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.
- Prevention of Cancer
- Behavioral and Lifestyle Education
- Early Detection
- Supportive Therapy
- Complementary and Alternative Therapy
- Diagnostic Interventions
- 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.
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, firstname.lastname@example.org.
- 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