I'm Back
Well, I'm back. Summer's over and it's time to get back to business with this blog. I will again try and post something every week and expect readers to nag me when I don't.
One thing that's changed is that I've had to add some spam barriers to the blog. Recently several spam comments were posted to the blog. Now I have to moderate the blog and screen for spam comments. I hope this isn't an inconvenience to anyone.
As we move into the Fall, I'd really like to hear from people who read the blog. I don't get many comments and, sometimes, it feels like I'm shouting down an empty well. From time to time I hear people mention the blog, but I'd really like to get some feedback. What kinds of topics would people like to see me address?
posted by Jeffrey Cohen @ 9/01/2007 07:44:00 PM
2 comments
2 Comments:
Since you are a bit of an insider, it might be interesting to hear your opinion of that whopper of a determination letter OHRP sent to UC Berkeley in June.
Matt,
Well, the Berkeley determination letter is a bit "picky" to say the least, but I think I understand where OHRP is coming from. Many people would say, "What does all that stuff about the wording of their policies and procedures and the details of their review of protocols have to do with protecting subjects?" However, it really does have a direct relationship to subject protection. In my experience, most of the situations where the rights and welfare of subjects are put in jeopardy come from the situations where things "fall through the cracks". Investigators overlook something in the design of their research and IRBs miss them in their review. As I have been working with institutions to improve their HRPPs and in helping institutions become accredited, I have become convinced that the best way to avoid having things "fall through the cracks" is to have good, detailed policies and procedures. That way, investigators know what they need to address and IRBs are less likely to miss things in their review. Also, it's not good enough to do the right thing, you (IRBs and investigators) need to be able to demonstrate to others that you have done the right thing. That's accountability and that's how we maintain the public trust in our research. If you read OHRP's letter, you'll see that most of their concerns are about things that the IRB missed, lack of documentation, and written policies and procedures that don't adequately address what is needed. If Berkeley addresses all of their concerns (which should be easy to do), they should have a better program and things are less likely to "slip through the cracks".
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