DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB F þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: May 2, 1995 RE: Subject Interview Study UpdateThi This memorandum outlines the progress of several aspects of the Subject Interview Study (SIS) since the April 10-12, 1995, meeting of the Advisory Committee. I. Characterization of Research Projects A variety of sources (including patients' medical records, research clinic charts, and institutional databases) have been searched to determine whether respondents to the Brief Survey were participants in research. For those respondents for whom some evidence of participating in a research project was identified, copies of consent forms were requested for the purposes of characterizing this research. A review group was established and convened at the Advisory Committee Office on April 21, 1995, to characterize this research based on consent forms. The names and titles of the seven external reviewers who constituted the review group along with Advisory Committee Staff are: Dr. Nancy Bartlett Assistant Professor of Medicine Washington University Medical Center Dr. Peter Glassman Staff Physician Los Angeles Veterans Affairs Medical Center RAND Corporation Dr. Perry Grigsby Professor of Radiology Washington University Medical Center Dr. Steve Larsen Chief of Nuclear Medicine Memorial Sloane Kettering Hospital Dr. Gail Povar Clinical Professor of Medicine and Health Care Services George Washington University Medical Center 1 Dr. Richard Stein Chief of Cardiology State University of New York Health Science Center at Brooklyn Dr. Robert K. Zeman Professor and Clinical Director of Diagnostic Radiology Georgetown University Medical Center The group first reached consensus concerning criteria to use in characterizing the research projects with respect to: 1.] The nature of the research project (i.e., therapeutic, diagnostic, or other) 2.] The "population disease burden"--the physical burden that persons being recruited for that particular project typically experience (i.e., high, medium, low) 3.] "Research incremental risk" (i.e., minimal risk, more than minimal risk) Attached is a sample form used by review board individuals to record their characterization decisions. Review board members were assigned consent forms for projects within their areas of expertise. Each member was then teamed with another member outside of that area of expertise, so that each project would be reviewed by a non-specialist as well as a specialist in the field. Through discussion and deliberation, each team aimed to reach consensus on the characterization of the research projects to which they had been assigned. If the pair did not reach consensus, which happened less than ten times, the proposal was brought to the entire group for discussion and resolution. Approximately 65% of the research projects were characterized at the meeting. The remaining research projects will be characterized by these same individuals via mail and teleconference during the next few weeks as the consent forms become available. II. Medical Records Follow-Up Based on initial analysis of data from the SIS, it appears that some patients' perceptions of their research involvement do not match their enrollment according to research documentation. The two types of discrepancies/discordances are: 1.] Patients who have indicated that they are research participants, but for whom no evidence of participation has been found 2.] Patients who have indicated that they are not research participants, but for whom evidence of research participation exists More information about these apparent discrepancies is being obtained. Advisory Committee Staff is currently examining these discordant responses by visiting participating institutions where such discrepancies exist. At these institutions, Advisory Committee Staff is searching for additional information that can be gathered from the medical and research records of specific patients involved in the SIS who have discordant responses. To date, discordant patient responses have been examined in six institutions. Visits have been scheduled at the remaining institutions, and should be completed by the middle of May. 2