September 20, 2006
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.
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:
They concluded their discussion by explaining the integration of GEI genetics and exposure biology components. These include the following:
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:
The four major components of the proposed NIH policy for GWAS address:
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.
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.
This page was last reviewed on March 3, 2010 .