Institutional Review Board

Elements of Consent Checklist

Complete this checklist for each consent form, information sheet, and verbal script. If elements of consent are missing, they should be included in the consent form prior to review.

IRBNet #: / PI:
Type of Consent:
CHW Template Sponsor Consent Form
Parental Signature Requirements (if appropriate, if known at the time of pre-review)
One Parent
Both Parents
X / Required Elements
A statement that the study involves research
Notes:
An explanation of the purposes of the research
Notes:
The expected duration of the subject's participation
Notes:
A description of the procedures to be followed
Notes:
NA / Identification of any procedures which are experimental
Notes:
A description of any reasonably foreseeable risks or discomforts to the subject (note: this includes non-physical risks such as risks to privacy, confidentiality, emotional, financial, etc.)
Notes:
A description of any benefits to the subject or to others which may reasonably be expected from the research
Notes:
NA / A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Notes:
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
Notes:
NA / For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained.
Notes:
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject (note: injuries do not have to be physical injuries thus regulations require that contact information for potential injuries is included in all consents)
Research Qs: Rights Qs: Injury Qs: Notes:
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
Voluntary: Refusal: Discontinuation: Notes:
X / Additional elements, required if applicable to the study
NA / A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
Notes:
NA / Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
Notes:
NA / Any additional costs to the subject that may result from participation in the research
Notes:
NA / The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
Notes:
1.  The consent should include language regarding use of data and specimens that have already been collected. Present NA
Note: If FDA-regulated research, consent should state that data that has already been obtained cannot be withdrawn. If not FDA-regulated, investigator should either provide subject a choice about withdrawal of data/specimens or clearly disclose that data/specimens that have already been obtained cannot be withdrawn.
2.  The consent should include language disclosing, if true, that if the subject withdraws from the interventional component of the study that the investigator may ask for permission to continue to follow up with the subject in person or to follow their medical record information. Present NA
(See FDA Guidance: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials and OHRP Guidance: Withdrawal of Subjects for Research: Data Retention and Other Related Issues for more information) Notes:
NA / A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject.
Notes:
NA / The approximate number of subjects involved in the study
Notes:
NA / For FDA-regulated clinical trials, approved after March 7, 2012, this statement must be included verbatim:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Notes:
NA / If a trial involves testing of FDA regulated materials, the consent form must contain a statement disclosing that the FDA has access to review and copy all relevant records
Notes:
NA / If a trial involves genetic testing or storage of sample for future genetic testing, language regarding the protections provided by the Genetic Information Nondiscrimination Act (GINA) has been included.

Additional Notes:

3