A Little-Known Lawsuit May Weaken University Ethics Boards

For 45 years, research at American universities has been supervised by Institutional Review Boards (IRBs), which are committees that ensure scientific research is conducted ethically. At most universities, faculty, students, and staff must obtain approval from the IRB before engaging in any aspect of scientific research. To protect research participants, the IRB scrutinizes research protocols, stimuli, and even recruitment materials (such as emails and flyers).

Researchers may not begin their research until they receive the IRB’s blessing. This, however, does not end the IRB’s supervision. Any change in procedures—even trivial changes to wording in a recruitment flyer or a clarification of instructions to research participants—must be submitted to the IRB before implementation. Likewise, any “unanticipated problem” that happens must be reported to the IRB so the committee can reassess whether the study’s characteristics need to be changed to prevent future unforeseen events. At most universities, the researcher must also report to the IRB when the study concludes and pledge that it was conducted in accordance with the approved procedure. This onerous system often delays research for weeks or months.

This system is being questioned by an unassuming graduate student who is the plaintiff of a new lawsuit challenging the IRB’s authority to supervise her research. Idil Issak at the University of Tennessee-Knoxville is an anthropology student who wants to conduct research by interviewing eight female Ethiopian nationals working in the domestic service industry in the United Arab Emirates (UAE). She wants to interview her research participants using standard research methods in cultural anthropology to gain new insights into these workers’ experiences. 

Issak’s experience with the IRB has been a Kafkaesque nightmare. Issak’s research would provide important insights into the experiences of these individuals who are vulnerable to exploitation. Issak’s research has implications for anthropology, human rights, and even international relations. Unless ignorance is bliss, the world would be better off with her research than without it.

Issak’s experience with the IRB has been a Kafkaesque nightmare. According to the complaint filed in the lawsuit, she has applied for approval for her research at least five times and has been rejected each time. The IRB requested that Issak meet UAE legal requirements that did not exist. At one point, the IRB even required her to obtain a “Memo of Cultural Appropriateness.” Apparently, the IRB does not think she is qualified to determine on her own whether her research is culturally appropriate, even though Issak has a bachelor’s degree and graduate-level training in anthropology, was born in East Africa (in Somalia), and has lived in the UAE twice. Issak’s doctoral committee—consisting of faculty experts in sociology, cultural anthropology, trauma, Ethiopian culture, and research procedures in the Middle East—has approved her research proposal and thinks it is culturally appropriate. But all of this is not good enough for the members of the IRB, none of whom have any expertise in topics related to Issak’s research.

Like many other social scientists whose proposals are initially rejected by an IRB, Issak has attempted to modify her research to obtain approval. She has dropped three-fourths of the initial proposal and has even changed the title of her dissertation in an attempt to mollify the IRB. To date, her efforts have been unsuccessful, and the IRB continues to stonewall her.

There is no evidence whatsoever that the IRB’s arbitrary actions have protected anyone from harm. There is no evidence whatsoever that the IRB’s arbitrary actions have protected anyone from harm. Indeed, it is not clear how Issak’s research could harm anyone at all. She wants to confidentially interview adults and analyze their responses. If this poses a risk of “harm,” then every lawyer, journalist, physician, and therapist has risked harming their clients. It takes an extreme level of paranoia and mistrust of Issak to think that her dissertation research could harm anyone.

In an emailed reply to my request for a comment, Issak stated, “After endless months of back and forth with the IRB at my university, I learned that this was not a genuine process of ethical oversight. Ridiculous administrative minutiae and bureaucratic hurdles left little room for actual protection of participants, forcing me to gut 75% of a carefully designed research study tailored to my participants’ needs and their specific socio-cultural context. And it left even less room for the advancement of knowledge.” 

With the help of the New Civil Liberties Alliance (NCLA), Issak is fighting back. Her lawsuit argues that the university IRB’s oversight of her research is unconstitutional because it limits her speech by mandating that she receive IRB approval before engaging in any interviews. NCLA staff attorney Margot Cleveland stated, “When the government mandates approval of communicative research by an IRB, the government is establishing a prior restraint of speech—something the First Amendment prohibits. Not only does the government infringe on free speech rights by imposing the IRB mandate, but it harms those who would benefit from research that is foregone because of the government strictures imposed on researchers.” 

