Epigenetics News

The U.S. Population Cohort Project on Genes, Environment, and Disease, Draft Report: Part I

Jun 26, 2006 commentary, news links

This is part one of a series examining the draft report of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) entitled “Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease.” The Committee is seeking comment from the public until July 31, 2006.

In May 2004, National Human Genome Research Institute Director Francis S. Collins made his case in Nature that the “time is right” for the Unites States to consider a prospective cohort study in which a large number of individuals within the U.S. would be monitored over time for the combination of genes and environment that may contribute to the causes of disease. In the article, Dr. Collins outlined a number of key characteristics that the study should have:

• A large number of participants, at least several hundred thousand, should be enrolled. This would ensure an adequate sample size for common disorders, particularly for gene-environment interactions.
  
• Minority groups should be intentionally over-sampled to permit meaningful inferences about these groups and for the study of health disparities.
  
• A broad range of ages should be represented to provide information on disorders from infancy to old age, with over-sampling of age groups as needed.
  
• A broad range of genetic backgrounds and environmental exposures should be included to provide enough variability to detect and compare associations and interactions.
  
• Family-based recruitment, including multiple generations, should be used for at least part of the cohort to increase the power of genetic analyses.
  
• A broad array of clinical and laboratory information, not limited to any single disease, should be collected at the beginning and at regular intervals thereafter.
  
• Sophisticated dietary, lifestyle and environmental exposure assessments should be carried out, using both questionnaires and biological measures.
  
• Biological specimens, including DNA, plasma and cells, should be collected and stored.
  
• A highly sophisticated data-management system should be included.
  
• Access to study data and biological materials should be free and open to allow research into many diseases by scientists in many sectors.
  
• Investigations during the study should not be limited to hypotheses conceived at its inception.
  
• Comprehensive community engagement should be a major feature in the design and implementation of the study.
  
• A state-of-the-art consent process should be adopted to allow multiple uses of the data and regular feedback to participants about progress.

The implications of the project would be substantial, particularly for researchers in the U.S. As the report notes:

In this report, SACGHS uses the term “project” to refer to an effort that would involve the longitudinal collection and storage of data and biological specimens from large numbers of people for the research use of multiple investigators and investigative teams.

In addition, the report expresses the concern of some investigators that such a large-scale project would undermine the ability of current investigators-both in the study of genes and environment and other area-to retain funding for their existing projects.

Overall, the report aims to focus only on “preliminary and intermediate questions, steps, and strategies in five areas that need to be addressed before considering the larger question of whether the United States should undertake such a project: research policy; research logistics; regulatory and ethical considerations; the public health implications of the project; and the social implications of the project.” As such, many of the specific details of the project, such as the type of data and specimens that would be collected, are left for future discussion.

Taking the Public’s View Into Consideration

One of the most widely discussed topics of the report is the strong recommendation that the public’s views and comments be taken into consideration before a funding decision is made for the project. The Committee makes only a very generalized recommendation for how these comments would be collected:

The public’s willingness to participate in a large population project should be assessed before embarking on such an expensive endeavor. Willingness could be assessed through opinion polls, requests for comments posted on agency websites, or through other measures.

The Committee also expresses concern that “most members of the public will be unfamiliar with the concepts of a large population project,”so “concerted efforts must be made to educate, inform, and solicit feedback and input.”

Issues Related to Research Policy of the Project

There are several strategies that are proposed in the report for the undertaking of the project, and the Committee itself seems to be in debate over which approach would be best suited for its viability.

…although a large cohort project may be needed to collect sufficient data to elucidate the contribution of genetic variation and environmental factors to common diseases, some believe it may not necessarily lead to a better understanding of common diseases or population health benefits if it does not include a carefully designed, hypothesis-driven, disease-specific component. Others believe that such a project cannot be hypothesis driven, but rather that it should be a viewed as a data and tissue resource for researchers to mine.

The next part of the series will delve into the recommendations the Committee makes to the Secretary into resolving these and other issues as the project moves towards a funding decision.

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