Institutional Review Board (IRB)
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human 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 January 12, 2027. Coastal Carolina University policy is that all faculty, staff and student must guard the truth, uphold the highest standards in their research and protect the public trust that the academic environment has long held.
Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects, as applicable.
When considering whether an activity meets the definition of human subjects research per DHHS regulations one must consider two federal definitions: research and human subject. 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.
IRB Decision Flowchart
To be used as a guide to assist faculty, staff and students in determining 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.
IRB Review Decision Flowchart (.pdf)
Coursework Involving the use of Human Subjects
For faculty assigning students coursework involving the use of human subjects, please refer to the Guidelines for Student Activities Involving Human Subjects to determine whether an IRB Review or Notice is required.
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. The University has contracted with 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.
CITI Program Registration Instructions(.pdf)
IRB Forms and Templates
Faculty and Staff Forms
- Exempt Review Request (.pdf)
- Exempt Review Categories(examples of Exempt studies)(.pdf)
- Expedited or Full Board Review Request (.pdf)
- Expedited/Full Board Categories (examples of Expedited/Full Board studies)(.pdf)
- Continuing Review Request (.pdf)
- Protocol Amendment Request (.pdf)
Student Researchers Forms
- Student Exempt Review Request (.pdf)
- Student Expedited or Full Board Review Request(.pdf)
- IRB Notice of Student Assignment or Classroom Project (.pdf)
- TEMPLATE: Informed Consent document (.docx)
- TEMPLATE: Online Survey Consent document (.docx)
- TEMPLATE: Photography-Video-Audio Recording Authorization document (.docx)
- TEMPLATE: Minor Participant Authorization document (.docx)
- TEMPLATE: Minor Photography-Video-Audio Recording Authorization document (.docx)
For questions or more information, please contact:
Patty Carter, IRB Coordinator - 843.349.2978
Stephanie Cassavaugh, IRB Administrator - 843.349.5030
IRB Board Members
- Dr. Jonathan Trerise (Chair) - Philosophy & Religious Studies
- Dr. Taylor Damonte - Director of Brittain Center/Blanton Endowed Professor
- Deni Gibbs - Community Member-At-Large
- Dr. Justin Guilkey - Kinesiology
- Dr. Hugh Lamont - Kinesiology
- Dr. Catherine Scott - Foundations, Curriculum & Instruction
- Dr. Kerry Schwanz - Psychology
Institutional Animal Care and Use Committee (IACUC)
The USDA Animal Welfare Act and the NIH Public Health Service Policy on the Humane Care and Use of Animals require that institutions conducting research with animals establish an Institutional Animal Care and Use Committee (IACUC). The IACUC provides oversight and helps ensure compliance with all laws, regulations and policies governing the care and use of research and teaching animals.
An IACUC protocol is required for all activities by Coastal Carolina University faculty, students, or staff that involve the capture, housing, handling, manipulation, death, or injury of live non-human vertebrates, or invasive procedures or other activities that substantially alter vertebrate behavior in the wild. Vertebrate animals include mammals, birds, reptiles, amphibians, and fish. Purely observational projects, where wild animals are observed in their natural habitat with no further human intervention, do not require an IACUC protocol.
Submit an IACUC Protocol
Complete a IACUC Protocol Form for Research with Vertebrate Animals and all required CITI online training modules (see below). Once training is complete and documented on the form, submit a pdf of the signed Protocol Form and any attachments to the OSPRS. Protocols may also be submitted to OSPRS as hard copies, either in person or via campus mail. Protocols may be submitted by faculty, staff, or students. Student protocols must include signed approval from their CCU faculty research advisor/mentor.
Required Training for Research Involving Animals
Completion of approved training is required of all CCU 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 (RCR) training and the Working with the IACUC module, along with species-specific module(s) (through CiTI Program, NIH or other) must be completed and certification filed with the Office of Sponsored Programs and Research Services before your IACUC protocol can be submitted. If you have not received certification, please go to the CITI website to complete your training requirements.
CITI Program Registration Instructions can be found here.
IACUC Protocol Form for Research with Vertebrate Animals
For more information or questions, please contact:
IACUC Committee Members:
- Dr. Ryan Yoder (Chair) - Psychology, 843.349.2925
- Dr. Miranda Brenneman - Psychology, 843.349.4035
- Dr. Sharon Gilman - Biology, 843.349.2248
- David Howard - Community Member At-Large
- Dr. Jennifer Kleinfelter, DVM - Attending Veterinarian
- Dr. Catherine Scott - Foundations, Curriculum and Instruction, 843.349.6558
- Dr. Robert Young - ex officio, Associate Provost for Research, 843.349.2277
Financial Conflicts of Interest (FCOI)
Financial conflicts of interest exist when a significant financial interest, defined below, could directly and significantly, affect the design, conduct, or reporting on results of funded research or educational activities.
As outlined in CCU policy ACAD-132, any Principal Investigator (PI) engaging in federally funded Public Health Service (PHS) research is required to complete FCOI training provided through the CITI Program.
CITI Program Registration Instructions for creating a NEW CITI Learner account.
CITI FCOI Registration Instructions for adding a FCOI course to an existing CITI learner account.
In accordance with the regulation, disclosures are required at the following times:
- At the time of application for PHS funding;
- At least annually during the period of award;
- Within 30 days of acquiring or learning of a newly acquired significant financial interest; and
- Within 30 days of an Investigator newly participating in the project.
To make a disclosure, please download the FCOI Disclosure Form and return it to OSPRS@coastal.edu.
The U.S. government regulates the transfer of information, commodities, technology and software considered to be strategically important to the U.S. in the interest of national security, economic and/or foreign policy concerns.
There is a complicated network of federal agencies and inter-related regulations that govern exports collectively referred to as Export Controls. In brief, export controls regulate the shipment or transfer, by whatever means, of controlled items, software, technology or services out of U.S. (termed an "Export").
Perhaps of even more consequence to the University, is that the government also restricts the release of certain information to foreign nationals here in the U.S. (referred to as a Deemed Export).
Export controls have the potential to severely limit the research opportunities of University faculty and their students and staff, as well as to prevent international collaboration in certain research areas.
Non-compliance with export controls can result in severe monetary and criminal penalties against both an individual as well as the University, and can result in the loss of research contracts, governmental funding and the ability to export items.
Please review the University's export control policy ACAD-131.
Research involving potential hazards associated with the use of toxic materials, infectious organisms and genetic recombination must be reviewed and approved by the University.
Questions concerning research involving hazardous materials should be directed to Joshua Desmond, Safety Compliance Manager, Environmental Health and Safety, 843-349-5094.
Since the search for knowledge is impeded and subverted by the misrepresentation of facts, the concepts of openness and honesty are commonly accepted norms within the scientific and scholarly community for proposing, conducting or reporting research.
Research misconduct means plagiarism, falsification, fabrication of data or other forms of deliberate misrepresentation. It does not include honest error or honest differences in interpretations or judgments of data.
Whenever any faculty member, staff or student engaged in research is accused of misconduct in scientific or scholarly research, the University will conduct an inquiry, make a determination concerning the truth or falsity of the allegations and take appropriate disciplinary action. The process of inquiry will be expeditious and protect the rights of all those concerned, including the complainant and the accused.