Governance is discussed at the onset in the NCI Best Practices, with the rationale that any collection of human biospecimens is guided by ethical, regulatory, and operational principles that are adopted, planned, and managed on an ongoing basis. A governance plan is the principled framework for a biospecimen resource that outlines the scientific objectives of the resource; the study protocol(s) or other documents defining the policies for participant recruitment; the biospecimen and data collection plans of the resource; the potential research use of the biospecimens and data; the data management and sharing plan(s); plans for the dissemination of study findings; and, as appropriate, policies and recommendations regarding the return of results to research participants. Governance plans also include appropriate protections for the physical integrity of biospecimens and data as well as procedures for the dissemination and use of the resource based on ethical, regulatory, and study principles. Governance plans require careful planning and transparent policies to ensure the long-term physical quality of biospecimens and the integrity of associated data; the privacy of research participants; the confidentiality of associated data; and the ethical, appropriate, and permitted uses of biospecimens and data. Plans for the intended use of the resource should be transparent and align with the information in the informed consent provided to participants.
Key ethical issues in biospecimen research activities 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.
Investigators and biospecimen resources should consult their institutional review boards (IRBs), as needed, as well as 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, privacy and confidentiality, and access to data. 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 information discussed in this document pertains to 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 and associated data. 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 NCI Best Practices contains the following topics:
- Overview
- Roles, Responsibilities, and Ownership
- Engagement of Patients, Providers, and Communities
- Transparency and Communication
- Informed Consent
- Return of Results
- Privacy and Confidentiality Protections
- Access to Biospecimens and Data
- Intellectual Property and Resource Sharing
- Conflict of Interest
- Biobank Sustainability
- Legacy and Contingency Plans