Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings 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.     

Protection for subjects in human research. Final rule

With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9.     

Protection of human subjects; compensating for research injuries; request for comments on report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

This notice requests public comment on the Report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research entitled "compensating Research Subjects," which was issued in June 1982.     

Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

Educational Research and the Protection of Human Subjects

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.