Research means a systematic investigation, including testing and evaluation, designed to develop or contribute to generalized knowledge. A human subject is a living individual about whom an investigator conducting research obtains personal data through intervention or interaction with the individual or identifiable private information. Protection of identifiable private information is critical to the protection of human subjects and has implications for informed consent, data collection, storage, retrieval and destruction.

Federal law requires that all protocols involving human subjects must be reviewed and approved, even if the proposal is not externally funded. UNC Pembroke is concerned that no research is undertaken that exposes participants to unreasonable risks to their health, general well-being or privacy. Specifically, the University is concerned that all research and related activities involving the use of human subjects:

1. Protect the rights and welfare of persons participating as subject
2. Use as subjects only persons who have freely given informed consent, and
3. Provide benefits to the subject of advance knowledge to the extent that any risk incurred is judged acceptable.

Review and approval is the responsibility of the Institutional Review Board, a panel of UNC Pembroke faculty, administrators and a community representative. The IRB is responsible for protection of the rights, welfare and privacy of research subjects through an initial review and subsequent oversight of all human subjects research.

Under both federal and university policy, the IRB has the authority to approve proposed research, require revisions in proposed research to ensure it includes safeguards to protect subjects or refuse to approve proposed research if the applicant can not or will not revise the protocol to prevent identified risks to the subjects. Once the research is approved the IRB has the authority to monitor the research to ensure that research is conducted as approved. Additionally, multi-year research projects are required to be reviewed and re-authorized annually.

The Chairperson or a designate will evaluate the protocol and determine the required level of review. Based upon the Code of Federal Regulations, Title 45 Part 46, the UNC Pembroke IRB will utilize the following categories of review:

Exempt Review: may include normal educational practices, educational tests, surveys, instruments, or observation of public behavior when subjects cannot be identified and the information gathered will not put the subjects at risk, research using existing data, documents, and records if publicly available and the subjects cannot be identified, and the evaluation of public benefit service programs. Applications that are exempt from review will be notified by electronic mail as soon as that decision is made. The documentation form will be signed and returned to the researcher as soon as possible.

Protocols that are developed for either instructional purposes or teaching research methodology and are not designed to contribute to generalized knowledge may be exempt from review. Under these circumstances the instructor assumes ethical and professional responsibility to monitor the progress of all research in the classroom. Research on vulnerable populations, including minors, pregnant women, fetuses, prisoners, seriously ill and mentally incapacitated individuals may not be exempt from review. Waiver of IRB review does not imply that students are exempt from human subjects protections.

Expedited Review: covers research that poses no more than minimal risk to human subjects. “Minimal risk” is the risk encountered in everyday life. Expedited review may be employed for minor changes in previously approved research, collection of small blood samples, collection of data through non invasive procedures routinely employed in clinical practice, collection of data from voice, video, digital or image recordings, the use of materials that have been collected solely for non research purposes, research on individual or group characteristics or behavior, or research employing survey, interview or oral history methodologies. Expedited review may be used for these types of research regardless of the age of the subjects.

Expedited reviews are completed by a subcommittee of the IRB and are generally completed within two weeks. A research proposal may be approved by the expedited review process. Minor modifications to the protocol may be requested. The applicant will be notified by electronic mail.

Full Review: includes research where the subjects can be identified and the data collected poses risks to the subjects, in terms of their financial or social standing, employment or criminal or civil liability. It also includes research that involves more than moderate exercise, research on individual or group characteristics or behavior that employs deception of the subjects or where they are placed under psychological or emotional stress, and research that poses potential physical, psychological, social, legal or other risks to the subjects.

Research on vulnerable populations, including minors, pregnant women, fetuses, prisoners, seriously ill and mentally incapacitated individuals will receive a full review to insure the presence of adequate protections.

If required, a full board review will be scheduled within one month. The research protocol will be distributed electronically to all board members. A majority of board members must be present at the review meeting. The principle investigator will be invited to present the research protocol and answer questions at this meeting. The protocol must be approved by a majority of the members present. Members of the IRB who vote to disapprove a protocol shall submit their reasons in writing to the IRB chairperson.

All IRB reviews begin with an application following an initial review of the application describing the nature of the research, a proposal may be:

• Exempt from IRB review
• Appropriate for an expedited review by the chairperson of the IRB or a subcommittee of the IRB
• Subject to review by the full IRB

Only the IRB Chairperson or designate can determine which type of review is applicable. Researchers should not assume their proposal is exempt from review. Regardless of level of review, a written record must be kept by the IRB of all research involving human subjects at UNC Pembroke.