§ 512.12 Content of research proposal.

When submitting a research proposal, the applicant shall provide the following information: (a) A summary statement which includes: (1) Name(s) and current affiliation(s) of the researcher(s); (2) Title of the study; (3) Purpose of the project; (4) Location of the project; (5) Methods to be employed; (6) Anticipated results; (7) Duration of the study; (8) Number of subjects (staff/inmates) required and amount of time required from each; and (9) Indication of risk or discomfort involved as a result of participation. (b) A comprehensive statement which includes: (1) Review of related literature; (2) Detailed description of the research method; (3) Significance of anticipated results and their contribution to the advancement of knowledge; (4) Specific resources required from the Bureau; (5) Description of all possible risks, discomforts, and benefits to individual subjects or a class of subjects, and a discussion of the likelihood that the risks and discomforts will actually occur; (6) Description of steps taken to minimize any risks described in (b)(5) of this section. (7) Description of physical and/or administrative procedures to be followed to: (i) Ensure the security of any individually identifiable data that are being collected for the project, and (ii) Destroy research records or remove individual identifiers from those records when the research has been completed. (8) Description of any anticipated effects of the research project on institutional programs and operations; and (9) Relevant research materials such as vitae, endorsements, sample informed consent statements, questionnaires, and interview schedules. (c) A statement regarding assurances and certification required by 28 CFR part 46, if applicable.