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Investigator: enter name, degree, mailing address and telephone number of principal investigator.
Sub-investigators: enter names and degrees of all investigators to be encountered by the subject. These names should be the same as those shown in the Brookwood Baptist Health Institutional Review Board application as sub-investigators.
EXPLANATION OF PROCEDURES Purpose of research study _____ Description of the study _____ Role of participant _____ What is being studied _____ Why it is being studied _____ Purpose of research _____ Indicate experimental/research
Who can take part in the study? _____ Inclusion criteria _____ Exclusion criteria
Procedures _____ List of all procedures _____ Intervals of procedures _____ Length of time participant in study _____ What will be given or received and how administered _____ Length of hospital stay, if required _____ Prior experience with drug or device
RISKS
_____ Describe all risks in detail _____ Describe all possible side effects (in consent form or as attachment)
BENEFITS
_____ Describe direct benefits in detail _____ Describe societal benefits in detail _____ State if none
ALTERNATIVE TREATMENT/PROCEDURES
_____ Describe in detail
FINANCIAL OBLIGATIONS
_____ Costs to participant, if any _____ Insurance coverage, if any COMPENSATION FOR PARTICIPATION
_____ Payment to be received by participant
CONFIDENTIALITY
_____ Indicate records are confidential _____ Safeguards used if data published _____ Who will have access to records RESEARCH-RELATED ADVERSE EVENT
_____ Name/phone number of treating doctor _____ Where will treatment be given EMERGENCY CARE AND COMPENSATION IN CASE OF INJURY
_____ Name/phone number of treating doctor _____ Where will treatment be given _____ Other forms of compensation, if any
HOW TO LEARN MORE ABOUT THE STUDY OR RAISE CONCERNS
_____ Name/phone number of investigator for questions about the study _____ Name/phone number of investigator for questions about compensation or medical treatment for research-related injuries _____ Listing of Institutional Review Board for questions about rights as research subject VOLUNTARY PARTICIPATION/WITHDRAWAL
_____ Statement regarding voluntary participation _____ Statement regarding withdrawal by participant during study _____ Statement regarding withdrawal of participant by physician DOCUMENTATION OF CONSENT
_____ Statement regarding legal rights _____ Copy of consent form given to participant _____ Signature and date line for participant (or guardian) _____ Signature and date line for investigator
