Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Session 2: Risks and Harms
Session 2: Risks and Harms
Pages 19-34
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From page 19... ...
research." Fisher added that because there is little evidence that certain types of social and behavioral research, such as surveys and interviews, carry significant risks, there are concerns that these disciplines may be over-regulated and that this over-regulation may mean that actual harms in other areas are being overlooked. Another issue raised by the ANPRM is which types of research should be eligible for expedited review.
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From page 20... ...
In addition, data security criteria could be empirically supported by relevant research to ensure adequate participant protections and to guard against overly burdensome security protections for low-probability and low-magnitude information risks that could discourage research. Finally, the issue of exempt research is of major importance to social and behavioral researchers.
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From page 21... ...
Steven Breckler discussed issues related to risk in psychology research. Charles Plott discussed whether some entire areas of social and behavioral research might be exempted from IRB review based on the topics they explore and the methods they employ.
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From page 22... ...
The formal definition that is used in epidemiology is the probability of a particular event occurring within some unit of time or period of exposure. Risk may also refer to a negative outcome, with or without reference to probability involved, as in the phrase "risky behaviors." Risk may also refer to general uncertainty, as in the idea of a "risky investment." In that case, the outcome might be good or bad, but the implication is that it will be bad.
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From page 23... ...
Another distinction is between permanent and transitory harm. "An unstated aspect of the daily life standard is that we assume the presumed harms are of low magnitude and short lasting," he said.
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From page 24... ...
. In general, Mustanski explained, the funders of prevention programs require some evidence that a program will be effective before providing funds, and because there has been little research into the effectiveness of prevention programs among adolescent men who have sex with men, there are no prevention programs for this group.
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From page 25... ...
These behaviors are often kept private and may, in some cases, be illegal, so being asked about them could be psychologically distressing. Because of such concerns, Mustanski said, many IRBs have considered that these surveys pose greater than minimal risk, and they often encourage or require researchers to provide a statement to potential participants that includes such warnings as "Some of these issues could make you feel uneasy or embarrassed" or "You may be very upset by answering these questions" or even "You may need psychological services after answering these questions." However, Mustanski said, there is evidence that the risks of such psychological stress are actually quite low, citing research on the participants in his own Project Q2 study, a long-running longitudinal study of LGBT youth, which asked questions about mental health problems, substance use, HIV, and sexual behavior.
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From page 26... ...
Mustanski posed the question of whether this evidence means that research on risky behaviors should no longer be considered "minimal risk" for the purpose of an IRB review, acknowledging that it is not an easy question to answer. When he asked the participants in one of his studies to compare their level of comfort answering survey questions with a typical visit to a doctor or counselor, 54 percent said it was more comfortable answering the survey questions, another 35 percent said it was about the same, and 11 percent said it was more uncomfortable answering the survey questions.
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From page 27... ...
"All in all," he said, "it took 10 months out of a 24-month grant to receive IRB approval." Mustanski closed with a brief discussion of the benefits that participants reported from being included in the study. The Common Rule specifies that a basic element of informed consent is letting participants know of any benefits -- to the participants or to others -- that can reasonably be expected from the study, but "benefit" is not clearly defined.
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From page 28... ...
Such evidence already exists for most of what happens in social and behavioral research, he said. Data are available on many foreseeable sources of harm: the methods and procedures used, the particular topics chosen, the features of the populations under study, and interactions among these factors.
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From page 29... ...
Minimal Risk Breckler echoed earlier speakers in highlighting the importance of how minimal risk is defined and assessed for social and behavioral research. The existing definition as Richard Campbell had explained is rooted in the concept of the risks ordinarily encountered in daily life.
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From page 30... ...
This balance between the risk of harms and the protections included in the study is key to determining minimal risk, Breckler said. "This point is often lost on IRBs -- that it's possible to mitigate reasonably foreseeable harms with protections that render those potential harms as minimal risk." That is why decision-making tools of this sort can be so valuable in determining which studies are minimal risk, he suggested.
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From page 31... ...
For example, cell phone licenses are sold using a process based on many years of research regarding the best ways to carry out auctions of complex goods. The Kidney Exchange, a program that allows transplant kidneys to be "traded" so that their recipients get the best possible matches, was designed using basic science and experiments in economics.
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From page 32... ...
That is it." If there were true risks involved in such research, Plott said, they would show up in a study that involved this many people. As it was, the only harms reported were extremely mild, and Plott suggested that they are not what would be considered "real harms." Part of the reason why there is no risk or harm involved in these studies, Plott said, is that the research topics are drawn from daily life.
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From page 33... ...
"We should ask ourselves," he commented, whether there "are there large areas that might not be part of this [IRB] process." He added that, "if no evidence of risk or harm exists, then the appropriate techniques, methods, areas, and fields of the social sciences might be identified and exempted, or excused." These considerations may hold not just for economics, political science, game theory, and judgment and decision making, he said.
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From page 34... ...
Presentation to the National Research Council Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences, Washington DC. Available: http:// www.tvworldwide.com/events/nas/130321/# [June 2013]
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