V. Benjamin Wilfond, M.D.

Benjamin Wilfond, M.D., Co-Director, Office of Bioethics and Special Populations Research, National Human Genome Research Institute (NHGRI), discussed the issues involved in informed consent for NHGRI genetic research. Dr. Wilfond focused on the challenges of genetic research related to informing subjects of medical, legal and social risks, and the projects's efforts to minimize risk. Some of the potential risks are misunderstanding of information, confusion about information, anxiety, implications for related family members, stigmatization, discrimination, vulnerable populations, and group harm from labeling or reinforcing stereotypes.

Dr. Wilfond felt strongly that informed consent is not a form but a process that includes a variety of ways to communicate. He discussed several of these elements: (1) assessing decisional capacity; (2) reasonable disclosure; (3) comprehension: and, (4) the voluntary nature of participation. Dr. Wilfond also emphasized that for research involving children, the major concerns should be: (1) the benefits to the child, not the parents; (2) minimizing harm; and, (3) protecting the child's autonomy and future rights.

Dr. Wilfond proposed the following ways to minimize harm to subjects: (1) disclose results to minimize stigma or do not disclose results to subjects; (2) remove linkage of samples to research findings; (3) Encrypt database; (4) disguise family pedigrees; (5) involve the patient community in research design; (6) obtain informed consent after IRB Review of informed consent process; and, (7) provide and assess genetic counseling, if results are disclosed; and (8) assess real or potential harms.

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