Regulations

In light of the comments on my last post, I thought I'd post some of my thoughts about regulations. I have said most of this in the many presentations I've given on the regulations, but I thought I'd repeat them for this blog.

First of all, none of this (meaning human research protections) should be about complying with regulations. Now, I'm not saying you don't have to comply with the regulations. As a former fed, I'd be the last person to say that. You do have to comply with the regulations. But, that shouldn't be the primary focus of human research protections programs. The primary focus should be on doing it right because it is the right thing to do. Researchers have a moral and ethical responsibility to the subjects of their research and all research activities need an independent, objective review to help ensure that the research is done ethically. The primary focus of both the researchers and the IRBs should be on the ethics (along with the appropriate documentation to maintain accountablity). The good news is that, if researchers and IRBs focus on the ethics, they are most of the way there to complying with the regulations, since the regulations were designed to implement the ethical principles. The rest is just "dotting the i's and crossing the t's".

The second point I want to make is that the regulations are the floor, not the ceiling. The regulations establish minimum standards that must be followed with regard to human subjects research. Institutions are fee and should decide for themselves what the appropriate standards are for research conducted under their auspices, as long as those standards at least comply with the regulations.

Finally, as I said in my comment to Zach in the last post, I do not think that institutions should base their human subjects research policies on complying with the regulations. They should base their policies on how the institution has decided to fulfill its responsibility to the subjects because it's the right thing to do. In doing so, of course, the institution must commit to complying with all relevant federal, state, and local laws and regulations. In addition, I think that the decision making that goes into developing and adopting these policies should be an open and transparent process that includes input from all the stake holders (including investigators). In this way, no one at the institution can say, "Who are you to say I have to do this?"