IRB Reviewer Checklist
8/15/2008
Waiver or Alteration of Requirement to Obtain Informed Consent
PROTOCOL NUMBER:PRINCIPAL INVESTIGATOR:
TITLE OF STUDY:
KEY: / White background box: All items in the box must be true
Gray background box: One item in the box must be true
q / Approval of a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent (All of the following are true)
q The research or demonstration project is to be conducted by or subject to the approval of state or local government officials
q The research is designed to study, evaluate, or otherwise examine:
q Public benefit or service programs
q Procedures for obtaining benefits or services under those programs
q Possible changes in or alternatives to those programs or procedures
q Possible changes in methods or levels of payment for benefits or services under those programs
q The research could not practicably be carried out without the waiver or alteration, because:
(State reasons here)
q The research is NOT subject to FDA regulation
q /
Approval of a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent (All of the following are true)
q The research involves no more than minimal risk to the participants, because:(State reasons here)
q The waiver or alteration will not adversely affect the rights and welfare of the subjects, because:
q The research could not practicably be carried out without the waiver or alteration, because:
(State reasons here)
q One of the following is true:
q Providing participants additional pertinent information after participation is not appropriate, because:
(State reasons here)
q Participants will be provided with additional pertinent information after participation
q The research is NOT subject to FDA regulation
Requirement for obtaining informed consent is: / q Waived
q Not waived
Signed / Dated
1