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Last Updated: 08/07/17

Guiding Principles for Cancer Moonshot℠ Biobanking Activities

This document sets out guiding principles for biobanking activities issued under Cancer Moonshot funds and is included in Requests for Applications, Funding Opportunity Announcements, and Requests for Proposals.

The goal in developing these guiding principles is to accelerate research by a) increasing the availability of biospecimens for Cancer Moonshot research through facilitation of investigator to investigator sharing of biospecimens, and b) increasing the reproducibility of Cancer Moonshot research through improved biospecimen practices and corresponding annotation. These guiding principles also seek to facilitate, where possible, increased engagement of research participants through researchers' communication of aggregate research results and, in some cases, individual genomic findings that may be medically actionable for research participants.

Guiding principles:

  • Cancer Moonshot biobanking activities will be consistent with the 2016 NCI Best Practices for Biospecimen Resources.
  • Informed consent:
    • Cancer Moonshot biospecimens will be obtained with consent of research participants.
    • Broad consent will be utilized for consenting research participants, in alignment with the NIH Genomic Data Sharing policy.
  • For all biospecimen collections conducted under Cancer Moonshot funds, there will be an emphasis on diversity in the collections to assure that minority and underserved populations are adequately represented in the research that utilizes the biospecimens. This emphasis must be carried through despite pressures to fill research analysis pipelines.
  • Biospecimen sharing:
    • Investigators working in research networks established under Cooperative Agreements will develop biospecimen governance policies to anticipate and facilitate the recruitment of diverse populations, and prioritize the sharing of biospecimens and associated data throughout the network.
    • To further accelerate cancer research, biospecimens collected under Cancer Moonshot funding will be made available to research projects outside the scope of the original research purpose. NCI will facilitate such sharing for the benefit of researchers by utilizing an existing NCI "virtual" biobank database, the NCI Specimen Resource Locator (SRL: Biospecimens collected under Cancer Moonshot funding and/or archival samples used in Moonshot-related activities will be made available to the extent it is permissible for cancer research within one year after the initial scientific goals of the research have been met. A minimal set of defined data on all biospecimens collected under Cancer Moonshot funding will be entered into the SRL.
    • Biospecimens will be made available by Cancer Moonshot investigators under cost reimbursement mechanisms that are clear and transparent to applicants. If grantees or contractors are already being funded by NCI for storage and distribution of biospecimens to researchers, cost recovery fees will return to NCI as prescribed in the 21st Century Cures bill.
  • Return of aggregate research results to research participants:
    • Current research indicates that patients and well individuals who engage in research are often keenly interested in hearing about the results of research to which they contributed biospecimens and/or data. Cancer Moonshot investigators should consider approaches for returning aggregate results of their research projects to the research participants who contributed biospecimens and/or data to the research. At minimum, Cancer Moonshot investigators should prepare annual summaries for NCI websites that describe, in lay language, their research progress and research results. NCI can provide this information to medical institutions who can, in turn, work to communicate this information to their patients.
  • Return of individual research results to research participants and/or their physicians:
    • Individual level research results, particularly the results of genomic research, can incidentally produce evidence of medically significant and actionable information that may potentially be helpful to research participants, their families, and their physicians. Cancer Moonshot investigators should consider the potential for such incidental findings as they develop their research programs. While interpretation of CLIA requirements may impede the communication of test results from some research laboratories, Cancer Moonshot investigators should work to find reasonable and pragmatic solutions to address such issues.
  • Adoption of NCI and NIH recommendations, templates, and other resources: