Human Subjects Research (IRB)
IRB Submission System
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Regulation
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.
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.
Revised Common Rule
The Federal Policy for the Protection of Human Subjects, known as the Common Rule has undergone substantive revisions. The effective date for the revised Common Rule is January 21, 2019.
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.
Resources
- Procedures for Research Involving Human Participants at UNC
- Definitions-Comparison-Chart
- Exempt-Comparison-Chart
- The IRB Submission Process-Using Streamlyne
- When to Update Exempt Protocols
ORSP has implemented eRA software, Streamlyne Research. Streamlyne Research has replaced IRBNet for all IRB application submissions and reviews. Streamlyne 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.
- Informed Consent – with Signature
- Informed Consent – without Signature
- Parental Consent
- Child Assent
- Word version of the Streamlyne New Protocol Questionnaire
- UNC Service for Recruitment of Research Participants
- Researchers needing to recruit research participants may advertise their studies on the Office of Research and Sponsored Programs website after obtaining an IRB approval.
- NOTE: if you have questions regarding recruitment of research participants, please contact Laura Martin.
- 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 Information Technology Security.