Ethical Legal and Policy Best Practices
In addition to technical issues relating to the physical integrity and quality of biospecimens, multiple ethical, legal, and policy issues should be considered in biospecimen research activities. Key ethical issues include respecting the autonomy of human research participants (human subjects 3 ). protecting human research participants from breaches of privacy and confidentiality, and minimizing individual and group harms. Legal and policy issues include adhering to relevant Federal, State, and local laws and regulations surrounding the collection, storage, dissemination, and use of biospecimens; developing appropriate guidelines for biospecimen access; ensuring that biospecimens are used in scientifically meritorious research; and establishing biospecimen resource governance. (Refer to Sections C1 through C6 for specific details about relevant regulations and policies.)
In 2005, the NCI hosted a workshop that assembled diverse representatives from the cancer research community as well as ethics, legal, and policy experts to discuss and propose approaches that could help unify, integrate, and improve NCI-supported biospecimen resources and biospecimen research in general. The recommendations that resulted from this workshop as well as additional NCI-sponsored meetings and work conducted between 2002 and 2005 formed the basis of the NCI Best Practices. This first revision to the NCI Best Practices provides additional recommendations formulated during the 2007 NCI-hosted Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research. Featuring leaders from the academic community, private sector, patient advocacy groups, and Government agencies, this landmark symposium-workshop was convened to develop recommendations for best practices concerning the custodianship of biospecimens and associated data at NCI-supported resources and to expand upon the original NCI Best Practices in four key areas: (1) Considerations for human research participants, investigators, and institutions; (2) financial conflicts of COIs; (3) intellectual property (IP) ; and (4) access to products and benefits. Recommendations generated during this symposium-workshop comprise the revisions to Section C of the NCI Best Practices .
The ethical, legal, and policy best practices outlined in this document identify key regulations and recommendations relevant to biospecimen collection, storage, dissemination, and use in research. These best practices are more detailed and extensive than, for example, a grant policy statement; however, not every element outlined in the NCI Best Practices would apply to every biospecimen research activity. Investigators and biospecimen resource directors should consider these principles carefully in conjunction with the objective of the research project and the mission of the biospecimen resource to determine the most appropriate operational policies. Furthermore, investigators and biospecimen resources should consult their IRBs, as needed, and appropriate institutional officials to determine how Federal and State regulations and policies would apply to their resource and how to implement recommendations in the NCI Best Practices related to human subjects research, as defined in 45 CFR Part 46 .
The regulations and proposed standards discussed in this document are for research using biospecimens in the United States. Many countries have their own ethical and policy standards for human subjects research including, in some cases, specific provisions for the use of biospecimens. Investigators and biospecimen resources should be aware of international standards that may be applicable and address any differences between international and U.S. regulatory requirements prior to the initiation of a new collaboration or collection.
The NCI views the terms "human research participant" and "human subject" as equivalent. The former term is used throughout this document in order to recognize the important and active role of patients and volunteers in research. "Human research participant" is intended to have the same meaning as human subject, as defined in 45 CFR Part 46 .