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. MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: July 6, 1995 RE: Prospective Recommendation on Compensation for Research Injuries At the June meeting, some Committee members suggested that the Committee provide additional support for its recommendation that the federal government review the area of compensation for research injuries of future research subjects (Recommendation 13a, chapter 19, draft date June 9). It was suggested that the Committee indicate that some or all of its members are in agreement with the recommendations and conclusions of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a group that studied this issue in detail in 1982. Many of you are familiar with the President's Commission two-volume report, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects. To refresh your memory, and to provide those who are not familiar with it with an opportunity to review it, we have enclosed volume one of the report, which includes a summary. (A table of contents for volume two is also attached. Please contact Tracy Smith if you would like a copy of the 509 page appendix as well.) We recommend that you review this report and then indicate on the attached "ballot" whether you agree with Commission's conclusions and recommendations. Depending on the response, a sentence will be added either to the body of the recommendation or to the explanatory note, e.g., the Committee is [or some or a substantial number of Committee members are] in agreement with the conclusions and recommendations of the President's Commission supporting the review and evaluation of various alternative compensation schemes by the federal government. For additional background reading, we have provided you with a relevant excerpt from a recent report of an Institute of Medicine committee titled Women and Health Research (National Academy Press, 1994). As noted in a footnote to the Advisory Committee draft recommendation, the Institute of Medicine recommended that the National Institutes of Health review the area of compensation for research injury. We have attached a "ballot" for you to return by the first day of the meeting (July 17) indicating whether you are willing to indicate your support to the President's Commission conclusions and recommendations. If you have any questions about any of this material, please contact Anna Mastroianni. Enclosoures: "Ballot" for faxing President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, June 1982, Volume I; and Table of Contents, Volume II, Appendices. Women and Health Research, National Academy Press, 1994, p. 169 and Appendix D.