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UNM IRB Process Changes

Friday, January 26, 2018

Good morning. This email is to clarify changes that have been implemented in UNM IRB policies and procedures. As previously communicated, the federal government has delayed the implementation of changes to the federal regulations (aka Common Rule). However, our office (and many other IRBs nationally) are moving forward with changes with regard to the review of non-federally funded research. A summary of these changes is provided below. If you are currently conducting research under the oversight of the UNM IRB, please review updated policies (version dated 1/19/2018) now available in the IRB Library. The UNM IRB Researcher Handbook has also been updated.

Three distinct review tracks:

  • Federally funded expedited or exempt projects
  • Non-federally funded minimal risk projects (including student research)
  • Greater than minimal risk (includes both federally funded and non-federally funded projects)

Continuing review no longer required for non-federally funded minimal risk projects

  • Although no longer automatically required, IRB reviewers may recommend continuing review, depending on the type of research and participant population
  • Amendments and Closures still must be submitted to the IRB

Implementation of Post Approval Monitoring (PAM) Program

  • PAM activities are recommended by IRB reviewers at time of initial review
  • Variety of PAM conducted by OIRB staff:
    • administrative check-in (if no continuing review);
    • directed self-assessments;
    • on-site assessments;
    • project team review;
    • informed consent audits/observations o
  • For more information, see SOP 409 Post Approval Monitoring Program

Elimination of requirement to submit Project Team Amendments

  • Project Team forms still required at the time of initial review
  • PI is responsible for tracking IRB requirements for project team
    • Verify current CITI or NIH Human Protections Training
    • Verify annual Conflict of Interest disclosure status
    • IRB retains the right to monitor project team compliance

No approval stamp on approved consent forms

  • PI is responsible for ensuring project team members have access to currently approved consent form(s) documented in IRB approval letter
  • Last signed consent forms no longer submitted at the time of continuing review
  • OIRB will provide approval stamp upon request

As always, please check our website for the most updated submission forms and IRB Submission Checklist and contact our office with any questions: irbmaincampus@unm.edu.