nology (e.g., “What Are Clinical Trials?”), along with a discussion of the review process and oversight structure. A list of questions potential participants should ask investigators, similar to those listed in Box 4.4, is also provided. More in-depth discussions of similar topics recently have been published by both Centerwatch and ECRI (formerly the Emergency Care Research Institute) (ECRI, 2002; Getz and Borfitz, 2002). For clinical trials, the Council for Public Representatives at NIH has recommended that each research site provide a list of “Frequently Asked Questions” for any individual considering participation (NIH COPR, 2001). The committee encourages further expansion and dissemination of these materials through multiple formats (including Web-based tools) in order to facilitate the engaged and meaningful participation of research volunteers.

As discussed in Chapter 3, individuals asked to serve in an oversight capacity within protection programs as a participant or community representative should be provided with the background knowledge and tools to fulfill this role. For example, unaffiliated members of Research ERBs should be provided with educational opportunities regarding the history of research, the need for ethical review, the methodology of research design, the federal regulations governing research, the role of advocacy for participants, and the processes for protocol review, as well as information on how to assess risk and consider possible benefits and the group dynamics pertinent to Research ERB deliberations.

Existing programs may serve as useful models for educating research participants about the research process. For example, Project LEAD, a project of the National Breast Cancer Coalition, includes language and concepts critical to understanding scientific research in clinical medicine, basic science, and epidemiology (Dickersin et al., 2001; Hinestrosa, 2001). Beneficial skills to develop through such programs might include those related to leadership, the critical appraisal of scientific literature, and those involved in understanding how research decisions are made. All of these skills can increase a participant representative’s confidence to ask questions and to share his or her perspective on technical issues (Hinestrosa, 2001).


Although research protocols are developed in many different ways, ultimately, a professional investigator is responsible for the conduct of the research and the relationship with the involved participants. This individual should work within the culture of a protection program that maintains the highest ideals of justice, beneficence, and respect for persons. To discharge his or her responsibility, the investigator should be trained in the methods and values of human research in addition to the technical aspects of a

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