Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape
- PMID:24639889
- PMCID: PMC3954467
- DOI: 10.1016/j.mpdhp.2013.06.015
Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape
Abstract
The use of human specimens in research has contributed to significant scientific and medical advancements. However, the development of sophisticated whole genome and informatics technologies and the increase in specimen and data sharing have raised new questions about the identifiability of specimens and the protection of participants in human specimen research. In the US, new regulations and policies are being considered to address these changes. This review discusses the current and proposed regulations as they apply to specimen research, as well as relevant policy discussions. It summarizes the ways that researchers and other stakeholders can provide their input to these discussions and policy development efforts. Input from all the stakeholders in specimen research will be essential for the development of policies that facilitate such research while at the same time protecting the rights and welfare of research participants.
Keywords: biorepositories; ethical issues; human specimen research; human subjects protection regulations; personalized medicine; research policy.
Conflict of interest statement
Conflicts of interest: M.J.B. is a member of the International Society for Biological and Environmental Repositories (ISBER).
Conflicts of interest: W.E.G. operates tumor banks as part of the Breast, Pancreatic and Cervical SPOREs at the University of Alabama at Birmingham and the Pulmonary Hypertension Breakthrough Initiative and prospective tissue repositories as part of the Cooperative Human Tissue Network and the Comprehensive Cancer Center and is a member of ISBER. He is also a member of the ethics group of the U54 grant, Morehouse School of Medicine/Tuskegee University/University of Alabama at Birmingham Comprehensive Cancer Center Partnership.
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