Research Review

(1) The Research Review Committee shall review each research proposal for the primary purpose of protecting the rights and welfare of participants. (2) The Committee must consider, as part of the review, the impact the proposed research may have on the participants in terms of health and physical safety, confidentiality and privacy, human dignity, self-determination and freedom of choice, care and treatment, fairness in selection of participants, freedom from undue discomfort, distress and deprivation, and such other interests that may be implicated by the particular research project. (3) The Committee must further consider, in determining whether the foreseeable risks to the participants are reasonable in relation to anticipated benefits, available relevant clinical experience and expertise, existing knowledge of relevant research findings, canons of professional conduct and professional ethics, applicable laws, policies and procedural guidelines, standards of scientific methodologyinthe conduct ofsuch research, the scientific merit of the research, the potentialvalue of the research in the advancement ofknowledge and the necessityor importance that persons receiving services from the Department are participants if the research involves individuals. (4) The Committee mayrequire the research investigator or other staff persons involved in the conduct of the research to appear before the Committee to address the proposal. The Committee may require also the submission of additional documentation and materials which it deems appropriate for consideration before reaching a decision on the proposal. (5) The Committee may appoint an advocate for the participants of a research project. The advocate shall provide counseling, assistance, and advocacy to individuals with respect to their participation in the research. No member of the Committee and no research investigator may be appointed as an advocate. The Committee shall be responsible for informing participants of the name and address of the advocate when one has been appointed.