5 ms·

I recommend reading the rest of the article; the author describes multiple state laws that apply in this case.

• j2kun 12y ago
  This is actually not so clear to me. The law in question [1] specifically states that it defers to the federal law [2], which clearly states in section §46.102(e): > "Research subject to regulation," and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity. Furthermore, the definition of "minimal risk" is given in part (i) of the same section, > the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine...psychological examinations or tests. The argument against Facebook and OKCupid are pretty slim here... How could you experience significantly more discomfort in daily life if OKCupid slightly changed their rating system? Any reasonable interpretation of this risk is negligible. [1] http://mlis.state.md.us/2002rs/bills/hb/hb0917t.pdf http://mlis.state.md.us/2002rs/bills/hb/hb0917t.pdf [2] http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf
  • dragonwriter 12y ago
    > The law in question specifically states that it defers to the federal law No, it says it incorporates the rules in the federal regulation, but applies them to all human research, expressly excluding all the other limitations in the federal rules that limit the applicability more narrowly. (No additional citation, because your own citations clearly establish this, contrary to your description.)
  • dalke 12y ago
    It's a bit tricky to understand the details, but I think I've got some of it figured out. There's "research" and there's "research subject to regulation." The federal law says that all research by or directed by federal departments is subject to this law. It also says that everyone, including you and I, who are doing research subject to regulation (which includes drug development) are also subject to the law. That is, even without MD 917, all research in MD which is subject to regulation would have been subject to the law. However, this leads to a gap. Anyone doing research, but not research that is subject to regulation, and not research which is funded or directed by a federal department or agency, is not subject to these ethical requirements. The MD law (see http://www.oag.state.md.us/Healthpol/hb917letter.pdf http://www.oag.state.md.us/Healthpol/hb917letter.pdf) is meant to close the gap, and include research which is not subject to regulation by a federal department. The "minimal risk" section you pointed out is for expedited review. That is, the research still needs an IRB, but the IRB can use the expedited review process instead. OkCupid didn't have an IRB, so the minimal risk section doesn't apply.
    • j2kun 12y ago
      Thanks. It's really hard to understand what MD917 is saying with all the strikethrough.
      • dalke 12y ago
        I agree. The problem is that MD917 is the bill, but not the actual law. Bills are often structured as a delta to the law.