Academic and Research Affairs
Duties and Responsibilities of the University Committee on the Use of Human Research Subjects (B-45)
OFFICE OF THE PRESIDENT
EXECUTIVE MEMORANDUM No. B-45
(Supersedes Executive Memo B-13)
February 17, 1977
To: Chancellors, Deans, Directors, and Heads of Schools, Divisions, Departments, and Offices
Re: Duties and Responsibilities of the University Committee on the Use of Human Research Subjects
Purdue University and the Purdue Research Foundation policies with regard to the use of human research subjects require a review to safeguard the rights and welfare of such subjects. In order to insure adequate safeguards, group reviews and decisions must be carried out in reference to (1) the rights and welfare of the individuals involved, (2) the appropriateness of the methods used to obtain informed consent, and (3) the risks and potential benefits of the proposed activity.
The establishment of appropriate policies and procedures, including group reviews and decisions, is the responsibility of the University Committee on the Use of Human Research Subjects, and such policies and procedures that are established shall be applicable to all research operations conducted at Purdue University or any of its facilities or conducted under the auspices of the University or its staff. These policies and procedures apply only to the use of human subjects for research and do not apply to the activities of the faculty and staff in the execution of their other professional duties.
Effective immediately, and continuing until further notice, the duties and responsibilities of the University Committee on the Use of Human Research Subjects are as follows:
- Establish a mechanism for and conduct reviews of research programs or projects to obtain group decision on guarding the safety, human rights, and welfare of human subjects. Consideration of safety, human rights, and welfare involves not only the effects on human subjects at the time, but residual and continuing effects throughout the life of the individual, subject to the normal processes of maturation, intercurrent disease, accident or the degenerations of aging. Intrusion upon the individual rights, privacy and freedom of individuals is also involved in the manner of utilization of results and their publication or other means dissemination of information.
- Make thorough evaluation of the potential risks and potential benefits connected with the procedures and agents to be used upon human subjects and determine whether the potential benefits justify the risks, if any.
- Assess the need for the proposed application of procedures and agents to human subjects in order to pursue the objectives.
- Provide an independent review of the facts and decide on the nature of its prosecution free of vested personal or professional interest in the general or specific objectives.
- Exercise executive authority to require change or discontinuance of the use of procedures or agents which pose a threat to human rights or welfare.
- Maintain an exchange of information and advice between the review group and the responsible individual, particularly to deal with proposed changes and with emergent problems which may alter the situation to safeguard rights and welfare of human research subjects.
- Prepare and disseminate information on the issues of human rights and welfare as related to the use of human research subjects and the practices and procedures, and rules related thereto, for use and guidance of the staff.
- Maintain records of each action, review and decision on the safeguarding of human rights and welfare with regard to a project or program involving human research subjects.
- Ascertain in all instances of the use of human research subjects that proper methods are established to obtain adequate and appropriate informed consent.
- Keep abreast of all additional granting agency rules and regulations involving human beings and initiate practices in the requirements on grants funded by the various agencies.
- Report, from time to time, to the Vice President for Research and Dean of the Graduate School and make recommendations to him concerning University practices that will meet the requirements on grants awarded by agencies.
Favorable recommendations by the Committee to review or rejection by the President of Unfavorable recommendations, restrictions, cannot be removed except by the Committee, or by the action of another duly appointed and appropriately constituted committee competent to review the project.
The Chairman of the Committee on the Use of Human Research Subjects shall serve as the administrative officer in carrying out the necessary administrative functions of the Committee and in promulgating the policies established by the Committee. The Chairman is authorized to appoint a qualified individual to serve, as needed, as an Executive Secretary in performing the administrative functions of the Committee.
The Chairman of the Committee and the Executive Secretary, or their duly to act authorized representatives, are authorized to act (under policies established by the Committee) for the Committee between meetings, reporting actions taken to the Committee for review at appropriate intervals.
In particular, as action consistent with the duties and responsibilities of the Committee as listed above, authority is granted to:
- Obtain information on projects involving human research subjects, particularly with respect to changes in protocol or emergent problems and to assure the Committee that its recommended course of action for specific projects is followed. Periodic review (dependent on the risk involved) of individual projects by consultation with the responsible staff and examination of appropriate records will be conducted.
- Provide for the maintenance of written records of the Committee, of group reviews and decisions on the use of human research subjects, and of sequent periodic reviews of individual projects.
- Provide advice and consultation to the staff on matters of employing human research subjects in investigation.
- Recommend that the responsible staff change or discontinue the use of research procedures or agents which pose a threat to human rights and welfare. Cases requiring more specific action will be referred to the Committee as a whole for final disposition.
Arthur G. Hansen