IC Directors' Meeting Highlights

September 20, 2006

To:	IC Directors
From:	Director, Executive Secretariat
Subject:	IC Directors' Meeting Highlights — August 24, 2006

Discussion Items

I. Genes and Environment Initiative Update

Dr. Collins began with an overview of the Genes and Environment Initiative (GEI). He reminded all that this initiative was proposed in the President’s budget for FY07 and its goal is to accelerate understanding of genetic and environmental contributions to health and disease. The two components of the initiative are genotyping of case-control studies of common disease (identifying genetic variants) and the development of innovative technologies and biomarkers to measure environmental exposures, diet, physical activity, psychosocial stress, and addictive substances.

The implementation and management of the GEI consists of the following:

• Budget requests $26M for the genetic component and $14M for the environmental component. This will be added to the IC base for FY07 and beyond
• In FY07-FY-10, GEI funds will be committed to a common pool and then will revert back to ICs in FY11 and beyond
• GEI will be managed by NIH-wide Coordinating Committee
• Funds from common pool will be allocated to IC leading a specific GEI effort

At this time Dr. Collins provided the names of the GEI Coordinating Committee and thanked them and the subcommittee members for all their work so far with this initiative.

He then discussed the steps involved in the flow of investigations from genome-wide association to clinical translation, provided information specific to the GWA component, and shared the planned timeline for the GWA studies.

Dr. Schwartz started by discussing how there needs to be improved specificity and accuracy with the current tools used to assess environmental exposure. He expanded on the exposure biology program by describing the links from personal exposures to biology to disease that include:

• Environmental sensors for point of contact to environment chemicals/biologics, physical activity, diet, psychosocial stress, and substances of abuse
• Biomarkers for the biological response to environmental agents
• Field deployable biosensors
• Application of biomarkers to the genetic studies in the GEI

They concluded their discussion by explaining the integration of GEI genetics and exposure biology components. These include the following:

• Genetics Program will prioritize study populations with stored biospecimens, high-quality environmental exposure data, and evidence for environmental influences on the disease
• Exposure Biology Program will prioritize exposures that are affected by genetics while focusing on public health problems
• New biomarkers developed through GEI will be applied to stored specimens in the genome-wide association studies supported through GEI

Dr. Zerhouni thanked Dr. Collins and Dr. Schwartz and their subcommittees for bringing to this group.

II. Trans-NIH Policies for Genome-Wide Association Studies

Dr. Nabel acknowledged and thanked all the participants that took part in the NIH Committee on the GWAS policy. She explained that the guiding principle for writing this policy is 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.

She shared the 2 major goals of the proposed policy:

• Advance science for the benefit of the public through the creation of a centralized NIH GWAS data repository
• Facilitate research and medical science to better address the health needs of people based on their individual genetic information

The four major components of the proposed NIH policy for GWAS address:

• Data sharing procedures
• Data access principles
• Intellectual property
• Protection of research participants

Dr. Nabel went on to describe the particular details of each major component of the proposed NIH policy for GWAS. She also reviewed some “items about which we may be hearing about” such as human subject issues for data sharing, data security and validation, and period of publication exclusivity for PIs.

She then shared some general questions that need public commentary regarding the GWAS policy. The proposed timeline includes Phase I: planning (completed); Phase II: public consultation that includes the 60 day RFI for public comment and public consultations (e.g., Town Hall and Science meetings); Phase III: policy development that includes final approvals and final policy release; and concludes with Phase IV: implementation of the final policy.

Dr. Zerhouni cautioned the group about unintended consequences and the need to establish a plan for adapting this complicated process by encouraging collaboration.

III. CFC

Dr. Tabak, this year’s NIH CFC Coordinator, announced upcoming events for the CFC campaign. He reminded all that last year’s campaign raised over $2 million and expressed gratitude for the generosity of the NIH community. The main kick-off event this year is the CFC free throw competition. This event will follow the October 12, 2006 IC Directors meeting.

Dr. Tabak reviewed the rules for the free throw competition and invited everyone’s participation.

Ann Brewer
cc: OD Senior Staff