{"data":{"id":"us-va/12vac5-20-40","jurisdiction":"us-va","citation":"12VAC5-20-40","heading":"Policy","body":"A. No human research  shall be conducted without informing the  subject or his legally authorized representative of the procedures, risks, and discomforts of the research. The consent of the  subject or his legally authorized representative to participate in the research shall be subscribed to in writing by the  subject or his legally authorized representative and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 12VAC5-20-100. Special arrangements shall be made for those who need assistance in understanding the consequences of participating in the research.\n\nB. Each human research activity shall be reviewed and approved by a committee as set forth in 12VAC5-20-70  composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.\n\nC. Every person engaged in the conduct of human research or proposing to conduct human research shall associate himself with an institution or agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in  this chapter.\n\nD. Nontherapeutic research using patients or residents within an institution as defined herein is forbidden unless it is determined by the research review committee that such nontherapeutic research  shall not present greater than minimal risk.\n\nE. The  person, institution, or agency conducting the human research shall  notify all  subjects of human research of the risks caused by the research  that are discovered after the research has concluded. If consent has been obtained by the signature of the legally authorized representative, the legally authorized representative shall also be notified.\n\nF. No official or employee of the institution or agency conducting or authorizing the human research shall be qualified to act as a legally authorized representative for a subject of the particular human research.","path":["Title 12. Health","Agency 5. Department of Health","Chapter 20. Regulations for the Conduct of Human Research"],"source_url":"https://law.lis.virginia.gov/admincode/title12/agency5/chapter20/section40/","current_through":"2026 Regular Session (effective July 1, 2026)","vintage":"","retrieved_at":"2026-09-14T04:49:49Z","sha256":"df63cd24c8df956a67b54e4ab3f9bd02d36c82ea92f979a54dd8c04889827fb5","source_id":"us-va-vac","stale":false,"prev":"us-va/12vac5-20-30","next":"us-va/12vac5-20-50"},"notice":"GroundRules: Original legal text. Not legal advice."}