Qualitative Sociologists Find Standard Randomness

Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.

[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” American Sociologist, October 6, 2016, 1–17, doi:10.1007/s12108–016–9331-z. Note: I read a version of this article in manuscript and am so credited in the article.]

Most IRB Chairs Can't Recognize Exempt Research or Non-Research

A study of criminal justice researchers' knowledge of IRB rules has found that IRB chairs can't agree on what makes a project exempt from review and think that IRB review is needed for public records. The authors of the study, one of whom is an IRB chair, seem not to realize the significance of these findings.

[Tartaro, Christine, and Marissa P. Levy. "Criminal Justice Professionals' Knowledge of Institutional Review Boards (IRBs) and Compliance with IRB Protocol." Journal of Criminal Justice Education 25, no. 3 (2014): 321–41. doi:10.1080/10511253.2014.902982.]

Northeastern U. IRB Makes Sex Research Untenable

Carey Noland, associate professor of communcation studies at Northeastern University, complains that "many IRBs . . . seem to have difficulty accurately assessing the potential harm involved with qualitative research on sex."

[Carey M. Noland, “Institutional Barriers to Research on Sensitive Topics: Case of Sex Communication Research Among University Students.” Journal of Research Practice 8, no. 1 (November 24, 2012): Article M2, http://jrp.icaap.org/index.php/jrp/article/view/332/262]

Sociologists of Sexuality Voice IRB Complaints

Sociologist Janice Irvine finds that IRBs "play a significant but largely unnoticed role in the marginalization of sexuality research," and that "the IRB closet obstructs a broad production of sexual knowledge—not simply about identities and communities, but also about a range of sexual acts, desires, and attitudes."

[Janice M. Irvine, "Can't Ask, Can't Tell : How Insitutional Review Boards Keep Sex In The Closet," Contexts 2012 11: 28, DOI: 10.1177/1536504212446457. The story has been picked up by the Chronicle of Higher Education: Dan Berrett, "Review Boards Force Sex Research Into the Closet, Survey Suggests," Chronicle of Higher Education, 28 June 2012.]

Will ANPRM Limit the Use of Published Data?

Despite the ANPRM's general goal of "reducing burden, delay, and ambiguity for investigators," the proposed policy for the re-use of pre-existing data threatens to increase all of those by expanding the current definition of human subjects research.

U of Michigan Reports Some Progress

The University of Michigan has released the results of a 2009 survey of investigator experiences in human research. The survey suggests that matters have improved somewhat since the university launched its HRPP Policy Innovation and Demonstration Initiative in 2007, but that more work remains to be done.

[Survey Research Center, Institute for Social Research, University of Michigan, "2009 Follow-Up Survey of Investigator Experiences in Human Research," December 2010. h/t: Human Research Protections Blog.]

Sex Researcher Calls for "An Evidence-Informed Process"

Brian Mustanski, Associate Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, calls for "moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based."

[Brian Mustanski, "Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach," Archives of Sexual Behavior, published online 29 April 2011.]

Survey Consent Form Language May Not Matter Much

Eleanor Singer and Mick P. Couper of the Survey Research Center of the Institute for Social Research at the University of Michigan find that the wording used to describe the confidentiality offered to survey participants may not play a big role in their decision to participate.

[Eleanor Singer and Mick P. Couper, "Communicating Disclosure Risk in Informed Consent Statements," Journal of Empirical Research on Human Research Ethics 5, no. 3 (Sept. 2010): 1–8.]

Singer and Couper sent out more than 150,000 e-mails to get 9,206 responses to a questionnaire about willingness to participate in a hypothetical survey. Respondents were significantly more likely to say they'd be willing to answer questions about work and leisure than about the more sensitive topics of money and sex. In contrast,

the precise wording of the confidentiality assurance has little effect on respondents’ stated willingness to participate in the hypothetical survey described in the vignette. Nor does adding a statement on the organization’s history of assuring confidentiality appear to affect stated willingness. However, these experimental manipulations do have some effect on perceptions of the risks and benefits of participation, suggesting that they are processed by respondents. And, as we have found in our previous vignette studies—and replicated in a mail survey of the general population—the topic of the survey has a consistent and statistically significant effect on stated willingness to participate.

Singer and Couper hint that researchers and IRBs should spend less time fretting about the wording of consent forms used by survey researchers, since it does not affect decisions and since it is hard to estimate the risk of disclosure. Rather, the real burden on survey orgnizations is to take precautions once they have collected the data.

