(a) The Department shall establish an Institutional Review Board which shall be composed of 12 members appointed by the Secretary of the Department. No more than 6 members shall be employed by the Department and no more than 3 members shall be employed by the hospital.

(b) The duties of the Institutional Review Board shall include, but not be limited to:

(1) Approval, modification or disapproval of all proposed pharmaceutical research programs and all written procedures and protocols governing such programs. Final approval of any program shall require an affirmative vote of 8 members. In evaluating any proposed research program, the Board shall consider whether the risks to patients are sufficiently outweighed by the potential benefits and the importance of the knowledge to be gained. In its deliberations, the Board shall be guided by the American Medical Association’s “Ethical Guidelines for Clinical Investigation,” the American Psychiatric Association’s “Ethical and Professional Guidelines Governing Research With Human Subjects” or similar documents.

(2) Ensuring that no patient participates in research who fits any exclusion criteria established by the pharmaceutical protocol or by the Board itself.

(3) Actively monitoring all such research programs on a regular basis. Such monitoring shall include the review of the effects of the research on patients and the review of individual patient records to ensure the continued protection of patient rights and continued compliance with regulations.

(4) Ensuring that the provisions of § 5175 of this title are complied with for every patient who participates in pharmaceutical research.

(5) Evaluating, together with the administration of the hospital and the Food and Drug Administration, all reactions and incidents which occur to research participants to determine whether the research pharmaceuticals in any way affected the patient so as to cause the reaction or incident.

(c) In order that the Board be active and effective, notices of meetings shall be sent to all members, minutes shall be maintained and distributed prior to meetings and all records, documents and correspondence shall be retained by an officer of the Board at the hospital. The Division of Mental Health shall provide administrative and secretarial assistance to support the Board’s functions.

(d) No member of the Board shall be permitted to vote on any research project in which the member has an active role or financial interest.

64 Del. Laws, c. 421, § ?3; 70 Del. Laws, c. 186, § ?1;