APPENDIX III: Consent Form Preparation Checklist

Title of study:

Sponsor:

Protocol no.:

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