REVIEW
Ethical and legal issues in research involving human subjects: do you want a piece of me?
Correspondence to:
Correspondence to:
Marshall B Kapp
Garwin Distinguished Professor of Law and Medicine, School of Law, Southern Illinois University, 1150 Douglas Drive, Carbondale, IL 62901-6804, USA; kapp{at}siu.edu
The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
Abbreviations: AAMC, Association of American Medical Colleges; HIPAA, Health Insurance Portability and Accountability Act; IRB, institutional review board; OHRP, Office of Human Research Protections; PHI, protected health information
Keywords: ethics; law; research; tissue
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