Scientists and subjects

As 2003 dawns, the world is grappling with the birth of the alleged first human clone, indigenous people are demanding the return of their sampled DNA and gene therapy is facing unforeseen setbacks. "Biobanks" are enticing citizens to donate DNA with promises of unspecified future health benefits and a revamped US government advisory committee is considering extending human-subjects protections to blastocysts.Despite the prominence of issues concerning the rights of human research participants, many investigators still have little training in this area of bioethics. For researchers seeking a handle on the increasingly complex ethics of their work, an upcoming online meeting-of-minds, the Scientists and Subjects (SAS) seminar, provides "an intensive, focused curriculum addressing core issues in human subjects research." Kenneth Pimple, Director of Teaching Research Ethics Programs at the Poynter Center for the Study of Ethics and American Institutions at Indiana University in Bloomington, developed the NIH-sponsored program, whose fourth offering will run January 13 to March 14, 2003.Following an introductory week, the seminar includes four units of two weeks each, covering topics such as, justifying human experimentation; analysis of the Belmont Report, which in 1979 established the three fundamental ethical principles for all research using human subjects; informed consent and therapeutic obligations in research. Participants read articles, write responses and share ideas through guided online discussion. SAS evolved from workshops Pimple was leading when he saw an NIH request for applications (RFA) for a short course in research ethics in 1999. "I thought, finally, an RFA with my name on it!" he recalled. The need for such a course has grown with biomedical science, said Robert Levine, an SAS advisory board member and professor of internal medicine at Yale University. "Twenty to thirty years ago, a few people could consult on ethical concerns, write up rules and regulations in the Federal Register, and review protocols and proposals and point out violations. There has been a growing concern that institutional review boards (IRBs) are missing some important things, and that they would work better if everyone knew ethics."For this fourth go-around, the eclectic participant mix is self-selected, in a first-come, first-served manner. In the program's first year, participants were nominated, and in the second and third years, they applied and were evaluated by the SAS advisory board. This year there is also a course fee of $50, as funding winds down. So far, the number of applicants "is beyond my expectations," Pimple said. Although readings are set, the group molds the experience, starting with each person citing "one troubling issue" on the registration form. "Perspectives from other seminar participants represent a variety of academic disciplines and administrative roles," said Julia Pedroni, a visiting assistant professor of philosophy at Williams College in Williamstown, Massachusetts and SAS advisory board member.Chuck Kowalski, for example, is a semi-retired "numbers guy" at the Center for Statistical Consultation and Research at the University of Michigan Dental School in Ann Arbor. Kowalski hadn't looked much beyond data analysis in clinical trials until he took the SAS seminar in 2000. "The course really lit my fire — I'm still doing reading in bioethics," he told The Scientist.Seminar graduates report that what they learned has lasting and spreading effects, from teaching students to protecting patients. "I have been much more effective reviewing protocols at the university IRB. In my own research I have been more attentive to regulations, but above all I now understand the rationale behind those regulations and their philosophical basis and controversies," said Ovidio De Leon, an associate professor of psychiatry at the University of Illinois, Chicago.

Scientists and subjects

Online bioethics seminar reviews basics in an increasingly complex research environment.

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