Social Work Research Gets Few Exemptions

Stephanie Valutis and Deborah Rubin, both of Chatham University, sought "to explore the attitudes toward, knowledge about, and practices of IRBs across colleges and universities as reported by BSW [bachelor of social work] and MSW [master of social work] program directors as they pertain to faculty and student research."

[Stephanie Valutis and Deborah Rubin, "IRBs and Social Work: A Survey of Program Directors’ Knowledge and Attitudes," Journal of Social Work Education 46 (Spring/Summer 2010): 195-212, DOI 10.5175/JSWE.2010.200800059.]

They sent a survey to social work programs around the country, receiving 201 responses. They asked both factual questions about the composition and operations of the IRBs, and questions about the program directors' attitudes.

Among the key findings:

• Familiarity improves attitudes. "Respondents who reported higher levels of knowledge about their IRBs had more positive responses to several attitude questions." (201)



• IRBs grant few exemptions for three types of social work research: closed case files (28 percent of IRBs consider them exempt from review), satisfaction surveys (23 percent), and staff interviews (16 percent). The article does not go into depth about what each type of research entails, why an IRB might choose to require review, or whether social work program directors believe such research should be exempt. (205)



• IRBs take a long time to approve research. While about half of program directors reported that the exempt and expedited reviews took less than two weeks, 17 percent reported exempt reviews taking one month or longer, and 11 percent reported expedited reviews taking that long. Thirty-seven percent reported full reviews taking one month or longer. And this question produced many "Do not know" responses, so the true level of delay may be much higher. (205)



• Some students aren't allowed to do research with human subjects. Seven percent of program directors reported that "social work students were not permitted to do research that required IRB approval." (206)

I have my doubts about the usefulness of this survey, for two reasons. First, the survey posed factual questions (e.g., "How long does it take for initial review of an expedited submission?") to program directors who had no easy way of finding out this information. The authors rightly note that "the many 'don't know' responses" suggest a lack of transparency in IRB operations. But a better survey would have reached IRB administrators or chairs as well, allowing for some comparison. [For an example of this type of survey, see Robert E. Cleary, "The Impact of IRBs on Political Science Research,"IRB: Ethics and Human Research 9 (May-June 1987): 6-10.]

As for the attitudinal questions, they only allowed respondents to agree or disagree with positive statements about IRBs, e.g., "The IRB process helps students learn research ethics." I can't credit the conclusion that "We did not find the frustration with the process and scope of IRB reviews discussed in the broader social science literature," when the survey offered no opportunity to register such frustration. In his pioneering IRB survey of 1976, Bradford Gray understood the need to give respondents a chance to react to more critical statements, e.g., "The review procedure is an unwarranted intrusion on an investigator's autonomy--at least to some extent." [Bradford H. Gray, Robert A. Cooke, and Arnold S. Tannenbaum, "Research Involving Human Subjects," Science, new series, 201 (22 September 1978): 1094-1101] This survey should have done the same.

Indeed, while Valutis and Rubin cite a fair amount of IRB-related scholarship, it is not clear that they read any previous surveys of this sort before designing their own. Rather, they report concerns about the use of "a new survey instrument." (209)

The article also shows some confusion about federal regulations. It states that "Calling research 'exempt' by federal guidelines means that the research poses no risk to human subjects." While it is true that the 1981 Federal Register announcement of the exemptions describes them as exempting "broad categories of research which normally present little or no risk of harm to subjects," little risk is not the same as "no risk." And the regulations themselves exempt some research, e.g., interviews with public officials, regardless of risk. Later, the article claims that "an example of criteria for exemption by federal guidelines is research that does not pose more than minimal risk to human subjects." Actually, that's the criterion for expedited review, not exemption. Finally, the article claims that "Federal regulations require that IRBs make IRB membership available by name, role on the board, and earned degrees, but this information may not be widely disseminated." Indeed, that information is included on federal assurances, but those assurances are rarely made public.

Valutis and Rubin have raised important questions about how IRB oversight affects the education of social work students. But complete answers will require further research.

Researchers Deceive Thousands of Professors

Professor Andrew Gelman reports that he was sent a deceptive e-mail as part of a research project by two business professors, Katherine Milkman and Modupe Akinola. Milkman and Akinola wished to see if "students from underrepresented groups" (presumably racial and ethnic minorities, and perhaps women) would be less likely to gain the interest of doctoral faculty than "other students" (i.e., white guys). So they sent e-mails to Gelman and about 6300 other professors in PhD-granting departments at American universities. The messages, purportedly from a student planning to apply to PhD programs and wishing for a brief meeting, varied by the name of the student and by the time of the proposed meeting. When a professor answered, they replied to cancel the meeting. The idea was to see if students with white-guy names received more or fewer invitations to meet than others.

