Saturday, March 04, 2006

Mission Creep

The other day I was asked to comment on the "Mission Creep" white paper. The paper recommends "...focusing on those areas of research that pose the greatest risk, such as biomedical research, while removing or reducing scrutiny of many fields within the social sciences and humanities that pose minimal risk." This is based on the assumption that the primary purpose of IRB review is to protect subjects from risk. Beneficence, which addresses the relation between risk and benefit, is only one of the three Belmont principles. There are respect and justice issues even in minimal risk, innocuous research. I believe that all research activity, even innocuous research, requires some sort of independent, objective review. Reducing the oversight over minimal risk research jeopardizes

The problem that this paper is responding to is not IRB review per se, but IRB review that is unduly burdensome and that imposes unreasonable requirements. So, while claims that IRB review is not necessary for minimal risk research are not reasonable, IRBs are somewhat responsible for the attacks on IRB review. I have long argued that the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations. The horror stories that social and behavioral researchers quote in their attacks on IRB review are true. I have seen institutions where expedited review takes longer than full review and where IRBs have imposed written consent forms on telephone interview research. These are IRBs that a) don't understand social and behavioral research, b) don't know how to use or are afraid to use the flexibility in the regulations, and c) don't pay sufficient attention to the efficiency of their procedures.

The White Paper correctly recommends that IRBs receive better guidance on how to review non-biomedical research and that there needs to be increased sharing of best practices among IRBs. However, critics of IRB review should focus their attention on educating IRBs on the appropriate review of non-biomedical research rather than trying to reduce IRB oversight of such research.


At 8:34 AM, Blogger Bioethics Dude said...

Amen! I strongly agree with this sentiment that the regs provide appropriate tools for IRBs to utilize so that Soc/Beh. research is approved not only appropriately given the risk/benefits, but also in an appropriately timely manner (e.g., by use of the exempt or expedited categories). As you've mentione, I've also seen this come about due to IRB's fears of interpreting the regs correctly and/or a simple fear of some punitive action. Another element that can come about is a confusion between mere probability and reasonable probabability (e.g., we had a study a while back where students would take home a pillow that would be scented w/ various scents -1 scent/per pillow, and then recall their dreams --not great research design, but...b/c an IRB member raised whether the PI prescreen for individuals who could have been molested and the scents could trigger that recal, the IRB discussed this for about 30 minutes, trying to persuade her that this is not a reasonably probable event given the subject population). I think that it is in the role of the IRB Admin. to refer back to the regs, Belmont, and whatever other guidance docs. to keep such confusion from happening. I've rambled on, sorry.

At 7:37 PM, Anonymous Anonymous said...

For years we have received the message that the regs are flexible and therefore do not subject social and behavioral IRBs to unreasonable requirements. However, along comes accreditation and - poof - that flexibility that we were told we had, vanishes into thin air. And we're back to the stranglehold of biomed research replete with busy work like checklists. It's time to have a conversation about changing the regs and giving us true flexibility through the regs and not in the interpretation of the regs for which we can be penalized.

At 10:55 PM, Blogger Jeffrey Cohen said...


I have to disagree. Accreditation does not diminish flexibility. AAHRPP standards expect that IRBs will use the flexibility in the regulations appropriately. In fact, an institution that does not utilize the flexibility available for minimal risk research will not be likely to receive accreditation. I have served as an AAHRPP site visitor and have helped institutions apply for accreditation and I can state from experience that accreditaiton does not impose a biomedical model on social/behavioral research or reduce flexibility for minimal risk research. All AAHRPP wants is for institutions to have written policies and procedures which provide criteria for how the flexibility is used. If anything, with its emphasis on efficient processes, accreditation should increase the institutions use of the flexibility in the regs.

At 5:43 PM, Anonymous Anonymous said...

Believe me - my frustration with accreditation comes out of first hand experience.
Let's take an example - audiorecording. The study qualifies as exempt, and is truly innocuous, but for the fact of audio-taping. OHRP says that all studies that include audio and videotaping must be reviewed under the expedited category 6. So, we bump it up to the expedited level. Along comes AAHRPP and says that if it is an expedited study then the IRB has to make all the findings and determinations it is required to make. So, now all the checklists have to be completed making for much busy work and no added protections. This whole focus on written procedures and checklists galore has lost sight of the true mission of a HRPP.
I fully understand and appreciate that accreditation can help standardize actions and process. But when IRBs, and more specifically the soc/beh ones, are so poorly resourced, our time can be better used if the regulations allow us more categories of exemption and really let us focus on research that actually involves risk to subjects.
What we need are regulations that do away with what is really ambiguity and not flexibility, so that we do not have to rely on our interpretations or those of OHRP or AAHRPP.

At 6:46 PM, Blogger Jeffrey Cohen said...


Where does OHRP say that audio recording is not exempt? Expedited review categories apply only to non-exempt research. If the information on the audio recording does not contain identifiers then it is exempt. Video recording is usually considered to be identifiable, so it would not be exempt, but a good case can be made that a subject's identity is not "readily ascertainable" from an audio recording. Thus, according to the definition of identifiable data in the regulations, it would not be identifiable.

That being said, I firmly believe that even minimal risk research needs to be thoroughly reviewed. As I said, risk to subjects is not the only aspect of ethical research. Minimal risk research can still violate subjects' rights and welfare. Written standard and checklists help ensure that even minimal risk research gets a good review. As a consultant, I have seen a lot of sloppy review by IRBs where there aren't written standards and checklists. I have seen research slip through as exempt or expedited that really has risk because the review was sloppy. Requiring thorough, well-documented review does not have to be a burden on either the investigators or the IRB. I have seen and had personal experience with very efficient IRBs that do a thorough job without being burdensome.

At 3:58 PM, Anonymous Anonymous said...

One of your statements caught my attention - you said "If the information on the audio recording does not contain identifiers then it is exempt. Video recording is usually considered to be identifiable, so it would not be exempt, - but being identifiable alone does not automatically make something not elegible for exemption. The study can be exempt unless data is BOTH identifiable AND public release would put subjects at risk...

At 4:06 PM, Blogger Jeffrey Cohen said...


You are absolutely right. Just because it is identifiable doesn't make in inneligible for exemption. I don't know what I was thinking when I said that. Thanks for keeping me on my toes!

At 2:04 PM, Blogger James said...


I have to weigh in here also on your comment " So, now all the checklists have to be completed making for much busy work and no added protections."

IMHO, it sounds as though you are considering the function to be merely filing out forms so that the file looks "pretty". I must beg to differ. Completion of the checklists indicates that a member of the IRB went through and evaluated each of the requisite items in order to substantiate the determination.

Yes, the methodology can be flexible, but one also must have a basis in fact for doing what they do. And, if going through the intellectual exercise insures that we are considering all reasonably possible eventualities, then it is not busy work - it is doing our job!


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