OSP FO# 11-035

AGENCY: Department of Health and Human Services (DHHS)/National Institutes of Health (NIH)/National Human Genome Research Institute (NHGRI)/National Cancer Institute (NCI)/National Institute on Deafness and Other Communication Disorders (NIDCD)

PROGRAM: Development of a Preliminary Evidence Base to Inform Decision-Making about Returning Research Results to Participants in Genomic Studies (R01)

OBJECTIVES: This program provides funding to develop a preliminary behavioral and social science evidence base to inform decision-making about whether, when, and how to offer to return individual research results to participants in genomic research studies (especially whole exome or whole genome sequencing studies) or to individuals who have provided samples or data for genomic repositories (such as biobanks or databases such as dbGaP).

Several unique characteristics of genomics research make issues related to the return of results especially daunting:

–    Genomics studies involve the generation of information which will, by definition, be voluminous in quantity and comprehensive in scope. Researchers will inevitably uncover a large number of incidental findings. Deciding what to do with these findings will present researchers with significant ethical challenges.

–    The trajectory of genomics research is typically very uncertain and open-ended. Secondary investigators may uncover new information about a provided sample that was not the stated subject of the original study.

–    The meaning of much genomic information is likely to be highly indeterminate and hard to interpret. The significance of the information uncovered through genomic analysis may evolve over time as additional knowledge is gained.

All of these factors—coupled with the limited resources typically available to researchers—can make the prospect of offering to return all or even most individual results to the participants in genomics studies unwieldy, and in some cases unrealistic. A pressing need exists to develop rational and workable criteria to help guide decision-making by researchers, managers of sample and data repositories, and IRBs about what types of information can, should, or should not be offered to participants in genomics studies. Such criteria must be informed both by normative and legal considerations and by solid empirical (behavioral and social science) evidence.

This program particularly invites studies that will investigate how participants in ongoing or planned genomics research projects understand, react to, and use individual research results when they are offered and returned. Studies that examine the actual psychosocial and behavioral impact of receiving (or not receiving) such results are especially invited.

A consortium will be organized that includes the principal investigators and relevant key personnel funded by this program; the consortium will meet at least one time per year, and more frequently by conference call, to identify and address common issues, explore opportunities for synergy among studies, and identify areas of possible consensus that can form the basis for policy recommendations in this area. For more information, please consult the program announcement below. The R01 grant mechanism solicits empirical, hypothesis-driven, confirmatory research and modeling approaches.

DEADLINE: March 10, 2011

FUNDING INFORMATION: This program will utilize the NIH Research Project Grant (R01) award mechanism, and “Just-in-Time” information concepts. The NIH anticipates providing $2 million per year to support 3–4 new grants. Budgets for direct costs are limited to $500,000 per year. The total project period for an application submitted in response to this funding opportunity may not exceed 3 years.

Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (express/courier service, non-USPS service)
Telephone: (301) 402-4997
Fax: (301) 402-1950
Email: mcewenj@mail.nih.gov
Web: http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-11-003.html

REMARKS: NIH requires that applications to this program be submitted electronically through Grants.gov (http://www.grants.gov). After submission via Grants.gov, applications will be retrieved and processed by the NIH Commons system (https://commons.era.nih.gov/commons/index.jsp). In order to prepare a responsive application, PIs should download both the complete program guidelines (RFA-HG-11-003) and the corresponding application package from Grants.gov as well as the NIH Grants.gov Application Guide (http://grants.nih.gov/grants/funding/424/index.htm). PIs must also be registered Commons users.

For more information about Grants.gov and the NIH Commons, or to register as a Commons user, please contact A. Brink Effgen (abeffgen@bu.edu) in the Office of Sponsored Programs (OSP) at x3-4365. In addition, please contact the OSP Assistant Director assigned to your school or department as soon as possible to coordinate submission through the Grants.gov system.

Complete program guidelines and application material may be obtained from the web site listed above or from the Office of Sponsored Programs (OSP). Please distribute this notice to any faculty or staff members who might be interested in the information. For more information, please contact the OSP at X3-4365 or ospinfo@bu.edu, or visit the OSP web site at http://www.bu.edu/osp.