Responsibilities of the IRB

Internal and External Adverse Events

Internal Adverse Events and External Adverse Events reported to the IRB are received and processed promptly by the Regulatory Affairs Specialist, or in his/her absence, by a designated IRB research review coordinator.  

Adverse Events that meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others will be brought to the attention of the IRB Chair or, in his/her absence, an IRB Vice Chair by the Regulatory Affairs Specialist. In processing Adverse Events that appear to meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others after review with the Chair, the Regulatory Affairs Specialist will:

  • Obtain further information, if the information submitted does not allow for adequate evaluation.
  • Place the event(s) on the agenda for review at the next convened IRB meeting where there is a member with appropriate expertise. If there is potential risk to human subjects that require action prior to a convened meeting, an emergency meeting may be convened (with the members attending either in person or via teleconference) or in exceptional safety circumstances, the IRB Chair has the authority to suspend some or all of the research activities.  When this authority is exercised by the IRB Chair, it will be reported at the next convened IRB meeting.
  • Perform a retrospective review of Adverse Events reported for the research protocol. If the Adverse Event was reported by the Investigator as being related to a research intervention, then an assessment of the Adverse Events across other research protocols involving the same experimental intervention may be performed.
  • Make an initial determination as to whether modifications to the study application are required to address the reported Adverse Event. In making this determination, the Regulatory Affairs Specialist will take into consideration the severity of the event, the number of reports describing the same or similar event, and the current consent form and research protocol risk statements.

Unanticipated Problems Involving Risk to Subjects or Others and Reportable Non-compliance

  • Reportable New Information received or identified by the IRB will be reviewed by the Regulatory Affairs Specialist, who will triage the submission.
  • The Regulatory Affairs Specialist will determine if the Reportable New Information submission contains complete information. If, in the opinion of the Regulatory Affairs Specialist, the information is incomplete, additional information may be requested.
  • The Regulatory Affairs Specialist will review the corrective action plan and determine if the plan provides adequate information. If the corrective action plan is found to be inadequate, in the opinion of the Regulatory Affairs Specialist, additional information may be requested.
  • If the Reportable New Information clearly does not represent 1) an Unanticipated Problem Involving Risk to Human Subjects or Others, 2) Serious Non-compliance, and/or 3) Continuing Non-compliance, the IRB Chair or designated Vice Chair will determine if any additional actions are warranted and, if applicable, the required action items will be provided to the study team.
  • The Regulatory Affairs Specialist will refer to the IRB Chair (or Vice Chair) Reportable New Information that may represent 1) an Unanticipated Problem Involving Risk to Human Subjects or Others, 2) Serious Non-compliance, and/or 3) Continuing Non-compliance.
  • The IRB Chair (or designated Vice Chair) will determine if the Reportable New Information submission contains complete information. If, in the opinion of IRB Chair (or Vice Chair), the information is incomplete, additional information may be requested.
  • The IRB Chair (or designated Vice Chair) will determine if the corrective action plan is adequate. If the corrective action plan is found to be inadequate, in the opinion of the IRB Chair, changes to the corrective action plan may be requested.
  • The IRB Chair (or designated Vice Chair) will determine if the Reportable New Information may represent 1) an Unanticipated Problem Involving Risk to Human Subjects or Others, 2) Serious Non-compliance, and/or 3) Continuing Non-compliance and refer those submissions that may meet this criteria to a convened IRB Committee.
  • The Reportable New Information submission, the determination of the IRB Chair or convened IRB Committee, and a record of the requested actions, if applicable, will be documented in PittPRO.
  • Failure to comply with IRB required actions, in the absence of a suitable justification, may qualify as Serious Non-compliance and be brought to the attention of a convened IRB Committee.

Management of Complaints or Concerns

It is the policy of the HRP to investigate reported complaints or concerns regarding the conduct or review of human subject research.  Complainants may include (but are not limited to) the following: participants (past, present or potential), participant family members, investigators, research staff, or other members of the research community. 

All consent documents must include telephone numbers for the Principal Investigator and the Human Subject Protection Advocate so that research participants can call if they have questions, concerns, or complaints.

Concerns or complaints, whether verbal or in writing, that are received by the HRP or ECS-HSR will be investigated as follows: 

  • All complaints and concerns will be handled in a confidential manner and all information will be kept as confidential as possible. 
  • The HRP Director (or designee) or the ECS-HSR Director (or designee) will record the following information, as appropriate, on an Intake Form: 
    • Complainant’s name and contact information unless the complaint is made anonymously.
    • Study ID and name of Principal Investigator, if applicable.
    • A detailed description of the complaint or concern.
    • Any actions taken to try and resolve the complaint or concern. 
    • Any individuals or offices that have been or need to be notified of the complaint or concern (e.g., PI or research staff, Institutional Officials, other Institutional Offices, etc.).
  • The IRB Chair or Vice Chair will review the reported information to determine if the complaint or concern may represent an Unanticipated Problem Involving Risk to Human Subjects or Others, Serious Non-compliance, and/or Continuing Non-compliance or may require additional actions. Those concerns or complaints that meet these criteria will be referred to a convened IRB.  
  • Other complaints or concerns that do not meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others, Serious Non-compliance, and/or Continuing Non-compliance but may require further review will be handled on a case-by-case basis.  