After receiving a debriefing e-mail explaining the sham, Gelman replied to the authors that "My helpful impulses toward inquiring students are being abused by this sort of study, which I think belongs in the trash heap of ill-advised research projects along with Frank Flynn's notorious survey from a few years ago when he tried to get free meals out of NYC restaurants by falsely claiming food poisoning." He later elaborated on his blog, "What bothers me is that we were involuntary participants in the study. The researchers took advantage of our time and our good nature (that we were willing to meet with an unfamiliar student). Not cool."

Texas's All-Star IRB Report

In February 2008, the University of Texas System formed an IRB Task Force to examine ways to improve IRB operations throughout the UT System. In April 2009, that task force issued its report: "IRB TASK FORCE REPORT: Trust, Integrity, and Responsibility in the Conduct of Human Subjects Research."

I recently obtained a copy of that report. While it has not previously been posted on the web, a University of Texas official assured me that a final policy report like this is public information under Texas law. So to make this important public document freely available, I have posted a copy on my website. (See link above.)

The report offers an exceptionally thorough and thoughtful consideration of how IRBs should work at great research universities. While some of its recommendations may be inapplicable to univerisities that are not part of larger systems or do not operate a medical campus, many of the task force's procedures and recommendations offer a model for others. I salute all those who were involved in the report's preparation.

In particular, I commend the following elements of the UT task force and its report.

Procedures

The UT system carefully set up the task force in a way that would build respect for its findings. In particular, it managed to:

1. Represent Multiple Disciplines

UT included task force members "representing a variety of academic disciplines," among them SACRHP member Lisa Leiden. (3, 24) It also sought help from a range of consultants, including such "national experts" Tina Gunsalus; John Heldens, Moira Keene, Dan Nelson, Ivor Pritchard, and Marjorie Speers. (8)

2. Include Stakeholders

At each UT campus, the task force solicited comments from university officials, IRB chairs, investigators, and other interested parties. (8)

3. Allow Adequate Time

The UT task force completed its deliberations over the course of a year, from February 2008 to February 2009, then released its report in April 2009. A report with so broad a scope cannot be rushed.

Recommendations

Careful investigation led to thoughtful recommendations. The report suggests that the UT system:

1. Employ Faculty Expertise

The UT report recognizes that researchers are often expert in a particular area of human subjects research, and it recommends that faculty experts be identified to prepare standards for specific types of research (e.g., research involving subjects with impaired capacity, internet research) and to consult on individual projects as needed. (10)

2. Utilize Flexibility and Empirical Evidence

The report recommends that the university encourage IRB staff to provide "an efficient level of regulatory review compatible with adequate protection of human subjects," rather than the most stringent level of review. In particular, it suggests that IRB staff and members employ empirical evidence when determining risk, by consulting experts or scholarly literature. (11) The report also suggests that IRBs rely strongly on experts when determining the scientific soundness of a proposal. (14)

3. Uncheck the Box

The UT report notes that, according to Speers, fewer than 50 percent of AAHRP accredited institutions check all the box on their federal-wide assurances, and that it is "primarily the major research universities that are considering unchecking the box," thus maximizing their flexibility in handling projects not directly funded by a Common Rule agency. (12) (More on this in an upcoming post.)

4. Diversify the IRB

The UT report recommends that "Institutional Officials should ensure that the institution's disciplines are well represented in the IRB." (18)

5. Provide IRB Oversight

The UT report recommends that institutions "consider the implementation of a research ombudsperson to increase the opportunity for rapid resolution of issues involving human subjects research." (21) It also suggests an ongoing "IRB Advisory Group" to implement recommendations and assist with human subject policy issues. (23)

6. Define Key Terms

The UT Report includes definitions of key terms. Among other things, these definitions make clear that information-gathering interviews, service surveys, and classroom activities may not meet the definition of human subjects research, and that biography and oral history interviews do not meet that definition. (27) As I mentioned earlier, this recommendation has already led to the deregulation of oral history at the University of Texas at Austin.

7. Explore Alternatives

The report include an appendix on "alternative IRB models," based on the November 2006 "National Conference on Alternative IRB Models." While it is promising that the task force is willing to consider such alternatives, I would have liked it to pick up on that conference's call for "further exploration" of models for social and behavioral research. The University of Pennsylvania policy on research in the sociobehavioral sciences might be such a model.

