Making Non-Compliance Determinations

Report
Gerald Treiman, IRB Chair
John Stillman, IRB Director
Maureen Brinkman, IRB Administrator
Ann Johnson, IRB Administrator
Introduction to Reporting
 The Report Form is used to submit problems, events, and
information to the IRB for review.
 Examples of problems or events include the following:
 Unexpected, related adverse events
 Deviations
 Adverse device effects
 Breaches of confidentiality or privacy
 Examples of information include the following:
 DSMB reports
 New information about the study that does not require and
amendment
 Complaints from participants
 Warning or determination letters
The Report Review Process
 There are 3 levels of review that may occur:
1. Administrative review – conducted by Maureen
Brinkman

Subcommittee review – conducted by Ingrid Nygaard,
Chris Stock, or Dennis O’Rourke
2.

3.
Starting point for all report forms EXCEPT adverse events
Starting point for adverse events
Convened board review
Report Form Determinations
 Report forms are reviewed to make the following
determinations
 Unanticipated problems (UPs)
 Non-compliance, not serious or continuing
 Serious and/or continuing non-compliance
 The administrative reviewer and subcommittee
reviewer can make the following determinations:
 The report is NOT a UP
 The report is NOT non-compliance
 The report is non-compliance, but not serious or
continuing
Report Form Determinations
 If the administrative reviewer or subcommittee
reviewer believe the report is a UP or
serious/continuing non-compliance, they forward it to
the convened board.
 Only the convened board can make the following
determinations:
 Unanticipated problems
 Serious and/or continuing non-compliance
Non-Compliance Review Process
 Can be initiated in the following ways:
 The PI tells us there is a deviation via the report form
 The IRB receives a complaint or other information that indicates
there may be non-compliance
 If the review process is initiated by a complaint/concern, the IRB
conducts an inquiry to verify that there is evidence of noncompliance. This may include:
 Interviews with study team members
 Audits of study records
 Collection of relevant data from other sources (e.g., OSP, FDA,
Sponsor, etc.)
 All inquires are conducted in cooperation with the PI. After all
relevant information is collected and evidence of noncompliance is established, the PI submits a report form for
review.
Definitions
 Non-compliance: failure to abide by the policies, requirements,
and determinations of the IRB, or federal rules and regulations
including the requirements of the VHA Handbook 1200.05
governing human subject research.
 Serious N0n-Compliance: An act or omission to act that resulted
in increased physical, psychological, safety, or privacy risk that
compromised the rights and welfare of research participants.
 Continuing Non-Compliance: A pattern of repeated actions or
omissions to act that suggests a future likelihood of reoccurrence
and that indicates a deficiency in the ability or willingness to
comply with federal regulations, VA [policy], requirements, and
determinations of the IRB governing human subject research.
Report forms submitted:
2,767
The Numbers:
Since January 2008
Admin Non-compliance
Determinations: 448
Sub-C Non-compliance
Determinations: 39
Serious/Continuing
Non-compliance
Determinations:
10
Protection of Research Participants
It is the policy of the University of Utah IRB that before an
administrative hold, suspension, or termination is put into effect
the convened IRB or IRB designee considers whether any
additional procedures need to be followed to protect the rights
and welfare of current participants.
These procedures may include but are not limited to:
 Submitting a list of all currently enrolled participants including
their status within the study;
 Transferring participants to another investigator;
 Making arrangements for clinical care outside the research;
 Allowing continuation of some research activities under the
supervision of an independent monitor; or
 Requiring or permitting follow-up of participants for safety
reasons.
Suspensions & Terminations
 Suspension: A suspension of IRB approval is a 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.
 Termination: A termination of IRB approval 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.
Reference Materials
 IRB Website  Event Reporting
 IRB Website  SOPs
 901: Unanticipated Problems Involving Risks to Participants and
Others
 902: Protocol Deviations
 903: HRPP and Non-Compliance
 904: Administrative Hold, Suspension, and Termination of
Approved Research
 905: Institutional Reporting Procedures
 906: Protection of Research Participants
 907: Research Complaints and Concerns
 908: Routine and For-Cause Audits
 Board Reviewer Checklist  Report forms
Case Studies
 Determinations/Decisions
 Does the report represent serious non-compliance?
 Does the report represent continuing non-compliance?
 What are appropriate corrective actions?

These should take into account how participants should be
handled in order to prevent further risk, based upon the
situation.
 Should the study be suspended or terminated?

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