Got the IRB Blues?
Some Things You Can Do
By Barbara A. Spellman
Unless you have been living in a cave, you should know by now that if you have the Institution Review Board (IRB) blues you are not alone. Two recent deaths of patients involved in medical experiments, plus an angry reaction to a sensitive questionnaire, have led many IRBs to become fearful and conservative in approving research involving human subjects - even the most innocuous "minimal risk" research that many of us do. IRBs may demand very lengthy consent forms, require us to describe the most minute details of every variation of every experiment we plan to run, refuse to use their discretion to grant exemptions or expedited reviews, or require us to put in our debriefings advice as to where the participants might turn for counseling in case the most mundane of events in an experiment might have upset them.
The good news is that these concerns have not gone unnoticed. There are currently at least four different organizations in Washington gathering information to address questions such as: Should there be differences between oversight for medical research and non-medically invasive behavioral research? Are consent forms always necessary or appropriate? What constitutes adequate protection for human subjects in behavioral and social science research?
In the last few months, APS has been very involved in both gathering information and speaking out on behalf of behavioral research. Here are some things we have learned about what you can do in the meantime to (quite ethically and legally) ease the IRB burden you might feel at your college or university. Some of these things can be done by individual researchers; to address other concerns you might band with other researchers in your department, go through your faculty senate, or discuss with the administrator in charge of research. Many of these suggestions come from Jeffrey Cohen, the Director of the Division of Education and Development in the Office for Human Research Protections (OHRP).
- Lobby to get more than one IRB at your university. Particularly if you are at a large university where biomedical research is done, it may be to your benefit to have separate IRBs - one for medical research and one for behavioral research.
- Make sure your IRB is well-supported. A properly-run IRB takes a lot of resources; a properly- and speedily-run IRB even more so. Perhaps it would be efficient to have more staff. You, your department, or even your faculty senate, might lobby those in charge for more resources and staff support.
- Make sure that there is adequate representation of the social and behavioral sciences on your IRB. The regulations state that an IRB should possess "the professional competence necessary to review specific research activities". Read: If your IRB is handling lots of social and behavioral research, it is required that someone with a social/behavioral background is on the IRB.
- Bite the bullet. Get on the IRB yourself and get your colleagues on it.
- Educate yourself and your colleagues. Encourage your IRB to use the flexibility built into the human protection system. You can educate yourself both about the rules at your own university and the federal guidelines. APS now has a section online (www.psychologicalscience.org) devoted to IRB news. There, you will find links to a lot of useful information:
- At the Office of Human Research Protections (OHRP) website you can find the federal regulations dealing with subject protection. You can learn what really are the required procedures for exemptions, expedited review, and consent forms.
- If you prefer not to choke on legalize, check out the article by Tom Puglisi published in the May/June 2001 Observer and accessible from the APS website. He has plenty of readable advice.
- NIH also has a website that explains many of the regulations in plain English. See: http://obssr.od.nih.gov/IRB/protect.htm.
- Attend, or organize, a workshop on research with human subjects. OHRP has a series of such workshops that are open to everyone. They state that "the meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB." For a schedule of the workshops and more information go to: http://ohrp.osophs.dhhs.gov/wrkshp.htm.
WHAT APS IS DOING:
- We will maintain a website with useful information about IRBs. (See: www.psychologicalscience.org/newsresearch/irb/)
- We will continue to advocate in Washington for more appropriate treatment of social and behavioral research in the human subjects protection system.
- We will be publishing articles on IRBs (see our website for a list of those we have already published).
- We will have more on the APS convention program relating to human subjects protection and research review.
- We would like to have a list of APS members who are experienced with IRBs (e.g., people who have chaired them or served on them for long periods) and who are willing to give guidance both to APS and to individual members. Please e-mail firstname.lastname@example.org, attn: IRBs with your name, a description of your experience, and how you are willing to help.
- We are developing an e-mail help-system for our members. If you have a problem you would like answered about IRB procedures (or lack thereof), send it to email@example.com. Unfortunately, at this time we cannot guarantee individual answers to specific questions. (But soon… see point 5 immediately above.) For now, if several people have similar concerns, we will try to gather information and either send a group e-mail or, if the issues are of broad enough concern, write an article addressing those issues.
- We will keep you informed of ways to make understanding and dealing with IRBs easier. For example, it might be helpful to see flowcharts to help decide whether your research is eligible for an exemption or expedited review. Or it might be useful to see examples of language that has been approved for use in consent forms. OHRP is working on some of these things. We will keep you informed and refer you to them when they are complete.
Barbara A. Spellman is Secretary of the APS Board. Along with Board Member Linda Bartoshuk, she is heading the APS's initiatives on Institutional Review Boards.