90-325.18. Institutional review boards; annual report; rules.
(a) An institutional review board that oversees investigational adult stem cell treatments administered under this Part is required to be affiliated with an accredited medical school located in this State, or an affiliated facility of an accredited medical school located in this State. An institutional review board that meets the requirements of this subsection may certify physicians to provide investigational adult stem cell treatment under this Part.
(b) An institutional review board overseeing an investigational adult stem cell treatment under this Part shall keep a record on each person to whom a physician administers the treatment and document in the record the provision of each treatment and the effects of the treatment on the person throughout the period the treatment is administered to the person.
(c) Each institutional review board overseeing an investigational adult stem cell treatment under this Part shall submit an annual report to the North Carolina Medical Board on the review board's findings based on records kept under subsection (b) of this section. The report shall not include any patient-identifying information and must be made available to the public in both written and electronic form.
(d) The North Carolina Medical Board may adopt rules concerning the role and function of institutional review boards under this Part. (2019-70, s. 1.)
Structure North Carolina General Statutes
North Carolina General Statutes
Chapter 90 - Medicine and Allied Occupations
Article 23A - Right to Try Act.
§ 90-325 - Short title; purpose.
§ 90-325.4 - Sanctions against health care providers prohibited.
§ 90-325.5 - Prohibited conduct by State officials.
§ 90-325.7 - Insurance coverage of clinical trials.
§ 90-325.17 - Authorized treatments.
§ 90-325.18 - Institutional review boards; annual report; rules.
§ 90-325.20 - Sanctions against physicians prohibited.