A Legally Authorized Person

The U.S. Department of Health and Human Services defines a legally authorized representative as “any natural person, judicial authority, or other entity of persons lawfully authorized under federal and state law to consent to participate in research on behalf of a designated person.” If a loved one does not appoint a power of attorney, it may be necessary to ask the court to appoint a guardian to manage their affairs. Guardians have the legal authority to look after the personal and property interests of another person called a ward. It is important to note that informed consent requirements in regulations are not intended to prevent applicable federal, state, or local laws that require the disclosure of additional information for consent to be legally effective (45 CFR 46.116(e)). According to the regulatory definition, children are “persons who have not reached the legal age to consent to treatments or procedures involved in the research, 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 the person who is legally considered a child may vary from state to state; In a large majority of states, 18 is the legal age of adulthood, but this does not apply to all states, places or territories. State law may also apply to certain circumstances in which a person under adulthood is legally permitted to consent to medical procedures: for example, some states allow children under the legal age of adulthood to consent to the provision of contraceptives. Some States provide for a mechanism for the emancipation of minors whereby a child younger than the legal age of adulthood can acquire certain civil rights, which may include the legal possibility of consenting to participation in research. Courts may grant guardianship to the person, guardianship of the person`s estate or property, or combined guardianship for both. A guardian who has been assigned by the court for both the personal welfare and financial interests of the municipality is called a general guardian.

The court may choose to appoint one person as the person`s guardian and another person as guardian of the person`s estate. The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the key safeguards provided for in the HHS regulations in Part 46 of 45 CFR. This requirement is based on the principle of respect for people, one of the three ethical principles of human research described in the Belmont report. The principle of respect for persons 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 who is able to think about personal goals and act under the direction of such considerations.” Respect for individuals requires that potential research participants have “the opportunity to decide what they should or should not do to them” and therefore requires appropriate standards for informed consent. The term guardian means “a person authorized under applicable national 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 research with a child that is a community is to grant permission instead of a child`s biological or adoptive parents. so that the community can participate in the research (45 CFR 46 402(c)). For a more in-depth discussion, see FAQs about researching with children. A power of attorney is a written power of attorney that gives another person the authority to act on behalf of a person in private, commercial or other matters. A power of attorney defines exactly which aspects of the individual`s life are managed by another. The person who authorizes another person to act on his or her behalf is designated as the principal or concessionaire of the power of attorney.

The person authorized to act on behalf of the principal is called an agent or lawyer. In addition, some research institutions use a “pool of student subjects” to identify students who may be willing to participate in the research, even if the exact type of research to be conducted has not yet been determined. Additional credits or other rewards are often offered as an incentive to encourage participation. Students who enroll in such pools have not legally consented to participate in a research study because they have not received enough information about the exact study they would be participating in. Therefore, enrolment in a thematic pool is only a first preparatory step by which individuals can express their willingness to be considered for participation in research. The student must also give informed consent, unless an IRB waives the consent requirement as soon as it is considered for a particular study (45 CFR 46.116). In addition, pool persons must be free to refuse participation in available research projects without penalty (45 CFR 46,116 (a) (8)).

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