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worth repeating |
Barbara Mishkin, a lawyer who specializes in cases involving misconduct in research, delivered the opening talk at a workshop on the issue sponsored by the Office of the Vice President for Research. Some excerpts: “One of the morals of this story is that when you have principal investigators at your institution who want to act both as a PI and as a sponsor, be sure that they understand the additional reporting requirements and the additional administrative requirements that come with being a sponsor. These are slightly different, and there are more of them than the requirements for being a PI. . . . We are seeing more and more of these—they want to be a sponsor of their own biomedical research, and they have no experience whatsoever. You’ve got to make sure that someone in an administrative office can tell them all about that. . . . “What we’re seeing now is much more litigation. First we saw a lot of NIH investigations of possible violations. . . . They have got regulations in place which do, now, provide due process in these investigations. So now you’ve got a lot of due process for professors accused, for protections for whistleblowers, and so forth. So that has now somehow receded, at least from my practice. . . . But we’re seeing now litigation by plaintiffs who claim that either they themselves or a member of their family had an injury done in some sort of sample research under a university’s auspices. And this is what is now coming to the fore, because you’ve got a small number of plaintiffs’ lawyers—one in New Jersey—who thinks this is a good way to make millions. So he has brought lots of complaints, class action suits. . . . And this is now predominantly what you are seeing as litigation in the courts.” |
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| —Beth Roberts |
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