Research

Human Research Protection Program Policy and Procedure Manual - Section 9

9 Complaints and Non-compliance 

9.1 Purpose

9.2 Definitions

9.3 Complaints

9.4 Non-compliance

9.4.1 Review of Allegations of Non-compliance

9.4.2 Review of Findings of Non-compliance

9.4.3 Inquiry Procedures

9.4.4 Final Review

9.4.5 Additional Actions

 

9 Complaints and Non-compliance
9.1 Purpose

The following procedures describe how complaints, allegations of non-compliance, suspensions and terminations of IRB approval are handled by the IRB.

 

9.2 Definitions

Non-compliance. Non-compliance is defined as failure to comply with any of the regulations and policies described in this document and failure to follow the determinations of the IRB. Non-compliance may be minor or sporadic or it may be serious or continuing. 

 

Serious non-compliance. Serious non-compliance is defined as failure to follow any of the regulations and policies described in this document or failure to follow the determinations of the IRB and which, in the judgment of either the IRB Chair or the convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of the human research protection program. Research being conducted without prior IRB approval is considered serious noncompliance. 

 

Continuing non-compliance. Continuing non-compliance is defined as a pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, suggests a likelihood that instances of non-compliance will continue without intervention.  Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance.

 

Allegation of non-compliance. Allegation of non-compliance is defined as an unproved assertion of non-compliance.

 

Finding of non-compliance. Finding of non-compliance is defined as an allegation of non-compliance that is proven true or a report of non-compliance that is clearly true. (For example, a finding on an audit of an unsigned consent document, or an admission of an investigator that the protocol was willfully not followed would represent reports of non-compliance that would require no further action to determine their truth and would therefore represent findings of non-compliance.)

 

Suspension.  A suspension is directive of the convened IRB or IRB designee either to stop temporarily some or all previously approved research activities or to stop permanently some previously approved research activities. Suspended protocols remain open and require continuing review.  A lapse of approval due to a lack of continuing review is not considered a suspension for these procedures.

 

Termination. A termination is a directive of the convened IRB or IRB designee to stop permanently all activities in a previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review.

 

9.3 Complaints

The Chair of the IRB or the RPO Director will promptly handle (or delegate staff to handle), and, if necessary, investigate all complaints, concerns, and appeals received by the IRB.  This includes complaints, concerns, and appeals from investigators, research participants, and others.

 

If the complaint meets the definition of non-compliance, it will be considered an allegation.

 

9.4 Non-compliance

All investigators conducting research as employees or agents of Brown University are expected to comply with the highest standards of ethical and professional conduct in accordance with federal and state regulations and IRB policies governing the conduct of research involving human participants.

The Principal Investigator is responsible for reporting any non-compliance by study personnel to the IRB.

 

9.4.1Review of Allegations of Non-compliance

All allegations of non-compliance will be reviewed by the IRB Chair and the RPO Director.  They will review:

  1. all documents relevant to the allegation;
  2. the last approval letter from the IRB;
  3. the last approved IRB application and protocol;
  4. the last approved consent document;
  5. the grant, if applicable; and
  6. any other pertinent information (e.g., questionnaires, DSMB reports, etc.).

 

The IRB Chair and RPO Director will review the allegation and make a determination as to the truthfulness of the allegation.  They may request additional information or an audit of the research in question.

 

If in the judgment of the IRB Chair and RPO Director, the reported allegation of non-compliance is not true, no further action will be taken. If in the judgment of the IRB Chair and RPO Director, the reported allegation of non-compliance is true, the non-compliance will be processed according to Section 7.4.2 Review of Findings of Non-compliance.

 

If in the judgment of the IRB Chair and RPO Director, any allegation or findings of non-compliance warrants suspension of the research before completion of any review or investigation to ensure protection of the rights and welfare of participants, the IRB Chair or RPO Director may suspend the research as described in Section 3.10 with subsequent review by the IRB.

