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Research Subject Advocacy Program
OverviewThe Research Subject Advocate (RSA) is a position mandated by the National Center for Research Resources under the NIH which funds the 82 CTRCs nationwide. The RSA role was defined and incorporated only recently (2001) in order to ensure that research was being conducted in ways that did not increase the risk associated with conducting studies. In the case of the Colorado Pediatric CTRC, where our study subjects are children, the RSA plays an especially important role for this protected group of individuals. RSAs also provide training and education for research participants, parents, investigators and co-investigators, study coordinators, and CTRC staff members. Sometimes this information is compiled into educational brochures, examples of which are shown below. Policies & ProceduresBased on extensive research into the history and practice of clinical research, our Center has developed a wide array of guidelines and training materials to help new or inexperienced investigators to apply, start-up and run a medical research study. The documents listed below can assist investigators as well as their mentors in carrying out high-quality research that is both effective and efficient. The Research Compliance Assistance ProgramCompliance Documentation PlanCTRC-Wide Data and Safety Monitoring PlanCTRC Protocol Change Request FormCooperative Pediatric DSMB Policy
Investigator AssistanceRSA review and approval of every protocol application is required at the Pediatric CTRC. Many investigators have found that this interaction actually is a great benefit to them to help them to develop their study design and the wording of their application prior to submission. This also prevents any surprises or delays during reviews at our monthly Scientific Advisory Committee meetings since investigators know exactly what is expected of them to ensure COMIRB and regulatory compliance. All protocols will require a Data and Safety Monitoring Plan (DSMP) in the application that specifies how PI-based or external DSMB oversight will be provided during the research period. Some studies may also be required to formally report periodically on their progress to a Data and Safety Monitoring Board. This determination will be made by the RSA in advance of the protocol application review to be sure that the investigator understands the reasoning behind this decision. When a local DSMB is required, the CTRC informatics and biostatistical staff will assist the investigator with necessary data collection and reporting to be sure that the DSMB has the necessary information to determine that the study is operating in compliance with the research protocol as designed and approved. The documents listed below can assist investigators with the development and submission of their protocol application. But also please feel free to call the RSA at anytime to discuss questions around an upcoming study or concerning one that is already underway. Background on the Cooperative DSMBGuidance in Formulating and Writing a DSMPYoung Investigator Guide to Protocol Writing & SubmissionInformation for Investigators: Minimal AssistanceInformation for Investigators: Intermediate AssistanceInformation for Investigators: Significant AssistanceYoung Investigator's Guide to Operationalizing ProtocolsYoung Investigator's Guide to Research Mentoring*For Mentors: Helping Young Investigators Operationalize Protocols*For Mentors: Helping Young Investigators Protocol Writing & Submission Checklist*For Mentors: Helping Young Investigators in Research Monitoring
Monitoring & OversightThe RSA performs protocol pre-review for all applications submitted to our Center. Recommendations are made to be sure that studies that are approved will meet all regulatory requirements. Oversight is also provided for all research once underway to track and respond to any adverse events or serious adverse events that might occur. Tracking for COMIRB compliance is also provided to be sure that local IRB obligations for investigators and studies are met. The RSA has created a Cooperative Data and Safety Monitoring Board for significant risk Pediatric research, and is the administrator on this board along with clinical experts who review studies according to the pre-defined oversight schedule. And finally, the RSA is the CTRCs primary interface between our Center and all regulatory groups, agencies and organizations. The RSA also will observe or participate in obtaining parental consent for research, or for obtaining the assent of a child to become part of a study if and when the child can understand this and make an informed decision. COMIRB Tracking DescriptionCommon Terminology Criteria for Adverse EventsRSA ResearchThe RSA in our Center also is a researcher. Particular interests are currently in the areas of obligations of parents of children with susceptibility to genetic conditions with environmental mediators; the context of assent (the child giving their own permission for involvement in a research study in addition to parental permission if and when the child can understand what that means); and the consent/assent process in terminally-ill children. Personal Message For Other RSAsI came to this position from a background in both biomedical ethics and pediatric research. My goal is to assure the safety of the children and parents who volunteer to participate in research supported by the Pediatric Clinical Translational Research Center. I pursue this goal in five general ways.
For Parents
Information about clinical researchInformación de investigación médicaClinical Research in Newborns and Infants
Please feel free to contact me with any questions, comments or concerns in these areas. I can be reached at: Ms. Terri O'Lonergan
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