Sunday, August 20, 2006

Accreditation

As a consultant, I have been spending a lot of my time working with institutions on accreditation. I thought I’d share some of my general thoughts about accreditation on this blog.

First, let me say that I am a big fan of accreditation. I have worked with several institutions on accreditation over the past year and I think I can say, without reservation, that going through the accreditation process results in better human research protection programs. It does this in a couple of ways. First, preparing for accreditation forces an institution to examine its HRPP very closely. This often reveals gaps, inconsistencies and inefficiencies that creep into even the best programs. By committing to becoming accredited, institutions have to come up with ways to fix these problems. Second, accreditation forces institutions to have detailed, written policies and procedures for their HRPPs. Detailed policies and procedures help improve HRPPs in two ways: 1) they reduce the need for the IRB to make decisions on a case-by-case basis, and 2) they clearly inform investigators as to what is required to obtain IRB approval. Both of these help make an HRPP more effective and efficient.

That being said, I think many institutions go about the accreditation process the wrong way. Many institutions approach the accreditation process by trying to develop policies and procedures that address the elements of the accreditation standards. Not only do I think that this is the wrong way to develop policies and procedures, I also think that it hinders the accreditation process. My perception, which may or may not be shared by AAHRPP, is that the accreditation standards were not written to be a guide to the preparation of written HRPP policies and procedures, but as a tool for evaluating HRPPs (the document is even called an Evaluation Instrument). An institution’s written policies and procedures should be a working document that is used as a guide to the review and conduct of human subjects research, not something to get their HRPP accredited. Institutions should first make sure that they have the best HRPP they can have and write up policies and procedures that describe that program as clearly as possible. Then, they can go through the accreditation standards to make sure that all of the elements are addressed and, where necessary, modify the policies and procedures to better address the elements. Doing it the other way around results, I believe, in less usable policies and procedures. It also hinders and delays the accreditation process because it results in obsessing about what AAHRPP is looking for in each element. I’ve heard of institutions spending months and months, even years trying to do this. It is much more efficient to do it the way I suggested and then, during the accreditation process, let AAHRPP tell you where you might have missed the mark for a given element. Institutions should remember that they have ample opportunity to address deficiencies before a final accreditation decision is made. I also strongly recommend that institutions go through the preliminary application process. This allows you to address the deficiencies that AAHRPP identifies before you submit your final application.

People talk about accreditation the same way that people talk about going to the dentist, with fear and trepidation. Like with the dentist, it causes people to put off applying for accreditation (I’m using this analogy because my wife has been nagging about putting off going to the dentist for the past couple of months). If approached correctly, the accreditation process doesn’t have to be as aversive as people think and it can be a very positive experience (although they don’t give you a lollypop).