General Requirements for Informed Consent
All investigators must obtain the legally effective informed consent of the subject or the subject's legally authorized representative.
An investigator must seek such consent only under circumstances that provide the prospective subject or legally authorized representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence.
The information that is given to the subject or the representative must be in language understandable to the subject or the representative.
The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
No informed consent, whether oral, written, or electronic, may include any exculpatory language, through which the subject or legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Informed Consent Process
In accordance with 45CFR46.117, Informed consent must be documented by the use of a written or electronic informed consent form approved by the IRB and signed (including in an electronic signature) by the subject or the subject’s legally authorized representative.
A written/typed copy must be given to the person signing the informed consent form. This includes electronically-distributed informed consent forms. For example, the Informed Consent Form that precedes an online survey must include a link that allows the potential participant the ability to download and retain a copy of the Informed Consent Form.
The informed consent form may be either of the following:
(1) Written (including Electronic) Informed Consent Form. The investigator must give either the subject or the subject’s legally authorized representative adequate opportunity to read the informed consent form before it is signed – either physically or electronically; alternatively, this form, in its entirety, may be read to the subject or the subject’s legally authorized representative.
(2) Oral Notification of Informed Consent. A short form written informed consent form stating that the elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative, and that the key information was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject’s legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject’s legally authorized representative, in addition to a copy of the short form.
Basic Elements of Informed Consent
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
- A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- 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.
- 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. This should include contact information for the PI (and a Faculty Supervisor, if the PI is a student) as well as the Office of Research.
- 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.
- One of the following statements about any research that involves the collection of
identifiable private information or identifiable biospecimens:
(a) 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
(b) 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 of information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable;
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- 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; and
- The approximate number of subjects involved in the study.
- 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;
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- 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).
Exceptions to Normal Informed Consent Procedures:
The IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:
- The research involves no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside of the research context;
- The research could not practicably be carried out without the requested waiver or alteration (i.e., the research could not practicably be conducted without a waiver consent, as opposed to being impracticable or inconvenient to obtain consent);
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided
with additional pertinent information after participation.
In cases in which the documentation requirement is waived, the IRB will require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
Applications that request waiver of the informed consent forms cannot receive Exempt Status; they require either Expedited Review or Full Board Review.