Over the last few years there have been a number of recommendations about what information should be given to subjects who are considering providing consent for the research related to and storage of human biological specimens. This is based primarily on theoretical assessments of what information should be important to subjects. However there are only limited data on how these recommendations are implemented or whether these recommendations address the informational needs of subjects. During the last year we conducted two empirical studies. We reviewed the description of genetics research in 258 consent forms used at the NIH Clinical Center. Genetics/secondary research was a major purpose of the study in 54% of these consent forms, while it was a minor purpose of the study in 46% of consent forms. Only 67% mentioned whether or not results would be provided and only 62% discussed any genetic specific risks. A minority of consent forms (20%) allow subjects to choose from up to five circumstances for how their samples could be used in secondary research including: the opportunity to permit or refuse secondary research of any kind (16%), on unrelated diseases (7%), on identifiable samples (4%), by other researchers (1%), or only after subjects were re-contacted for additional consent (10%). These options were not mutually exclusive; nine different combinations of the five option categories were found. These characteristics suggest that investigators and/or IRBs are not approaching consent forms for genetic research using biological samples in a consistent manner. We have just completed a survey of 1200 patients at 5 medical centers in the US using 30-minute telephone interviews to assess their attitudes towards genetics research and are in the process of analyzing the data.
| Hull, Sara Chandros; Gooding, Holly; Klein, Alison P et al. (2004) Genetic research involving human biological materials: a need to tailor current consent forms. IRB 26:1-7 |
