The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine
http://www.100md.com
《新英格兰医药杂志》
During the past decade, national, regional, and international organizations and advisory bodies, bioethicists, patient advocates, and biomedical researchers have examined the legal, ethical, and social implications of collecting, storing, and conducting research with human-tissue samples. In The Stored Tissue Issue, Weir and Olick assess the ongoing debates about and controversy over the need for and specificity of informed consent; the privacy, confidentiality, and ownership issues related to samples and the genetic information derived from them; and the extent to which commercial profits should be shared with persons and communities that give their genetic material to researchers.
Although Weir and Olick cover familiar terrain, a key feature of the book is their critical analysis of the recommendations by the National Bioethics Advisory Commission (NBAC) in its report, "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance." Weir and Olick contend that the NBAC failed to achieve "the right balance" between the desire to protect persons who give researchers their tissue and genetic material and the goal of promoting biomedical research. For instance, the authors note that when the interests of persons are in conflict with the interests of researchers on matters of informed consent, the NBAC consistently offers policy recommendations that favor the interests of biomedical researchers. The authors assert that such recommendations underplay the mutual interests that both parties have in controlling the conditions of tissue research, as well as the importance of individual choice as a key feature of the principle of informed consent. Indeed, Weir and Olick point out that surveys of public opinion indicate that people want information about how researchers propose to use their genetic samples, and they want control over the uses to which their samples will be put.
Weir and Olick also show that the recommendations of the NBAC do not reflect some of the common themes found in several international policy statements. Among these are the notion of human dignity, the right of people to control how their samples are used, and the commercial aspects of research that involves the use of genetic samples. Drawing from these themes, the authors issue a list of recommendations that differ from the NBAC approach, particularly with regard to informed consent. They recommend that researchers and institutions disclose detailed information about policies that concern the collection, storage, use, privacy, and commercial benefit of genetic samples; that institutional review boards have a more active role in overseeing research that involves stored samples; and that institutions provide institutional review boards with the resources they need to do a thorough and responsible job.
Weir and Olick recommend that U.S. regulations on human research require disclosure by researchers about financial conflicts of interest and commercial gain, strengthen the requirements for informed consent in tissue research, state explicitly that persons have a right to self-determination over the use of their samples, require community consultation as well as community approval and individual consent for the collection of genetic samples from identifiable groups, and redefine the standard for minimal risk of harm so that potential psychosocial injuries and adverse effects on groups as a result of research with genetic samples are included in the definition.
The authors say that their recommendations are "intended to be reasonable, realistic, and productive of significant change" toward improving the practices used in the collection and storage of tissue samples and the research that involves them. What Weir and Olick do not say is whether the growing list of conflicting recommendations can be brought into harmony at the national and international levels and how such harmony can be accomplished. Nonetheless, as research with banked tissues and genetic material and data continues to increase, all who hold a stake in this area should give careful attention to the authors' assessment of the problematic ethical issues and their call for greater collaboration among researchers, institutions, and persons who participate in tissue research.
Karen J. Maschke, Ph.D.
Hastings Center
Garrison, NY 10524
maschkek@thehastingscenter.org(By Robert F. Weir and Rob)
Although Weir and Olick cover familiar terrain, a key feature of the book is their critical analysis of the recommendations by the National Bioethics Advisory Commission (NBAC) in its report, "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance." Weir and Olick contend that the NBAC failed to achieve "the right balance" between the desire to protect persons who give researchers their tissue and genetic material and the goal of promoting biomedical research. For instance, the authors note that when the interests of persons are in conflict with the interests of researchers on matters of informed consent, the NBAC consistently offers policy recommendations that favor the interests of biomedical researchers. The authors assert that such recommendations underplay the mutual interests that both parties have in controlling the conditions of tissue research, as well as the importance of individual choice as a key feature of the principle of informed consent. Indeed, Weir and Olick point out that surveys of public opinion indicate that people want information about how researchers propose to use their genetic samples, and they want control over the uses to which their samples will be put.
Weir and Olick also show that the recommendations of the NBAC do not reflect some of the common themes found in several international policy statements. Among these are the notion of human dignity, the right of people to control how their samples are used, and the commercial aspects of research that involves the use of genetic samples. Drawing from these themes, the authors issue a list of recommendations that differ from the NBAC approach, particularly with regard to informed consent. They recommend that researchers and institutions disclose detailed information about policies that concern the collection, storage, use, privacy, and commercial benefit of genetic samples; that institutional review boards have a more active role in overseeing research that involves stored samples; and that institutions provide institutional review boards with the resources they need to do a thorough and responsible job.
Weir and Olick recommend that U.S. regulations on human research require disclosure by researchers about financial conflicts of interest and commercial gain, strengthen the requirements for informed consent in tissue research, state explicitly that persons have a right to self-determination over the use of their samples, require community consultation as well as community approval and individual consent for the collection of genetic samples from identifiable groups, and redefine the standard for minimal risk of harm so that potential psychosocial injuries and adverse effects on groups as a result of research with genetic samples are included in the definition.
The authors say that their recommendations are "intended to be reasonable, realistic, and productive of significant change" toward improving the practices used in the collection and storage of tissue samples and the research that involves them. What Weir and Olick do not say is whether the growing list of conflicting recommendations can be brought into harmony at the national and international levels and how such harmony can be accomplished. Nonetheless, as research with banked tissues and genetic material and data continues to increase, all who hold a stake in this area should give careful attention to the authors' assessment of the problematic ethical issues and their call for greater collaboration among researchers, institutions, and persons who participate in tissue research.
Karen J. Maschke, Ph.D.
Hastings Center
Garrison, NY 10524
maschkek@thehastingscenter.org(By Robert F. Weir and Rob)