Informed Consent Process, Elements, and Waivers

IRB Member Fact Sheet--Version Date: Unknown

Summary
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:

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
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.

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.  

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.
 
Definitions
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)].

Further Information
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