No consensus yet exists on how to handle incidental fnd‐ings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two‐year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.
Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions.
Biobanks and archived datasets 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 (IFs) and individual research results (IRRs) of potential health, reproductive, or personal importance to individual contributors (using “biobank” here to refer to both collections of samples and collections of data). This paper reports recommendations from a 2-year, NIH-funded project. The authors analyze responsibilities to manage return of IFs and IRRs in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). They suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When re-identification 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 roster of returnable findings, (2) analyze a particular finding in relation to this, (3) re-identify the individual contributor, and (4) recontact the contributor to offer the finding. The authors suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and that are clinically actionable should generally be offered to consenting contributors. The paper specifies 10 concrete recommendations, addressing new biobanks and biobanks already in existence.
At the University of Minnesota, we have defined 'nondirected donation' as organ donation by a volunteer who offered to donate an organ to anyone on the cadaver waiting list. From October 1, 1997, through October 31, 2003, we have had 360 inquiries about nondirected donation, have completed 42 detailed nondirected donor (NDD) evaluations for kidney donation, and have performed 22 NDD transplants. We herein review our program policies and how they have evolved, describe our evaluation and the motivation of our potential donors, summarize the outcome of NDD transplants, and raise issues requiring further attention and study. Our experience continues to support nondirected donation for kidney transplants. Key words:Altruistic, Good Samaritan organ donation, living donor evaluation, living kidney donor, nondirected kidney donation IntroductionAt the University of Minnesota, we distinguish 'nondirected donation', which involves a living person's offer to donate an organ to anyone on the cadaver waiting list, from 'directed donation', which instead involves designation of a donor organ for a specific individual. Historically, the medical community has been suspicious of individuals offering to be nondirected donors (NDDs), fearing that ultimately they might harass the recipient or hospital because of their donation (1) or assuming that such individuals are likely to be mentally unstable. Yet when Sadler reported the first NDD cases in the 1960s, he noted that these donors were emotionally stable, self-supporting, and well educated. The donors did not feel coerced, and there were no psychological complications following donation. However, soon after Sadler's report, donations by any type of nongenetically related volunteers ceased, because it was felt that the outcomes (the then low patient and graft survival rates) of living unrelated donor (LURD) transplants (of which NDDs are a subset) did not justify the risk to the donors. But, since then, immunosuppression, as well as patient graft survival rates, have improved; in addition, less invasive donor surgical techniques (laparoscopic nephrectomy) have been developed. Consequently, LURD transplants have now become an acceptable and widely practiced option. In most LURD transplants, the donor has some type of emotional connection to the recipient (e.g. spouse, friend). In others, the donor may have come forward in response to a community or church appeal, or to a plea in the local media or on the Internet. The combination of improved access to media forums, of the well-publicized severe organ shortage, and of the recent awareness of laparoscopic nephrectomy recovery has led to an increased response by potential volunteer donors. In 2001, the number of living donors (related and unrelated) exceeded the number of deceased (formerly called cadaver) donors for the first time (2). In association with this increase in genetically and emotionally related volunteer donors, offers from potential NDDs have also increased.We previously reported on the development of our policy for ...
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