Consent Form Checklist
Institutional Review Board
1. Is the consent form written in everyday (“lay”) language?
2. Is it free of any language that requires the subjects to waive their legal
rights, including any release of the investigator, sponsor or college or its
agents from liability for negligence?
3. If minors are included in the study, is provision made for obtaining
parental consent?
4. Does the consent form include each of the following basic elements of
informed consent?
a. an explanation of the purposes of the research and the expected
duration of the subject’s participation.
b. A description of the procedures to be followed.
c. A description of any benefits to the subject or others.
d. A description of any reasonably foreseeable risks or discomforts.
e. A statement describing the extent to which confidentiality of records
identifying the participant will be maintained.
f. Information regarding whom to contact for answers to questions
about the research study and the research subject’s rights.
g. A statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits, and the participant may
discontinue participation at any time without penalty or loss of
h. Appropriate FERPA notice and waivers (if appropriate).
If there was a “NO” response to any of the above questions, the consent form must be revised
accordingly, unless the investigator can satisfactorily justify why it is appropriate without revision.
Clear Form