Responsibilities of the IRB

Contents:

• General Responsiblities of the IRB
• Management of Complaints or Concerns
• Distribution of Information, Reviewer Assignment, and Presentation to a Convened IRB Committee
• Possible IRB Committee Actions
• IRB Vote and Documentation in the Meeting Minutes
• Communication of IRB decisions

General Responsiblities of the IRB

RNI submissions are received and processed promptly by the Regulatory Affairs Specialist, or in their absence, another qualified HRP staff member. 

In processing the RNI, the Regulatory Affairs Specialist will, after review with the Chair or designee as needed:

• Obtain further information, if the information submitted does not allow for adequate evaluation or as requested by the IRB chair or designee or IRB Committee.
• Make an initial determination as to whether the corrective action plan is adequate.  This includes whether modifications to the study application or consent form(s) are required.  If the corrective action plan is found to be inadequate, in the opinion of the Regulatory Affairs Specialist, additional actions may be requested.
• 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.
• Acknowledge RNI as not meeting the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-Compliance.
• Refer RNI that might meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-Compliance to the IRB Chair or designee.
• Place RNI involving Adverse Events that may meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others on the agenda for review at the next convened IRB Committee meeting where there is a member with appropriate expertise.
• Place all other RNI submissions that may represent an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-compliance on the agenda for review at a convened IRB Committee meeting.
• Draft minutes for IRB Committee meeting discussion and Investigator correspondence.
• Communicate IRB determination of the RNI to the Investigator.
• Review Investigator’s response to IRB requested action(s) for satisfactory completion or refer to IRB Committee for further review, with the assistance of the IRB Chair or designee as needed.

For RNI submissions determined by the Regulatory Affairs Specialist to possibly represent an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-compliance, the IRB Chair or designee will:

• Request further information, if the information submitted does not allow for adequate evaluation.
• Make a preliminary assessment as to whether the corrective action plan is adequate.  This includes whether modifications to the study application or consent form(s) are required.  If the corrective action plan is found to be inadequate, in the opinion of the IRB Chair or designee, additional actions may be requested.
• Acknowledge RNI as not meeting the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-Compliance.
• Refer RNI that might meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others or Serious or Continuing Non-Compliance for review at a convened IRB Committee meeting.
• If the RNI describes a potential risk to human subjects that requires action prior to a convened meeting, convene an emergency meeting or in exceptional safety circumstances, suspend some or all of the research activities.  When this special authority is exercised by the IRB Chair, it will be reported at the next convened IRB meeting.
• Review and approve drafts of minutes of IRB Committee meeting discussion and Investigator correspondence.
• Assist Regulatory Affairs Specialist in review of Investigator’s response to IRB requested action(s).

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 subjects research.  Complainants may include (but are not limited to):: 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 from any source including the Pitt Concern Connection, 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 designee 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 Committee meeting.  
• 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 and 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

For all RNIs assigned to a convened Committee, the members will have access to the following:

• RNI submission;
• IRB-approved application if the report is related to a study;
• Preliminary recommendations of the Regulatory Affairs Specialist or IRB Chair or designee;
• Other applicable documentation such as ECS-HSR compliance activity report and the Investigator’s response to the report, as applicable.

If the RNI meets the definition of an  Adverse Event, it will be assigned to two Scientific Reviewers with relevant expertise. The Scientific 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 Scientific Reviewers, all members of the convened IRB committee will be given the opportunity to comment on the recommendations.

A primary reviewer system is not required for reviewing RNI 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 RNI 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.

2. Implementing Administrative Actions, such as:

• Requesting the IRB Chair or designee 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 their 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.

3. 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 may 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.

4. 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 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.

5. Requiring other action as determined to be appropriate by the IRB Committee.
6. 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.

 

7/3/2024