Institutional Review Board (IRB)
The use of human subjects in research at UNC is regulated by University Regulations 3-8-104, enacted by the Board of Trustees to ensure that all research involving human subjects carried out under the auspices of UNC conforms to ethical standards.
3-8-104 Human Subjects. It is the policy of the University that all research and research-related activities, in which humans are used as subjects, shall be subject to review under current Public Health Service regulations by an Institutional Review Board (IRB). The involvement of humans subjects in research covered by this policy shall be prohibited until the IRB has reviewed and approved the research protocol.
All research projects conducted under the auspices of the university (e.g. by faculty, students, or staff) involving human subjects must be reviewed and approved by the university's Institutional Review Board (IRB). Faculty, students and staff planning human research must submit requests for IRB approval prior to any data collection.
UNC Regulations and procedures regarding the use of human subjects are guided by the ethical principles set forth in the Belmont Report. The university and the IRB adhere to the federal regulations found at CFR Title 45, Part 46. The role of the IRB is to support UNC researchers in conforming to the ethical standards for the protection of human subjects, researchers, and the university. The IRB is committed to carrying out this charge in a manner that will support and assist researchers.
Possible IRB Federal Regulations Update
While the following is currently in effect, a recent request to delay changes until 2019 has been made by the U.S. Department of Health and Human Services (HHS) to the Office of Management and Budget (0MB). See the this link for the little information that is available.
IRB Federal Regulations - Effective January 1, 2019 (updated 10/22/2018). Changes to the US federal regulations governing human subjects research will take effect January 1, 2019. The amended rules are the first changes to human subjects research regulations since 1991. While many changes will reduce the burden on researchers and institutional compliance areas, some of the new requirements come with additional responsibilities. Please see this link for the updates It is certainly a busy time for UNCO IRB in preparing for these Common Rule changes. Here is a summary of what has occurred and what we look forward to during the next few months in order to implement the changes by January, 2018:
- IRB Board Members have been trained in all the areas that will be changed.
In 2019, if the change date stays in effect the following will occur:
1.IRB Board Members will set up informational sessions with their respective departments, schools and/or colleges.
2.The IRB Co-Chairs will offer informational sessions through the Graduate Student Association, Center for Teaching and Learning, and an open meeting to the campus, "Ask the IRB".
3. The IRB Co-chairs will work with any remaining units to ensure they receive information about the changes in a timely manner.
4.Researchers who conduct research that involves biospecimens will be contacted individually by the IRB Co-Chairs with pertinent information.
5.Omnibus course researchers will receive additional information by email so they may update their courses accordingly.
- The addition of a website on the IRB changes
- UNC IRB procedures updates Informed consent form template and composition updates
- Additional self-training materials
Visit our FAQ page.
- Procedures for Research Involving Human Participants at UNC (pdf)
- The IRB Submission Process-Using IRBNET
- IRB.net for UNC users
UNC has implemented the IRBNet system to streamline the IRB application and review process. IRBNet provides a paperless, electronic method for submission, tracking and review of applications for IRB approval. Researchers can create, edit, and submit their applications for IRB approval, and IRB members can review and take action on applications at any time from any computer with Internet access.
- Writing an IRB application narrative (pdf)
- Submitting a new project in IRBNET (pdf)
- Revising an existing project in IRBNET (pdf)
- Submitting a continuation review request in IRBNET (pdf)
- Protocol for research involving human body specimens (pdf)
- Requirements for course-based research (Omnibus) (pdf)
- IRB Frequently Asked Questions
- UNC Human Subjects Federal Wide Assurance: FWA00000784
- View Additional IRB Resources
- Federal policies and guidelines on the use of human subjects
- Training in the use of human subjects
- "Ethically Impossible" STD Research in Guatemala 1946-1948
The revelation that in the 1940s the U.S. Public Health Service supported research in Guatemala that intentionally exposed thousands of Guatemalans to sexually transmitted diseases without their consent resulted in an investigation by the Presidential Commission for the Study of Bioethical Issues. The findings of that investigation are available in this Commission report and related study guide.
- A Study Guide to "Ethically Impossible"
"Designed for higher education, this study guide allows students to assess for themselves the PHS debates about the scientific validity and political sensitivity of the research.
- UNC Service for Recruitment of Research Participants
Researchers needing to recruit research participants may advertise their studies on the Office of Research website after obtaining an IRB approval.
NOTE: if you have questions regarding recruitment of research participants, please contact Nicole Morse.
- UNC Data Security Plan for Research Involving Human Subjects
As part of the IRB application, researchers need to identify any data that are stored electronically and that if disclosed, would cause material or legal harm to research participants. Researchers who are collecting, handling, or storing such data must define their security level, as specified in the UNC Data Security Plan, and submit an application to UNC Information Management and Technology (IM&T).
NOTE: If you have question regarding data security, please contact Forrest Swick, Information Technology Security.