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| Research Services and Sponsored Programs |
| CONTENTS |
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Responsible Conduct in Research: Human Subjects Research |
POLICIES AND PROCEDURES Researchers should make themselves familiar with the UNCW Institutional Review Board Policy and Procedures. The IRB policy includes important information about researcher responsibilities and review procedures. All research projects involving human subjects must be approved by the UNCW IRB. To determine if your project meets the federal definitions of “research” and “human subjects,” please review the Research and Human Subject Decision Charts. Researchers may also find the IRB Principal Investigator Guidance Manual helpful in becomming familiar with IRB policies and procedures. If you would like a hard copy of the IRB PI Guidance Manual, please contact Leanne Prete at 962-7774 or pretel@uncw.edu.
Related Policies and Resources
What happens after I submit my forms? How long will it take before I hear something? After you submit your forms, the regulatory compliance officer will conduct an initial review to make sure the application is complete prior to forwarding to the IRB Chair. The IRB Chair will then review the protocol to determine which type of review is required pursuant to Regulations for the Protection of Human Subjects (Title 45 Part 46) . If the protocol requires review by the full IRB at a convened meeting, the principal investigator is informed usually by phone or e-mail and the protocol is placed on the agenda for the next scheduled meeting. If the protocol can be reviewed by expedited review, or if the IRB Chair determines the protcol is exempt from further review, the IRB Chair conducts the review. The turn-around time for expedited or exempt reviews can be very prompt, sometimes within a week. The IRB Chair sends the approval sheet to the principal investigator along with approved informed consent forms if applicable.
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