Falling Short of Fundamental Fairness: Why Institutional Review Board Regulations Fail to Provide Procedural Due Process

JurisdictionUnited States,Federal
CitationVol. 43
Publication year2022




Research on human subjects holds profound potential for the future of the human race.(fn1) Human subjects research promises the development of new treatments that extend and improve the quality of life and help prevent disease.(fn2) Rapidly evolving sciences, along with the sustained development of conventional therapies, offer the hope of cure or treatment for currently untreatable ailments and may ultimately transform the practice of medicine.(fn3) Social science research on human subjects also provides valuable ways of gaining information about the dynamics of a society.(fn4)

Under federal regulations, an institutional review board ("IRB") must approve all research on human subjects that the federal government conducts or supports.(fn5) An IRB is a board of five or more members that reviews research proposals to ensure the safety of the research performed.(fn6) Nearly all universities and other research institutions in the United States have IRBs.(fn7) IRB review applies to medical research and social science research.(fn8) Social science research includes the use of questionnaires, interviews, conversations, or surveys to obtain information from human subjects.(fn9)

Over the past several decades, professors and students have often complained that IRBs hamper the pursuit of knowledge and abridge their liberty of academic freedom.(fn10) IRBs have been widely criticized as obstructionist, wasteful, unresponsive to researchers' needs and essentially ineffective at protecting research ethics and safety.(fn11) Specifically, critics argue that IRBs impose a significant delay on research, eliminate the ability of a researcher to work anonymously and have virtually unfettered discretion to interfere with research.(fn12) Accordingly, researchers whose projects IRBs deny approval can, and have, disputed the IRB action based on procedural due process.(fn13) This Article analyzes IRB regulations in terms of procedural due process and demonstrates that by allowing IRBs to act with broad discretion, and not providing what courts commonly recognize as basic procedural protections, current IRB regulations fail to provide procedural due process as guaranteed by the Fifth and Fourteenth Amendments of the United States Constitution.(fn14)

411 U.S. 778, 790 (1973)). It is also notable that one element cited by Judge Henry J.

This Article proceeds in three sections.(fn15) First, the Background of this Article examines the scope, role, history, operation and legal guidelines of IRBs before turning to an evaluation of the concepts of procedural due process and a procedural due process analysis.(fn16) The Argument of this Article then advances the proposition that current IRB regulations fail to provide necessary procedural due process protections and are therefore unconstitutional.(fn17) The Argument of this Article also addresses the objection that a procedural due process analysis fails to apply to IRB regulations because no deprivation of liberty occurs in the IRB context.(fn18) Finally, this Article concludes by summarizing the Argument and providing several suggestions that lawmakers could follow to remedy procedural due process violations associated with IRB regulations.(fn19)


A. The IRB: An Overview

Federal regulations require that all research on human subjects funded, regulated, or supported by the federal government be approved by an institutional review board ("IRB").(fn20) IRBs are boards composed of at least five members that approve, monitor, and review research on human subjects.(fn21) The primary function of an IRB is to minimize the risk of harm that research performed on human subjects may cause.(fn22) IRBs perform this task by reviewing medical and social science research proposals and either granting or denying researchers permission to conduct the research.(fn23)

1. The Role of IRBs

Institutional review boards ("IRBs") have four basic functions.(fn24)The principal function is to safeguard the welfare and rights of human subjects.(fn25) The federal government instituted regulations governing IRBs because research on humans can be dangerous.(fn26) There are grim examples of human subjects research that has gone amiss, causing serious injury, or in some cases, even death.(fn27) IRB review of research proposals is an intended bulwark against such mishaps that attempts to anticipate and minimize risks associated with human subjects research.(fn28)

The second function of IRBs is to protect institutional interests.(fn29)Some research projects involving human subjects have the potential to negatively affect an institution's public image because of those projects' controversial subject matter.(fn30) Such research issues include fetal research, the use of prisoners in clinical trials, research on sexually transmitted and communicable diseases, and even simple surveys.(fn31) IRBs can help avoid public image problems and safeguard an institution's reputation by eliminating politically volatile studies before researchers conduct them.(fn32)

The third function of IRBs is to protect the researcher.(fn33) Complaints by human subjects relating to clinical studies are not infre-quent.(fn34) Such complaints range from objections about unsolicited requests for research participation to non-timely payment for volunteer human subjects.(fn35) An IRB often intercedes between the complaining human subject and the researcher because the IRB has approved the study.(fn36) IRBs respond to these complaints by re-examining research protocol or, in some cases, requesting a researcher cease enrollment in a study.(fn37) By having an IRB perform the investigative functions relating to complaints, an institution that potentially understands the value of the research in its scientific context remains involved in protecting the legitimate work of the researcher.(fn38)

The fourth function of IRBs is to retain public trust in the conduct of scientific research.(fn39) Human subjects required for scientific studies may not be willing to participate if they distrust the science generated by institutions.(fn40) IRBs are a visible sign of a research institution's dedication to rigorous and well-regulated scientific study.(fn41) By working to protect the safety of human subjects, IRBs help retain public trust in science and thereby ensure a supply of willing human subjects in clinical trials.(fn42)

2.The Scope of IRB Review

Institutional review board ("IRB") review extends to medical and social science research.(fn43) Medical research includes, for example, research involving drug studies, brain scans, blood draws, and organ transplants.(fn44) In contrast, social science research includes the use of questionnaires, interviews, conversations, or surveys to elicit information from human subjects, as well as oral and written directions to human subjects involved in experiments.(fn45) Examples of social science research include a researcher asking Americans how they intend to vote or what their opinion is of a political scandal.(fn46) Therefore, a researcher must first obtain IRB permission regardless of whether that researcher wants to perform a dangerous physiological experiment or to inquire about individuals' political opinions.(fn47)

3.The History of IRBs

Formal committees to review medical research have only existed in the United States for the last several decades.(fn48) Prior to the establishment of such committees, a researcher's own judgment was the only form of regulation of experimentation on human subjects.(fn49) In an attempt to make research on human subjects safer, the federal government established institutional review boards ("IRBs") in response to research abuses.(fn50) However, prior to the establishment of IRBs, abuse of human subjects in research trials was widespread.(fn51)

During World War II, the elite of the Nazi medical community carried out some of the most notorious experimentation on human subjects in human history.(fn52) This research included subjecting innocent victims to deliberate infection with disease, as well as experiments relating to seawater, high altitude, malaria, mustard gas, and sterilization.(fn53) The Nuremberg Trials, conducted after World War II, at which the Allies tried Nazi doctors who had conducted experiments on prisoners in concentration camps, revealed the full inhumanity and extent of the experimentation conducted by the Nazis in such camps.(fn54)

Despite substantial publicity relating to the Nuremberg Trials, researchers in the United States opposed the implementation of regulatory supervision over their research because they believed it to be unnecessary.(fn55) Without monitoring and regulation, exploitation of human research subjects continued in the United States.(fn56) For example, in the early 1950s, inmates in Ohio were subjected to painful and dangerous cancer trials.(fn57) Indeed, during this period in the 1950s, nearly all human participants in the initial and most dangerous stage of clinical research were prisoners.(fn58) Abuses of prisoners in the United States continued when the Central Intelligence Agency secretly conducted...

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