News

Text:
Increase font size
Decrease font size

Processing time delays

We continue to experience delays in processing time.  Recent changes in our computer system (IRBIS) have impacted the time it takes to review and approve submissions.  We appreciate your patience while we get through this transition.  Click here for guidance on how to monitor the status of your submission.

Important information about event reporting

  1. Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available.
  2. A UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) that is also a Serious Adverse Event must be reported ASAP, but no later than one (1) week from the time you become aware of the event.
  3. All other UPIRSOs must be reported ASAP, but no later than two (2) weeks from the time you become aware of the event.
  4. Protocol violations must be reported ASAP, but no later than one (1) week from the time you identify the issue.
  5. Other events that are reportable to the IRB include subject complaints and breach of confidentiality.
For more information, please review UNC SOP 19.0 and 23.0 http://research.unc.edu/files/2014/05/2014-04-24-OHRE-Standard-Operating-Procedures-FINAL-CLEAN.pdf

Good Clinical Practices Training Required

The CITI Good Clinical Practice (GCP) training module is now required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects and a drug, device or biologic is included in the study.  Deadline for completion is October 1, 2014.  A refresher course will be required every two years.

The GCP training requirement is in addition to the OHRE requirement for Human Research Ethics Training (CITI Human Subjects Research Protection modules).

If you have further questions regarding the required GCP training, please contact the Office of Clinical Trials at oct@unc.edu or call 919-843-2698.

SOPs Revised April 24, 2014

A new version of the IRB SOPs (dated 4/24/2014) is posted here and includes the following changes:

  • SOP 3.2-Revised to reflect current practices regarding inter-institutional agreements (specifically, reliance on central IRBs).
  • SOP 19-Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) reporting revised to require reporting of events that meet all three criteria (previously events that meet criteria 1 & 2 (related and unexpected) were reportable to the IRB)
  • SOP 22-Revised to clarify that all events meeting the criteria for an UPIRSOs or cases of alleged serious or continuing non-compliance, will be reviewed by the convened IRB for a final determination.
  • SOP 29-Revised HIPAA section to add information regarding “compound authorizations”
  • SOP 37- New SOP: Sponsor-initiated holds, suspension and termination of IRB approval  (Sections of SOPs 14.3 and 18.1 deleted to eliminate duplication.)
  • Revised appendices:  F, I, J, K, Q, R, U and Y

Changes to routing of IRB correspondence

Two changes to the routing of IRB correspondence, effective immediately:
1) Co-Investigators will now be copied on all IRB-related correspondence automatically, in addition to Principal Investigators and Faculty Advisors. Other members of the research team (e.g., Study Coordinators, Regulatory Associates) can still be added to the copy list, optionally, as currently done.
2) Department heads will be copied on determinations that a project is "Not Human Subjects Research" (NHSR). While these activities do not require IRB approval, they may still raise concerns and/or warrant departmental oversight.