FUIRB Submission Protocol Description
Furman University is dedicated to the protection of both the rights and welfare of volunteer human subjects engaged in research endeavors under the auspices of the University. The University has entered into an agreement with the Office for Human Research Protocol (OHRP) termed the IRB Registration and Federal wide Assurance (FWA) program, pledging compliance with the “Common Rule” for federally supported research. Furman University will apply this Assurance to all research using human subjects, irrespective of the funds or guidance of the research. To this end, the University has established an Institutional Review Board For Proposed Research Involving Human Subjects, referred to as the IRB throughout the remainder of this document. Guidelines are adopted from those guidelines detailed in the IRB guidebook by the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (http://www.hhs.gov/ohrp/
This brief overview of the Furman University Institutional Review Board policy is written to aid researchers in negotiating the IRB procedures. It is not intended as a replacement for the FUIRB Guidebook, which is available to all Furman Faculty. Researchers may use this brief guide to ensure that they are following the IRB submission protocol but should consult the full guidebook for specific concerns related to their submission. Below are listed steps in submitting an IRB proposal:
- In order for researchers to submit research proposals to the FUIRB, that researcher must demonstrate completion of the educational criteria for access to human participants. See section VII FUIRB Guidebook. IRB proposals will not be reviewed until and unless the researcher has obtained educational certification. Criteria for certification include: completion of NIH computer-based tutorial, reading of The Belmont Report FUIRB Appendix) and Responsibilities of the Investigator Prior To and After Project Approval (FUIRB Section XII).
- The FUIRB maintains the right and responsibility to oversee all activities, research and otherwise, in which teachers and researchers submit human participants to activities that are of minimal or greater risk. Minimal risk is defined as risk(s) of harm anticipated by the research protocol that are no greater, considering the probability and magnitude, than those encountered in daily life or during the performance of routine physical or psychological examination or tests (45 CFR 46.102i). Classroom activities in which students and other known or anonymous participants are subjected to deception or incomplete disclosure constitutes minimal or greater risk.
- The FUIRB maintains three levels of evaluation for IRB submissions. These include 1) Exempt status, 2) Expedited review and 3) Full-review. Researchers and teachers should consider the definition of each level of submission prior to completing the IRB Forms. See sections VIII-I, VIII-2 and VIII-3 for respective description of each of these categories.
- All submissions to the FUIRB should include FUIRB Form A, plus Form B (Exempt status), C (expedited review) or D (Full-Board Review).
- Use of human participants, which does not constitute research (see section V of FURIB Guidebook) and does not place participants at greater than minimal risk (section V) should submit Form A plus an exempt status notice (Form B). Submissions for Exempt Status will be acted upon by the FUIRB within one week of receipt.
- Expedited Review requires the evaluation of the FUIRB Chair and two IRB members. Proposals will be acted on within 1 week of submission to the IRB Chair.
- Researchers must await approval and notification by the FUIRB prior to commencement of any activities being reviewed by the FUIRB.
- Full-Review proposals require evaluation by the full FUIRB. The full FUIRB meets monthly and considers Full-Review proposals at the monthly meeting. The FUIRB Chair must receive proposals two full weeks prior to the committee meeting. Researchers should consult with the FUIRB Chair (Professor Ray Moss) for specific deadlines.
- Researchers are encouraged to refer to the Decision Tree Diagram to aid in the process of determining the appropriate FUIRB submission (See FUIRB Appendix 4).