801: Random Scheduled Investigator Post Approval Review Findings - Reporting Requirements

Updated Oct. 4, 2019

One of the goals of the Quality Improvement Program (QIP) is to educate researchers on the mechanisms by which human subjects are protected. QIP was developed to strengthen human research protections and to demonstrate a commitment to continuous improvement in research compliance. Identifying the strengths and weaknesses of protection efforts is essential to maintaining a quality program.   In keeping with this intent, results of Random Scheduled Investigator Post Approval Review are not shared with the Institutional Review Board (IRB) unless significant deficiencies in human subject protections are found.

Selection Criteria for Identifying Studies for Review

  • Include IRB approved protocols in which subjects have been enrolled or identifiable data have been obtained.
  • Include at least one Full Board submission per year.
  • May include Exempt or Expedited protocols.
  • May include federal, state, or industry funded projects.
  • May exclude protocols that are subject to ongoing agency audits.

Areas Reviewed during the Site Visit

  • Recruitment & Compensation
  • Subject Population
  • Subject Enrollment
  • Informed Consent (Content and Process)
  • Data Collection, Storage, Transmittal, Destruction, and Security
  • Data and Safety Monitoring Board (DSMB) and Plan (DSMP)
  • Adverse Events
  • Project Personnel (Qualifications and IRB Training)
  • Continuing Review
  • Amendments
  • Protocol Adherence (Violations/Deviations)
  • Other areas as determined by the review

Arranging for a Random Scheduled Investigator Post Approval Review of Research Team Files and Activities

Written notification of pending review will be sent from the Research Compliance Officer (RCO). It is the responsibility of the RCO to schedule the visit after notice has been sent.

 Elements of a Random Scheduled Investigator Post Approval Review Research Team Files and Activities

Reviews may include, but are not limited to the following activities:

  • Interviews of the principal investigator, co-investigators and/or research staff
  • Review of randomly selected participant files to:
  • Determine whether the approved inclusion/exclusion criteria were met
  • Determine that participants were not enrolled until after all appropriate approvals were obtained
  • Determine whether the correct informed consent document(s) was utilized and that informed consent was obtained in the manner approved by the IRB
  • Determine whether the approved dose ranges of the study drug were administered
  • Review of study files to:
  • Determine whether all of the amendments were reported before changes were implemented unless it was necessary to eliminate apparent immediate hazard
  • Determine whether adverse events and unanticipated problems were reported in a timely manner
  • Determine if the advertisements and other recruiting materials in use are the versions approved by the IRB
  • Determine whether the informed consent document complies with federal regulations
  • Determine whether IRB (RI) and VA R&D administrative file(s) contain all modifications and adverse events submitted by the investigator
  • Determine whether IRB review was timely
  • Review projects to verify from sources other than the researcher that no unapproved changes have occurred since previous review
  • Monitor conflict of interest concerns to assure the consent documents include the appropriate information and disclosures
  • Determine if continuing reviews were completed within one year (or more often if appropriate)
  • Observe the consent process as determined necessary by the convened IRB (i.e. considered when a complaint is received regarding the informed consent process, or when investigator veracity is doubted)
  • Conduct any other monitoring or review activities as deemed appropriate by the IRB
  • Confirm completion of compliance education for PI and research staff
  • Compare list of subjects (# enrolled/accrued) provided by the Investigator with continuation review report for consistency

Outcome of Reviews

Following completion of the review, RCO will prepare a written report for the PI. The report may include recommendations for aligning the research protocol, if necessary, with institutional policies and regulatory requirements and/or specify corrective actions, if any.

  • If the quality improvement review identifies a need for revision of the research protocol or informed consent processes, the PI is responsible for submitting an amendment/modification to the current approved protocol in accordance with IRB requirements.
  • If the quality improvement review identifies serious or continuing noncompliance, the PI will adhere to established processes of the investigation, correction and reporting of any material noncompliance, as may be required or appropriate. {See Policy #}

Reportable to the IRB and Institutional Official

Significant Deficiencies in Human Research Protections (including, but not limited to):

  • A major protocol deviation
  • Unanticipated problem involving risk to subject or others which has not been previously reported to the IRB
  • Serious or continuing noncompliance

Not necessarily reportable to the IRB and/or Institutional Official

  • Unintentional administrative/management errors which do not impact subject safety, do not substantially alter risks to subjects, or do not affect data integrity
  • Unintentional deviations that are largely outside of the reasonable control of the PI [e.g. missed appointments, misinformation by participant regarding eligibility and exceeding the number of participants in survey research with a link, etc.]
  • Intentional changing of the order of procedures without risk to participants for the convenience of the participant