Boston University
Charles River Campus IRB
Policies and Procedures
Title: Reporting Incidents to Institutional Officials, Regulatory Agencies, and other Oversight/Accreditation Organizations
Date: March 19, 2019

Purpose:

The purpose of this policy is to outline the procedure for reporting: 1) unanticipated problems involving risks to subjects or others, 2) any serious or continuing noncompliance, or 3) any suspension or termination of IRB-approved human subjects research.

Defined Terms:

Continuing Noncompliance:  Any noncompliance that occurs in a persistent or repeated manner.

Noncompliance:  Failure to comply with the regulations, institutional policies, laws, or the requirements or determinations of the IRB

Serious Noncompliance:  Any noncompliance that: 1) adversely affect the rights and welfare of the subjects, 2) increases risks to subjects or others or alter the risk/benefit ratio, 3) compromises the integrity or validity, or 4) results from the willful, knowing, or intentional misconduct on the part of the investigator or research staff.

Suspension:  IRB-approved research or some of the activities in the research are temporarily stopped in order to protect human subjects pending completion of an investigation.  Once the investigation is complete, a determination is made as to:  1) lift the suspension and allow protocol activities to resume or 2) terminate the study or some activities of the protocol.

Termination:  IRB-approved research is permanently stopped.  No further work may be done on this research.

Unanticipated Problem Involving Risks to Subjects or Others:  Any incident, experience or outcome that is: 1) unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and the informed consent document, and the characteristics of the subject population being studied, 2) related or possibly* related to participation in the research, AND 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

*Possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research.

Policy

In compliance with federal regulations, Boston University (BU) reports: 1) unanticipated problems involving risks to subjects or others, 2) any serious or continuing noncompliance with federal regulations or the requirements or determinations of the BU IRB, or 3) suspension or termination of BU IRB approval of research.

The BU’s assurance of compliance is restricted to federally funded research.  The same criteria and process for conducting noncompliance investigations, making determinations about reporting, and actions will apply to all research regardless of funding source.  If an event involves research that is not federally funded, the event will be reported to the Dean, Institutional Official, and other federal agencies as applicable.  Depending on the nature or the severity of the non-compliance, the IRB reserves the right to voluntarily report to the Office for Human Research Protections (OHRP) any event that is not federally funded.

Procedures

  1. The IRB Director and the Chair/Vice-Chair of the IRB are responsible for preparing the event reports. The report will include the following information:
      • Name of the institution
      • Title of the research project and protocol number
      • Grant/Award number
      • Name of the Principal Investigator
      • Summary of the study
      • Summary of the event
      • Description of the investigation
      • Findings of the investigation
      • Determination of the IRB
      • Actions the institution is taking or plans to take to address the problem
    1. The report will be reviewed by the following for final approval:
      • IRB Director
      • IRB Chair /Vice-Chair
      • IRB Members
      • Institutional Official
    2. After final approval, the report will be sent to the following, as applicable:
      • Institutional Official
      • IRB Director
      • IRB Chair/Vice-Chair
      • IRB Members
      • OHRP (if federally funded)
      • Department Chair
      • School Dean
      • Principal Investigator
      • Faculty Advisor
      • NIH or other funding source
      • Food and Drug Administration (FDA), if the study is subject to FDA regulations
      • Sponsor
      • Any Federal Agency that is supporting or overseeing the research
      • Others, as deemed appropriated by the Institutional Official
    3. The Institutional Official is responsible for sending out the final report
    4. The IRB Director and the IRB Chair/Vice-Chair of the IRB will ensure that the procedures in this policy are generally completed within 30 days of the dates when:
      • The IRB determines that the event is an unanticipated problems involving risks to subjects or others
      • The IRB determines that the event is serious or continuing noncompliance
      • The IRB or Institutional Official suspends or terminates IRB-approved research

    Reporting to AAHRPP

    The BU CRCCharles River Campus IRB will report to AAHRPP within 48 hours of becoming aware of any of the following:

    • Any negative actions taken by a government oversight office, including, but not limited to, OHRP determination letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, or FDA restrictions placed on the IRB or BU CRC researchers
    • Any litigation, arbitration, or settlements initiated related to human research protections
    • Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the BU CRC’s HRPP

    The IRB Director is responsible for reporting the above issues to AAHRPP.

    Title: Reporting Incidents to Institutional Officials and Regulatory Agencies

    Author: Cynthia Monahan

    Effective Date: April 1, 2013

    Last Review/Update Date: March 19, 2019

    Revision #: 2

    Approved:
    Cynthia Monahan, IRB Director
    Kathryn Mellouk, Associate Vice President-Research Compliance

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