Freedom of Information Act Office
IC Directors' Meeting Highlights
August 30, 2010
|From:||Vesna Kutlesic, Ph.D.|
|Subject:||IC Directors Meeting Highlights—July 22, 2010|
Human Subjects Protections:
Dr. Kathy Hudson reported on the current status and priority areas for human subjects protections. Since The National Research Act in 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, revisions of human subjects protections have not been in step with dramatic changes in the scientific landscape. Consequently, in November 2009, the Human Subjects Research Subcommittee with the Committee on Science, NSTC formed the Human Subjects Research Regulation Working Group.
The overarching goal of this interagency (i.e., HHS, FDA, NIH, VA, OMB, OSTP) working group is regulatory reform aimed at enhancing protections and reducing burden, delay, and confusion. Key activities of this working group include developing broad goals, drafting six priority areas, creating a decision tree to guide risk-based review, and drafting the ANPRM. Public comment will be sought for the six priority areas related to developing: 1) Database and mechanism for adverse event reporting; 2) Mandatory single IRB protocol review for multi-site studies; 3) Revised rules for IRB review process; 4) Strengthened informed consent, and 5) Expanded protections to more research subjects; and 6) System for uniform guidance.
Big Think Common Fund Proposals:
Drs. Larry Tabak and Tom Insel reported on Common Fund proposals stemming from the Big Think Meeting hosted by Dr. Francis Collins in May 2010 for the purpose of identifying priority scientific areas.
Dr. Tabak discussed the case made at the Big Think Meeting for a Common Fund proposal for an increased investment in metabolomics. Three general themes emerged at the Big Think Meeting supporting a proposal for increased funding of this scientific area including: 1) enhanced phenotyping could be achieved through the integration of genomics, proteomics and metabolomics data, 2) single cell omics can add much to our knowledge through new discoveries derived from cellular heterogeneity, and 3) more investment is needed in technology development to enable comprehensive profiling of multiple analytes and single cell measurements. Dr. Tabak also briefly highlighted several positive outcomes of the Common Fund Metabolomics Program conducted from 2005 to 2009.
During the group discussion that followed, there was support for using Common Fund resources to fund technology development needed to conduct metabolomic studies.
Dr. Tom Insel reported on the case made at the May 2010 Big Think Meeting for a potential Common Fund proposal aimed at increased funding of large NIH-supported cohort studies. It was proposed that cohort studies might be able to address several types of questions, including: “Can existing cohorts be combined?" “ Can an HMO Research Network suffice?” and, “Are new cohorts needed?”
To help define questions that might be addressed with existing cohorts, Dr. Collins requested a detailed compilation of cohort studies funded by NIH that include roughly 5,000 participants or more. The results of this analysis found 139 large cohort (> 5000 participants) studies funded between FY 2004 and FY 2009 – across 16 ICs. However, several limitations of this data were identified which begged the question whether we have gained the most from these investments? Questions for the FY 2011 Common Fund include: 1) “Do we need a new cohort study?” (pros: better sample, better design, prospective data, not disease specific) and (cons: cost, data depth, limits for many questions); 2) “Can we make better use of existing studies?” (pros: efficiency, leverages current costs, minimal infrastructure needed) and (cons: apples and oranges being compared); and 3) “Can we do both?”
During the discussion that followed there was little current support for this proposal. Key issues raised included the potential costs of these studies, and given their long-term nature, whether the Common Fund was the appropriate source of funding. It was also proposed that the harmonization of existing studies internationally should be considered, to better enable comparison of findings across studies. A concern was also raised that HMO collaborations may not be representative of the entire U.S. population. The general consensus of the group was that it would be better to drill down to the key elements of existing cohort studies and lay down guiding principles before moving on to fund additional cohort studies.