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 PATIENTS ASSENT TO PARTICIPATE
IN A CLINICAL RESEARCH STUDY")
|
________ Included |
________ Not Included |
|