Suggested Resource Sharing Plan Elements for Biospecimen Management and Sharing

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• Overview
• Suggested Biospecimen Management and Sharing Elements
• Need More Information?

Overview

As stated in section B.1.5.4. of the NCI Best Practices for Biospecimen Resources, biospecimen utilization is the process of biospecimen management in an effort to promote collaboration and timely research. The Epidemiology and Genomics Research Program (EGRP) encourages investigators to consider the long-term trajectory of resource sharing and NIH investments when developing the Resource Sharing Plan.

A description of biospecimen management and sharing in the Resource Sharing Plan section of the grant application that provides complementary information to the Data Management and Sharing plan is strongly encouraged. Specifically:

• Investigators submitting a new or recompeting grant application with a large budget (≥ $500,000 for direct costs in any year) are expected by EGRP to include a biospecimen management and sharing plan in both their Awaiting Receipt of Application (ARA) request and their grant application’s Resource Sharing Plan. Learn more about ARA requirements
• Investigators submitting a new or recompeting grant application with a small budget (< $500,000 for direct costs in any year) are strongly encouraged to provide a description of biospecimen management and sharing, where appropriate, in the Resource Sharing Plan. If a Resource Sharing Plan containing a description of biospecimen management and sharing is not provided in the grant application, and biospecimens are being collected as part of the proposed study, the program director may ask for this information prior to the notice of award being issued.
• NIH notices of funding opportunities (NOFOs) may have specific biospecimen management and sharing requirements. In this case, NOFO requirements will take priority over the general recommendation described on this page.

Suggested Biospecimen Management and Sharing Elements

EGRP suggests that investigators should include a brief description of each of the following elements of the biospecimen management and sharing plan:

• Anticipated number and type of specimens to be collected
• Description of how biospecimens will be stored (i.e., where will the specimens be housed) and managed (refer to sections B.2 and B.3 of the NCI Best Practices for Biospecimen Resources).
• Description of how biospecimens can be accessed by investigators associated with the study as well as by investigators external to the study during the time of the grant (refer to section C.4 of the NCI Best Practices for Biospecimen Resources). The description should state: 1) how the investigators plan to advertise their biospecimen collections to others; and 2) the process for requesting access to the biospecimens. Investigators should at the very least state their intention to submit a description of their collection(s) into an NIH biospecimen database by the end of the grant funding period (e.g., the Cancer Epidemiology Descriptive Cohort Database or the NCI Specimen Resource Locator)
• Description of any restriction that limits or prohibits biospecimen sharing (e.g., consent form). See section C of the NCI Best Practices for Biospecimen Resources and the NIH resource that provides sample language for use by investigators and IRBs when developing informed consent for secondary use of data/biospecimens.
• Sustainability plan, describing plans for storing and sharing the biospecimens after the funding period ends. This should include: 1) perceived value and utilization of the biospecimens (refer to NCI evaluation of specimen resources); and 2) where the biospecimens will be stored and how this will be funded (refer to section C4.4 Models of Sustainability of the NCI Best Practices for Biospecimen Resources)

Examples of biospecimen sharing policies and forms developed by NCI-funded population-based studies are available on EGRP’s webpage with Biospecimen Resources for Population Scientists.

Need More Information?

Visit the following EGRP webpages for information on complying to NIH data sharing policies and process for submitting large budget grant applications:

• Data Management and Sharing Plans
• Process for Submitting Large Budget Cancer Epidemiology Grant Applications (≥ $500,000)
• Contact an EGRP program director. Those who do not already have an assigned program director are invited to review the EGRP staff list to identify program directors with related scientific responsibilities.