Institutional Review Board (IRB)
新! 的 new IRB submission system, Streamlyne, has gone live! 点击 在这里 欲知详情.
的 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人类受试者. 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). 的 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. 通过教师, students, or staff) involving human subjects must be reviewed and approved by the university's Institutional Review Board (IRB). 教师, 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 贝尔蒙特的报告. 的 university and the IRB ad在这里 to the federal regulations found at CFR Title 45、第46部分. 的 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. 的 IRB is committed to carrying out this charge in a manner that will support and 协助研究人员.
经修订的通用规则!
的 Federal Policy for the Protection of Human Subjects, known as the Common Rule has undergone substantive revisions. 生效日期 for the revised Common Rule is JANUARY 21 2019. 请参考 这个文档 for important changes and revisions.
有问题?
访问我们的 常见问题页面.
IRB的指导
- Procedures for 研究 Involving Human Participants at UNC (pdf)
- Definitions Comparison Chart (pdf)
- Exempt Comparison Chart (pdf)
- 的 IRB 提交 Process-Using Streamlyne
ORSP has implemented eRA software, Streamlyne 研究. Streamlyne 研究 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. 研究ers 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 可上网.
额外的资源
- Federal policies and guidelines on the use of human subjects
- Training in the use of human subjects
- Informed Consent Templates
- Word version of the Streamlyne New Protocol Questionnaire
- UNC Service for Recruitment of 研究 Participants
研究ers needing to recruit research 参与者 may advertise their studies on the Office of 研究 and 赞助项目 website after obtaining an IRB approval.
请注意: if you have questions regarding recruitment of research 参与者, please contact 克里斯·萨克斯顿. - UNC Data Security Plan for 研究 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 参与者. 研究ers 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).
请注意: If you have question regarding data security, please contact 福勒斯特Swick, Information Technology Security.
