The Institutional Review Board (IRB)
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Coastal Carolina University. The IRB is registered with the Office for Human Research Protection (DHHS) and holds the Federalwide Assurance # FWA00004137 which provides assurances that the University will comply with all applicable federal laws and regulations related to research involving the use of humans as participants. This assurance is valid through July 16, 2016.
Human Subject Regulations Decision Charts
The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
Brief Presentation: What Needs IRB Review & Approval Considerations
The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.
Completion of IRB-approved training is required of all Coastal Carolina University faculty, staff, and students conducting research with human participants or animal subjects. The university has contracted with the Collaborative Institutional Training Initiative (CITI) to provide a comprehensive online modular training program which is used by universities nationwide.
Responsible Conduct of Research training (through CITI Program, NIH, or other) must be completed and certification filed with the Office of Grants and Sponsored Research before your IRB or IACUC protocol can be submitted.
Click here to begin CITI training