Journal of Continuing Education in the Health Professions



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CURRENT ISSUE BACK ISSUES SUBSCRIBE ADVERTISE ABOUT JCEHP FOR AUTHORS JCEHP AWARD SEARCH (Members only) FULL-TEXT		Volume 21 (4) Volume 21, Issue 4, Fall 2001 J Contin Educ Health Prof 2001; 21(4):198-202 ISSUES IN RESEARCH What's so important about conducting research involving third parties? Murrelle L McCarthy CR A b s t r a c t Controversy has arisen over the long-standing practice of collecting family health and behavioral history information in the course of conducting biomedical research. Identifiable individuals (third parties) on whom investigators collect private data through primary research subjects (probands) also are considered research subjects. At issue is whether informed consent is required from third parties prior to obtaining information about them from probands. A recent federal regulatory ruling dictates that investigators must either obtain informed consent from all third parties or their research must qualify for a waiver of consent. Because of the ruling, a traditional family medical history questionnaire, typical of those routinely used in genetic epidemiologic studies of familial risk, failed to meet the criteria for the waiver. The implications of this ruling are far-reaching. They could influence the quality of research in the United States on the causes of most human diseases. To enable continuing medical and bioethical education on the topic, in March 2001, Virginia Commonwealth University hosted a 2-day open conference, "Third Party Rights and Risks: A Forum on Informed Consent from Persons Affected by the Study of Human Subjects." International leaders from the fields of biomedical ethics and law convened with federal regulatory officials, Institutional Review Board members, academic and industry scientists, and patient-family rights advocates to discuss and debate this critical topic. Conference presenters submitted papers to clarify the issues, promote continued debate, and assist in the formulation of policy recommendations regarding third-party rights and risks. Lessons for Practice Investigators should consider carefully the ethical implications and the scientific importance of data collected on third parties through primary research subjects. When requesting a waiver of informed consent for third parties, investigators should defend systematically the need for such a waiver, defining clearly the steps to be taken to minimize the risk to third parties and to protect information about them. Institutional Review Board members should be thoroughly trained in federal regulations pertaining to data col-lection on third parties. Institutional Review Boards should require of investigators thorough documentation of the justifications used for seeking a waiver of consent for third-party data collection, recording meticulously their own deliberations of such requests. Researchers and Institutional Review Boards should work together to ensure that acceptable standards of ethical conduct are adhered to scrupulously in research involving data collection on third parties. MeSH Terms: Clinical Trials; Confidentiality; Epidemiology, Molecular; Ethics, Medical; Family Health; Genetic Privacy; Human Experimentation; Medical History Taking; Patient Rights; Pedigree; Questionnaires
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