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 G Part 1 þþþDRAFT þ FOR DISCUSSION PURPOSESþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: RE: Approach to Ethical Analysis of Historical Case Studies in Light of Current Ethical Standards The ethical analysis of each of the case studies will include the following as primary considerations: I. Favorable Balance of Harms and Benefits Was the experiment/research appropriate considering the state of scientific knowledge about potential harms and benefits at the time that the work was conducted? In this context, "appropriate" means that the balance of harms and benefits is favorable, so that any risk of harm to subjects is offset or outweighed by: ù An equal or greater potential for benefit to subjects (the easier case), or ù Sufficient potential for benefit to others in the form of generalizable scientific knowledge that could not otherwise be obtained (the harder case). The focus here is on the level of scientific knowledge at the time, otherwise one would be judging the scientific justification of the day against information that emerged only later and in the light of which the earlier study would not have been of interest. II. Selection of Subjects Was the selection process one in which, by current standards, the burdens and benefits of the research were equitably distributed? Did the selection process in fact satisfy the current expectation that no specific group in our society should bear a disproportionate burden as a pool of potential research subjects, unless the condition under investigation was one uniquely found in that population? No moral judgments about past investigators will necessarily be imputed if currently prevailing selection standards are not met; rather, this question seeks to understand the relationship of current standards to earlier practices. II. Information Provided Was the information about the purposes, risks and possible benefits (if any) of the experiment provided to potential subjects in a manner that was both complete and understandable to them (to the extent that this can be ascertained from the information that is available to us)? Again, no moral judgments about past investigations will necessarily be imputed; this question also seeks an understanding of the relation between current standards and previous practices. IV. Consent Was subject consent obtained, and was it done so in a fully voluntary and non-coercive manner as currently required (to the extent this can be ascertained from the information that is available to us)? Once again, no moral judgments about past investigators will necessarily be applied to those who, working in a different time, failed to satisfy current consent standards. However, it is important to assess whether our current requirements would in fact prevent practices that might have been approved or permitted in the past. V. Prior Review Was there prior review of the research proposal by a responsible, disinterested third party? If so, did the review process consider ethical factors such as those mentioned above, or was it concerned rather with issues such as national need, scientific merit, the qualifications of investigators, or resource allocation? Prior review is now considered to be essential in an ethically acceptable system of biomedical or behavioral research. The failure of institutions to provide for such a review process at an earlier time may prove to be important in explaining the possibility that ethically questionable experiments were conducted. Alternatively, to the extent that prior review was present but failed to screen for such practices, this information may be important in identifying the essential elements of an efficacious system of prior review. * * * * * In summary, this exercise is not intended to pass judgment on the conduct of past investigators. The Advisory Committee has not yet addressed the question whether it will render such judgments and, if so, against what criteria (i.e., historical or contemporary). Rather, the intent is for the Advisory Committee to develop expertise in evaluating the extent to which an experiment conducted in the past would today be considered ethically acceptable.