The University IRB Chair or Vice Chair communicates the IRB’s determinations to the principal investigator. If the IRB’s decision requires immediate action on the part of the principal investigator, the decision will be communicated verbally to the principal investigator as soon as possible and followed up with written notification by the IRB Chair or Vice Chair within 10 working days of the decision.
A date for the investigator response is specified in the written notification. Failure to comply with this date, in the absence of a suitable justification, will be handled in accordance with University IRB policies involving the reporting and handling of other unanticipated problems.
Compliance of the principal investigator with the directed actions specified by the reviewing University IRB committee are reviewed and approved by the IRB Chair or an IRB Vice Chair unless full board review of the principal investigator’s response/actions is determined to be required by the reviewing University IRB committee.
If the principal investigator has additional information that may be relevant to the situation at hand, it will be brought to the attention of the reviewing University IRB committee for consideration.
Institutional Official, Regulatory Agencies, Sponsors and Others
In addition to the IRB correspondence sent to the investigator, reports of any unanticipated problems involving risks to human subjects or others, any serious or continuing non-compliance, any suspension or termination of IRB approval will be sent to all applicable parties, which may include:
- The Office for Human Research Protections – for research funded by any agency that is a signatory to the “Common Rule” at 45 CFR 46;
- The Food and Drug Administration – for research that is subject to the FDA regulations at 21 CFR 50 and 56;
- The federal or non-federal external funding agency For DOD funded research, the letter will be sent to the attention of the Director, Defense Research and Engineering;
- The VAMC R&D Committee and the regional VA Office of Research Oversight;
- The UPMC Office for Sponsored Programs and Research Support;
- Other University offices (e.g., Office of Research, Conflict of Interest, Risk Management);
- The principal investigator;
- The department chair;
- University or UPMC legal counsel;
- University or UPMC risk management;
- UPMC Institutional Officials.
- 45 CFR 46.103(b)(5)
- 21 CFR 56.108(b) (1), 312.53 (c) (vii) and 312.66 – Investigators are required to report promptly to the IRB all unanticipated problems involving risks to human subjects or others
- OHRP - Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (http://www.hhs.gov/ohrp/policy/advevntguid.html)
- NIH Guidelines for Research Involving Recombinant DNA Molecules http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
- Standard Operating Procedures for the Education and Compliance Office for Human Subject Research http://www.ecohsr.pitt.edu/regulatory-information/ECO_SOP.pdf.