 

9.4.2 Review of Findings of Non-compliance

If in the judgment of the IRB Chair and RPO Director, the reported finding of non-compliance is not serious, not continuing, and the proposed corrective action plan seems adequate, no further action is required; and the IRB is informed at the next convened meeting.  Otherwise, the matter will be presented to the IRB at a convened meeting with a recommendation that a formal inquiry (described below) will be held. 

All findings of non-compliance referred to the IRB will be reviewed at a convened meeting.  All IRB members will receive:

  1. all documents relevant to the allegation;
  2. the last approval letter from the IRB;
  3. the last approved IRB application; and
  4. the last approved consent document.

 

At this stage, the IRB may:

  1. find that there is no issue of non-compliance;
  2. find that there is non-compliance that is neither serious nor continuing and an adequate corrective action plan is in place;
  3. find that there may be serious or continuing non-compliance and direct that a formal inquiry (described below) be held; or
  4. request additional information.

 

9.4.3 Inquiry Procedures

A determination may be made by the IRB that an inquiry is necessary based on several issues that may include but are not limited to:

 

  1. participants' complaint(s) that rights were violated;
  2. report(s) that the investigator is not following the protocol as approved by the IRB;
  3. unusual and/or unexplained adverse events in a study; and/or
  4. repeated failure of investigator to report required information to the IRB.

 

A subcommittee is appointed consisting of IRB members, and non-members if appropriate, to ensure fairness and expertise. The subcommittee is given a charge by the IRB, which can include any or all of the following:

 

  1. review of protocol(s) in question;
  2. review of sponsor audit report of the investigator, if appropriate;
  3. review of any relevant documentation, including consent documents, case report forms, participants’ investigational and/or medical files etc., as they relate to the investigator's execution of her/his study involving human participants;
  4. interview of appropriate personnel if necessary;
  5. preparation of either a written or oral report of the findings, which is presented to the full IRB at its next meeting;
  6. recommend actions if appropriate.

 

9.4.4 Final Review

The results of the inquiry will be reviewed at a convened IRB meeting where the IRB will receive a report from the subcommittee.  If the results of the inquiry substantiate the finding of serious or continuing non-compliance, the IRB’s possible actions could include, but are not limited to:

 

  1. request a correction action plan from the investigator;
  2. verification that participant selection is appropriate and observation of the actual informed consent;
  3. an increase in data and safety monitoring of the research activity;
  4. request a directed audit of targeted areas of concern;
  5. request a status report after each participant receives intervention;
  6. modify the continuing review cycle;
  7. request additional investigator and staff education;
  8. notify current participants, if the information about the non-compliance might affect their willingness to continue participation;
  9. require modification of the protocol;
  10. require modification of the information disclosed during the consent process;
  11. require current participants to re-consent to participation;
  12. suspend the study (see below); or
  13. terminate the study (see below).

 

The investigator is informed of the IRB determination and the basis for the determination in writing and is given a chance to respond.  If the IRB determines that the non-compliance was serious or continuing, the results of the final review will be reported as described below in Section 10.

 

9.4.5 Additional Actions

A finding of serious or continuing non-compliance may also result in the following sanctions, among others:

 

  1. suspension or termination of IRB approval of specific research protocols or of all research involving human participants in which the investigator participates;
  2. sponsor actions - in making decisions about supporting or approving applications or proposals covered by this policy the Department of Health and Human Services or Agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension as described in Section 3.10, and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the Department of Health and Human Services or Agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human participants;
  3. institutional or individual action by the federal OHRP. The OHRP may
    • withhold approval of all new studies by the IRB;
    • direct that no new participants be added to any ongoing studies;
    • terminate all ongoing studies, except when doing so would endanger the participants; and/or
    • notify relevant state, federal, and other interested parties of the violations.
    • individual disciplinary action of the investigator or other personnel involved in a study, up to and including dismissal, pursuant to University policies and procedures.
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