The Framingham Heart Study (FHS), one of the longest standing NIH-sponsored studies of risk factors for cardiovascular diseases, is considered a national resource. The success of the FHS rests upon the unique, longstanding commitment of our family member participants. Questions regarding the best way to conduct human research may arise during the planning and conduct of epidemiologic research at the FHS. Such difficult questions may arise more frequently in the current era when new technologies are increasingly introduced into the FHS, leading to early or preclinical diagnosis of cardiovascular disease using biomarkers, subclinical imaging, and genetic testing. FHS researchers make decisions regarding whether and how to conduct their research in conjunction with existing regulatory and monitoring bodies, such as the Boston University Committee for Human Research, the FHS Observational Study Monitoring Board, and the FHS DNA Advisory Board. In making such decisions, the FHS research team benefits greatly from advice from a diverse panel of individuals, most notably those of FHS participants and also those of local physicians, clergy and ethicists.
The objective of the Framingham Heart Study Ethics Advisory Board (FHSEAB) is to serve as an advisory body to the Framingham Heart Study (FHS) Executive Committee regarding the ethical conduct of research in the Framingham Heart Study.
The initial membership of the FHSEAB consists of:
2 representatives from FHS Participant Coordinator Staff
1 representative from the Offspring cohort
1 representative from the Generation III cohort
1 representative from the OMNI cohort
1 local clergy
1 expert in research ethics
2 local physicians
1 genetic counselor
Meetings take place quarterly throughout the year at the Framingham Heart Study.
1-2 hour meeting, open to any participant in the Framingham Heart Study. Questions regarding the ethical conduct of research are presented by FHS investigators to the FHSEAB. The Advisory Board reviews, discusses, and make recommendations regarding these questions.