AAHRPP is coming! AAHRPP is coming! Eventually, anyway — we’re expecting an AAHRPP site visit in the months ahead as part of our reaccreditation process, and some IRB members will likely be asked to meet with the AAHRPP site visitors. To help you prepare, our IRB Members Blog will review some elements that AAHRPP will consider when reviewing our application. These will come in no particular order, so forgive us if we jump around some.
Standard II-3 requires the IRB to approve each study according to applicable laws, regulations, codes, and guidance. See IRB Policy 7.1 for the complete list of approval criteria (and remember that all of our contingencies should pertain only to these criteria; anything else is, strictly speaking, outside the IRB’s purview). Element II.3.A of this standard requires the IRB to have and follow written policies and procedures for identifying and analyzing risks and identifying the measures in place to minimize such risks. IRBs must consider whether risks to subjects are minimized by using procedures consistent with sound research design, whether risks to participants are reasonable relative to potential benefits, and whether enough resources are available to protect participants.
So think for a moment how you might explain to an AAHRPP interviewer how you would explain your consideration of these criteria. If the research involves procedures that would be done regardless of research participation, can the results of these procedures be used in the research? If everything being done for the study is being done only for the study, and not for any standard-of-care reason, are appropriate protections in place? Is there a less-risky way to obtain the information? Risks can include not only possible physical harm, but the potential for emotional or social harms, loss of confidentiality, etc.
In reviewing research, the IRB should also consider the importance of the knowledge that is expected to result from the research. Are the possible risks (and just about every study involves some potential risk) in proportion to the knowledge expected to be gained?
And think about the available resources to carry out the research. In most of the treatment-related research we see, we know that there will usually be enough in the way of medical expertise and physical resources available to minimize risks. However, for treatment and other types of studies, other resources may also come into play. Is there a possibility subjects may need referrals for follow-up care or counseling as a result of something learned during the research? Do the listed staff have the appropriate skills and qualifications to carry out their research roles?
The entire AAHRPP evaluation instrument is available online. Discussion of analyzing risks begins on page 82. We hope you will at least take a quick look at the instrument before the eventual AAHRPP site visit. If nothing else, it’ll highlight just how much work is involved in getting a human research protection program accredited.