DATE: April 3, 2017
TO: UNC Research Community
FROM: The UNC Office of Human Research Ethics (OHRE)
RE: New Safety Information Standard Operating Procedures (SOPs)
We are pleased to announce three new OHRE Standard Operating Procedures:
- SOP 1401, Reporting New Safety Information
- SOP 1402, Management of New Safety Information
- SOP 1403, Questions, Concerns, or Complaints from Research Participants or Third Parties
The University of North Carolina at Chapel Hill and OHRE are committed to protecting the rights, safety and welfare of research participants. Consistent with this commitment, these SOPs establish procedures for (i) reporting new safety information to the IRB, (ii) managing and reviewing new safety information received in IRBIS, and (iii) receiving, reviewing and resolving questions, concerns, or complaints from research participants or third parties. The key points of the SOPs are described in the summary available here.
The SOPs will be effective June 2, 2017.
The IRB welcomes investigators and research personnel to begin using the new SOPs prior to the effective date. Town hall meetings and training sessions pertaining to the announced SOPs are scheduled for the month of May (see details below). Updates to the training schedule will be posted on our website.
| Calendar | Date / Time | Time | Training/Meeting | Audience | Location |
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May 2, 2017 | 3:00pm-4:00pm | The IRB’s New Safety SOPs – Special Training Session 1 | Investigators and research personnel at the Lineberger Comprehensive Cancer Center | Marsico Hall, Room 2004 |
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May 3, 2017 | 1:00pm-2:30pm | Introducing the IRB’s New Safety SOPs – Town Hall Meeting 1 | Investigators, research personnel, administrators | Hitchcock multipurpose room, Sonya Haynes Stone Center, 150 South Rd., Chapel Hill |
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May 4, 2017 | 12:00pm-1:30pm | All you Need to Know About the IRB’s New Safety SOPs | Members of the Network for Research Professionals, investigators and research personnel | NC TraCS, Brinkhous-Bullitt, Room 219 |
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May 5, 2017 | 1:00pm-2:30pm | Introducing the IRB’s New Safety SOPs – Town Hall Meeting 2 | Investigators, research personnel, administrators | Bioinformatics, Room 1131 (Auditorium) |
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May 10, 2017 | 3:00pm-4:00pm | The IRB’s New Safety SOPs – Special Training Session 2 | Investigators and Research Personnel at the Lineberger Comprehensive Cancer Center | Bioinformatics, Room 1131 |
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May 16, 2017 | 9:30am-10:30am | The IRB’s New Safety SOPs – Special Training Session | Investigators and research personnel at the Division of Infectious Diseases | Bioinformatics, Room 1131 |
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May 17, 2017 | 9:00am-12:00pm | Special Pop-up: Q & A about the IRB’s New Safety SOPs | Investigators and research personnel | CTRC Conference Room 1045, 1st Floor Burnett-Womack |
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May 18, 2017 | 1:00pm-2:00pm | The IRB’s New Safety SOPs – Special Training Session | Investigators and research personnel at the Diabetes Care Center Clinical Trials Unit and Pulmonary Clinical Trials Unit | 300 Meadowmont Village, Suite 202, Chapel Hill, Conference Room |
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May 25, 2017 | 9:00am-12:00pm | Special Pop-up: Q & A about the IRB’s New Safety SOPs | Investigators and research personnel | Davis Library, Room 3001 (15) |
If you have any questions about this announcement, please email Jeanne Lovmo, Compliance Manager, lovmo@unc.edu.