Informed Consent Process, Elements, and Waivers
IRB Member Fact Sheet--Version Date: Unknown
Federal regulations require that, as part of the criteria for IRB approval of research, informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with Title 45 CFR 46.116 and Title 21 CFR 50 Subpart B, as applicable.
IRB Member’s Role
Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. When reviewing protocols, it is important for IRB members to remember that informed consent is an ongoing process, not just a form or an isolated event. Informed consent is used as a means to ensure that human subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The surrogate consent of someone other than the subject is not the same as the subject's own consent, although it may be an appropriate substitute when a subject is unable to give informed consent.
46.116 General requirements for informed consent
Unless a waiver has been granted by the IRB, no investigator may involve a human being as a subject in research covered without obtaining the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the 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 shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the 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. Basic elements of the informed consent document include:
Additional elements of the informed consent document, when appropriate, include:
- 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; and
- 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.
- 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;
- 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.
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent noted above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
46.117 Documentation of informed consent
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
Of note, in cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research, for example, use of an Information Sheet.
- That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
46.408 Assent and Parental Permission
The IRB is responsible for ensuring that adequate provisions are made for obtaining the child’s assent and the permission of each child’s parents or guardians. The IRB may find the permission of one parent is sufficient for research approved under 46.404 or 46.405. Under 46.406, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has legal responsibility for the care and custody of the child. A waiver of parental permission is possible under 46.408(c).
Use of Surrogate Decision Makers
UW-Madison campus policy requires that research in which a surrogate decision maker will be utilized to provide consent on behalf of a subject lacking capacity must fall into one of the following categories:
Before a surrogate decision maker may provide consent on behalf of a subject, it must be determined that the subject lacks capacity. The priority of decision-makers is generally as follows: a. Subject with capacity; b. Subject with variable capacity (when subject has capacity); c. Subject with research power of attorney/research advance directive; d. Subject with guardian OR health care power of attorney; and e. Next of kin (in the following order): the spouse, adult child, parent, adult sibling, grandparent, adult grandchild, or a close friend of the potential subject.
- Minimal risk
- More than minimal risk but holds out the prospect for direct benefit
- More than minimal risk with no prospect of direct benefit only if subject signed a research power of attorney/research advance directive noting that s/he wants to participate in such research.
Surrogate decision makers should make a decision about research participation based on what the subject would have decided if capable of consenting, or what is in the best interest of the subject.
FDA and VA Informed Consent Requirements
Protocols that require FDA oversight or VA oversight must also follow FDA and/or VA informed consent requirements. The required elements of informed consent are similar to those in the Common Rule. However, additional information or specific language may be required. For example, consent forms for enrolling VA subjects must include VA-specific compensation for injury language and tissue banking language, as applicable to the study. NOTE: In general written informed consent cannot be waived in the case of FDA-regulated studies.
Assent: A child’s affirmative agreement to participate in research. [45 CFR 46.402(b)].
Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].
Legally-authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research [45 CFR 46.102(c)].
For further information about research involving children, please contact the Health Sciences IRBs Office at (608) 263-2362 or consult our website at http://www.medicine.wisc.edu/irb