Introduction & History

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).

The comprehensive Procedure Manual for Research with Human Subjects for distribution to the University community both online and in hard copy form 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 or clinical investigation that involves human subjects conducted by NSU 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.

Additional information provided in the manual includes: a definition of research involving human subjects that 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 Office of Sponsored Programswill 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 designated IRB member or alternate in his/her center/college, who will be responsible for reviewing the research and determining if it warrants review by the IRB. If so, the documentation will be forwarded to the Office of Sponsored Programsfor coordination of the IRB review.

Finally, the Office of Sponsored Programs 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.