APPLICATION & REVIEW PROCESS

 

How to Apply to the CARE-Q Consortium

Email CARE-Q to inquire about joining the CARE-Q Consortium and becoming a CARE-Q Member. A CARE-Q Member will answer questions and discuss the application and site review process. Additional documents, including the Terms of Application and Terms of Membership, will be provided once an Institution is ready to begin the process.

What are the costs?

There is currently no application fee. However, the Applicant institution pays travel expenses (air, travel, accommodations & food) for 2-3 Review Team members to visit the institution, usually over a 2-day period. Review Team Members' time is considered part of the course and scope of their employment at their respective institutions and, therefore, no additional compensation is expected.

As CARE-Q grows, a nominal annual fee may be implemented to cover operational expenses (e.g., website, conference line, computer support, etc.)

Application and Site Review

  1. CARE-Q Application
  • Describe the Institution’s IRB operations
  • Summarize its key characteristics, including metrics
  • Review and complete the ‘Terms of Application and ‘Terms of Membership’
  1. IRB Written Procedures Self-Assessment
  • Complete the ‘IRB Written Procedures Self Assessment’, which has been adapted from the OHRP/FDA Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs, May 2018
    • CARE-Q Review Team will use this to review Institution’s IRB standard operating procedures and other documentation (e.g., guidance documents; website) to evaluate Institution’s compliance with OHRP/FDA regulations
  1. Institutional Visit / IRB meeting observation conducted by CARE-Q Reviewers
  • Interviews with key stakeholders (e.g., IRB staff, IRB Members, Researchers,  and Institutional Officials)
  • Observation of at least one IRB meeting
  • Review a subset of IRB files
  • Follow the ‘lifecycle’ of several IRB applications from submission to approval

Governance

The Board of Governors is a senior advisory group that provides oversight, leadership, and guidance to the CARE-Q program and issues final Certification to a site.

 

Certification

  • Granted for 5 years by Board of Governors based on Review Team Members reports summarizing the findings from the Self-Assessment and Institutional Visit
  • May be rescinded if Institution fails to follow ‘Terms of Membership’

Engagement

  • Coordinated quality improvement activities
  • Programs (e.g., via webinar) reviewing institutions’ best practices and processes

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