Goal

Most importantly, the UT task force understood the IRB problem as something larger than an administrative challenge. While it explored ways to increase IRB "effectiveness, efficiency, and productivity," it went beyond such managerial concerns to probe big questions about "IRB authority, mission, and functions," the "unnecessary obstruction of research and lapses of effective human subject protection," and best practices from the available literature. (8)

The task force hoped to foster a "culture of conscience" rather than a "culture of compliance," and it understood that conscience cannot be dictated from above. (20) If other universities also seek to promote a culture of conscience, they must give a voice to all those involved with human subjects research.

IRB Warns That Opinions May Vary

Michael Bugeja, director of the Greenlee School of Journalism and Communication at Iowa State University, reports a run-in with his IRB.

[Michael Bugeja, "Avatar Rape," Inside Higher Ed, 25 February 2010.]

Bugeja was interested in "avatar rape": forced, simulated sex in a virtual environment such as Second Life. As a journalism professor, he wanted to know what other university scholars and administrators thought about the problem. But his IRB imposed conditions that discouraged responses.

In researching the phenomenon, I sought viewpoints from directors of information technology and women's studies at Big XII and other peer institutions. My research assistant Sam Berbano and I spent two months working with our Institutional Review Board, seeking approval to post our survey online.

Given the sensitive nature of the topic, the IRB asked us to warn survey participants about possible harm to their reputations should their responses be published. To lessen risk, the IRB also required signed copies of consent to anyone responding to our survey. So we opted for a snail mail version with a disclaimer: "A risk of participation in this survey may arise if some may find your opinions in the free-response section at variance with their own."

My research assistant wondered how a survey measuring opinion about avatar rape could have more potential for harm than participation in a virtual environment in which such a digital act could occur.

As it turned out, only one respondent out of 43 provided comments for this essay.

Is variance of opinion the kind of risk to "reputation" against which 45 CFR 46 is supposed to protect? I don't think so, but who knows? The interagency group that inserted "or reputation" into the 1991 regulatory amendments never explained its decision, even in the face of an objection that "reputation is a subjective term that is difficult to define operationally."

What I can say is that as a scholar and educator, I strive to expose people to opinions they do not share. At Iowa State University, such an outcome is classified as a hazard.

Survey: Most IRBs Lack Sociologists

The Western Massachusetts Institute for Social Research kindly alerted me to its survey of socioogists, conducted in the summer of 2009. Of the 98 respondents who have conducted research in the past five years, 90 reported that they had undergone IRB review.

The survey found that IRBs are more likely than sociologists to judge a study risky. Only 13 respondents "said that they believe that some harm could have come to respondents as a result of their involvement in the research," but 20 reported that a member of the IRB believed there was such a risk.

This is not surprising. The premise of IRB review is that committees are better able to flag potential harms than are individual researchers, so the higher levels of risk seen by the IRBs could indicate that they are working well, or that they are overestimating the risks of research.

To distinguish the two possibilities, it would help to know why the IRB members saw risk. In 1979, for example, Lauren Seiler and James Murtha showed that IRB chairs commonly insisted on modifications even though most had never heard of harm coming to a participant in sociology research. [Lauren H. Seiler and James M. Murtha, "Federal Regulation of Social Research," Freedom at Issue, Nov-Dec 1979.] Is that still the case?

Another finding of the Western Massachusetts survey is that a minority (44 percent) of respondents reported that the IRB that reviewed their research included a sociologist. Federal regulations require IRBs to include members "with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution." This was one of the few protections offered to social scientists worried that their research would be subject to the whims of people outside their field. But it appears that many or most IRBs have failed to meet this standard.

Former IRB Chair Decries Inconsistency

Jim Vander Putten, Associate Professor of Higher Education at the University of Arkansas-Little Rock, kindly alerted me to his essay, "Wanted: Consistency in Social and Behavioral Science Institutional Review Board Practices," Teachers College Record, 14 September 2009.

Vander Putten, who chaired his university's IRB for six years, complains that IRBs fail to make decisions consistently. He accuses them of both under- and over-protection, and then offers two suggestions for reform.

Internet Survey Sparks Outrage

Two newly PhD'd "cognitive neuroscientists"--Ogi Ogas and Sai Gaddam--got a book contract (rumored to be quite lucrative) with a popular press to write a book called "Rule 34: What Netporn Teaches Us About The Brain."

