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Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
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Office of the President RESEARCH INVOLVING HUMAN SUBJECTS The responsibility for compliance with regulations concerning experimentation with human subjects shall rest with the Chancellors, the Vice President - Agricultural Sciences, and the University Dean of The regulations issued by the United States Public Health Service (copy attached) shall be applicable to all investigations involving human subjects for which the University is responsible, not just those funded by the USPHS, except for those supported by other granting agencies which have their own regulations. flict between regulations of the funding agency and the USPHS, the more restrictive regulations shall prevail. In order to provide maximum protection from legal liability to the researchers, the campus review committees, and The Regents, a standard form titled “Consent to Act as Subject for Research and Investigations” (copy attached), shall be used on all campuses for those investigations for which written consent from the subject must be sought under the regulations (see pages 9-10 of the attached copy of the USPHS pamphlet). The Office of the General Counsel shall be asked by the campuses to review the policies and procedures formulated by the campuses to assure that legal requirements are met. Furthermore, in the event that, in connection with a specific research proposal, the investigator or the campus review committee identifies a significant legal issue, approval of that proposal shall be sought from the In order to assist the researchers as well as the campus review committees in their effort to identify the common types of legal issues which might be presented and to develop criteria for their resolution, the General Counsel has offered to review, at least for some initial period of time, all research proposals involving experimentation with human subjects. For those who do not wish to avail themselves of this offer to have all such proposals reviewed, the General Counsel has provided the following list of criteria which may be used in determining whether to submit a particular such project for legal review: a. The involvement of minors. In the case of conb.. The involvement of adults whose competence to give an informed consent may, in the opinion of the principal investigator, or the committee, be subject to question.
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c . Doubt in the minds of the principal investigators or members of the committee as to whether the explanation set forth on the consent form is sufficient-fullyto inform the subject of the research in regard to the procedures to be performed and the risks attendant thereto. The necessity for the principal investigator or those working under his direction to perform acts requiring licensure under the provisions of law relating to the 5 . If a proposed investigation is to include students of the University as subjects, the Student Health Service Director of the campus responsible for the research to be conducted, if not already a member of the review committee, shall be consulted in the review of that