Study Name____________________________________________________
Date________________
Project Director Name____________________________________________
CONSENT FORM CHECKLIST
The process of obtaining informed consent must comply with requirements of 45 CFR 46.116. The documentation of informed
consent must comply with 45 CFR 46.117. The following checklist summarizes the points that must be addressed for obtaining
consent and its approval by IRBs.
__.116
Element*
ITEM
GENERAL
.117(c)(1)
Consent Form documents the basis for consent and is the subject's reference. Requires
signature except for waivers or confidentiality and minimal risk research.
Readability - the form must be understandable to people being asked to participate avoid scientific jargon and "legalese."
Format - avoid use of first person except for the statement of consent.
Exclude any language that makes or appears to make the subject waive any legal
rights.
PURPOSE/DESCRIPTION
B1
State clearly if it is a research study.
B1
Describe procedures to be followed and which are experimental.
B1
Prominent discussion of purpose of study.
Why the subject qualifies for study.
B1
Duration of subject involvement.
What treatment is different for the patient if a participant in the study.
A6
Approximate number of subject's in study.
RISKS AND BENEFITS
B2
Description of risks or discomforts to subject.
A1
Description of risks or discomfort to embryo fetus and limitation for pregnant women
or nursing infants.
B3
Description of possible benefits to subject or future subject.
B6
Description of voluntary compensation and treatment if the subject is injured related to
the research. Applicable for research posing greater than minimal risks.
ALTERNATIVE TREATMENT
B4
Alternative Treatment - What alternative is available if subject elects not to
participate.
(over)
COMMENTS
__.116
Element*
ITEM
COMMENTS
CONDITION OF SUBJECT
B6
For research involving more than minimal risk: availability of medical treatment or
compensation if injuries occur, what services are available and who pays.
B7
Contacts (at least two) for questions concerning research subject's rights, research
project and research-related injury. (Provide local or 800 phone numbers.)
B8
State clearly that participation is voluntary and refusal to participate or discontinuation
results in no loss of benefits to which subject is otherwise entitled.
B8
For studies of prison population: state that the study participation will not affect their
treatment or consideration for parole.
A2
Why subject's participation may be terminated by principal investigator.
A4
Consequences of subject's decision to withdraw from research and procedures, if
applicable.
A5
Notification of significant finding(s) that may determine subject's willingness to
continue.
CONFIDENTIALITY
B5
FDA
Describe the extent subject's personally identifiable private data will be held in
confidence.
Subjects in FDA regulated "clinical investigations" must be informed that the FDA
may inspect the records of the study.
Does study have (or need) Certificate of Confidentiality.
Will subject be recontacted? Is there potential for use of data in other legitimate
research?
If applicable, state that reports of "imminent harm" to the subject will be reported to
authorities.
FINANCIAL CONSIDERATION
B6
Compensation to subject must not be coercive in amount or method of distribution.
A3
Disclose any potential costs to subject.
*
Bx references the Basic element number of __.116(a). These elements are required for informed consent.
Ax references the Additional element number of __.116(b). This information must be provided for appropriate studies.
FDA indicates an additional requirement for clinical investigations.
February 1994