Abstract
Issues of disclosure arise in neuroscientific research during the informed consent process, whenever incidental findings are identified, and when study results are generated. The possibility of disclosure of incidental findings and/or research results may raise informational expectations on the part of subjects and may alter a study's risk:benefit ratio. We recommend that the informed consent process address this potential consequence of research participation, and specify the conditions under which particular types of information will be offered, the conditions under which information may not be disclosed, and any provisions for helping subjects make sense of the information to be disclosed.
Notes
Code of Federal Regulations. (CFR). Title 45. PUBLIC WELFARE. Department of Health and Human Services. National Institutes of Health. Office for Protection from Research Risks. Part 46. PROTECTION OF HUMAN SUBJECTS.