The files of complaints or concerns as well as the actions taken by the HRP staff, IRB Committee(s), ECS-HSR or investigators to resolve such complaints will be maintained by either the HRP or ECS-HSR.  Files are maintained according to Chapter 21.

Distribution of Information, Reviewer Assignment and Presentation to a Convened IRB Committee

Adverse Events that are Unanticipated Problems Involving Risk to Human Subjects or Others

All members of the convened Committee will have access to the following:

  • The Reportable New Information submission;
  • The IRB-approved study application;
  • The recommendations of the Regulatory Affairs Specialist;
  • Any other applicable documentation.

Each Adverse Event will be assigned to two primary reviewers with relevant scientific expertise.

The primary reviewers will summarize the Adverse Event and their decision regarding concurrence with the actions recommended by the Regulatory Affairs Specialist or, in the event of disagreement, propose alternate actions.  After the presentation from the primary reviewers, all members of the convened IRB committee will be given the opportunity to comment on the recommendations.

Unanticipated Problems Involving Risk to Human Subjects and Others and Reportable Non-compliance

All members of the convened IRB Committee will have access to the following:

  • All available documentation regarding the Reportable New Information;
  • The IRB-approved study application;
  • The ECS-HSR compliance activity report and the Investigator’s response to the report, as applicable, if the Reportable New Information is the result of an ECS-HSR review.

A primary reviewer system is not required for reviewing Reportable New Information submissions that are not Adverse Events.

The ECS-HSR may summarize the ECS-HSR compliance activity reports for the IRB Committee.  All other cases of Unanticipated Problems Involving Risk to Human Subjects or Others or Reportable Non-compliance will be summarized by the IRB Chair or designated Vice Chair.   All members of the convened IRB committee will be given the opportunity to comment on the recommendations.

Possible IRB Committee Actions

The IRB takes whatever actions are deemed necessary to address the Reportable New Information or reported complaints or concerns about the conduct of human research.  Examples of actions that might be taken include, but are not limited to:

  1. Investigating the Event by:
  • Requesting additional records or information about the event and its outcome;
  • Interviewing the involved Investigators, research staff, and/or research subjects;
  • Interviewing other individuals who may have knowledge of the event;
  • Requesting an independent audit of the event/protocol or of other related protocols.
  1. Implementing Administrative Actions, such as:
  • Requesting the IRB Chair (or designated Vice Chair) to meet with the involved Investigator and/or research staff, and the appropriate department chair and/or dean to discuss the event/problem;
  • Requesting a corrective plan of action and/or written standard operating procedures from the involved investigator and/or his/her department chair or dean;
  • Requiring members of the research team to participate in pertinent training and education programs;
  • Notifying other organizational entities (e.g., legal counsel, institutional risk management, the Authorized Institutional Official, the Research Integrity Officer, the UPMC Clinical Trials Office, UPMC Privacy Officer, etc.) as warranted;
  • Suspending the Principal Investigator’s privilege to serve as a Principal Investigator or requiring a replacement of the Principal Investigator for the protocol(s) in question;
  • Placing restrictions on an Investigator’s privileges to conduct human subject research.
  1. Requiring Modifications of the Associated Protocol, such as:

  • Instructing the Principal Investigator to provide information concerning the event to subjects currently enrolled in the study;
  • Requiring the investigator to perform additional follow-up or monitoring of the enrolled subjects;
  • Revising the timeframe for continuing IRB review.

For multi-center studies - if the IRB or the local investigator proposes changes to the protocol or informed consent document/process in addition to those proposed by the study sponsor or the coordinating center, the IRB should request in writing that the local investigator discuss the proposed modifications with the study sponsor or coordinating center and submit a response or necessary modifications for review by the IRB.

  1. Terminating or Suspending IRB Approval of the Research Study

When terminating or suspending some or all research activities, the IRB will consider what additional actions the Principal Investigator or institution should take in order to protect the safety, rights and welfare of human subjects.  These additional actions may include but are not limited to:

  • Transferring the human subjects to another research study (i.e., based on equivalent inclusion/exclusion criteria);
  • Making arrangements for clinical care outside the research;
  • Allowing continuation of some research activities under the supervision of an independent monitor;
  • Requiring or permitting follow-up of the human subjects for safety reasons;
  • Requiring Adverse Events or outcomes to be reported to the University IRB and the sponsor;
  • Notifying current human subjects of the University IRB’s decision to terminate or suspend the research study;
  • Notifying former human subjects of the University IRB’s decision to terminate or suspend the research study.
  1. Requiring other action as determined to be appropriate by the IRB Committee.
  2. Requiring no further action.

IRB Vote and Documentation in the Meeting Minutes

The IRB will determine the recommended actions, call for a vote and document the outcome in the Committee minutes. The IRB votes as to whether the event represents an Unanticipated Problem Involving Risk to Subjects or Others, Serious Non-compliance and/or Continuing Non-compliance.  This vote will be recorded in the meeting minutes. If the IRB votes to suspend or terminate the research study, the reasons for the suspension or termination will be documented.

Communication of IRB decisions

 Please see Reporting of IRB Determinations, Chapter 18.

5/14/2021