Masonic Cancer Center

A comprehensive cancer center designated by the National Cancer Institute

Review and Monitoring of Non-Therapuetic Interventional Clinical Research

The CPRC/Non-Therapeutic Interventional (CPRC/NTI) subcommittee's mission is to evaluate, approve or reject, and to monitor all non-therapeutic cancer-related research at the University of Minnesota.

In contrast to the CPRC/TI committee, which has responsibility for oversight of research directly related to cancer treatment (i.e., procedures designed specifically to eliminate or control the malignancy), the CPRC/NTI subcommittee is responsible for the range of research that can best be defined as a "non-therapeutic intervention." For purposes of the CPRC, non-therapeutic interventions are defined as cancer-related research that involves direct intervention with study participants that does not involve post-diagnosis procedures intended to eliminate or control the malignancy.

Examples of interventions include pharmacological, physical, behavioral, educational, and detection/diagnostic procedures that are intended to impact disease risk, disease occurrence, disease- or treatment-related complications, or quality of life. Research, whether clinically- or population-based, that does not involve a direct intervention with study subjects is considered to be observational research and generally does not require monitoring by the CPRC/NTI. Given the diversity of cancer research at the University of Minnesota, determining if a specific research project fulfills the definition of a "non-therapeutic intervention" is not always straight-forward. For this reason, the subcommittee has adopted the policy of reviewing all non-therapeutic cancer-related research, with those determined to be observational exempt from future review and monitoring.

Classifications
  • Prevention of Cancer
  • Chemoprevention
  • Behavioral and Lifestyle Education
  • Early Detection
  • Supportive Therapy
  • Complementary and Alternative Therapy
  • Diagnostic Interventions
  • Observational
  • Descriptive
    • Pharmacokinetic
    • Long-term follow up
    • Use of Tissues from Existing Tissue Banks

Studies determined after initial review by the subcommittee to be "observational" may not require additional monitoring. PIs submit all cancer-related protocols to this committee regardless of whether they are observational, which provides documentation for the PI if audited.

CPRC/NTI submission

Items required for committee review:

  • A CPRC Standard Application with signatures (hard copy)
  • A completed electronic version of study protocol that addresses the study background, research objectives/specific aims, study eligibility requirements, research design and methods, and statistical analysis plan. Templates for the research protocol are available on our website.
  • Complete electronic version of IRB application and consent form(s)
  • Expedited review must be requested in writing and justified
  • All research proposals requiring scientific review by the CPRC are to be submitted to the CPRC Manager, Clinical Trials Office, MMC 6, 612-626-5174, ccprc@umn.edu.
Review Sequence
  • The review process is based on standard NIH/NCI review directives.
  • Meeting time: The CPRC/NTI meets monthly on the third Thursday of each month
  • The CPRC/NTI Manager reviews all submissions for completeness, assigns a protocol number, and routes CPRC/NTI communications to CPRC/NTI chair and members.
Classifications of Protocols Not Reviewed by the CPRC/NTI
  • Therapeutic Interventional Trials (reviewed by the CPRC/TI)
  • Single-case, compassionate-use protocols
  • Treatment/management guidelines not asking a research question
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  • Last modified on October 22, 2013