This article is a US Government work and, as such, is in the public domain in the United States of America.
Article first published online: 22 APR 2010
This article is a US Government work and, as such, is in the public domain in the United States of America. Published 2010 Wiley-Liss, Inc.
American Journal of Medical Genetics Part A
Volume 152A, Issue 5, pages 1250–1256, May 2010
How to Cite
Levy, D., Splansky, G. L., Strand, N. K., Atwood, L. D., Benjamin, E. J., Blease, S., Cupples, L. A., D'Agostino, R. B., Fox, C. S., Kelly-Hayes, M., Koski, G., Larson, M. G., Mutalik, K. M., Oberacker, E., O'Donnell, C. J., Sutherland, P., Valentino, M., Vasan, R. S., Wolf, P. A. and Murabito, J. M. (2010), Consent for genetic research in the Framingham Heart Study. Am. J. Med. Genet., 152A: 1250–1256. doi: 10.1002/ajmg.a.33377
This paper was conceived and drafted during Dr. Levy's Fellowship in the Medical Ethics Fellowship Program at Harvard Medical School.
How to cite this article: Levy D, Splansky GL, Strand NK, Atwood LD, Benjamin EJ, Blease S, Cupples LA, D'Agostino Sr. RB, Fox CS, Kelly-Hayes M, Koski G, Larson MG, Mutalik KM, Oberacker E, O'Donnell CJ, Sutherland P, Valentino M, Vasan RS, Wolf PA, Murabito JM. 2010. Consent for genetic research in the Framingham heart study. Am J Med Genet Part A 152A:1250–1256.
- Issue published online: 22 APR 2010
- Article first published online: 22 APR 2010
- Manuscript Accepted: 21 JAN 2010
- Manuscript Received: 17 AUG 2009
- NIH. Grant Number: N01-HC-25195
- genome-wide association;
- medical ethics;
- population study
Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease, including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. Published 2010 Wiley-Liss, Inc.