Human cloning and human dignity: an ethical inquiry--policy recommendations.
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There is currently no public policy that provides guidance concerning whether and when physicians infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) can safely perform invasive procedures. A committee of experts in the fields of medicine, law, and biomedical ethics and 1 community member, aided by an advisory board, was established to produce recommendations for policy reform. An extensive literature review was conducted for these 3 infectious diseases, medicine, surgery, epidemiology, law, and bioethics to gather all relevant data. Special recommendations are made regarding the management of physicians who are infected with HIV, HBV, and/or HCV. This policy proposal includes a list of exposure-prone procedures and a decision chart that indicates under what conditions infected physicians can practice beyond the need for disclosure of their serological status.
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Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of research. These views of risk conflict with scholarship showing that risk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risk encountered and more attuned to the priorities of trial subjects.
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