Access to Biospecimens and Data

Timely access to human specimens and data is crucial for research fields such as genomics, proteomics, metabolomics, molecular imaging, and nanotechnology. Researchers in these areas often rely on federally funded biospecimen resources for high-quality biospecimens and associated data. To best serve the needs of the research community, biospecimen resources should establish guidelines for sample distribution and clinical data sharing consistent with ethical principles; governing statutes and regulations; and, if applicable, informed consent language. These guidelines should have the following characteristics:

Clear to ensure their comprehension and adoption;
Flexible to allow application to diverse and evolving scientific needs; and
Amendable to facilitate their adaptability over time.

In addition, the guidelines established by biospecimen resources should delineate when biospecimens and clinical data are narrowly or broadly accessible and what justifications should be provided in the access requests to the biospecimen resources. These guidelines should apply to all new collections and, whenever practicable, to existing collections.

Under the NIH Genome Data Sharing Policy [69] human data in an NIH-designated repository is available to the broader scientific community under controlled-data access (unless otherwise specified, consistent with participant consent). Requests for controlled-access data are reviewed by an NIH Data Access Committee (DAC), and are granted based primarily on whether the proposed research use is consistent with the data use limitations (which are based on the informed consent of participants). NIH DACs do not review for the scientific merit of proposed research to use data in the NIH-designated repository. Investigators granted access to data in an NIH-designated repository must comply with the terms and conditions for the use of the data as set for in the Model Data Use Certification Agreement [112]. Accessing investigators must also abide by National Center for Biotechnology Information security best practices [113]. Information about access under the NIH GDS Policy should be included in the informed consent, consistent with NCI recommendations that the informed consent document describe whether data associated with or derived from biospecimens will be shared with other investigators and, if so, the oversight mechanisms for such sharing [see Section 2.3.2].

C.4.1. General Principles for Access Decisions

Access decisions should be guided by the following general principles, as appropriate:

Timely, equitable, and appropriate access to human specimens without undue administrative burden.
Scientific merit and institutional research qualifications, proven investigator experience with the proposed method, and a research plan appropriate to answer the study question.
Community attitudes and ethical/legal considerations as primary factors.
Fair, transparent, and clearly communicated access procedures.
Appropriate allocation of biospecimens based on the nature of the scientific investigation (e.g., discovery, prevalence, initial validation, and hypothesis testing) and the need for annotation. The level of identifiability of the biospecimen and related transfer documents should be appropriate for the proposed research.
A mechanism for addressing disputes over allocation decisions.
An investigator agreement covering confidentiality, use, disposition, and security of biospecimens and associated data.
The parties’ written agreement in an MTA or other appropriate document that is consistent, as applicable, with the NIH Research Tools Policy [114] and other applicable NIH sharing policies [68].

C.4.2. Research Plan

A scientifically sound and appropriate research plan should be included in access requests. If applicable to the study design and biospecimen resource purpose, the following specific issues are among those to be considered by the biospecimen resource in access decisions:

Use of standardized, validated research biomarker assay methodology.
Statistical evaluation that shows that the study question can be addressed with the samples available and, if applicable, a negotiated arrangement with a clinical protocol coordinating group to provide timely statistical analysis of study results.
Compliance with protocol-specific requirements needed to achieve study goals before other access is considered.
Confirmation that an investigator has defined funding and IRB approval for the project, if applicable (for information on application for and exemption from IRB approval, see OHRP guidance [115].
Agreement that the investigator will publish or provide public information about the project outcome according to applicable NIH policies, which may include the Research Tools Policy, and the Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research [116] (see: [117] and the 2013 update to the policy [118]). Of note, the NIH Research Tools Policy permits reasonable short-term publication delays; e.g., to file a patent or allow a collaborator to review a manuscript.

C.4.3. Access Policies

Appropriate policies should be developed to ensure that researchers’ access to biospecimens and associated clinical data is appropriate and in compliance with all applicable Federal and State privacy and human subjects regulations and statutes as well as the human research participant’s informed consent. The following issues should be considered when developing access policies:

Inclusion of appropriate provisions for the security of biospecimens and confidentiality of associated data in the usage agreement between the biospecimen resource and the researcher. For OHRP guidance on the use of coded biospecimens and data, see [74].
Consistency of the MTA or other appropriate document, as applicable, with the NIH Research Tools Policy [114] and other applicable NIH sharing policies [68].
Development of an informatics system to facilitate use or disclosure of biospecimens consistent with the research participant’s permission for the use of his/her biospecimens, including procedures to identify if and when that research participant has revoked consent for future research use.

C.4.4. Models of Sustainability

Appropriate models of biospecimen resource sustainability should emphasize accessibility to biospecimens and data and sustainability of the biospecimen resource within a framework that maintains public trust. These models should account for potential loss of funding; i.e., a legacy plan should be in place. (Also see Section C.1.2.) For example, in a cost-recovery model, charges for samples, if any, are used only to recover reasonable costs associated with operation of the biospecimen resource and not to generate undue profit for the biospecimen resource. Biospecimen resource sustainability models other than cost recovery (e.g., a collaborative agreement model involving more than one approved funding partner) may also be considered to support a biospecimen resource over the long term. NCI has developed a publicly available Biobank Economic Modeling Tool to aid in cost recovery and financial planning for biobanking, available online at (BEMT link: [16]). Note that receipt of Government funding, regardless of other financial sources, results in the expectation that biospecimens and resulting research resources and data will be available, consistent with applicable NIH sharing policies [68].

C.4.5. Availability of Biospecimens

The existence of biospecimens may be made public through the resource’s Web site itself and/or through well-known resources such as the NCI Specimen Resource Locator [67], which serves as a directory of biospecimen resources. Restrictions on accessibility to stored biospecimens should be indicated in these tools. In addition, biospecimen resources should encourage investigators to indicate the source of the biospecimens when research data resulting from the use of biospecimens are published.