As part of their work, they launched an online survey aimed at authors of sexually explicit, online fan fiction. Many people who read the survey found it to be poorly designed and offensive, and anger grew as fan authors came to fear that the book would present erroneous information about their community.

The study was not IRB approved. Because the researchers had graduated from Boston University by the time they launched the survey, BU's IRB has disclaimed any authority over the matter, though it may have asked the researchers to stop using presenting themselves as being affiliated with the university. While some of the commentary on the event has included discussions about what the IRB might have done had it been presented the protocol, we can only speculate about whether IRB review would have changed the project for better, worse, or not at all.

Moreover, the chief concern of critics seems not to be that individual survey respondents would be harmed, but that their community as a whole would be harmed by a mass-market book written by inept, ignorant authors. Since the National Commission, policy makers have generally agreed that IRBs should not try to defend whole communities against mischaracterization by scholars.

Still, readers of this blog may be interested in a case where researchers' lack of preparation irreparably alienated the very people whom they wished to study.

For a good introduction, see Alison Macleod's human element blog. Many links follow.

When Seligson is Non-Seligson

The first article in the July 2008 PS symposium is Mitchell A. Seligson's “Human Subjects Protection and Large-N Research: When Exempt is Non-Exempt and Research is Non-Research." While it's great to have someone interested in the contradictions of IRB regulations, the absurdity of the present regime seems to have left Seligson hopelessly confused, and his incoherent essay calls for both expansion and contraction of IRB authority.

Rather than trying to outline his argument, let me just list some of the questions to which he poses contradictory answers.

1. Should social science and humanities research follow the Belmont Report?

Early in his essay, Seligson attacks the Belmont Report as irrelevant to social science research, especially survey research. He particularly dislikes its call for an assessment of risks and benefits, noting

the problem of assessing risk is especially vexing for all of those who rely on large-N studies, typically in the field of survey research. Ironically, when only a handful of subjects are used in a campus laboratory-based experiment, the IRB is likely to approve the project with no objection. But survey research, which invariably relies on large-N studies, is viewed with suspicion by many IRBs simply because the risk, however small, is seen as being replicated 1,000 or more times, since most samples strive for confidence intervals of 63% or better. Protocol analysts, who are used to seeing laboratory experiments and focus groups with samples of fewer than 100, are often taken aback when they confront the large sample sizes inherent in most survey research. And when they do, they question why such a large sample is needed. As a result, it is not at all uncommon to have IRB protocol analysts ask survey researchers to cut down their sample sizes. (479)

He also is skeptical of the Common Rule, especially its protections for pregnant women--irrelevant and damaging to survey research. And he quotes--seemingly with approval--the AAUP's 2006 recommendation "that research whose methodology consists entirely of collecting data by surveys, conducting interviews, or observing behavior in public places be exempt from the requirement of IRB review.”

But then Seligson turns around, lamenting that "historians are not only exempt from IRB control, they have no requirement or even need to take human subjects protection training and pass tests on their knowledge of the principles and rules. Literature faculties often have no knowledge at all of human subjects protection." (480) He wants "faculty members in a broad range of institutions to familiarize themselves with the IRB regulations and to take the tests to demonstrate their knowledge of same," including "the Belmont principles." (482)

Why? Why should faculty members be required to familiarize themselves with guidelines that Seligson has told us are inapplicable to their work? Does he just want company in his misery?

2. Can researchers be trusted?

Seligson thinks that IRB regulations did not help survey research, because

Long before human subjects regulations and the invention of IRBs, survey researchers in all fields instinctually knew that by guaranteeing anonymity they would encourage frankness on the part of respondents. . . . Political scientists who carry out surveys have been aware for decades of the importance of guaranteeing anonymity to their subjects. (480)

If this track record weren't enough, he notes that governments and universities trust political scientists to behave ethically in other aspects of their work.

Even though political scientists conducting educational tests and surveys are exempt from federal regulation, they are not, after all, exempt because the federal government believes we cannot be trusted. What is so strange here is that in countless other important ways, we are trusted by that same federal government. When we grade tests taken by our students, we are not allowed to discriminate on the basis of race, creed, national origin, sexual preference, etc. Yet we are not asked to sign a statement saying that we will not discriminate before ~or indeed after! we grade each exam or before we determine final grades. We hold office hours, but are not asked to submit an application prior to each office hour, not even prior to the start of each term, to the affirmative action offices on our campuses that we will not sexually harass students. We submit articles to conferences but are not asked to submit signed statements saying that we did not plagiarize the material. (481)

