at 492.

[124] See e.g., Columbia Univ., Case 02-RC-14301 (2015), stating “To date, Brown remains controlling on the issue of graduate assistants as employees and I am compelled to follow that precedent.”

[125] See Brown Univ., 342 NLRB at 492.

[126] The data, adjusted to current dollar amounts shows that the average cost of attending a four year university in 1976-77, the same year as the Cedars-Sinai decision cost roughly $2577. Conversely, the adjusted average tuition in 2004, the same year as the Brown decision, was $16,509. National Center for Education Statistics, Average Undergraduate Tuition and Fees and Room and Board Rates Charged for Full-Time Students in Degree Granting Institutions, by Type and Control of Institutions: 1964-65 through 2006-07, https://nces.ed.gov/programs/digest/d07/tables/dt07_320.asp (last visited Jan. 15, 2016).

[127] Bettinger & Long, Does Cheaper Mean Better? The Impact of Using Adjunct Instructors on Student Outcomes, The Review of Economics and Statistics, 598 (2010); Hutchens, supra note 25 at 126.

[128] Gregory M. Saltzman, Union Organizing and the Law: Part-Time Faculty in Graduate Teaching Assistants, NEA 2000 Almanac of Higher Education, 44 (2000).

[129] At Yale University, seventy percent of undergraduate courses are taught by non-full-time faculty members, including graduate students and part-time or adjunct faculty. Id.

[130] Id.

[131] Id.

[132] The students in Brown received a $12,800 stipend per year. Some graduate students were also fortunate enough to have their university health fees for on-campus health services included in the stipend. However, not all graduate students received this benefit and no graduate students received traditional fringe benefits such as sick leave, retirement, vacation, or traditional comprehensive health insurance. Brown Univ., 342 NLRB 483, 486 (2004).

[133] 29 U.S.C. §152 (3) (2015).

[134] Sure-Tan, Inc. v. NLRB, 467 U.S. 883, 891 (U. S. 1984).

[135] NLRB v. Town & Country, 516 U.S. 85, 90 (U. S. 1995), quoting American Heritage Dictionary, 604 (3d ed. 1992).

[136] NLRB v. Town & Country, 516 U.S. at 91, quoting H.R.Rep. No. 245, 80th Cong., 1st Sess., 18 (1947).

[137] NLRB v. Town & Country, 516 U.S. at 91, quoting 79 Cong. Rec. 9686 (1935).

[138] Id.

[139] Sure-Tan, Inc. v. NLRB, 467 U.S. 883, 891 (U. S. 1984).

[140] Sundlund Constr. Co., 309 NLRB 1224, 1226 (1992).

[141] Seattle Opera Ass’n, 33 NLRB 1072 (2000), enforced 292 F.3d 757 (D.C. Cir. 2002).

[142] Seattle Opera v. NLRB, 292 F.3d 757, 763 (D.C. Cir. 2002) (emphasis in original).

[143] Black’s Law Dictionary defines an apprentice as, “a person, usually a minor, found in due form of law to a master, to learn from his art, trade, or business, and to serve him during the time of his apprenticeship.” That definition highlights that an apprentice is there to learn, indicating student status, but also uses the traditional master servant relationship indicative of an employer-employee relationship. Black’s Law Dictionary 80 (7th ed. 1999).

[144] Newport News Shipbuilding and Dry Dock Co., 57 N.L.R.B. 1053, 1058-59 (1944).

[145] General Motors Corp., 133 NLRB 1063, 1064-65 (1961).

[146] Boston Med. Ctr., 330 NLRB 152 (1999).

[147] Id. at 161.

[148] The Department of Labor would likely reach a similar conclusion regarding the status of graduate students. The DOL has established criteria for when interns must be compensated under the Fair Labor Standards Act. Among the criteria the DOL looks at to determine whether a student intern must be compensated under the FLSA are: whether the internship is similar to training which would be given in an educational environment; whether the internship experience is for the benefit of the intern; whether the intern displaces regular employees and works under the close supervision of existing staff; the employer providing the training derives no immediate advantage from the activities of the intern and on occasion its operation may actually be impeded; whether the intern is entitled to a job at the conclusion of the internship; and whether the employer and intern understand that the intern is not entitled to wages for the time spent in the internship. Graduate students undoubtedly benefit from the teaching experience, but in doing so, displace faculty or other instructors that the university would have to hire to teach those courses. The Department of Labor, Fact Sheet #71: Internship Programs Under the Fair Labor Standards Act, http://www.dol.gov/whd/regs/compliance/whdfs71.pdf (last visited Feb., 4, 2016).

[149] Adelphi Univ., 195 NLRB 639, 640 (1972).

[150] Id.; see also supra notes 49-52.

[151] The Leland Stanford Junior Univ., 214 NLRB 621, 623 (1974).

[152] Boston Med. Ctr. Corp., 330 NLRB 152, 152 (1999).