Although regulations state that children are not able to provide legally effective informed consent to participate in research, some may be able to give consent. Consent means a child`s express consent to participate in research. The mere fact of not raising objections should not be construed as consent without consent (45 CFR 46.402(b)). Legal Representative (LAR) means a physical, judicial, or other body authorized under applicable law to consent, on behalf of a potential subject, to the subject`s participation in the process(es) involved in the research (45 CFR 46.102(c)). The regulations state that „no researcher may include a human being as a subject in research covered by this policy unless he or she has obtained the legally effective informed consent of the subject or the subject`s legally authorized representative“ (45 CFR 46.116). The question of who can be an LAR is determined by the laws of the jurisdiction in which the research is conducted (e.g., local or state law). Some states have statutes, regulations or common law that deal specifically with the consent of a person other than the subject to participate in research. Most states do not have legislation that specifically addresses the issue of consent in the context of research. In these states, the law that deals with the question of who is authorized to give consent on behalf of another person to certain medical procedures or more generally to medical treatment may be relevant if the research involves those medical procedures or treatments. Unless the Institutional Review Board (IRB) determines that the requirements for informed consent can be waived, researchers should obtain and obtain lawful informed consent (as described in 45 CFR 46.116) for the now adult subject for any ongoing interaction or intervention with subjects. Indeed, the prior parental consent and the consent of the child do not correspond to the legally valid informed consent for the now adult subject.

However, the IRB may authorize a waiver of informed consent under 46.116(d) of 45 CFR if it determines and documents that the requirements are met. In order to have the opportunity to obtain the consent of a subject`s legally authorized representative, the investigator must request the use of substitute consent. When recruiting individuals with severe cognitive or psychiatric impairment, it is essential to establish procedures to determine which individuals are able to give legally valid consent and which are not. A legal representative is a person who, according to the law, has the capacity to act on behalf of another person (for example, a minor participant in the study). RAL can be a parent, grandparent or caregiver who has the legal authority to give consent on behalf of another person who has been invited to participate in the research. Yes, under certain circumstances. HHS regulations require a researcher to obtain legal consent after informing subjects or a legally authorized representative before allowing subjects to participate in research (45 CFR 46.116), unless an IRB has waived this requirement. Similarly, for research involving children, permission must be obtained from the parents or guardians of potential subjects (45 CFR 46.408(c)), unless an IRB has waived this requirement. To ensure adequate consent or parental consent, it may be necessary to repeat or complete the initial consent process.

The rules also state that „an examiner may obtain such consent only in circumstances that give the prospective subject or his or her representative ample opportunity to consider whether or not to participate and to minimize the possibility of undue coercion or influence“ (45 CFR 46.116). This requirement may also require the repetition or completion of the original consent procedure. The requirement to obtain legally valid consent from individuals before engaging them in research is one of the key protections in HHS regulations in 45 CFR Part 46. This requirement is based on the principle of respect for the person, one of the three ethical principles of research involving human subjects described in the Belmont Report. The principle of respect for the person requires that individuals be treated as autonomous actors and that the rights and well-being of persons with limited autonomy be adequately protected. The Belmont Report notes that an autonomous agent is „an individual capable of thinking about personal goals and acting under the direction of such advice.“ Respect for individuals requires that aspiring research subjects have „the opportunity to decide what should or should not happen to them“ and, therefore, requires appropriate standards of informed consent. It is important to note that informed consent requirements in regulations are not intended to anticipate applicable federal, state, or local laws that require disclosure of additional information for consent to be legally effective (45 CFR 46.116(e)). Use of ARLs for Research Conducted Outside Virginia Different states may vary as they define: 1) The age of children and/or minors, including emancipated minors, 2) Who may authorize their participation in research and the participation of children in judicial detention and 3) Who are qualified, act as legally authorized representatives. Decisions about who can act as an AR, that is, consent on behalf of another person`s participation in the research, are based on the province or territory where the research is conducted.

The principal investigator must understand the impact of state laws on the proposed research and describe how different government requirements are met in the research. Also note that research conducted abroad is subject to applicable laws to designate a legally authorized representative for the region or country where the research is conducted. Conditions limiting the use of the ARL in Virginia: A legally authorized representative cannot consent or grant permission: Similarly, if the research does not involve ongoing interactions or interventions with subjects, but still meets the regulatory definition of „research involving humans“ (e.g., it involves ongoing analysis of samples or data when the subject`s identity is readily identifiable by the researcher(s)). (is)), it would then be necessary for the examiner(s) to obtain and obtain the legally effective consent of the now adult subjects. The IRB may consider waiving 45 CFR 46.116(d) of the informed consent requirements to allow subjects to continue to participate in research. For the consent or parental authorization process using the short form, the rules state that there must be a witness for the oral presentation, who then signs the short form and a copy of the written summary approved by the IRB of what is owed to the subject or legally authorized representative of the subject or to the parents of a child who is a subject. should be said. The subject or legally authorized representative of the subject or parents must sign the short form, and the person actually obtaining consent must sign the copy of the abstract (45 CFR 46.117(b)(2)). Therefore, three types of people are involved in this specific consent process: the legally authorized subject or representative or parent of a child who is a subject, the person who receives consent, and the witness. According to the regulatory definition, children are „persons who have not reached the legal age to consent to research-related treatment or proceedings under the applicable law of the jurisdiction in which the research is conducted“ (45 CFR 46.402(a)). In the United States, the legal age of adulthood is a matter of state and local law.

This means that who is legally considered a child may vary from state to state. In the vast majority of states, age 18 is the legal adulthood, but this is not true for all states, cities or territories. State law may also address certain circumstances in which a person younger than adulthood is legally permitted to consent to medical procedures: For example, some states allow children younger than the legal age to consent to the provision of contraceptive services. Some states provide for a mechanism for the emancipation of minors, whereby a child younger than the legal age can acquire certain civil rights, which may include the legal possibility of consenting to participate in research. Guardian means „a person authorized under applicable state or local law to consent to universal medical care on behalf of a child“ (45 CFR 46.402(e)) The role of a guardian in the context of research involving a child who is a ward is to grant permission in place of a child`s biological or adoptive parents. for the station`s participation in research (45 CFR 46.402(c)). For a more detailed discussion, see the FAQ on Research with Children. In federal regulations, the terms „parent“ and „guardian“ apply specifically to persons legally authorized to consent on behalf of a child. Note that in the case of a legal guardian, the child usually, but not always, lives with the guardian. In addition, not all siblings in a family can have the same legal guardian.