Quality Assurance/Improvement Program for Human Research Protections

The Office of Research Integrity (ORI) and the University of Kentucky (UK) Institutional Review Board (IRB) developed a Quality Assurance/Improvement Program (QA/QIP) to strengthen human research protections at UK and demonstrate UK’s commitment to continuous improvement in compliance. Identifying the strengths and weaknesses of protection efforts is essential to maintaining a quality program and enables the ORI and the IRB to continue UK’s tradition of excellence.

Implementation of the QA/QIP at UK serves to evaluate human research protections at varying levels, increase awareness of existing processes, operating procedures, educational programs, and acquire information necessary for enhancing protections. The QA/QIP provides a means to assess UK’s level of compliance with federal, state, and institutional regulations, and Good Clinical Practice (GCP) guidelines, which is a key element in meeting the highest standards for human subject protections.

Components of the program focus on educating the University’s researchers on the mechanisms by which human subjects are protected. It also allows researchers, ORI staff, and IRB members the opportunity to improve human research protections performance. The QA/QIP can provide useful information to identify educational/training initiatives for researchers, their staff, ORI staff, and IRB members.

The QA/QIP consists of three main components which examine the entire research process and may focus on the researcher, the IRB’s review process, and/or the IRB records maintained by ORI. See Directed On-Site Reviews, PI Self-Assessment Reviews, and Administrative Assessment Reviews for more information. 

This type of review is conducted by the ORI QA/QIP and initiated upon request by the Institutional Review Board (IRB), the Vice President for Research, or ORI Director, due to unusual circumstances, significant risks to subjects, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IRB’s attention, or any case requiring further scrutiny as deemed appropriate by the IRB.

The ORI QA/QIP may be accompanied by a representative of the IRB. A comparison of the IRB’s records maintained by ORI, with the investigator’s research records, may also be conducted to determine accuracy and consistency and to verify that no material changes were made to the protocol prior to IRB approval. The findings of the directed review are shared with the Principal Investigator (PI) and his/her research staff and reported to the IRB to make a determination about whether further action is necessary.

If in reviewing the results of a directed review, the IRB determines that the exposed deficiencies warrant suspension or termination of the research, the IRB develops a plan for follow-up, which may entail, but is not limited to, another QA/QI review, or monitoring of the informed consent process. If ORI conducts a directed Quality Assurance/Improvement Review (QA/QIR) on a protocol that falls under the purview of a unit with which ORI has written and approved joint standard operating procedures (e.g., IBC, MCC), the appropriate unit representative is given a copy of the final QA/QIR report.

This type of review may be voluntarily performed by the PI or his/her research staff. However, a PI may also be prompted by direct invitation at the discretion of the IRB, Vice President for Research, or ORI Director to perform a self-assessment review.

The ORI provides a web-based self-assessment form (also available electronically, or in paper copy) to be completed by the PI and/or research staff. The PI self-assessment tool includes questions and information pertaining to federal regulations governing human research protections, local IRB policies and procedures, and International Conference on Harmonisation (ICH) GCP guidelines. The results from a PI self-assessment review can be submitted to a secure database, after which time, the ORI can return suggested corrective actions to the PI for areas in need of improvement.

The IRB will not be notified of results from a PI self-assessment review unless the results of the review reveal significant deficiencies in protection of human subjects in research, or the IRB directed a PI to complete the self-assessment. Reports can be generated by the ORI using the data collected from submitted self-assessment forms and may enable identification of educational initiatives for researchers. These reports are run on an as-needed basis and analyzed accordingly by the QA/QIP.

• UK PI Self-Assessment Forms:
  • Medical PI Self-Assessment
  • Nonmedical PI Self-Assessment
  • Nonsignificant Risk Device (NSR) Self-Assessment (PDF)
• Optional self-assessment tool: Quality Assurance/Improvement Program Subject Survey Tool - "Research Participant Satisfaction Survey"
  
  Research investigators may use or adapt this sample survey to obtain feedback from study participants to support quality improvement of human subject protection practices and the informed consent process. Whether used routinely or as part of a Self-Assessment, feedback from your research participants may provide valuable information to help improve compliance and enhance effectiveness of your informed consent process.
  
  Please note, you should not treat a subject differently because of any outcome from the survey. The information you obtain should only be used to identify how the informed consent process can be improved.  Every effort should be made to prevent anyone who is not on the research team from knowing who responded to the survey and what responses were provided.
  
  Research Participant Satisfaction Survey Template

This type of review is conducted by the ORI QA/QIP and is initiated at the discretion of the Director of ORI and/or the Vice President for Research. A thorough examination of the IRB records may be conducted for improvement of management or to evaluate the procedures applied and/or issues addressed by the Office of Research Integrity staff and the IRB for protection of human subjects in research.

An example of evaluating IRB procedures would be the use of the Consent/Assent Form Checklist. IRB member performance evaluations are periodically conducted to verify qualifications. The results of an administrative assessment are shared with the ORI Director. The results may impact current practices and may require additional educational activities for ORI staff, IRB members, or investigators/study personnel.

In addition to the above-described administrative assessment reviews is the Program Assessment for Accreditation, a significant component in support of maintaining AAHRPP accreditation. This assessment focuses on maintenance of applicable documentation representing current policy and procedures; utilization of the AAHRPP Self-Evaluation Instrument; and evaluation of current HRPP practices to ensure appropriate fulfillment of accreditation standards.

• Directed On-Site Review [C5.0050] (Revised 4/1/19)
• PI Self-Assessment Review [C5.0150] (Revised 4/1/19)
• Administrative Assessment Review [C5.0200] (Revised 4/1/19)

One of the goals of the Quality Assurance/Improvement Program is to educate researchers on the mechanisms by which human subjects are protected. In keeping with this intent, results of routine Quality Assurance/Improvement Reviews (QA/QIR) and Principal Investigator (PI) Self-Assessment reviews are not shared with the Institutional Review Board (IRB) unless significant or serious deficiencies in human subject protections are found. Educational programs/announcements are developed for investigators, their research staff, ORI staff, and IRB members based on the results of the QA/QIP Reviews. If findings from a QA/QIR are reported to the IRB, the IRB makes a determination whether to report the findings to the UK Institutional Official, other internal departmental faculty/staff, and/or to external agencies as described in the "Mandated Reporting to External Agencies SOP".

It is standard operating procedure to report results from a Directed QA/QIR to the IRB.

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

• A major protocol violation (for more information and details, see Protocol Violations section on the Other Reviews web page and/or the Protocol Violation Review SOP)
• Unanticipated problem involving risk to subject or others which has not been previously reported to the IRB (for definitions, see the Policy on Prompt Reporting for Unanticipated/Anticipated Problems/Events)
• Serious or continuing noncompliance (for definitions, see Noncompliance SOP)

Minor Deficiencies in Human Research Protections (might include, but is not limited to):

• Administrative/management errors which do not impact subject safety, do not substantially alter risks to subjects, or do not affect data integrity