Section 130. Participation of residents in human research

A. Written procedures approved by its governing authority shall govern the review, approval, and monitoring of human research. Human research means any systematic investigation, involving a resident or a resident's parents, guardians, or family members as the subject of the research, which may expose the subject to physical or psychological injury and which departs from the application of established and accepted therapeutic methods appropriate to meet the individual's needs. 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 6VAC35-101-330 (maintenance of residents' records) and all records and information related to the human research shall be kept confidential in accordance with applicable laws and regulations.

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

Historical Notes

Derived from Volume 29, Issue 25, eff. January 1, 2014.

Statutory Authority

§§ 16.1-309.9, 16.1-322.7, and 66-10 of the Code of Virginia.