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.]

Protocol Submission

Items required for committee review:

• A CPRC Standard Submission Form (MSWord doc)
• Complete IRB application including protocol (if applicable) 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 806, C516 Mayo, phone: 612-624-1959)

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
• Retrospective chart review
• Focus Groups