Delaware Code Title 16. Health and Safety § 5173. Institutional Review Board

(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.