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), 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 and associated data 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).

Over the course of many years, NCI has convened workshops and meetings 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. The resulting recommendations formed the basis of the NCI Best Practices, first published in 2007. The first revision to the NCI Best Practices, released in 2011, provided additional recommendations formulated during the 2007 NCI-hosted Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research. In the 2016 revision to the NCI Best Practices, the ethical, legal, and policy best practices were updated based on more recent information and guidance concerning informed consent, return of research results and incidental findings, and community engagement.

Ethical, legal and policy considerations for biobanking represent a growing area of research and policy. Investigators and biospecimen resources should consult their IRBs, as needed, and appropriate institutional officials to determine how Federal and State regulations and policies may apply to their resource and how to implement information in the NCI Best Practices related to human subjects research as defined in 45 CFR Part 46. Biospecimen resources that expect to make samples available for NIH-funded research should be aware of NIH data sharing policies. The NIH Genomic Data Sharing (GDS) Policy has set forth expectations regarding informed consent [C.2], privacy and confidentiality [C.3], and access to data [C.3]. To maximize the utility of samples for NIH-funded research, biospecimen resources should anticipate that their sample collections will need to be consistent with NIH GDS Policy requirements.

The regulations and proposed standards discussed in this document are for research using biospecimens in the United States. Many countries have their own ethical, legal 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.

This section of the Best Practices contains the following topics:

• Principles for Responsible Custodianship
• Informed Consent
• Privacy and Confidentiality Protections
• Access to Biospecimens and Data
• Intellectual Property & Resource Sharing
• Conflicts of Interest