Perceptions of using biological materials in research

在过去的几年里，有一些关于应该向那些考虑同意与人类生物标本有关的研究和储存的受试者提供哪些信息的建议。这主要是基于对哪些信息对受试者重要的理论评估。然而，关于如何实施这些建议或这些建议是否满足受试者的信息需求，只有有限的数据。去年我们进行了两项实证研究。

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.