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) Institutional Setup Issues in Community Research

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

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

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

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

Do not confuse with F&A rate! Constitutes legal permission an institution must have in place in order to conduct research with federal support 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 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 Can be revoked by Govt. if failure to comply Federal Wide Assurance (FWA)

Registration with the OHRP Registration with the OHRP 5 minimum members 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 Investigator can be on IRB but cannot vote on their own protocol Institutional Review Board Formation Contract with “Central” IRBs or create Locally

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

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

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