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 PURPOSESþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: October 3, 1994 RE: Current Ethics Policies and Practices The attached materials are intended to serve as a resource and background material for the Committee's upcoming discussion of ethical analyses of case studies. Included are a reference guide for IRB members (borrowed from Johns Hopkins University) and a copy of the current federal regulations for research involving human subjects. The framework for case study analysis that will be introduced at the October meeting will be employed for successive case studies. The attached resource and reference materials should be reviewed and retained for those future discussions. Staff will be happy to provide more reference materials on this subject as the Committee desires. Attachments: 1. Guidelines and Procedures, Committee on Human Research, The John Hopkins University School of Hygiene and Public Health 2. Protection of Human Subjects, 45 CFR Part 46, June 18, 1991