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Freedom of Information Act Office

IC Directors' Meeting Highlights

September 25, 2007

To: IC Directors
From: Kerry Brink, Assistant to the Deputy Director, NIH
Subject: IC Directors Meeting Highlights—July 26, 2007

Discussion Items

I. Update on NIH Peer Review

Dr. Larry Tabak, of the National Institute for Dental and Craniofacial Research of (NIDCR), provided an update on the ongoing diagnostic phase of the peer review study and evaluation. The effort involves both external and internal working groups:

  • External - The Advisory Council to the Director (ACD) Working Group on Peer Review, co-chaired by Dr. Yamamoto and Dr. Tabak;
  • Internal - The Steering Committee Working Group on Peer Review co-chaired, by Dr. Tabak and Dr. Berg.

Dr. Tabak explained that as NIH adapts to rapidly changing fields of science and ever-growing public health challenges, the principles of the peer review analysis are to ensure the processes used to support science are as efficient and effective as possible for applicants and reviewers alike. The two working groups are seeking broad input from both external and internal communities. So far, the many activities in 2007 include:

  • External Request for Information (RFI) (July-September);
  • Internal Survey for NIH staff (July-September);
  • Three Regional Meetings (Chicago, New York City and San Francisco);
  • Two External Consultative meetings in Washington, D.C. with professional societies and advocacy groups (July-October);
  • Science Liaisons selected by the ACD working group to enhance outreach to stakeholders and to solicit opinion (July-October);
  • Steering Committee Working Group internal NIH staff consultative meetings (July-August);
  • Institute and Center Director Prior Experiments and Specific Statements (July-August).

In parallel, the Center for Scientific Review (CSR) has launched several peer review pilots and initiatives, which will help inform the ongoing effort. Once the diagnostic phase is complete, analyses and summaries of the various inputs, data collected and breadth of ideas will be provided to NIH leadership to determine next steps, including piloting and associated evaluations.

II. Proposed Policy for Data Sharing of NIH Supported Genome-Wide Association Studies (GWAS)

Dr. Elizabeth Nabel of the National Heart, Lung, and Blood Institute (NHLBI), explained that the opportunities for scientific advances in understanding complex, common diseases are now extraordinary. The cost of extensive genotyping has fallen rapidly making studies feasible. Whole genome information when combined with clinical and other phenotypic data offers the potential for increased understanding of basic biological processes affecting human health, improvement in prediction of disease and patient care.

The goal of the NIH policy is to advance science for the benefit of the public through the creation of a centralized NIH GWAS data repository. The policy addresses data sharing procedures, data access principles, intellectual property and issues regarding the protection of research participants through all phases of GWAS. Elements of the policy include:

  • Ongoing, high-level agency oversight;
  • Revisit and revise policy as appropriate;
  • Regular input from public representatives, including those with expertise in bioethics, privacy, data security, and appropriate scientific and clinical disciplines;
  • Central Data Repository will provide a single point of access and will facilitate broad and consistent access to NIH-sponsored GWAS datasets;
  • All data and information will be submitted to a high security network through a secure transmission process;
  • For a defined period of time, following the release of a given genotype-phenotype dataset through the GWAS data repository, investigators who contributed the data to the GWAS repository will retain the exclusive right to publish analyses of the data set.
  • Broad use of NIH supported genotype-phenotype data consistent with NIHs Best Practices for Licensing the Genomic Inventions.

Dr. Nabel explained that the greatest public benefit will be realized if data from GWAS are made available, under terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of investigators. NIH is committed to protection of research participants and Freedom of Information Act (FOIA) requests for individual-level GWAS data will be denied.

IC Directors approved the next steps to include information dissemination to Trans-NIH committees with notice in the NIH Guide and the Federal Register (Policy and Preamble). The policy is expected to be in place for grants funded in FY 2008.

Kerry Brink
cc: OD Senior Staff

This page last reviewed on September 30, 2011

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