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.
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