Chapter 18 - Reporting of IRB Determinations
It is the policy of the IRB to comply with all applicable local, state, and federal regulations that require the following to be reported:
- Unanticipated problems involving risks to human subjects or others;
- IRB initiated suspension or termination of IRB approval;
- Serious or continuing noncompliance with federal regulations or the policies of the University of Pittsburgh HRP.
Time Frame for Communicating IRB Decisions
Reports are issued within 10 working days of the receipt of the final written report by the reviewing University IRB committee to the applicable parties as outlined below. Please refer to Chapter 17 for studies involving gene transfer intervention.
Contents of the Report of IRB Findings
At a minimum, the following information should be included in the report of IRB findings:
- Name of the institution conducting the research;
- Title of the associated research project and/or grant proposal;
- Name of the principal investigator on the corresponding research protocol;
- Number assigned by the University IRB to the research project and the number of any applicable federal award(s) (grant, contract, or cooperative agreement)
- A detailed description of the reason for the report;
- Actions taken by the institution to address the reported issue.
Parties Responsible for Preparation and Distribution of Correspondence
Serious or Continuing Non-Compliance and Unanticipated Problems Involving Risks to Human Subjects or Others
Correspondence related to determinations of serious or continuing non-compliance or that involve risk to subjects related to ECO-HSR compliance report activities will be prepared by the Director of the ECO-HSR or his/her designee for approval by the IRB Chair and Legal Counsel.
Correspondence related to determinations of serious or continuing non-compliance or that involve risks to human subjects or others related to unanticipated problems will be drafted by the Regulatory Affairs Specialist for review and approval by the Director of the ECO-HSR, the IRB Chair and Legal Counsel.
After review and comment by the above parties, the Authorized Institutional Official will review, approve and sign the report and ensure the report is distributed to all applicable parties. For non-federally funded and non-FDA regulated studies, the correspondence is signed by the IRB Chair and distributed to all applicable parties.
Study Termination or Suspension by the IRB
The IRB Chair or his designee will suspend or terminate the study within the PittPro system. Correspondence is sent to the Principal Investigator as well as to all listed co-investigators and research staff. The study moves to a “suspended” or “terminated” state.
Compliance Activity Reports
Correspondence related to Compliance Activity Reports where the study remains active and no serious or continuing non-compliance were identified, or protocol modifications were required will be prepared by the ECS staff for signature of the Director of the ECS-HSR.
Correspondence related to a Compliance Activity Report which resulted in a determination of serious or continuing non-compliance; an unanticipated problem involving risks to human subjects or others; or study termination or suspension will be performed in the same manner as other determinations of this kind.
When a protocol modification is necessary as the Compliance Activity Report, the correspondence associated with the protocol modification will be drafted by the IRB staff with input from the ECS-HSR for signature by the IRB Chair or Vice Chair.
Recipients of the IRB Correspondence / Reports
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 HRP 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 Sponsored Programs, Conflict of Interest, Risk Management);
- The principal investigator;
- The department chair;
- University or UPMC legal counsel;
- University or UPMC risk management;
- UPMC Institutional Officials.
Reports to AAHRPP
Reports will be sent to AAHRPP as soon as possible but generally within 48 hours after the organization or any researcher becomes aware of: (i) Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human research protections. (ii) Any litigation, arbitration, or settlements initiated related to human research protections. (iii) Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the HRPP.
- 45 CFR 46.103(b)(5)
- 45 CFR 46.113
- 21 CFR 56.108(b)
- 21 CFR 56.113