Statement of Policy - Oversight - Appeals Process
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In order to protect the rights, well-being, and personal privacy of individuals, to assure a favorable climate for the conduct of scientific inquiry, and to protect the interests of the University of Washington, the policy and procedures described below have been established for the conduct of research involving human subjects (University of Washington Handbook VOL. IV, Part II, Chapter 2, "Use Of Human Subjects").
The following general principles apply equally to all research involving human beings, whether carried out solely with University resources or with the assistance of outside funds. The University assumes responsibility for communicating and explaining these principles to University personnel, and for providing procedural guidelines to effect their observance.
The Research Advisory Board shall have general oversight responsibility for University policy on the protection of human subjects and shall consider policy changes that may be required to comply with Federal regulations, to ensure fairness to investigators, or to protect more adequately the rights and welfare of human subjects in research. When appropriate, such policy changes should be recommended by the Board to the Vice-Provost for Research.
If a Subcommittee of a Human Subjects Review Committee makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator may appeal, in writing, for review by the appropriate Human Subjects Review Committee.
If a Human Subjects Review Committee makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator should first discuss the matter with the Chair of the relevant Human Subjects Review Committee, taking care to explain the reasons for believing that the proposed procedures are in compliance with University policy and with Federal regulations. If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision of the Committee, in writing, to the Vice-Provost for Research.
Upon receipt of an appeal the Vice Provost shall convene an ad hoc committee constituted so as to fulfill the Federal requirements pertaining to Institutional Review Boards, and with a majority of the members being past but not current members of Human Subject Review Committees at the University of Washington. This ad hoc committee shall consider the appeal and issue a recommendation within no more than sixty days from receipt of the appeal by the Vice-Provost for Research. The ad hoc committee shall give the investigator an opportunity to present orally, or in writing, or both, the reasoning underlying the appeal. Upon completion of the review, the ad hoc committee shall communicate its decision in writing to the Vice-Provost, giving the reasoning for the decision. A copy of the decision of the ad hoc committee shall be given to the investigator. The decision of the ad hoc committee shall be treated as a decision of a University of Washington Human Subjects Review Committee (Institutional Review Board duly approved by OPRR prior to convening as an IRB appeals board).