Managing incidental findings and research results in genomic research involving biobanks and archived data sets.

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.

Punishing physicians who torture: a work in progress.

BACKGROUND: There are only a few anecdotal accounts describing physicians being punished for complicity with torture or crimes against humanity. A fuller list of such cases would address the perception that physicians may torture with impunity and point to how to improve their accountability for such crimes. METHODS: We performed a multilingual web search of the records of international and national courts, military tribunals, medical associations (licensing boards and medical societies), medical and non-medical literature databases, human rights groups and media stories for reports of physicians who had been punished for complicity with torture or crimes against humanity that were committed after World War II. RESULTS: We found 56 physicians in eight countries who had been punished for complicity with torture or crimes against humanity. Courts punish crimes. Medical societies punish ethics violations. Fifty-one physicians (85%) had been punished by the medical associations of five countries. Eleven (18%) had been punished by domestic courts. International courts had imprisoned two (3%) physicians. Several were punished by courts and professional associations. There are open cases against 22 physicians. CONCLUSIONS: Punishments against physicians for crimes against humanity are becoming institutionalized. Medical associations must lead in shouldering responsibility for self-regulation in this matter. Physicians have supervised torture ever since medieval "Torture Physicians" certified that prisoners were medically capable of withstanding the torture and of providing the desired testimony. Revelations of sadistic medical experiments on prisoners during World War II turned the world against physician torturers and led to the "Doctor's Trial" at Nuremberg, a trial that held physicians accountable for crimes against humanity. This paper describes the largest case series of physicians who have been punished for abetting torture or other crimes against humanity committed after World War II. We wanted to: 1) describe and categorize the hearing procedures, 2) identify the roles of punished physicians, 3) categorize acts for which physicians are punished, and 4) describe the political cultures in which punishments arise. Our larger aim was to learn whether punishments against physicians for abetting torture or crimes against humanity occur under sufficiently diverse environments as to inform generalizable public policy to punish and perhaps to deter this kind of medical misconduct.