Dear Dr. X,
I am sorry it has taken over 5 weeks for you to receive your letter from the IRB. What's more, your response, whenever you actually respond to it--because investigators such as yourself take a long time to respond but like to blame the entire time it takes for your study to be reviewed on the IRB--will have to go back to the full IRB. Lucky you.
We needed a consultant for your study because it was so obscure and strange in design. You won't like to hear this either but federal regulations require us to seek out expertise when none are available on the Board for your line of research.
But I hope you take my advice and simply answer the questions, give in and agree with the IRB on the minor issues raised, and did I say answer the questions? Most investigators (often study coordinators) DO NOT answer the questions. The result? More delays.
These sorts of delays are easily but erroneously blamed on the IRB. Still, the IRB is such an easy target and the temptation so great that it is understandable. However, it's a shared blame and one which can be fixed given a re-prioritization of the powers-that-be to resourcing, education, and collaboration. In time, I believe this will occur.... It must, actually, for the sake of advancement of science in the long run.
This is a letter I could never write in real life. And so I write this make believe letter here on this make-believe blog.
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About Me
- GTMR
- Is written for--and read by--anyone who loves, hates, or loves to hate IRBs. This blog primarily focuses on medical research, but social-behavioral IRBs fans and detractors are also welcome (I feel your pain).
Alphabet Soup
- AAHRPP: Association for the Accreditation of Human Research Protection Programs
- CoC: Certificate of Confidentiality
- HIPAA: Health Insurance Portability and Accountability Act
- IRB: Institutional Review Board
- OHRP: Office of Human Research Protections
- PAM: Post Approval Monitoring
- PI: Principal Investigator
- SOPs: Standard Operating Procedures
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3 comments:
Good point as far as it goes, but IRBs bear responsibilities as well. If an IRB is so set in how they process and review protocols and have time consuming and labor intensive work/business procedures in place and craft needlessly verbose issues letters that do a poor job of identifying the true issues at hand, one can't blame PIs and coordinators for not responding to issues or having much respect for the IRB office in general. Some IRBs do a very poor job of customer service and seem intent on creating an adverserial relationship with PIs rather than serving as results oriented office seeking a collaborative relationship wiht PIs in improving protection of human subjects. Good luck dealing with you've got to deal with.
I think your comment is a fair one. I think it points to a larger issue of the value of IRB review in the first place and whether it protects subjects as it purports. I, for one, have not become so pessimistic that I think IRBs are useless. I think things can be done better from both the IRB-side and the Investigator-side.
I agree that IRBs are not useless, but the system is in vast need of an overhaul in a number of areas including the Federal Regulations guiding IRBs; the theoretical basis of IRB review (The Belmont Report is 30 years old--time to revisit it, re-evaluate its principles and stop resting on its laurels); providing a suitable framework for IRB review of non medical research studies (it's ludricous to apply a largely biomedical framework to studies from the realms of Social Science and the Humanities); and to provide a balance between an IRB's role in helping to create a research culture where protection of human subjects is taken seriously and the inevitable role of an IRB in reviewing, modifying and approving protocols such that the local institution is protected from being sued if something goes wrong, or if a suit comes to trial, to ensure that the institution either wins its case or its penalites are minimized (some IRBs are bogged down in processes and minute policy for the sole purpose of protecting the interests of risk adverse institutions and/or institutional officials rather than engaged in meaningful oversight of research subject protection).
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