Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences May 3 , 2006

EGRP NEWS FLASH
From the Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute

Federal Register Notice Seeks Comment on Guidelines for NCI-Supported Biorepositories

Draft First-Generation Guidelines for National Cancer Institute (NCI)-Supported Biorepositories (PDF) were published in the Federal Register on April 28, 2006. They are open for public comment until May 30, 2006. The guidelines affect all NCI-supported investigators who have funding to collect, process, store, distribute, and/or use biospecimens. Existing collections of blood, urine, buccal cells, tissue, and any other biospecimens obtained with NCI support also are included under the guidelines.

Please comment on the feasibility of these guidelines because compliance with all of its portions will affect future funding decisions about investigator-initiated population science research that uses biospecimens. These study-associated collections of biospecimens are viewed as biorepositories under the guidelines.

The Federal Register Notice is attached as a PDF, or you may download it from NCI’s Office of Biorepositories and Biospecimen Research (OBBR) Web site, where you also will find Frequently Asked Questions about NCI and biorepositories: biospecimens.cancer.gov. The addresses for submitting your comments are given at the end of this message.

The following three areas within Section III.Guidelines may be of particular interest to epidemiologists:

1. Technical and Operational Guidelines, E5. Biorepository Informatics: Data Management and Inventory Control and Tracking (p. 25186)
2. Ethical, Legal, and Policy Guidelines, B. Access to Biospecimens and Data (p. 25187)
3. Ethical, Legal, and Policy Guidelines, E2: Intellectual Property (p. 25187)

Two years ago, NCI surveyed its intramural and extramural research programs and identified 125 large-scale biorepositories. The study revealed substantial heterogeneity in biorepository management practices and that the NCI-supported biorepositories are neither optimized nor coordinated to maximize these investments.

NCI embarked on a coordinated effort to develop a common biorepository infrastructure that promotes resource sharing and team science, and ensures availability of the best possible quality specimens.

The proposed guidelines in the Federal Register are a synthesis of best-practices in biobanking that have been collected by the internal NCI Biorepository Coordinating Committee (BCC) and two workshops that were held to solicit input from the research community about:

1. The ethical, legal, and policy issues surrounding biorepositories;
2. How to best collect, process, and store biospecimens depending on their use;
3. Appropriate quality assurance and quality control protocols;
4. Regulatory bioinformatics systems to share biospecimens and their associated data; and
5. How scientific access to the biospecimens and their associated data should be determined.

The BCC is chaired by Anna Barker, Ph.D., NCI Deputy Director for Advanced Technologies and Strategic Partnerships, and Carolyn Compton, M.D., Ph.D., Director of OBBR. EGRP Program Directors Shannon Lemrow, Ph.D., and Carol Kasten, M.D., are members of the committee.

EGRP would appreciate receiving a copy of comments that you submit in response to the Notice so we immediately know your thoughts. Please copy Dr. Lemrow at lemrows@mail.nih.gov.

Submit your comments to NCI either by:

• e-mail: biospecimens@mail.nih.gov and enter “First-Generation Guidelines Comment” in the subject line, or by
• postal mail:

  First-Generation Guidelines
  Office of Biorepositories and Biospecimen Research
  Office of the Deputy Director for Advanced Technologies and Strategic Partnerships
  National Cancer Institute
  National Institutes of Health
  31 Center Drive, Room 10A03
  Bethesda, MD 20892

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