Q. What is an Institutional Review Board (IRB)?
A. An IRB is an organizational committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving human subjects in an effort to protect them. IRB approval is required for federally funded non-exempt research projects.
Q. What risks do IRBs protect people from?
A. Looking for information about perceived risks, I located the following:
The HHS regulations at 45 CFR part 46 do not define or use the term adverse event, nor is there a common definition of this term across government and non-government entities. In this guidance document, the term adverse event in general is used very broadly and includes any event meeting the following definition:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Q. Why do you assert that there is an intellectual freedom issue with IRBs?
A. The Constitution protects speech from licensing; the doctrine of prior restraint is a related concept. People who engage in interviews are taking part in a conversation; likewise surveys are an exchange of words between people. One person is asking questions, while another is invited to answer. I believe that this is why there is an exemption clause for interviews and surveys in the Common Rule--because its creators recognized that speech enjoys the highest protection available. Both the easily-ignored exemption clause and the fact that this is a funding--not an absolute--requirement, make it insidious. It is possible to go even further with this critique, as does Philip Hamburger:
Americans once enjoyed the benefit of an absolute prohibition against laws requiring the licensing of speech and the press, but in the twentieth century this old freedom of speech and the press came to be submerged under newer doctrines. In particular, the U.S. Supreme Court developed doctrines on spending and prior restraint that gave the impression that the federal government could impose licensing of speech or the press as long as it did so through conditions on expenditures or with a strong government interest. The Court’s doctrines thus simultaneously emboldened the government to think that it could impose the licensing and deprived academics of any confidence they had a constitutional ground to object. This was the constitutional disaster that gave rise to the IRB laws, and therefore the central question is not whether the IRBs are constitutional under the Court’s doctrines, but rather whether these doctrines should be understood to obliterate the old, absolute freedom from licensing.
The American Library Association's opposition to CIPA was based in part on the fact that blocking software use constitutes prior restraint. Intellectual freedom advocates generally assert that restricting speech over vague, theoretical, unproven assertions that expression may somehow "hurt" someone causes greater harm than the speech itself.
Q. Aren't institutional review boards (IRBs) a long-standing and well-established tradition for colleges and universities?
A. No. Efforts toward the regulation of federally-funded research began in the 1970s. The Belmont Report was written in 1979; the current Common Rule , identical to 45 C.F.R. 46, subpart A, was adopted by several government agencies in 1991. They are a relatively new phenomenon.
Q. IRBs sound very reasonable to me. Can you provide any actual reports of difficulties encountered?
A. Yes. See Zachary Schrag's horror stories section at: http://www.institutionalreviewblog.com/search/label/horror%20stories
Q. Did the laws passed by Congress leading to the creation of today's Common Rule intend to regulate all academic activities involving interactions between people, including surveys and interviews (those which are speech-based)?
A. No. As historian Zachary Schrag notes in his article entitled How Talking Became Human Subjects Research, the law passed by Congress authorizing creation of the rules in 1974 "'limited its scope to “biomedical and behavioral research.'" According to Schrag, discussions took place in 1979 regarding what should be included, excluded, and/or not subject to approval. "Despite the debate, both sides agreed that the bulk of social research should be excluded from the requirement of IRB review." He goes on to describe:
After months of debate, everyone could agree that the National Commission [for the Protection of Human Subjects of Biomedical and Behavioral Research] had exceeded its congressional mandate when it proposed IRB review for every interaction between a researcher and another person. The question on the table was how far to extend, and how best to phrase, the necessary exemptions.
Q. Don't IRBs protect people who are being interviewed for oral history or journalism projects?
A. No. When a person is interviewed, it is impossible for either party to know for sure what will come out in the conversation. For example, an officer appearing in a live TV inteview might be asked if she believes the military strategy in Afghanistan is going well, and the respondent might answer with criticism of the entire administration that damages her career. Therefore, no amount of prior review of questions or signing of informed consent documents can eliminate any risk of possible embarassment or other such negative emotions during an interview; however, the red tape, paperwork, and other IRB interference are far more likely to ensure that the interview never happens to begin with. When it comes to putting the finished interview in an archive, it's important for the archive to have the interviewee and interviewer sign a release form; since this is usually done after the interview, if the interviewee decides not to sign the form, nobody will every archive or access the interview. In other words, informed consent is basically built into the simple standard legal release used by most archives.
Q. Why are IRBs particularly problematic for oral historians and journalists?
A. As Arnita Jones wrote in her letter on behalf of the American Historical Association to the Federal Office for Human Research Protections in December, 2007: " . . . in practice, the application of these rules to oral history are not appropriate and fundamentally impede and abridge scholarly work in our discipline." The AHA has an excellent Q & A on their web site.
Q. Don't IRBs keep people ethical?
A. No. The vasty majority of ethics statements are not linked to any prior approval process; they are adhered to by professionals, who are fully aware of the consequences of unethical activity in the forms of being professionally censured, losing one's job, risking litigation, and/or losing one's standing in the community. Awareness of ethics, personal integrity, professionalism and the reality of consequences keep people ethical, not paperwork and bureaucracy. As one of the early participants in the conversation noted, "Effective responsibility cannot be equated with a signature on a piece of paper." Does filling out forms and signing some papers keep anybody ethical? Would filling out forms and signing some papers change an unethical person into an ethical one?
Finally, a great deal of potentially dangerous biomedical research is taking place in privately-funded venues which are not subject to IRB review; it is completely illogical to regulate speech on college campuses while neglecting to regulate much more serious situations elsewhere. Ultimately, we have to ask ourselves questions like:
Q: Don't IRBs protect people who are participating in anonymous online surveys?
A. From what?
Q: Since IRBs can simply exempt interviews and surveys, what's the big deal?
A. Some IRBs choose to assert that just about anything is "generalizable," and hence subject to full board review, resulting in long delays that make quick opinion polls impossible and discourage innovation. The response to this by many students and faculty is to simply avoid the IRB altogether, which means that inquiry doesn't happen (which means chilling speech). And it isn't just about isolated incidents where IRB members are being unreasonable. For example:
My IRB experience with graduate student projects on leadership was eye opening. A colleague and I taught the course. We spent hours checking student IRB forms, and half the semester was consumed in getting their protocols past the committee chair. All of these projects involved harmless interviews and questionnaires to be done in the workplace. The overwhelming majority of the students’ employers not only supported their research, but in many instances were paying for them to attend graduate school. All of my students found the IRB debacle to be nitpicking nonsense. Many of them ultimately received an “incomplete” for the course. It would be convenient simply to blame our IRB chair for this debacle. However, that person was not only a highly competent and cooperative IRB chair and an established social scientist, but also an extraordinarily cooperative friend of mine. In short, the IRB fiasco is not about persons, but about a system.
After that initial experience, the program redefined the project so that all students could get IRB approval by providing the same answers on the form. This adaptation made IRB compliance less onerous, but it severely limited the student’s choice of topics and deprived them of the opportunity to do real science. Since then, the course has introduced a whole new kind of research option for students that avoids IRB involvement. I surmise that in most educational settings, the demands of IRB compliance have led to requiring topics and projects that are easier to get past boards. (White, page 559)
Q. But when something is "generalizable," isn't it infinitely more dangerous?
A. How?
Q. Might IRBs actually generate a false sense of security?
A. Yes. As one sociologist noted in 1967:
There is also the danger that an institutional review committee might become a mere rubber stamp, giving the appearance of a solution, rather than the substance, for a serious problem of growing complexity which requires continuing discussion.
Q. Why don't oral historians just assert that oral history doesn't conform to the Common Rule's definition of research?
A. Historians tried this strategic approach; one result was a 2003 letter from the Office for Human Research Protections (OHRP) stating:
OHRP concurs with the proposed policy stating that oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board (IRB).
However, this statement had so many loopholes that it was easy to ignore. In some cases, it seems to have just enraged some IRBs, since a fair number of statements on college & university IRB policy pages may be found asserting that oral history must indeed be subject to IRB oversight. This argument is also problematic, because it a) depends upon understanding the Common Rule's definition of "research," and b) runs the risk of making it sound as though oral history is not a scholarly endeavor. While asserting that IRB regulation is prior restraint of speech (and hence, a violation of Constitutional rights) should be a more powerful argument, anyone familiar with the CIPA cases realizes how difficult that argument is to fight in the current atmosphere of the Supreme Court.
Q. Why doesn't somebody with an unreasonable IRB just appeal the decision?
A. There really isn't anyone to appeal to. As Ronald F. White notes:
IRBs are “courts of last resort”: there is no external monitoring of IRB decisions and no appeals process. As institutionalized monopolies, these committees are shielded from external scrutiny, immune from assessment, and therefore systematically unaccountable for their decisions. If the IRB disapproves a scientist’s research or demands substantial protocol revisions, he is simply out of luck. (White, Page 551)
Q. What about our concern for privacy?
A. Privacy is an important issue. However, the need to protect privacy must be balanced against other important considerations. Just as some services cannot be provided if people do not give some personally identifiable information, some exchanges of thoughts, ideas, and other information cannot take place as well. Privacy protection should be balanced with other needs:
Unfortunately, the concept of confidentiality is itself socially constructed and often viewed through the lens of deontological (rights-based) theory. The right to confidentiality, therefore, is often asserted as an absolute claim, independent of cost-benefit scrutiny. As paternalistic IRBs seek to enforce this zero-risk concept of unbounded confidentiality paternalistically on behalf of research subjects, it becomes more difficult for researchers to construct protocols and to share information with other researchers. (White, Page 556)
Q. What are the answers?
A. There are arguably better ways of addressing concerns: C.K. Gunsalus asserts that the implementation of effective complaint systems would prove more effective than IRB paperwork. White suggests that colleges and universities make research ethics a required course. Ultimately, it is of paramount importance that colleges and universities establish policies that protect the academic freedom of faculty and students.
