Monday, January 09, 2006

Working to do human subjects research right.

Today, some news that makes me smile (and not that bitter, cynical smile): UCSF has announced that it has received full accreditation for its program to protect research participants from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

This is a voluntary accreditation -- nothing the federal government requires, for example -- that undoubtedly required a great deal of work from UCSF investigators and administrators to obtain. (AAHRPP describes the process as including a preliminary self-assessment, followed by appropriate modifications of your institutions human subject protection program, preparation of a detailed written application, an on-site evaluation of your program by a team of experts, and review of these materials by the AAHRPP council on accreditation.) Here's what the UCSF news report has to say about the process:
While the US Department of Health and Human Services requires federally funded medical research centers to provide written assurance that all human research is in compliance with federal regulations and is guided by national ethical principles, the AAHRPP assessments are more rigorous and comprehensive.

AAHRPP reviews all programs involving research participants or their biological specimens– not only those programs that are federally funded -- and its assessment includes additional protections not required by the federal agency, such as community education and quality improvement activities.

The AAHRPP accreditation process took more than a year of preparation and several months of review, including evaluation of complex research protocols and related safety and privacy measures, as well as the caliber of training of investigators and the strength of the institutionwide commitment to human subjects' protection.

In the process, scrutiny was brought to bear on the effectiveness of interactions between various units needed to ensure the best protection, such as the institution's investigational drug pharmacy program, clinical research centers, committee examining potential conflicts of interest, office overseeing sponsored research, and overall medical center organization.

Notice that the focus here goes beyond whether an institution is following the letter of the law. Federal regulations on reserach with human subjects only extend to federally funded research. The AAHRPP is looking at all the research programs with human subjects at an institution -- whether funded by the feds, private donors, pharamaceutical companies, or any other entity -- to evaluate the human participant protections. And, as noted above, not only is AAHRPP asking for "additional protections not required by the federal agency, such as community education and quality improvement activities," but it is also attentitve to institutional features (e.g., "the effectiveness of interactions between various units needed to ensure the best protection") that are connected to how well programs to protect research participants function. The question is more than whether the institution is in compliance with standards right now, but whether the institution is set up in such a way that continued compliance is a robust part of the way things are done.

Why, you might ask, in the already busy crush of trying to get research done, would an institution take on the extra burden of applying for an accreditation that is not required of it? Part of the answer may be in the attention to how interaction between different units of an institution make compliance more natural. It's easier, in the long run, not to have to struggle to meet the necessary federal regulations -- having a system where the different units are all looking after subject protection, while maybe requiring more effort to set up, is a lower maintanence way to stay in compliance. Moreover, getting this sort of voluntary accreditation sends an unambiguous signal to the people in your organization that the institution is really committed to protecting human subjects, not just grudgingly meeting a bunch of onerous regulations imposed by the government. And, as AAHRPP points out,
Each time a new organization becomes accredited, the global benchmark for human research protection in science is raised.

In other words, working to make things good for human subjects at your institution is a way to make things better for human subjects everywhere.

The AAHRPP website makes for interesting reading, especially its discussion of five domains of standards for human research protection programs (Organization, Research Review Unit, including IRBs, Investigator, Sponsored Research, and Participant Outreach). Also, their advice for an institutional self-assessment looks like it would be valuable for any institution doing research with human subjects, regardless of whether that institution wanted to seek the AAHRPP accreditation.

Kudos to UCSF. Keep making us proud!


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