N.Y. Comp. Codes R. & Regs. tit. 14 § 27.10 - Research Involving Human Subjects Admitted to Mental Health Facilities

This regulation recognizes the importance of research in understanding mental disability, and sets forth the procedure for having patients at mental health facilities participate in research projects.  The regulation only allows patients to participate in research that does not conflict substantially with their individual service plans, prohibits patients from participating in any research that deprives the patients of their rights, privileges or protections.  Directors of facilities are required to maintain lists of all patients involved in research projects and is required to share this list with the Mental Health Information Service upon request.
 
This regulation requires that informed written consent from patients comply with requirements from N.Y. Comp. Codes R. & Regs. tit. 14 § 27.9 (a), (c) (stating that consent must be acquired from parents or guardians of patients under 18 years, and that consent must be acquired from the patient if s/he is over 18 and has sufficient mental capacity to consent).  The regulation further states that if the patient does not have sufficient mental capacity to consent, the facility director is allowed to consent if the research director demonstrates to the institution review committee that the project has “overriding therapeutic importance” for the patient’s condition and that the project cannot be carried out without the patient’s consent.  The regulation further states that research projects involving patients require the Department of Mental Hygiene’s approval, and that researchers require specific written approval from the department’s division of research in order to use experimental or treatment procedures.