IRB Reviewer Worksheet for Revisions
Protocol ID
*
Protocol Title
*
Reviewer Name
*
First Name
Last Name
Email
Does the amendment appear to be adequate and complete?
*
Yes
No
Does the amendment address any safety concerns?
*
Yes
No
If there are any safety issues, are they adequately covered in the informed consent?
*
Yes
No
N/A
Does the informed consent contain the elements required by BRGMC?
*
Yes
No
N/A
If the consent was updated, do the previously consented patients need to be reconsented?
Yes
No
Are the amendment and protocol accurately reflected in the informed consent?
*
Yes
No
Is the benefit/risk relationship still acceptable?
*
Yes
No
Is the HIPAA form incorporated with the consent?
*
Yes
No
If not, has a separate HIPAAform been submitted?
*
Yes
No
Comments
Recommendations
Amendment is acceptable as submitted.
Amendment is acceptable, consent form needs BRGMC required elements included.
Amendment is not acceptable.
Reviewer Signature
Today's Date
*
/
Month
/
Day
Year
Date
SUBMIT
Should be Empty: