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Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center

Institutional Setup Issues in Community Research. Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center Adjunct Associate Professor , Dept of Radiation Oncology, University of Texas Health Science Center San Antonio (UTHSCA).

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Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center

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  1. Institutional Setup Issues in Community Research Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center Adjunct Associate Professor, Dept of Radiation Oncology, University of Texas Health Science Center San Antonio (UTHSCA)

  2. Initiating Community Research Clinical Research Initiation Issues Research Conducted Institution Specific Institutional Setup Issues Audits / Annual Progress Reports Dr. Bains’ Talk Dr. Steinbergs’ Talk

  3. Initiating Community Research • Human Subject Protection Course • Administrative Setup • Filing of Federal Wide Assurance (FWA) • Institutional Review Board (IRB) • Data Safety and Monitoring Plan

  4. Human Subject Protection Course (online) http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp • Identify events that have influenced current ethical guidelines and regulations • Identify the three fundamental ethical principles that guide the ethical conduct • Describe the role of international guidelines in the protection of human participants • Recognize when a study requires human participant protections • Responsibilities of organizations or individuals in protecting human participants • Identify issues to consider when selecting participants of special populations • Define confidentiality and how it can be maintained throughout the research process • Informed consent and elements to be included in an informed consent document • Describe responsibilities of the researcher in seeking consent from research participants • Identify new and emerging issues in informed consent that need to be considered • Define institutional review board, its membership requirements and responsibilities • List the criteria each study must meet in order to be approved by an IRB • Four ways that protections of human participants are ensured throughout in studies • Special challenges when conducting international research • Describe regulations applicable to international research supported by US monies.

  5. Administrative Setup • Find “Mentor” at experienced research center • Negotiate F&A rate (overhead rate) with the Health & Human Services ( not same as FWA! ) • Setup an Electronic Transfer mechanism for fund draw downs • Identify Financial Contact person (CFO) • Hire Grant Administrator/Manager

  6. Federal Wide Assurance (FWA) Do not confuse with F&A rate! • Constitutes legal permission an institution must have in place in order to conduct research with federal support • Commits Institution to principles and guidelines that protect human participants • Belmont Report usually cited in USA • Designation of IRB for oversight • Can be revoked by Govt. if failure to comply

  7. Institutional Review Board Formation Contract with “Central” IRBs or create Locally • Registration with the OHRP • 5 minimum members • At least 1 non scientific (community) member • Minority/Special population representative • Scientific Members (with expertise in research) • Authorized Institutional Member (Responsible for compliance with commitment to FWA) • Investigator can be on IRB but cannot vote on their own protocol

  8. Data Safety & Monitoring Plan (DSMP) Phase I and Phase II Trials • Clear monitoring process delineated in protocol • Contact information for entity responsible for monitoring • The interval in which the data is monitored • Description of the data being monitored • A mechanism for communicating with all sites enrolling pts • Mechanisms for compliance with required reporting of AE’s • Specifying person responsible for receiving AEs and SAEs • Notification of Research sponsor if protocol suspended • Plans for assuring data accuracy and protocol compliance

  9. Data Safety & Monitoring Plan (DSMP) Phase III Trials • In addition to previously mentioned requirements... • Requires a data safety monitoring board (DSMB) • DSMB must be independent of IRB and Investigators

  10. Initiating Community Research Clinical Research Initiation Issues Research Conducted Institution Specific Institutional Setup Issues Audits / Annual Progress Reports Dr. Bains’ Talk Dr. Steinbergs’ Talk

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