Scientific Review Committee (SRC) - PRMC Cancer Prevention and Control Subcommittee
VCU Massey Cancer Center (MCC) has established the Protocol Review and Monitoring Committee (PRMC) in line with mandates from the National Cancer Institute (NCI) regarding research with human subjects. As an NCI designated cancer center, we are required to report on ALL research activities including those that are not considered clinical trials (even those collaborating with outside hospitals, researchers, etc.), regardless of whether you contact patients.
All cancer-related research proposals must be reviewed and approved by the VCU MCC PRMC prior to Institutional Review Board (IRB) submission.
Research studies subject to PRMC review include the following:
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the general population
The Cancer Prevention and Control subcommittee (CPC) of the PRMC was established to review non-therapeutic studies that do not involve investigational medications or procedures, for example, behavioral interventions and secondary analysis of patient data. For Cancer Prevention and Control studies, approval is obtained from the CPC subcommittee, although the level of review will vary from protocol to protocol. Submitted protocols that are funded by an agency such as the NIH, NCI, or ACS, and have received scientific peer review prior to funding, will not be subject to further scientific review by the CPC subcommittee. Thus, CPC subcommittee members review all new protocols for their scientific merit, prior to submission to the VCU IRB. The PRMC Parent and the CPC subcommittee also review to assess participant competition with other protocols. The CPC subcommittee reviews protocol amendments for changes that might affect competition with other studies involving the same participant population.
It is possible that two or more research projects will recruit subjects diagnosed with the same cancer. Under these circumstances, it is the responsibility of all investigators to work together to avoid undue burden for patients. Investigators can choose to divide subjects so that each subject is offered the opportunity to participate in one study or investigators can pool their subjects and offer them the choice between studies, or the opportunity to participate in more than one study. The procedures will be study specific. It is the investigators’ responsibility to ensure that study PIs are working together across studies to avoid the duplication of effort.
NEW PRMC SUBMISSION
Approval from the PRMC CPC subcommittee must be obtained prior to submitting the protocol to the VCU IRB. VCU’s IRB requires that the PRMC CPC approval letter accompany any new protocol submission to the IRB. Submitting to IRB without the PRMC CPC approval letter will delay IRB protocol review. If you have any questions about whether or not your study should be submitted for review, please email the PRMC CPC subcommittee coordinator at email@example.com.
To submit to the PRMC CPC Subcommittee, submit the following to firstname.lastname@example.org:
- The Protocol Submission Form [pdf]. Use these instructions [pdf] for completing the Submission Form.
- CITI (Collaborative Institutional Training Initiative) Human Subjects Protection and Good Clinical Practice Training completion certificates for the principal investigator and all study staff, if proof of training has not been previously submitted.
- Your completed protocol document Please make sure that the complete statistical analysis for your study is included. (Statistical analysis detail is not required on the IRB submission form, but is required for PRMC review.)
- Your VCU IRB informed consent document(s).
- Any surveys or other instruments to be utilized
- Letter or email of clinical support indicating approval from a MCC or affiliated research team or clinician.
Approval letters will be sent electronically to the PI after the protocol is approved. Once you obtain PRMC approval, include a copy with your VCU IRB application.
Advertisement or Mass Communication
If an advertisement or mass communication is planned for your study, please contact Jenny Owen in Massey Cancer Center's Communications Office prior to submission to the IRB at: email@example.com.
Please plan to allow at least two weeks for review and approval of an advertisement or mass communication.
The items to be reviewed would include items such as, but not limited to, the following:
- Recruitment letters
- Newspaper advertisements
- Radio announcements
- Public service announcements
All amendments made to studies approved by the PRMC must be submitted to the PRMC when they are submitted to the IRB. Please include a summary of changes, both redlined and clean versions of the revised document(s) and, once received, the IRB approval letter. Amendments that change the target population must include a memo detailing physician support and a competition plan that explains how conflicts will be resolved. If an amendment that does change target populations is submitted without such plan, the investigator will be notified by the CPC subcommittee coordinator that a plan is required. Once the plan is submitted, the amendment will proceed through the PRMC review process.
Studies are monitored by the PRMC CPC subcommittee for accrual on an annual basis at the quarterly PRMC CPC subcommittee meeting.
Accrual Reporting Reminder
VCU requires that all clinical trials be managed in the OnCore Clinical Trials Management System. Subject accrual must be entered into the OnCore system. Please contact ONCORE@vcu.edu to schedule training to use the OnCore system.
For non-clinical trial studies, the Massey Cancer Center reporting specialist will send out an accrual form to the study contact to complete and return.
Study Status Changes
The date when a study opens to accrual, continuing reviews and suspensions/ or holds should be reported to the PRMC CPC subcommittee coordinator. Studies closed to accrual or closed by the IRB should also be reported to the PRMC.