References:
Gunsalus, C. K. "The Nanny State Meets the Inner Lawyer: Overregulating While Underprotecting Human Participants in Research." Ethics & Behavior 14.4 (2004): 369-382. Web. 2 Jul 2010. http://www.law.uiuc.edu/faculty/documents/other/gunsalusethicsbehavior.pdf .
Hamburger, Philip. "Two-Dimensional Doctrine and Three-Dimensional Law." Northwestern University Law Review 101.2 (2007): 563-567. Web. 6 Jul 2010. http://www.law.northwestern.edu/lawreview/v101/n2/563/LR101n2HamburgerII.pdf.
Schrag, Zachary. "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991.." Journal of Policy History 21.1 (2009): 3-37. Web. 2 Jul 2010. http://zacharyschrag.com/wp-content/uploads/2010/05/schrag_howtalking_final.pdf .
White, Ronald. "Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State." Independent Review 11.4 (Spring 2007): 549-564. Web. 1 Jul 2010. <http://www.independent.org/publications/tir/article.asp?a=630>.
Ethics & IRB Links
The Bill of Rights
http://www.archives.gov/exhibits/charters/bill_of_rights_transcript.html
The Common Rule
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.108
Prior Restraint
http://www.answers.com/topic/prior-restraint#
AAUP-- Research on Human Subjects: Academic Freedom and the Institutional Review Board (2006)
http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm#12
AHA Statement on IRBs and Oral History Research
http://www.historians.org/perspectives/issues/2008/0802/0802aha1.cfm
Statement of the American Folklore Society On Research with Human Subjects
http://www.afsnet.org/aboutAFS/humansubjects.cfm
Human Subjects and IRB Review:
Oral History, Human Subjects, and Institutional Review Boards (OHA web site)
http://www.oralhistory.org/do-oral-history/oral-history-and-irb-review/
Institutional Review Boards, Regulatory Incentives, and Some Modest Proposals for Reform
http://www.law.northwestern.edu/lawreview/v101/n2/687/LR101n2Carpenter.pdf
The New Censorship: Institutional Review Boards
http://volokh.com/files/hamburger.irb.pdf
Student Fights Research Board
http://ludwig.missouri.edu/405/IRBstory.html
The Belmont Report
http://ohsr.od.nih.gov/guidelines/belmont.html#goa
"The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. (2) By contrast, the term ”research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective."
American Library Association Resources
Resolution in Support of Academic Freedom
"RESOLVED, that the American Library Association reaffirms the principles of academic freedom embodied in the American Association of University Professors’ “Statement of Principles on Academic Freedom and Tenure” (1940); and be it further
RESOLVED, that the American Library Association opposes any legislation or codification of documents like the “Academic Bill of Rights” (ABOR) that undermine academic and intellectual freedom, chill free speech, and/or otherwise interfere with the academic community’s well-established norms and values of scholarship and educational excellence."
Importance of Education to Intellectual Freedom: An Interpretation of the Library Bill of Rights
"Libraries of all types foster education by promoting the free expression and interchange of ideas."
The Universal Right to Free Expression: An Interpretation of the Library Bill of Rights
"Threats to the freedom of expression of any person anywhere are threats to the freedom of all people everywhere. Violations of human rights and the right of free expression have been recorded in virtually every country and society across the globe."
Minors and Internet Interactivity: An Interpretation of the Library Bill of Rights
Note on this inclusion: Arguments about implementing prior restraint (aka blocking software/filters) on Internet access for young people have often focused on "protecting" children from various things; the answer to these concerns by the American Library Association has thus far focused on educating young people to live well in a free society, not by restricting their ability to receive information or to express themselves in a vital medium. The same argument can and should be equally applied to research involving speech between adults in colleges and universities. Education, not bureaucracy, is the answer.
"The use of interactive Web tools poses two competing intellectual freedom issues—the protection of minors’ privacy and the right of free speech. Some have expressed concerns regarding what they perceive is an increased vulnerability of young people in the online environment when they use interactive sites to post personally identifiable information. In an effort to protect minors’ privacy, adults sometimes restrict access to interactive Web environments. Filters, for example, are sometimes used to restrict access by youth to interactive social networking tools, but at the same time deny minors’ rights to free expression on the Internet. Prohibiting children and young adults from using social networking sites does not teach safe behavior and leaves youth without the necessary knowledge and skills to protect their privacy or engage in responsible speech. Instead of restricting or denying access to the Internet, librarians and teachers should educate minors to participate responsibly, ethically, and safely."