Urban Latino African American Cancer Disparity Project

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/huma
nparticipant-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 FA 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
Do not confuse with FA rate!
Federal Wide Assurance (FWA)

• 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 AEs
• 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