Best Practice Assessment

Version Date: February 25, 2026

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1. Introduction and Purpose
2. Definitions and Acronyms
3. Best Practice Assessment
4. Materials Required
5. Document Approval
6. Revision History

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Introduction and Purpose 

The Office of Quality Compliance (OQC) was established to promote ethical, efficient, and high-quality research while safeguarding data integrity. The OQC conducts three types of assessments to achieve these goals: Self-Assessment, Research Climate Assessment, and Best Practice Assessment(BPA). The three assessments aim to assist research teams in evaluating, implementing, and maintaining compliance with federal and local regulations, University of Utah research standards, and, where applicable, Good Clinical Practice. This document outlines the OQC’s Standard Operating Procedures (SOP) for conducting a BPA.

Definitions and Acronyms 

BPA:	Best Practice Assessment
CAPA:	Corrective and Preventative Action Plan
ERICA:	Electronic Research Integrity & Compliance Administration
IRB:	Institutional Review Board
OQC:	Office of Quality Compliance
ORIC:	Office of Research Integrity & Compliance
SOP:	Standard Operating Procedures

 

Best Practice Assessment 

1. The OQC is requested to conduct a BPA by the Office of Research Integrity & Compliance (ORIC) for any research that has been identified as requiring additional assessment. Other compliance entities on campus may request a BPA, if needed.
2. A BPA may be prompted by one of the following, but not limited to:
   1. Whistleblower complaints
   2. Research participant complaints
   3. Employee complaints
   4. Request from any entity within ORIC
3. The objectives of a Best Practice Assessment are to:
   1. Review concerns and/or complaints about research activities and/or potential unprofessional behaviors/conduct in research.
   2. Assess compliance with federal regulations, state law, institutional policy, and good clinical practices.
   3. Verify that the specific components and conditions of Institutional Review Board (IRB) approval are being implemented in research practices and are being adequately documented.
   4. Verify that information submitted in an IRB application and study activities are consistent with funded and approved grant proposal documents and methods (applicable to grant-funded research).
   5. Verify that information submitted in an IRB application and study activities are consistent (applicable to sponsor-funded research).
   6. Ensure the continuous protection of human participants and their rights when participating in a research study (applicable to human participant research).
   7. Develop an action plan to address unprofessional behaviors/conduct and/or research quality and integrity issues, as necessary.
4. Participation in a BPA is not voluntary. However, the OQC intends that these assessments will facilitate productive discussions and provide education that improves the quality of research.
5. The BPA will be conducted in a timely manner and given priority over all other assessments being conducted by the OQC.
6. Research teams will be notified of the BPA and receive follow-up communications through a combination of scheduled meetings and email correspondence with the OQC, as well as email notification through the Electronic Research Integrity & Compliance Administration (ERICA) system.
   
   1. Research teams may also receive notification from the ORIC that a BPA is required and will be conducted by the OQC.
7.  Upon notification of a BPA, the research team may be asked to complete a Self-Assessment. The Self-Assessment provides the OQC reviewers with an overview of research activities and helps prepare research records for assessment.
   
   1. The OQC creates the Self-Assessment within the IRB profile for the study, and a notification is sent to the PI and contacts through the ERICA system.
      
      1. The notification includes a link to the Self-Assessment, which automatically navigates the user to the Self-Assessment in ERICA.
   2. The research team is provided ten (10) business days to complete the Self-Assessment.
      1. If multiple studies are included in the BPA, the research team may be required to complete a separate Self-Assessment for each study, with an additional timeline provided for each Self-Assessment.
8. Once the research team completes the Self-Assessment, the OQC will conduct the BPA. The assessment may be conducted either remotely or on-site, as determined by the OQC.
   1. On-site assessments: OQC staff will require dedicated workspace (e.g., office space or conference room) and access to all study documents including regulatory and participant study documents.
   2. Remote assessments: OQC staff will require unrestricted electronic access to all study documents (i.e., regulatory documents and participant study documents). In case of technical issues, a research team member needs to be available by email and/or phone.
   3. Interviews will be requested with identified research staff. Previous team members may be invited to participate in the interview portion of the BPA. Each individual will be asked a standard set of questions determined by the OQC. The information provided during the interviews is aggregated to provide anonymity for those who agree to participate.
9. At the conclusion of the BPA, the OQC will share a BPA report of queries, aggregate findings, and a list of resources and recommendations for team members, to obtain additional information and provide educational assistance. The OQC team will facilitate contact with resources, as needed. A written response to the OQC may be required from the PI and/or Department Leadership to address aggregate findings.
   1. The BPA Report will be provided to the requestor.
   2. A summary meeting will be scheduled to discuss the report, review recommendations for the research/research team, and if needed, propose a Corrective and Preventative Action Plan (CAPA).
      1. The Department Chair or Dean may also receive a copy of the BPA Report and be invited to attend the summary meeting.
   3. Following the meeting with the requestor, the BPA Report will be provided to the principal investigator/lead researcher for review, and a meeting will be scheduled to review the BPA Report.
   4. Once the meetings with the requestor and the principal investigator/lead researcher conclude, a final BPA Report will be provided to those parties and the research team. The report will also be shared with the Associate Vice President for Research Integrity & Compliance’s Office and other necessary University entities.
10. In some cases, BPA findings and/or information from interviews may necessitate reporting to another entity within the institution.
11. The timeline for a BPA  varies, depending on research team availability and other factors.
12. If there are compliance issues identified that require corrective action, a CAPA will be created. The OQC will collaborate with the research team to develop specific actions to address the concerns and establish a timeline for their completion. The OQC will monitor the research team’s progress in meeting the deadlines outlined in the CAPA.
13. A Follow-Up BPA may be required. Any follow-up and associated details will be outlined in the final BPA Report.
14. Best Practice Assessments are an internal institutional process. Research teams should retain documents associated with the BPA, including the initial notification of assessment, completed self-assessment, the BPA Report, and other relevant correspondence. However, it is recommended that these documents are not filed in the official, external-facing regulatory record.

Materials Required 

• An active ERICA account and access to the desired study(ies)

Document Approval 

Caren J. Frost, PhD, MPH
Associate Vice President for Research Integrity and Compliance,
University of Utah
Date: 06/01/2023

Revision History