512.12—Content of research proposal.
When submitting a research proposal, the applicant shall provide the following information:
(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;
(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.