Frequently Asked Questions Regarding Human Subjects Research
- Where do I submit my IRB application?
Applications are submitted to the IRB through the web-based IRBNet tool that can be accessed at: https://www.irbnet.org.
- Who is responsible for ethical conduct in research with human subjects?
The primary responsibility for maintaining ethical standards and protecting human rights rests with individual researchers and research advisors. The Institutional Review Board (IRB) offers an added measure of assurance and serves as a local resource for the interpretation of ethical guidelines.
- What is the responsibility of the Institutional Review Board?
The IRB is a committee of researchers charged with the responsibility for reviewing all proposed research involving human subjects for adherence to ethical standards. IRB members work with individual researchers to ensure that federal and university policies are followed and that human rights are safeguarded.
- What kinds of research are subject to review by the IRB?
The federal regulations governing research using human subjects define research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." Research is subject to IRB review when an investigator, in the course of conducting research, obtains:
- Data through intervention or interaction with a living individual, or
- Identifiable private information about a living individual.
Examples of generalized knowledge include, but are not limited to (1) studies being conducted with the intent of publishing journal articles; (2) theses, dissertations, or other investigations that will be biographically available; (3) research that is presented at conferences or other professional venues; and (4) pilot studies that form the bases of subsequent research or are conducted in collaboration with investigators from other institutions.
Students who present research data as part of in-class presentations may need to obtain IRB approval if they are also intending to present their results at conferences or submit their papers for publication.
Research that analyzes archival records from individuals may also be subject to review by the IRB. Evaluations of workshops and programs are not considered "research" if results are not to be distributed outside the institutional setting.
- Who is obligated to follow IRB procedures?
All UNC faculty, staff, and students who conduct research with human subjects are obligated to follow UNC IRB policies and procedures.
- What kinds of reviews are conducted?
Protocol applications for IRB review fall into three categories. Before completing an IRB protocol, investigators are advised to thoroughly study the IRB guidelines to determine the type of review their research will require - exempt, expedited, or full-board review.
Each of these three categories of review has specific guidelines for submission, and receives different levels of scrutiny during review.
Please refer to the Procedures for Research Involving Human Participants for more information.
- How do IRB members review proposed research?
IRB members have been trained in ethical principles and in UNC procedures governing human subjects in research. They review applications to ensure that all information specified in the guidelines is included. Paying close attention to principles of ethical conduct, IRB members examine applications to ensure that risk and harm are minimized; benefits to science, humanity, and research subjects are maximized; the autonomy and privacy rights of subjects are protected; and the costs and benefits of research are fairly distributed among persons and groups. IRB members examine consent forms particularly closely to ensure that the necessary language and instructions are included and that subjects are fully informed of the risks as well as their rights.
- Who is on the IRB?
The IRB is comprised of UNC faculty members with diverse disciplinary and methodological expertise. In addition, the board includes a community member and a non-scientific member in accordance with federal regulations. The Office of Sponsored Programs provides administrative support. Current UNC IRB Membership
- What if my research involves collaborators at other institutions who have received IRB approval from their institutions?
UNC faculty members and students who are collaborating with individuals at another institution must attach a copy of the other institution's approved IRB protocol with their UNC protocol application. The UNC IRB will usually confirm that adequate provisions have been taken to protect the rights of human participants through a review of the other institution's approved protocol, although occasionally the UNC IRB may find it necessary to ask for clarification. In some cases, UNC or the other collaborating institution may function as the authorized agent for IRB review for both institutions. UNC IRB co-chairs and the IRB administrator at OSP can provide additional information.
- What other kinds of permissions are needed?
Written permission from appropriate authorities (individuals who are authorized to make commitments on behalf of another organization or institution) is required when researchers collect data in other institutions. Examples include schools, child care centers, hospitals, sports arenas, shopping malls, and other universities. This signed letter of permission must be submitted as part of the IRB protocol application.
- What if my students need to conduct research as a class assignment?
IRB procedures include provisions for instructors who require students to conduct research in class as part of an omnibus arrangement. Please refer to the description of Classroom Research and the Procedures for Research Involving Human Participants for detailed information.