Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations - IRB PRO128

Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations - IRB PRO128

This procedure outlines responsibilities for dealing with compliance issues with Human Subjects regulations or IRB requirements or determinations.
Effective Date:
Responsible Party:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO128
Effective Date:   3/30/07
Revision Date:  12/10/08
Subject:  Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations


Investigator Responsibilities

The Investigator:

  • Notifies the IRB as soon as possible, but in no event later than 5 working days, when protocol changes to eliminate an apparent immediate hazard to human subjects are initiated prior to IRB approval.
  • Reports to the IRB any information (of which they are or reasonably should be aware) related to non-compliance with federal regulations pertaining to research or UAB IRB requirements or determinations. Reports will be made as soon as possible, but in no event later than 10 working days.
  • Responds to all requests from the IRB for further information or clarification regarding concerns or issues under investigation.

OIRB Responsibilities

The OIRB Director or Designee:

  • Receives all compliance-related allegations from any source (e.g., investigators, IRB members, participants or their family members);
  • Documents the allegations in writing, as necessary;
  • Notifies immediately the IRB Chair (or Chair’s designee) about the report;
  • In conjunction with the IRB Chair, administratively resolves issues of non-compliance clearly neither serious nor continuing and documents this in the protocol record; otherwise
  • Notifies the investigator of the allegation; and inquires to obtain additional information when the investigator is not the source of the report; prepares a written notice to be sent to the investigator from the IRB Chair (or designee) and OIRB Director (or designee) within 2 working days of receipt of the allegation. The notice will:
    • Detail the allegations;
    • Identify the issues raised by the allegations;
    • Request a response to the issues from the investigator;
    • Request any additional information necessary for the IRB to evaluate the report;
    • Require a response by the investigator within 5 days of receipt of the letter.
  • Has the communication of notice and inquiry delivered to the investigator, documents and verifies the date of receipt and sends a copy of letter to the Institutional Official;
  • Receives the Compliance Subcommittee report (see below) and routes to the IRB Chair for review;
  • Provides a summary of reports of non-compliance issues that have been administratively resolved to the convened IRB monthly;
  • Schedules Compliance Subcommittee report for presentation to the convened IRB;
  • Completes the reporting requirements in POL024 UAB Policy on Reporting to Institutional Officials and Regulatory Agencies.

The OIRB Regulatory Compliance Manager:

  • Schedules the compliance subcommittee meetings and arranges attendance of the investigator following referral from IRB Chair and OIRB Director;
  • Sends a copy of the excel spreadsheet tracking compliance issues to the IO quarterly.

OIRB Responsibilities

  • At the request of any IRB member, make available all materials in the protocol file for review of the non-compliance allegation.

IRB Responsibilities

The IRB Chair or (designee):

  • Assesses the compliance allegations conveyed by the OIRB Director;
  • In conjunction with the OIRB Director, administratively resolves issues of noncompliance clearly neither serious nor continuing;
  • Assists the OIRB Director in drafting the communication of notice and inquiry to the investigator;
  • Takes one of the following actions:
    • Determines if the research should be placed on administrative hold prior to presenting allegations to the convened IRB;
    • Determines if the research should be inspected and/or monitored with or without notice to the investigator prior to presenting allegations to the convened IRB;
    • Reviews investigator’s responses to communication of notice and inquiry.
    • Makes referral to the compliance subcommittee when preliminary findings suggest possible serious or continuing non-compliance or the non-compliance is not amenable to administrative resolution;

The IRB Compliance Subcommittee:

  • Reviews all referrals for non-compliance from the IRB Chair;
  • Receives and reviews the following materials:
    • The recorded allegations;
    • All information gathered during the inquiry phase of the investigation including responses, monitoring reports, and other materials generated to evaluate the issues;
    • Human Subjects Protocol;
    • Relevant IRB-approved consent documents;
    • Research protocol, Sponsor protocol and Investigator Brochure, as applicable;
    • Most recent investigator progress report, if any;
    • Any other relevant materials;
  • Holds a meeting with the investigator to ascertain preliminary findings;
  • Issues a written report of findings and recommendations to the IRB on the matter;
  • Forwards a copy of the report of preliminary findings to the investigator;
  • Forwards report of preliminary findings and subcommittee’s recommendations to the IRB Chair and OIRB Director for referral to the convened IRB for inclusion on the agenda at the next appropriate meeting;
  • Schedules report for presentation.

      The convened IRB:

      • Receives and reviews the Compliance Subcommittee’s written report prior to a meeting in which a compliance referral will be presented; and other documents relevant to determine and resolve the allegation of non-compliance;
      • Considers the oral presentation of the compliance subcommittee’s findings at a meeting to which the investigator has the opportunity to attend and provide information;
      • Considers whether to make a determination of non-compliance following presentation of all the evidence;
      • Following a determination of non-compliance,
        • Classifies the non-compliance as serious, continuing, or NSNC in accordance with POL028 UAB Policy on Compliance with Human Subjects Regulations or the Requirements of the IRB;
        • Identifies the activities which resulted in non-compliance;
        • Requests a corrective action plan from the investigator to remedy the noncompliance.
      • Considers the following range of possible actions:
        • Modification of the protocol;
        • Modification of the information disclosed during the consent process;
        • Providing additional information to past subjects;
        • Notification of current subjects when such information may relate to their willingness to continue to take part in the research;
        • Modification of the continuing review schedule;
        • Monitoring of the research;
        • Monitoring of the consent;
        • Suspension of the research;
        • Termination of the research;
        • Additional education for investigators on human research protections; and
        • Referral to other organizational entities.
      • Receives and reviews the summary of reports of non-compliance issues resolved administratively
      • Upon request to the OIRB Director, may obtain written information gathered about the resolution of the allegations and protocol related materials for any administratively resolved compliance issue. 

      Approved on December 10, 2008, by:

      Ferdinand Urthaler, MD
      IRB Chair

      Sheila Deters Moore, CIP
      OIRB Director