Institutional Review Board (IRB) FAQs

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective subject should be presented with the information, then given an opportunity to ask questions and have them answered, prior to signing the consent document.

Basic elements of informed consent:

1. 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;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject 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 subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
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 subjects' rights, and whom to contact in the event of a research-related injury to the subject
8. 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.

Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

1. 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;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. 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
6. The approximate number of subjects involved in the study.

Yes. Sample consent forms may be found within the Informed Consent guidance material that is available online on the Institutional Review Board website. Sample forms are presented to provide guidance to researchers from various disciplines. Additional forms may be added periodically.

Assent is defined as, "A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402(b)]". While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects - whether all or some of the children are capable of assenting to participation. Where appropriate, IRB’s may choose to review on a case-by-case basis whether assent should be sought from given individual subjects.

The IRB may waive the requirement for written documentation of informed consent, if it finds and documents either of the following:

• Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality
• The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained outside of the research context.

In situations in which signed consent will not be obtained, it is often advisable to present subjects with an information sheet or letter that contains the elements of informed consent, for their future reference.

Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent under two sets of circumstances:

1. If the project involves no more than minimal risk; the waiver doesn't adversely affect subjects; the research couldn't practicably carried out without the waiver; and, where appropriate, subjects are given information about the project afterwards.
2. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and the research could not practicably be carried out without the waiver or alteration.

Otherwise, written informed consent must be obtained. For additional information, review the applicable federal regulation online at  45 CFR 46.116.