BACKGROUND
To ensure an effective informed consent process, the Institutional Review Board (IRB) and investigators comply with all applicable federal regulations (e.g., 21 CFR 50, 45 CFR 46.116, 117, and 38 CFR 16.116, 117). These regulations mandate the inclusion of eight basic informed consent elements (described below). Six additional elements may be required, depending on the nature of the research. IRB policy also specifies the information to include in the consent process.
The informed consent template included in the full and expedited IRB applications outlines the required elements of informed consent. The investigator may use a short form if approved by the IRB in accord with applicable federal requirements.
DEFINITIONS
Informed Consent: Informed consent is an ongoing educational process that takes place between the investigator and prospective subject, allowing the investigator and the participant to exchange information and ask questions
Consent: Consent is the act of agreement and is only valid if the person providing consent has been fully informed, possesses the cognitive ability to understand what is being agreed to and also possesses the ability to self determine and is of the legal age or disposition to do so. The term is also used to refer to the consent form itself.
Assent is defined as affirmative agreement of a child or an individual with impaired consent capacity to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Permission is defined as the agreement of parent(s) or guardian to the participation of their child or ward in research or clinical investigation. Permission includes the element of consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications.
In Virginia, the terms child or children refer to all individuals under 18 years of age unless the individual(s) is legally emancipated. (See section Emancipated Individuals for details of Virginia state law.) Individuals under 18 years of age who are not emancipated meet the federal definition for child [e.g., Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and U.S. Department of Education].
Legally Authorized Representative (LAR) is an individual who has the authority to make research participation decisions on behalf of another. In accord with state law and federal regulation, individuals who can serve as legally authorized representatives are as follows:
Consent by an LAR should involve all the same considerations that informed consent from a competent subject involves.
- Permission and/or authorization by a legally authorized representative for children: Consistent with Virginia health care decision statutes for choosing an LAR for children, the following responsible parties in the order of priority listed shall be authorized to make research participation decisions on behalf of the child: (a) the judicially appointed guardian of the person, if the guardian has been appointed and if the decisions to be made under the consent are within the scope of the guardianship; (b) the parent of the child.
- Permission and/or authorization by a legally authorized representative for individuals with impaired consent capacity: Consistent with Virginia health care decision statutes for choosing a legally authorized representative for adult subjects unable to consent, one of the following responsible parties, in the following order of priority (if no individual in a prior class is reasonably available, willing, and competent to act), is authorized to make research participation decisions on behalf of the person: (a) the judicially appointed guardian of the person, if the guardian has been appointed and if the decisions to be made under the consent are within the scope of the guardianship; (b) the attorney-in-fact named in a durable power of attorney, if the durable power of attorney specifically includes authority for the decisions to be made under the consent; (c) the spouse of the person; (d) an adult child of the person, or if the person has more than one (1) child, the majority of the adult children who are reasonably available for consultation; (e) the parents of the subject; (f) the nearest living relative, or if more than one of the same relation, a majority of the nearest living relatives.
In Virginia, a guardian is an individual who may serve as an LAR as defined above. These individuals meet the federal definitions for guardian.