This is not a new legal argument, but Issak’s case is the first time that this legal theory will be tested in the courts. A simple comparison shows how constitutionally problematic the IRB oversight of social science research is:

• No IRB approval needed: “Hi, I’m a reporter from the Everytown Tribune. Who are you planning on voting for in the next election?”
• IRB approval needed: “Hi, I’m a political science student from Upstate College. Who are you planning on voting for in the next election?”

Every American would balk at the idea of journalists being required to obtain approval from the government before interviewing people. And yet, when social scientists who happen to work for a public university want to interview people, they need to get approval in advance from a government panel. There is no legal or logical reason why social scientists need ethical supervision from the government but journalists do not.

Some university-affiliated individuals have their speech regulated and others do not. The university (and the governing federal regulations) anticipate this conundrum and explicitly exempt research in journalism, oral history, biography, and other areas from IRB oversight so that students in these areas do not need government approval before engaging in their work. But this does not avoid the constitutional problem because (1) the IRB still claims oversight of social scientists at universities but not social scientists working outside of the university system, and (2) this creates a new form of discrimination where some university-affiliated individuals have their speech regulated and others do not.

The legal theories in Issak’s case are untested, and the university is fighting back. Among the university’s arguments is the claim that scientific research is conduct that can be regulated and not speech. The Supreme Court just weakened that argument. Last March, the court ruled 8-1 in Chiles v. Salazar in favor of a therapist whose work solely consisted of talking to clients. In this case, the Court explicitly rejected the State of Colorado’s theory that it was legally permitted to regulate the content of the therapist’s interactions with her clients because she was engaging in conduct rather than speech. If a state-licensed therapist cannot have their professional speech regulated by the government, it is hard to see how a state university can regulate students’ and scientists’ professional speech by merely calling it “conduct.”

“The facts in Ms. Issak’s case establish the IRB regulates speech.” When I asked Cleveland about the impact of this ruling, she replied, “The Supreme Court’s decision in Chiles v. Salazar made clear that ‘[u]nder the First Amendment, what matters is not how a government describes its law or whether the law may regulate conduct in other circumstances. What matters is whether, in fact, the law regulates speech in the case at hand.’  And, the facts in Ms. Issak’s case establish the IRB regulates speech. Thus, under Chiles, the IRB mandate can only stand if it withstands strict scrutiny—something it cannot do given the Defendants would allow Ms. Issak to ask the same exact questions without IRB review if she were speaking as a journalist or a historian.” (The Office of the Tennessee Attorney General, which is litigating the case on behalf of the university and the IRB, declined to comment.)

Issak’s case is currently scheduled to be heard in May 2027. At that point, it will be over three years since she originally applied for IRB approval of her research. The judge may take a year or more to issue an opinion. Even if she wins, there may be appeals; it may be a very long time before this case is settled.

It is important to recognize that a win for Isaak would not eliminate IRBs. No one disputes that IRBs have jurisdiction over research that consists of non-speech activities. For example, medical research in which patients receive medication or an experimental medical treatment would be unaffected by Issak’s case. Likewise, social scientists whose research consists of more than speech activities—such as collecting heart rate data or administering electric shocks—would still need ethical approval from an IRB. Private universities would also have more leeway to continue to regulate their students’ and employees’ research that consists solely of speech.

But a legal precedent holding that an IRB’s actions violated a citizen’s freedom of speech would be a powerful first step toward limiting the power of IRBs. While most researchers’ experiences with IRBs are not as terrible as Issak’s, many have stories of unnecessary delays, unqualified reviewers, and arbitrary mandates that did little to protect research participants. In time, many research projects may be freed from government oversight. If this occurs, it would make Issak’s dissertation one of the most impactful of the 21st century.

Russell T. Warne is a former associate professor of psychology in the Department of Behavioral Science at Utah Valley University.