Making Non-Compliance DeterminationsGerald Treiman, IRB ChairJohn Stillman, IRB Director

Maureen Brinkman, IRB AdministratorAnn Johnson, IRB Administrator

Introduction to ReportingThe 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 eventsDeviationsAdverse device effectsBreaches of confidentiality or privacy

Examples of information include the following:DSMB reportsNew information about the study that does not require and

amendmentComplaints from participants Warning or determination letters

The Report Review ProcessThere are 3 levels of review that may occur:

1. Administrative review – conducted by Maureen Brinkman

Starting point for all report forms EXCEPT adverse events

2. Subcommittee review – conducted by Ingrid Nygaard, Chris Stock, or Dennis O’Rourke

Starting point for adverse events

3. Convened board review

Report Form DeterminationsReport forms are reviewed to make the

following determinationsUnanticipated problems (UPs)Non-compliance, not serious or continuingSerious and/or continuing non-compliance

The administrative reviewer and subcommittee reviewer can make the following determinations:The report is NOT a UPThe report is NOT non-complianceThe report is non-compliance, but not serious or

continuing

Report Form DeterminationsIf 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 problemsSerious and/or continuing non-compliance

Non-Compliance Review ProcessCan be initiated in the following ways:

The PI tells us there is a deviation via the report formThe 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 non-compliance. This may include:Interviews with study team membersAudits 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 non-compliance 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

Serious/ContinuingNon-compliance Determinations:

10

The Numbers:Since January 2008

Admin Non-compliance Determinations: 448

Sub-C Non-compliance Determinations: 39

Protection of Research ParticipantsIt 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 & TerminationsSuspension: 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 MaterialsIRB Website Event Reporting

IRB Website SOPs901: Unanticipated Problems Involving Risks to Participants

and Others902: Protocol Deviations903: HRPP and Non-Compliance904: Administrative Hold, Suspension, and Termination of

Approved Research905: Institutional Reporting Procedures906: Protection of Research Participants907: Research Complaints and Concerns908: Routine and For-Cause Audits

Board Reviewer Checklist Report forms

Case StudiesDeterminations/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?