6VAC35-41-140: Participation of residents in human research

A. The provider shall have procedures, approved by its governing authority, to govern the review, approval, and monitoring of human research. Human research means any systematic investigation, including research development, testing, and evaluating, involving human subjects, including but not limited to a resident or his parents, guardians, or family members, that is designed to develop or contribute to generalized knowledge. Human research does not include statistical analysis of information readily available on the subject that does not contain any identifying information or research exempted by federal research regulations pursuant to 45 CFR 46.101(b).

B. Information on residents shall be maintained as provided in 6VAC35-41-330 (maintenance of records) and all records and information related to the human research shall be kept confidential in accordance with applicable laws and regulations.

C. The provider may require periodic progress reports of any research project and a formal final report of all completed research projects.