Institutional Review Board

  • PURPOSE AND FUNCTION OF THE IRB

     

    Saint Francis University has established an Institutional Review Board (IRB) to review all research involving the use of human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the project directors, and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to assist researchers in the protection of the rights and welfare of human subjects. Review and approval by the IRB is meant to aid both the subjects and the researchers by objectively assessing the potential risk and accommodations made to minimize the risk within the study.

     

    All research involving the use of human subjects conducted by SFU faculty, staff, or students, or sponsored, in part or in whole, by SFU must be reviewed and approved prior to the start of the project and then conducted in full compliance with applicable IRB policies and procedures. Research is defined by federal regulations as a systematic investigation including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. It encompasses work which is conducted on or off campus and includes questionnaires, interviews, surveys, tests, observations, and other experiments, even if the work is preliminary to a more extensive study. It includes secondary analyses of data previously collected. It also includes any systematic collection of data from human subjects that occurs in conjunction with classroom projects, unless the work is done as a learning exercise for the student and will never be published or presented outside of the course.

     

    It is the responsibility of the researcher to refer his or her project to the IRB whenever humans are used as subjects in research, even if the researcher does not consider the subjects to be at risk. Current law places the burden of liability for negligence and harm directly on the researcher and the institution. The IRB policies and procedures are formulated to protect the University, the researcher, and in the case of the students, the faculty research advisor, from liability through imposition of minimal standards for research and through procedures for careful review of projects.

     

    The Public Health Service Act (Title IV, Part G, Section 491a) required the Department of Health and Human Services (DHHS) to issue regulations for the protection of human subjects of research and to implement a program of instruction and guidance in ethical issues associated with such research. The regulations are codified as Title 45 Part 46 of the Code of Federal Regulations, Protection of Human Subjects (45 CFR 46), issued on June 18, 1991. These regulations apply to all research involving human participants that is conducted or supported, in whole or in part, by DHHS in foreign or domestic settings.

     

    The establishment of Saint Francis University IRB and its policies and procedures are primarily derived from 45 CFR 46. The policies and procedures are intended to provide a resource for the preparation and submission of research applications for IRB reviews. A copy of 45 CFR 46 is with each IRB member. Another copy of this CFR and other federal documents and guidelines can be found in the library in a three-ring binder entitled Protecting Human Research Subjects, Institutional Review Board Guidebook and written by R. Penslar (Ref. 610.72 P38). Another binder is in the office of the IRB chairperson.