All human subject cancer or cancer-related protocols (therapeutic/treatment, prevention, ancillary/companion and correlative), must be reviewed, approved, and monitored by the Kansas Masonic Cancer Research Institute's Protocol Review and Monitoring Committee (PRMC). Approval must be obtained prior to the Principal Investigator beginning the submission process to the Human Subject's Committee (HSC). Monitoring of the ongoing research will take place after all compliance approvals have been completed.
The University of Kansas Medical Center and the Kansas Masonic Cancer Research Institute are committed to striving toward national distinction as a designated National Cancer Institute (NCI) cancer center. Institutions that are dedicated to the advancement of cancer research exemplify scientific excellence and effectively integrate diverse research methods and approaches in focusing on cancer are recognized by the NCI by receiving cancer center designation. These centers integrate basic, clinical, prevention, control and population sciences research. The National Cancer Institute requires that a successful center not only achieve excellence in research but also be organized and run in a manner, so that the research is maximized by critical organizational and administrative characteristics. All NCI designated cancer centers must satisfy characteristics in the areas of cancer focus, institutional commitment, organizational capabilities, facilities, center director, and interdisciplinary coordination and collaboration. This policy establishes a mechanism of scientific review and over sight of that research and gives authority to that mechanism.
The Protocol Review and Monitoring Committee's (PRMC) purpose is to scientifically review all human subject cancer or cancer-related protocols and establish their relative priority to the institutional mission. In addition, the PRMC is responsible for reviewing the appropriateness of Data and Safety Monitoring plans, monitoring accrual and patient safety for all cancer or cancer-related studies within the institution.
Clinical research studies involve the consenting of participants to either participate in a study, provide information (questionnaires, etc.) or specimens such as blood, tissue, etc.
Therapeutic/Treatment: Studies that evaluate new treatments or new ways to use a current or new treatment such as drugs or combinations, therapies, surgical or radiation techniques, or methods of treatment for cancer.
Prevention: Studies that look at cancer prevention, high-risk characteristics, and recurrence. Version 08/05/2005 2
Ancillary or Companion: Studies that are in addition to or related to another study in order to get additional information on a group of subjects or to look at a different set of variables collected, or a cancer-related study that involves management of disease, quality of life, or follow-up on survival.
Correlative: Laboratory based cancer research involving human participants, human tissue or related by-products.
Responsibilities of the Protocol Review and Monitoring Committee
This policy will follow the aims and purposes outlined below.
It will be the responsibility of the PRMC to:
None. This policy applies to all cancer and cancer-related research and investigators conducting such research at the University of Kansas Medical Center and it's affiliated agencies.
*For information regarding submission of protocols, including forms, deadlines, committee review dates and necessary documents; please contact the KMCRI Clinical Trials Office.