Required Consent Elements
Consent forms must contain the following, as required by 45 CFR § 46.116(a)(1-8):
1. A statement that the study involves research.
2. The purpose of the research.
3. The expected duration of participant involvement in the study.
4. A description of the procedures to be followed.
5. Identification of the procedures which are experimental.
6. Description of any reasonably foreseeable risks or discomforts to the participant.
7. Description of any benefits to the participant or to others that may reasonably be expected from the research.
8. Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
9. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. For FDA-regulated research, a statement that notes the possibility that the FDA might inspect the records.
10. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained. To address Element 10, the following statement must be in the Informed Consent:
HARVARD’S WORDING FOR DISCLOSURE OF COMPENSATION FOR INJURY –
“If physical injury resulting from participation in this research should occur, although Harvard’s policy is not to provide compensation, medical treatment will be available including first aid, emergency treatment and follow-up care as needed, and your insurance carrier may be billed for the cost of such treatment. In making such medical treatment available, or providing it, the persons conducting this research project are not admitting that your injury was their fault.”
11. The Consent form includes the contact information of the research team for the participant to obtain answers to questions about the research and voice concern or complaints or about, or problems with the research. The consent form should also include the contact information for a person independent of the research for participants to voice complaints about the research, obtain answers to questions in the event the research staff could not be reached or if they wished to talk with someone other than the research staff, and to obtain information about their rights as a research participant.
12. A statement that participation is voluntary and refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and that the participant may discontinue participation at any time without penalty or loss of benefits to which they would otherwise be entitled.
Additional Elements of Informed Consent to be used when appropriate as defined below and, as required by 45 CFR § 46.116 (b)(1-6)
1. A statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable such as when the research involves investigational test articles or drugs or other procedures in which the risks to the participants are not well known.
2. A statement that if the participant is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable. This statement must be included when the research involves pregnant women or women of child-bearing potential and the risk to the fetuses of the drugs, devices or other procedures in the research is not well known. In the majority of cases this statement would apply to clinical studies, but any social and behavioral studies involving stress may also be considered and as such this statement may be required according to the judgment of the CHS.
3. Anticipated circumstances under which the participation may be terminated by the investigator without regard to the participant’s consent. This statement should be considered for inclusion in the consent when there are anticipated circumstances under which the investigator may terminate participation of a participant.
4. Any additional costs to the participant that may result from participation in the research. This statement would be appropriate when it is anticipated that participants may have additional costs.
5. The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation. This statement must be included when withdrawal from the research is associated with adverse consequences.
6. A statement that significant new findings developed during the course of the research which may relate to the willingness of a participant to continue in the study will be provided to the participant. This statement is appropriate when the research is long term and interim information is likely to be developed during the conduct of the research.
7. The approximate number of participants involved in the study should be stated in the consent when the research involves more than minimal risk.
If the study involves the collection of DNA for genetic analysis, a statement must be included indicating that information is being obtained for this purpose and specific options and information for the participant (such as whether participant’s biological samples may be used for other purposes, and whether any incidental finding may be determined about the participant’s condition) should be given to the participant, as well as other elements as determined by the CHS, depending on the nature of the study. On the consent form, the statements should appear as “Yes or No” options and read: (1) I wish to receive a letter with information about the study once some relevant results have been obtained. I understand that this letter cannot discuss my personal case or data related directly to my family; (2) I agree to donate genetic material for the approved study; and (3) I agree that my genetic material may be stored and used for future studies.
Documentation of Consent
According to federal regulations 45 CFR § 46.117(b) documentation of signed consent is required in the following manner (unless a waiver of consent/element of consent is granted; see waiver criteria, below):
1. A written consent document must contain the required elements of informed consent, as outlined above. The consent form may be read to the participant or the participant's legally authorized representative, and ample time should be given to the participant / legal representative to read it before it is signed (and dated for FDA-regulated research); or
2. A short form written consent document, stating that the elements of informed consent required by § 46.116 (or 21 CFR § 50.27 for FDA-regulated research) have been presented orally to the subject or the subject's legally authorized representative, may be used. However, when this method is used, there must be a witness to the oral presentation. The IRB must approve the written summary of what is to be said to the participant or their representative (and dated for FDA-regulated research).) Only the short form itself is to be signed by the participant or their representative. However, the witness shall sign (and date for FDA-regulated research)both the short form and a copy of the summary, and the person actually obtaining consent shall sign (and date for FDA-regulated research) a copy of the summary. A copy of the summary shall be given to the participant or their representative, in addition to a copy of the short form.
The OHRP Informed Consent Checklist is also available for assistance with creating the Informed Consent document