Gift Giving to Biobanks

We agree with Mark Rothstein\u27s goal of giving tissue donors control over their donated tissues. But we think using the research model as the basis for attaining this goal, while widely employed and accepted, should be abandoned. The research regulations were originally adopted to deal with interventions on living human beings, not on the tissue of human beings. The Nuremberg Code (a reaction to concentration camp experiments), the Willowbrook experiment, the Tuskegee syphilis experiment, and the other examples of the abuse of research subjects that provided the rationale for regulating research on human subjects clearly had nothing to do with research on their tissues. The regulations were directed at protecting the safety and welfare of the living human beings who are being intervened upon by researchers. Moreover, most of the concern over tissue collection has little, if anything, to do with research. For example, the creation of a tissue repository, regardless of the Office for Human Research Protections (OHRP 1997) position and guidance, is not research at all. There is no hypothesis, no methodology, no statistical design, and so forth. It is a mere warehouse of tissues, and all the tissue could be discarded without anyone ever doing anything to them resembling research. Nonetheless, the fact that tissue banking per se is not research doesn\u27t mean that there should be no rules for the donation of tissue to tissue banks. But rules for the donation of tissue to banks should not be dictated by inapt research regulations

The Genetic Privacy Act: A Proposal for National Legislation

Privacy is a major issue in medical law, and genetics is a major force in contemporary medical science. Nonetheless, the combination of these two fields has only recently been seen as central to both individual rights and medical progress. Disclosures in June of 1996 that White House officials had wrongly acquired and read FBI files of raw background checks of prominent Republicans reminded Americans that there is no such thing as a completely secure and secret file of personal information. Had these files contained DNA profiles or samples, they would have supplied additional information about the unsuspecting individuals-information that could be used against the individuals without their knowledge. In late June 1996, Senator Pete V. Domenici (R-N.M.) introduced S.1898, the Genetic Confidentiality and Nondiscrimination Act of 1996 (GCNA), which was based in large part on the proposed Genetic Privacy Act of 1995 (GPA) drafted by the authors.\u27 This article outlines the purpose and provisions of the GPA. Along the way, it highlights some of the differences between the GPA and the GCNA

Scientific Research with Children: Legal Incapacity and Proxy Consent

Before an investigator can use any person as a subject in biomedical or behavioral research, he must obtain that person\u27s informed consent. This consent must be voluntary, competent, and understanding.1 There are two questions that arise in regard to experimentation on children. First, is a child legally capable of giving an informed and understanding consent? Second, do parents have the legal capacity to consent to the performance of research on their children? This article will attempt to answer both of these questions

Amici for Appellees: Brief for Bioethicists for Privacy as Amicus Curiae Supporting Appelles Brief for Bioethicists for Privacy as Amicus Curiae Supporting Appellees

Amicus is an ad hoc group of 57 philosophers, theologians, attorneys and physicians .. .who teach medical ethics to medical students and physicians. The members believe that permitting competent adults to make important, personal medical decisions in consultation with their physician is a fundamental principle of medical ethics, and that the doctor-patient relationship deserves the constitutional protection the Court has afforded it under the right of privacy

Palliative care: End-of-life symptoms

Gregory B. Crawford, Katherine A. Hauser, and Wendy I. Janse

Scientific Research with Children: Legal Incapacity and Proxy Consent

Before an investigator can use any person as a subject in biomedical or behavioral research, he must obtain that person\u27s informed consent. This consent must be voluntary, competent, and understanding.1 There are two questions that arise in regard to experimentation on children. First, is a child legally capable of giving an informed and understanding consent? Second, do parents have the legal capacity to consent to the performance of research on their children? This article will attempt to answer both of these questions

The Genetic Privacy Act: A Proposal for National Legislation

Privacy is a major issue in medical law, and genetics is a major force in contemporary medical science. Nonetheless, the combination of these two fields has only recently been seen as central to both individual rights and medical progress. Disclosures in June of 1996 that White House officials had wrongly acquired and read FBI files of raw background checks of prominent Republicans reminded Americans that there is no such thing as a completely secure and secret file of personal information. Had these files contained DNA profiles or samples, they would have supplied additional information about the unsuspecting individuals-information that could be used against the individuals without their knowledge. In late June 1996, Senator Pete V. Domenici (R-N.M.) introduced S.1898, the Genetic Confidentiality and Nondiscrimination Act of 1996 (GCNA), which was based in large part on the proposed Genetic Privacy Act of 1995 (GPA) drafted by the authors.\u27 This article outlines the purpose and provisions of the GPA. Along the way, it highlights some of the differences between the GPA and the GCNA