Library Document Details

Procedure to Ensure Prompt Reporting Of Unanticipated Problems Involving Risks to Subjects or Others to the IRB - IRB PRO106

Abstract:
This procedure delegates responsibilities of the Investigator, OIRB and IRB for ensuring prompt reporting of unanticipated problems encountered in research.
Effective Date:
1/25/2010
Responsible Party:
Contacts:
OIRB
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO106
Effective Date:   3/30/07
Revision Date:  10/1/07, 4/29/09, 1/25/10
Subject:  Procedure to Ensure Prompt Reporting Of Unanticipated Problems Involving Risks to Subjects or Others to the IRB

PROCEDURE

Investigator Responsibilities

The Principal Investigator:

  • Submits reportable problems (see Attachment to POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB) to the OIRB on FOR226 the Problem Report form promptly according to the list of problems;
  • Submits requests for modifications to the protocol and/or informed consent process or documents in response to the reported problems using separate procedure for approval of modifications (see PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB);
  • Retains all reports of reportable and unanticipated problems involving risks to subjects or others for submission of summaries to the IRB at the time of continuing review;
  • Submits summaries of the adverse events and unanticipated problems to the IRB at the time of continuing review.
  • Ensures the research staff follow the reporting requirements for non-compliance, suspension or terminations of research, protocol deviations and violations, complaints, data and safety monitoring reports and other information as required by the IRB;
  • Ensures reporting requirements of the sponsor/funding agency are met in accordance with their regulations and guidance, if applicable (see GUI339, GUI338).

OIRB Responsibilities

The Administrative Staff:

  • Documents receipt of reported problems , collates by performance site, and routes to Senior Staff member;
    • Reports of a breach in confidentiality will be immediately brought to a Senior Staff member.
  • Returns to investigator problem reports received from senior staff that have been determined to not satisfy the criteria for prompt reporting (see POL006).

The Senior Staff:

  • Refers any reports of breach in confidentiality to the Institutional Official or his designee within one (1) business day of receipt in the OIRB;
  • Reviews problem reports for completeness, assesses nature and perceived seriousness of problems to determine if they meet defined criteria for unanticipated problems involving risks to subjects or others;
  • Refers to the Chair (or Chair’s designee) in a timely manner;
  • Either arranges for incomplete reports to be returned to the investigator or gathers information to complete the problem report form as dictated by the seriousness of the report to make the determination above;
  • Receives notification of unanticipated problems involving risks to subjects or others. These reports may be communicated by any means (e.g., personal conversation, telephone call, e-mail, in writing). Senior staff will document the receipt and content of reports, as necessary;
  • Returns problem reports that do not meet the reportable criteria to administrative staff to return to investigator.
    • Upon receipt of the Institutional Official determination, works in consultation with Office of Counsel to determine whether subjects should be notified of the breach in confidentiality and notifies PI of decision.

OIRB Director with the IRB Chair reports to the Institutional Official IRB determinations of problems involving risks to subjects or others in accordance with POL024.

IRB Responsibilities

The Chair or Designee:

  • Reviews each problem and determines whether the problem (1) is not expected given the nature of the research procedures and the subject population being studied and (2) suggests that the research places the subjects or others at greater risk of harm or discomfort related to the research than was previously known or recognized:
    • If this is not true, the Chair or designee documents on the Problem Report form that the problem is not an unanticipated problem involving risks to subjects or others. No further action is taken under this policy. Indicate that the IRB only reviews adverse events determined to be unanticipated problems involving risks to subject or others;
    • If this is true, the Chair or designee documents on the Problem Report form that the problem meets the definition of an unanticipated problem involving risk to subjects or others. Such problems are referred to the convened IRB for review and, if determined to be an unanticipated problem, are reported to regulatory agencies and institutional officials according to POL006.
  • Signs and returns to the senior staff member a Problem Report qualifying as a reportable event or after determining it meets the criteria for an unanticipated problem involving risks to subjects or others;
  • Reports IRB determinations of reportable unanticipated problems involving risks to subjects or others to the Institutional Official in accordance with POL024.

The convened IRB:

Each assigned IRB member:

  • Receives summaries of reportable problems (including adverse events) scheduled for review
  • Reviews the Institutional Official's decision about reported breaches in confidentiality including the decision regarding the manner and method of notifying subjects, if applicable;
  • Reviews all problems determined by the Chair (or designee) to qualify as an unanticipated problems involving risk to subjects or others;
  • Reviews summaries of all reportable and unanticipated problems at continuing review;
  • Considers one or more of the following range of actions after deliberation:
    • Modification of the protocol;
    • Modification of the information disclosed during the consent process;
    • Provision of additional information to past subjects;
    • Notification of current subjects when such information might relate to their willingness to continue to take part in the research;
    • Requirement to reconsent current subjects;
    • Monitoring of the research;
    • Monitoring of the consent;
    • Suspension of the research;
    • Termination of the research; and
    • Referral to other organizational entities.

Institutional Official Responsibilities:

  • Determines if notification of breach in confidentiality of research subjects is required based on risk assessment;
  • Reports determination of IRB in accordance with POL024.

Approved on May 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director