This project is an empirical evaluation of attitudes of patients and the public towards research involving human biological specimens. Over the last few years there have been a number of recommendations about what information should be provided to subject who are considering providing consent for the research and storage of human biological specimens. This is based primarily on theoretical assessments of what information should be important to subjects as well as speculations on what information they would want to know. However there is little data about what information patients are actually interested in hearing, why they are interested in it, and how they think that this information might influence decision to participate in research. During this year, as a preliminary step, the more than 800 consent forms used at the NIH Clinical Center were used to assess how such research is described. A 43item questionnaire was developed around 6 key topics. There are 232 consent forms that discuss this information, the investigators are in the process of completing this evaluation. Next year we will conduct a quantitative survey in 450 subjects to determine what information people are interested in knowing and the relative strength of these preferences. This project will begin with focus groups of subjects including prior participants in genetic disease research and others from the general public. The results of these focus groups will be used to develop a quantitative survey of these same issues.
| 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 |
