guide for preparing and conducting clinical research study

PROTOCOL CONSENT AND ASSENT DOCUMENT CHECKLIST

This checklist serves as a guide to investigators to assist in the development of informed consent and assent documents necessary for IRB review. Please consult your IRB office for requirements that may be specific to your Institute.

ADULT CONSENT
(NIH-2514-1 – "CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY")

________

Purpose of the Study and Background Information

________

Identification of Inclusion Criteria and Exclusion Criteria of Study Population

________

Description of Procedures

________

Explanation of initial evaluation procedures and screening tests

________

Explanation of experimental procedures

________

Explanation of conditions for early withdrawal

________

Description of Risks/Discomforts (The following should be included, when appropriate)

________

Explanation of foreseeable risks or discomforts to the subject, an estimate of their likelihood, and description of steps taken to prevent or minimize them

________

Pregnancy Testing

________

Contraception Required

________

Blood Drawing

________

HIV Testing

________

Description of Potential Benefits

________

Description of Financial Compensation

________

Discussion of Alternative Procedures or Treatments

________

Statement that Principal Investigator will Discuss New Findings with the Subject

MINOR ASSENT
(NIH-2514-2 – "MINOR PATIENT’S ASSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY")

________ Included ________ Not Included  

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