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 | ||
________ |
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 | ||
________ Included | ________ Not Included |
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