Minnesota Gene Pool Blog

The purpose of the report is to explore policy issues related to engaging in a very large study that is representative of the U.S. population to collect the necessary information for both biological and epidemiological studies that would help discern the relationship and interactions between genes and environmental factors that affect health. This would be a huge undertaking, so it is laudable that the SACGHS has begun to address this issue. They correctly observe that:

"A large population research project raises multiple policy issues because
1) it will involve an unprecedented number of participants and, thereby, will have a significant public profile and a direct impact on many people;
2) it requires a relatively large investment of public resources and, as such, warrants scrutiny of and deliberation about its relative value to science, society, and the Nation; and
3) the nature f the information that will be derived from it raises ethical, legal, social and public policy concerns that could be unique and/or significant, particularly in view of the number of potential participants�.

The SACGHS has identified five issue areas that need further exploration before a decision to engage in a large study of the U.S. population could even be made. These areas include issues related to:
1. Research policy
2. Research logistics
3. Regulatory and ethical considerations
4. Public health implications of the project
5. Social implications of the project

In the report, the SACGHS outlines the issues they have identified in each of these areas and some policy options for addressing each one. I will not re-cap the content further, but refer you to the report’s succinct executive summary. I will, however, offer a few brief observations on the report and its recommendations.

First of all, the report recognizes how important it will be that the public at large is and continues to be engaged in this project, should it occur. This is obviously very important, so it is good that the SACGHS clearly recognizes and addresses this.

Second, the report recognizes the existence of the many uses of this type of data and is sensitive to multiple perspectives of entities who may have interest in this information, including (but not limited to) the interests and concerns of racial groups, business interests, academia, ethicicists, policy makers, and public health.

Third, the areas related to issues on research policy and research logistics are especially detailed and well covered, offering very specific strategies for assuring that the project is multidisciplinary in nature and that the data generated is available for both public and private concerns, including issues related to protecting intellectual property.

Fourth, the sections on ethical issues and regulation, public health implications and social implications of the the project are, unfortunately, the least developed and the least specific. Although it is laudable that these issues were considered to be major enough to be considered part of the top five (all three are in the list detailed above), the recommendations provided by the SACGHS were vague and very nonspecific compared to the recommendations for the first two major issues, which were much better developed. Hopefully, in the next draft of this report, there will be a little more meat on the bones of this section.

The full report can be accessed here.