Exempt research is not subject to the formal informed consent requirements in the Common Rule; however, the Belmont Report ethical principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether to participate in research. For this reason, if researchers will be interacting with subjects, subjects should be informed of the research and their agreement to participate should be obtained. In these situations, researchers should, at a minimum, provide subjects with the information listed below to enable subjects to make a voluntary decision whether to participate in the research. In some cases, researchers may find it necessary or appropriate to provide more information.
At a minimum, the following information should be provided:
- That subjects are being asked to participate in research;
- A description of the study procedures;
- A statement regarding any potential risks or benefits of participation;
- A statement that participation is voluntary;
- The name, affiliation, and contact information of the researcher(s).
Depending on the complexity of the study, the familiarity of the potential subjects with research, and the forum for interaction with subjects, this information may be presented in a number of different ways. A Study Information Sheet template specific to Exempt research is available that can be used for this purpose. For survey research, a short written statement incorporated into the beginning of a written survey may be more appropriate. In other situations, a verbal discussion covering the elements above may be sufficient. If you have questions regarding how information regarding the research should be conveyed to potential subjects, please contact HSO staff for assistance.