Human Subjects Protection, Unintended Consequences Edition

The New York Times has a story here (oddly printed in the Arts section) dealing with some unintended consequences of the proposed changes to the Common Rule, which protects human subjects of research. One of the major proposed changes (which I earlier mentioned here) is to implement HIPAA-like privacy and security standards to protect the data gathered in human-subjects research. The idea is to relieve IRBs from having to consider "informational risks" when they evaluate studies (risks related to subjects' having their personal data leaked out into the world). The Times article notes that the actual HIPAA standards prevent data collected for one purpose from being released to researchers for another. This means that studies-about-studies (like the recent work of Susan Reverby, which uncovered unethical US research in Guatemala) could be much more difficult to conduct. Jerry Menikoff of OHRP has said that the government will work on the problem, based on the comments received from historians and social scientists. This is an example of a good feature of our administrative law system: federal regulations are always released in draft form with a comment period, precisely so that problems like this can be pointed out by interested parties and addressed before the rules become final. The rub is that regulators are not as responsive to comments as we'd sometimes like them to be. But in this case, researchers have in Jerry Menikoff a former academic bioethicist with real expertise in this area. He'll take all the comments seriously.