{"data":{"id":"us-va/12vac35-180-40","jurisdiction":"us-va","citation":"12VAC35-180-40","heading":"Policy","body":"A. No human research may be conducted without obtaining the informed consent of the  individual or his legally authorized representative.  This informed consent   shall be documented in writing and supported by the signature of a witness.  Adequate and appropriate arrangements shall be made for those who need special assistance in understanding the consequences of participating in the human research.\n\nB. 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 an individual participating in the particular human research.\n\nC. Each human research activity shall be approved by a research review committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.\n\nD. Institutions or agencies, as defined by this chapter, may participate in human research activity when such activity has been considered and approved by a university institutional review board (IRB) that complies with the relevant requirements of § 32.1-162.19 of the Code of Virginia.\n\nE. Nontherapeutic human research using  individuals receiving  services in a residential or hospital setting is prohibited unless it is determined by the research review committee that such nontherapeutic human research will present no more than a minor increase over minimal risk to the  individual.\n\nF. The  person, institution, or agency conducting the human research shall be required to notify all individuals who are subjects of the human research of  risks caused by the human research  that are discovered after the human research has concluded.","path":["Title 12. Health","Agency 35. Department of Behavioral Health And Developmental Services","Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research"],"source_url":"https://law.lis.virginia.gov/admincode/title12/agency35/chapter180/section40/","current_through":"2026 Regular Session (effective July 1, 2026)","vintage":"","retrieved_at":"2026-09-14T04:51:32Z","sha256":"0c28c93e0977ba78c03e0de1440edf877c0aacfba3dfb6aa0bbf7651ae6842b1","source_id":"us-va-vac","stale":false,"prev":"us-va/12vac35-180-30","next":"us-va/12vac35-180-50"},"notice":"GroundRules: Original legal text. Not legal advice."}