Since political scientists have proven more or less trustworthy in these areas, Seligson wants IRBs "to stop assuming, . . that we are all guilty of violations of human subjects rights unless we can prove otherwise." (482)

That's all very nice, but he's unwilling to extend the trust to researchers in other fields. He writes,

some humanists may be naive about the risks involved in disclosing names of subjects. One can imagine many kinds of risk to respondents. One such risk is dismissal of employment from an employer who either might not like the views expressed in the oral history or testimonio or deems them harmful to the company’s welfare. Potential employers might look at the oral history information and deny a position based on the statements contained therein. Another risk could be ostracism at work or in one’s neighborhood for expressing politically unpopular views. One can even imagine law enforcement officials using oral histories to prosecute individuals for revelations that suggest criminal behavior. (480)

In other words, Seligson does not trust interview researchers to have the same instinctual knowledge of ethics he ascribes to survey researchers, he ignores oral historians' sixty-year record in favor of hypothetical abuses, and he assumes historians are guilty of violations of human subjects rights unless we can prove otherwise. Perhaps he wants us to get approval before grading tests as well.

3. Can IRBs be trusted?

Overall, Seligson takes a dim view of those in charge of human subjects regulations, whom he terms "overzealous bureaucrats, both federal and on campuses," and wants retrained. (482) He even relays the follwoing anecdote:

A very senior IRB official at one university, in order to impress upon a political science faculty member his omnipotence, asked, “Do you ever use the library to read books about President Bush?” When the response was affirmative, he said, “Unless you file for IRB approval before opening those books, you will be held in violation, since Bush is a human, is living, and the books almost certainly contain personal information.” (480)

I'm willing to believe a lot of bad things about IRBs, but even I can't swallow a story like this without names and dates attached.

Yet while portraying IRB officials as power-mad bureaucrats, Seligson wants to expand their jurisdiction "to cover all studies of any kind that obtain data on living humans." (482) Wouldn't that include a book about President Bush?

Seligson concludes that "the roadmap to the future should be clear." Maybe it should be, but this article isn't helping. Fortunately, the other essays in the symposium are better researched and reasoned.

Study Finds IRBs Exaggerate Risks of Survey Questions

Michael Fendrich, Adam M. Lippert, and Timothy P. Johnson, "Respondent Reactions to Sensitive Questions," Journal of Empirical Research on Human Research Ethics 2 (September 2007): 31-37

Perhaps because they are punished for being too lax but never for being too strict, IRBs tend to err on the side of what they consider caution, exaggerating the risks of proposed research. It's easy to do so when, as these authors put it, "board members often rely on their 'gut' feeling in determining the potential for survey questions to effect adverse reactions."

To replace that gut feeling with some evidence, Fendrich, Lippert, and Johnson asked survey respondents who had been asked about illegal drug use whether they had felt felt threatened or embarrassed by the questions. Not much: the average score was less than 2 on a 7-point scale. But when asked if other people would feel threatened by those questions, the numbers shot above 5. Thus, survey respondents are as bad as IRBs at guessing how other people will feel about being questioned.

The authors conclude:

Consent documents often summarize potential adverse subject reactions to questions. For example, in the current study, the University of Illinois at Chicago’s REC [research ethics committee] approved consent document contained the following two sentences under the heading: “What are the potential risks and discomforts?”

There is a risk that you may feel anxious, uncomfortable or embarrassed as a result of being asked abut drug use and drug testing experience. However, you are free not to answer any question, and you are free to withdraw from the study at any time.

If our findings can be generalized to other studies asking questions about drug use, the first sentence may inappropriately convey an exaggerated sense of a drug survey’s risk. Even though voluntary participation is a non-contingent right, the second sentence seems to link the right of refusal and the voluntary nature of participation to this exaggerated risk.

The first author’s experience as a member and Chair of a behavioral science REC leads him to conclude that paragraphs like those cited above are common in survey consent documents. Researchers may pair statements about rights with statements about risk in order to appease REC concerns about study interventions to address risk. In the absence of empirical data, RECs should be cautious about recommending and approving consent documents that include clauses suggesting that questions about drug use cause emotional discomfort. Furthermore, RECs should recommend that consent documents decouple important reminders about subject rights from statements about potential risk (whether or not those risks are valid). While it may be important to reinforce rights in a consent document, we believe it is contrary to best practice to even imply that voluntary participation (and the right to withdraw or refuse to answer questions) should be contingent on adverse reactions. The type of text described above, however, would be obviated if RECs adopted a more realistic view of subject perceptions regarding drug use surveys.