Faculty and Administration Manual
Institutional Review Board (IRB) Governance
3.0 Operational Procedures
1.1 The Institutional Review Board (IRB) for the Protection of Human Research Participants is an independent compliance committee mandated by the U.S. Department of Health and Human Services (DHHS). (See Title 45 Part 46 of the Code of Federal Regulations.) The most recent version of the regulations, adopted in 1991, includes the adoption of the Federal Policy for the Protection of Human Subjects, generally known as the "Common Rule." This policy, promulgated by the sixteen federal agencies that conduct, support, or otherwise regulate research involving human participants, is designed to make uniform the human research participant protection system in all relevant federal agencies and departments.2.0 PURPOSE
2.1 The role of the IRB is to protect the rights and welfare of individuals recruited to participate in research activities conducted under the auspices of the College of Charleston. The IRB has the authority to approve, require modifications in, or disapprove all research activities involving human participants that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB. Research that has been reviewed and approved by the IRB is subject to continuing IRB review and must be reevaluated at least annually, or more frequently if specified by the IRB.3.0 OPERATIONAL PROCEDURES
3.1 The IRB is comprised of nine (9) regular voting members and one non-voting ex-officio member, the Director of Research & Grants Administration or his/her designee.