tag:blogger.com,1999:blog-525778292565554519.post3681216637807291600..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: Hospital IRB Forbids Interviews with PatientsZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-525778292565554519.post-65839703840873455862010-07-28T21:39:59.306-04:002010-07-28T21:39:59.306-04:00Thank you for these comments.
First, my impressio...Thank you for these comments.<br /><br />First, my impression is that the Yale case studies are based on real events. They have been anonymized, though unless details have been substantially changed, it should be possible to identify the researchers involved once they publish their findings, if not before.<br /><br />Second, I agree with you that strategies exist to prepare a researcher for this kind of interview. <a href="http://www.yale.edu/bioethics/comment1case3.htm" rel="nofollow">Dr. Lois Sadler's comment on this case</a> cites some literature offering such strategies, of which the most relevant appears to be Karen Kavanaugh, and Lioness Ayres, "<a href="http://www3.interscience.wiley.com/journal/33709/abstract" rel="nofollow">Not as bad as it could have been: Assessing and mitigating harm during research interviews on sensitive topics</a>," <em>Research in Nursing and Health</em> 21 (1998): 91-97. But Kavanaugh and Ayres do not claim that any strategy will prevent all participants from getting upset. People who are in pain will, at times, express that pain, and there is nothing wrong with that. And keep in mind that this researcher, a trained nurse, did have a plan: she explained to the patients what the project was about, and when one asked her to leave, she left. It's not clear to me that any other action would have been better. <br /><br />Finally, it would be lovely if IRBs played "an important role in identifying risks that the researchers have failed to consider and prepare for." But the system we have now gives IRBs enormous power to shut down research without requiring them to know anything about that research. This mismatch between knowledge and power regularly produces the kind of arbitrary decision-making we see here.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-84817590462123039162010-07-28T14:44:12.207-04:002010-07-28T14:44:12.207-04:00Is this a real case or one created for training pu...Is this a real case or one created for training purposes? I couldn't tell.<br /><br />As someone who has been both in the research role and IRB reviewer role on similar studies this strikes me as an account of the IRB failing to recognize that it lacked the experience and knowledge to do a proper review. The problem is compounded by the fact the interviewer also seems to lack experience. And, when a problem arose, the IRB failed to address it appropriately. It should have sought the necessary expertise, and required changes to the protocol and consent process.<br /><br />You write: "The IRB system is premised on the idea that risks and benefits are predictable." Well unexpected things happen, and that's recognized in the regulations, but in this case it shouldn't have been that hard to say "Gee, this person is interviewing people who may be dying about their religious beliefs in relation to their illness. Maybe that might bring up thoughts of impending death that could be distressing. Has the researcher considered this possibility and has she considered how to conduct these interviews in a way that minimizes the risk of distress to the subject?" <br /><br />Usually in interview studies where there is a possibility, even a small one, that the interviewee might become upset, there should be some type of contingency plan in the protocol if the interviewee appears to be showing signs of distress. The interviewer may be required by the protocol to ask the interviewee if they wish to continue or the interviewer may on their own accord decide it is best to terminate the interview. In some research interviewees may be offered access to counseling and other services. And all this should be covered in the informed consent i.e. the subjects should be informed that there is a possibility that the questions might cause distress, that participation is voluntary, that they can refuse to answer specific questions and that they can stop at any time. <br /><br />IRBs are not perfect but this strikes me as a good example of why some sort of independent review of social science research, in accord with the regulatory requirements, which was not the case in this instance, is important. True, much social science research doesn't involve significant risk and should probably be treated as exempt, but there are plenty of research activities undertaken by social scientists where the IRB has an important role in identifying risks that the researchers have failed to consider and prepare for.Alannoreply@blogger.com