Informed Consent Form

 What is Informed Consent Form?

Federal regulations require investigators to: ensure that potential participants clearly understand the risks and benefits associated with the research before enrollment, provide potential participants with all information necessary to decide whether or not to participate in the research, and most importantly, protect the rights, safety, and welfare of all research participants under their care. One of the three ethical principles outlined in the Belmont Report is “Respect for Persons” and this principle is applied to research with human participants in the form of informed consent. Informed consent is the process of information exchange between the participant and the investigator (or designee), beginning with initial contact and continuing throughout the study, to ensure that the participant can freely decide whether or not to participate in research.

Informed consent is an essential part of ethical research involving human participants. Institutional Review Boards (IRB) and investigators are responsible for ensuring that research involving participants provide informed consent prior to participating in research, unless the requirement for informed consent is waived or altered (in non-exempt research) by the IRB.

Basic elements of Informed Consent:

The consent process must include the following basic elements:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the participant;
3. A description of any benefits to the participant or to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained, and when applicable, that notes the possibility that the Food and Drug Administration may inspect the records;
6. 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;
7. An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant; and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:  
1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or 
2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. 

When appropriate, one or more of the following elements will also be provided to potential participants during the consent process:

1. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent;
3. Any additional costs to the participant that may result from participation in the research;
4. The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant;
5. A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant; and
6. The approximate number of participants involved in the study.
7. A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; 
8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). 

NOTE: Any informed consent, whether written or oral, must not include exculpatory language such that the participant is made to waive, or appear to waive, any of his or her legal rights or to release the institution or its agents, the investigators, or sponsor from liability for negligence.

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