Institutional Effectiveness & Research

What is the Institutional Review Board (IRB)

Under FDA regulations, an Institutional Review Board (IRB) is a committee established by an institution to protect the rights and welfare of human subjects recruited to participate in research activities. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Federal and state regulations require all human subjects research conducted by Rowan Cabarrus Community College faculty, staff, and students to be approved by the IRB before the research can be conducted.

The IRB does not assume the role of evaluating the soundness of the proposed research study, the merits of the research design nor the potential contribution of the research to scholarly literature.

IRB safeguards individuals involved in federally supported research by ensuring that:

  • risks have been considered and minimized;
  • the potential for benefit has been identified and maximized;
  • research-volunteers are provided with substantial information about the study and volunteer only after being provided with legally effective informed consent;
  • that all private information will be handled with confidentiality; and
  • that research is conducted in an ethical manner and in compliance with established standards.

Frequently Asked Questions

Does my project require review?

IRB approval is required for any primary investigator who is applying for funds from the federal government and is conducting research involving human subjects.

Determining project’s need for IRB review – To determine whether your proposed project will need IRB approval, please refer to this decision chart.

Research – systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102 (e)(1)).

Human Subject – a living individual about whom an investigator conducting research obtains data through intervention or interaction with individual(s) or identifiable private information (45 CFR 46.102 (e)(1)).

Some types of research may not require IRB review. If you are unsure please review the decision chart or send an email to irb@rccc.edu.

Human subjects research may include surveys and interviews, behavioral investigations, and demonstration and service programs and clinical trials. In addition, the FDA includes under the definition of reviewable research, any use of an FDA regulated product except for use of a marketed product in the practice of medicine.

“Exempt” does not mean that your research is excluded from IRB review. All exempt studies are initially reviewed by the IRB. After its review, the IRB will determine a protocol application’s exempt status and any requirements that apply.

Investigators are not permitted to make changes to the research without IRB review. You must notify the IRB to any changes in your study by completing a modification form before they can be implemented.

Why is institutional review required?

It is required for your protection, as well as that of Rowan-Cabarrus Community College. The Principal Investigator (PI) is responsible for rectifying any damage caused to a participant in their research project. The IRB is a service that the college provides to assist the PI in avoiding situations where they may inadvertently ask sensitive questions.

When do I need to obtain IRB approval?

IRB approval is required before starting any data collection. If you begin your research and start collecting data without prior IRB approval you risk losing all of that data and must begin again with the collection process if approved.

What is involved in an institutional review of research?

In many cases, research at Rowan-Cabarrus will be conducted to satisfy requirements for a Doctoral degree at another institution. In those cases, you will need to get Institutional Review Board (IRB) approval from the degree-granting institution, and Rowan-Cabarrus will be a cooperating institution. If the research is NOT conducted in conjunction with another college or university, Rowan-Cabarrus will conduct its own review of the project, applying the standards set forth by the U.S. Department of Health and Human Services — Office for Human Research Protections (OHRP) in Federal regulations (45 CFR 46.102 (e)(1)).

Are there other resources I can turn to?

The Office of Human Research Protections website is the authoritative source on all things IRB.

How do I start the process?

In most situations, the process starts with your degree-granting institution (if not Rowan-Cabarrus) and filing for IRB approval. However, we are open to meet with you when you are still in the design stage and help you steer around common pitfalls when designing your project. Remember that to get approval, you will need to specify all of the details of your design and submit copies of all instruments, consent forms, and certification(s); the sooner you establish these details, the better.

Once you have obtained IRB approval from your granting institution (if applicable) send your entire IRB packet with approval (if applicable) to irb@rccc.edu along with the completed Rowan-Cabarrus application form.

The IRB conducts several types of reviews depending on the nature and scope of your research project. The timeframe for review and required accompanying material depends on the type of review.

  • Expedited Review – list of certain kinds of research involving no more than minimal risk, or for minor changes in already-approved research. Review process will take approximately seven calendar days.
  • Full Board Review – all other federally supported research involving human subjects. Review process will take approximately thirty calendar days.

Reporting Problems and Violations

Any staff or student at Rowan-Cabarrus who is aware of any problems involving risks to subjects or others; serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB must report the information to the IRB Chair. The report can be made by contacting the IRB chair directly at irb@rccc.edu. The Chair will then alert the appropriate institutional officials, the head of the agency supporting the research, any applicable regulatory body, and the Office for Human Research Protections.

Related Links

Questions?

Please contact the Rowan-Cabarrus Institutional Research department (iedata@rccc.edu or irb@rccc.edu).