Institutional Review Board (IRB)

The Institutional Review Board

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 Protections (OHRP) 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 October 14, 2021.

Human Subject Regulations Decision Charts

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 US Department of Health and Human Services (DHHS) regulations at 45 CFR part 46.

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.

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, state or local governments.

OHRP Decision Charts

Required Training for Research Involving Human Subjects

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 Sponsored Programs and Research Services before your IRB protocol can be submitted. If you have not received certification, please go to the CITI website to complete your training requirements.

Instructions for CITI registration - student (.pdf)

Forms

Exempt Review Request (.docm)

Expedited/Full Board Review Request (.docm)

Continuing Review Request (.pdf)

Amendment Application (.pdf)

Research Interview Consent (.docm)

Minor Consent Form (.docm)

Informed Consent for Exempt Research (.docx)

IRB Focus Group Consent Form (.docx)

For questions or more information, please contact:

Patty Carter, IRB Coordinator
Office of Sponsored Programs and Research Services
160 K Coastal Science Center
Conway, SC  29528
843-349-2978
pcarter@coastal.edu

Stephanie Cassavaugh, IRB Administrator
Office of Sponsored Programs and Research Services
843-349-5030
scassavau@coastal.edu