PRIM&R Thoughts

Just back from PRIM&R in Orlando. It was a fantastic meeting; one of the best yet. The theme of the meeting was one that resonated with me because it is a theme that I have been stressing for almost 30 years - balancing the needs of human subjects and science. I have been saying for years that the role of the IRB is not to protect subjects but to facilitate ethical research. The IRB does that by balancing these two social concerns - the rights and welfare of human subjects and the need to advance science and human understanding.

One way to help achieve that balance is for IRBs to understand and use the flexibility in the regulations. The regulations give the IRB considerable flexibility and authority to effectively and efficiently conduct reviews that are appropriate to the research and not impose unreasonable burdens on researchers. Why don't some IRBs utilize the flexibility in regulations? As Kristina Boror, Director of the Division of Compliance Oversight at OHRP, said at a workshop on flexibility at PRIM&R, some of the reasons include:
- Ignorance of regulatory flexibility
- Fear of making the wrong decision
- Fear of OHRP or other compliance oversight determination
- Mistrust of reviewers or investigators

So, the first thing is for IRBs to understand the flexibility in the regulations. IRBs have flexibility with regard to the definition of human subjects research, determining exemptions, using expedited review and waivers of informed consent and/or documentation of consent. IRBs should understand how to use these flexibilties withing the parameters of the regulations.

Many IRBs are afraid to use the flexibility because they are afraid that they will be "shut down" for making the wrong decisions. Our former boss at OHRP, Greg Koski, coined a term for this - "reactive hyper-protectionism". Fear of regulatory oversight causes rigidity in applying the regulations. This is not what the regulations intend and it is not what OHRP or FDA intend. The regulations were written so that IRBs would use the flexibility and OHRP and FDA expect IRBs to use the flexibility. As long as the IRBs understand the parameters in place for using the flexibility and stay within those parameters, the feds are not going to second guess them. Also, institutions do not get "shut down" for individual decisions, they might get criticized by OHRP or FDA, but they only get "shut down" for system-wide failure to adequately protect subjects.

Then there is mistrust of investigators and reviewers. If the IRB is flexible, then the investigators will "get away with murder" (an actual comment I got from IRB members at an institution I was consulting for) and IRB reviewers will not do a substantive review. Well, this relates to the Belmont principle of respect. IRBs need to respect their investigators and reviewers and appreciate that they generally want to do the right thing. As long as the IRB has clear written policies and procedures, so that investigators and reviewers know the parameters of the flexiblity and how to apply it, then IRBs can trust the process and don't need to be "hyper-protectionist".

Finally, Ivor Pritchard, in his keynote address at PRIM&R, pointed out the risk of inconsistency inherent in flexiblity. This is a real risk and IRBs need to vigilent in making sure that, in applying the flexiblity, they remain reasonable consistent in the review process. The best way to do this is to have clear written policies and procedures so that the flexiblity is consistently applied.

In closing, I want to reiterate what I have been saying for some time. An IRB that is overly rigid in applying the regulations and does not use the flexibilty in the regulations is not living up to its mission and, by imposing unreasonable and unnecessary burdens on investigators, is actually doing harm to subjects and human welfare.