Wofford College encourages the conduct of research in each department, and in collaboration with other educational institutions, agencies, and organizations. While respecting the right of faculty to full academic freedom in research, the College is firmly committed to adhering to basic ethical principles underlying the acceptable conduct of research involving human subjects.
The National Research Act Public Law 99-158, the most recent extension of that law The Health Research Extension Act of 1985, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provide guidelines for research with human subjects to ensure their protection in the design and conduct of research. These federal regulations require that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that such research is reviewed and approved by the institution's Institutional Review Board (IRB).
In August 1999, the Senior Vice President and Dean of the College appointed an Institutional Review Board Task Force, comprised of faculty and administrators from various departments, to review the organization, functions, and responsibilities of the College's IRB. As a result of its work, the Task Force recommended the following actions:
The Task Force has developed a comprehensive Policy and Procedure Manual for Research with Human Subjects for distribution to the College community both online and in hard-copy form. The manual provides detailed information to support institutional initiatives for guaranteeing compliance with federal regulations governing the protection of human subjects and to guide principal investigators in procedures relevant to the development of research protocols that include human subjects. The following is a summary of key points included in the manual.
Any research, including that used for teaching, that involves human subjects conducted by Wofford faculty, staff or students, whether funded or unfunded, shall be under the jurisdiction of the IRB. The IRB is responsible for determining and assuring that 1) the welfare and rights of human subjects are adequately protected and informed consent given, if necessary; 2) human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research; 3) the necessity and importance of the research outweighs the risks to the subjects; and 4) the researcher(s) is/are qualified to conduct research involving human subjects.
Members of the IRB Committee will be appointed by the Senior Vice President and Dean of the College to staggered three year terms. Members will have varying professional, racial, ethnic, cultural, and gender differences, knowledge of professional regulations and conduct, and sensitivity to community attitudes. They will include:
Additional information provided in the manual includes: a definition of research involving human subjects which must have IRB review and approval and that which is exempt; types of IRB review and resulting actions; policies governing cooperative research; and extensive guidelines for conducting research involving special populations, such as pregnant women and fetuses, prisoners, and children. Guidance also is provided for preparing all documentation, including the submission form, research protocol, and informed consent form, along with samples of each, and the procedures to be followed in submitting such documentation to the IRB for review.
For all funded research involving human subjects, the IRB Chair will be responsible for coordinating the submission of required documentation to the IRB for review. In the case of unfunded research involving human subjects, faculty, staff, and students proposing research involving human subjects will submit all documentation to the IRB Chair, who will be responsible for reviewing the research and determining if it warrants review by the IRB. If so, the complete packet of documentation will be forwarded to the Chair for coordination of the IRB review.
Finally, the College will provide staff support to the IRB in all phases of its work, track and monitor submissions, and maintain records related to all research involving human subjects.
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