Who Can Be Legally Acceptable Representative

To answer this question, the hhscolic regulations of 45 CFR Part 46 should be consulted in addition to the laws of the jurisdiction in which the research is conducted. If an adult is incapable of consenting, for example due to trauma, intellectual disability, certain forms of mental illness or dementia – whether temporary, progressive or permanent – in general, only a legally authorized representative of that adult may give consent to participate in the research, unless the IRB waives the requirement in accordance with the requirements of paragraph 46.116(c)(d) of the CFR on the requirement: obtain informed consent or in accordance with emergency waiver provisions authorized under the supervision of the HHS Secretary under 45 CFR 46.101(i). The informed consent process should be an active process of information exchange between the examiner and the potential subject. The exchange of information between the examiner and potential subjects may take place, inter alia, through one or more of the following forms of communication: personal contact; Post; telephone; Video; or by fax. Potential topics should have ample opportunity to ask questions and seek clarification from the examiner. Potential subjects should be able to decide freely whether to register for research first or to retire later, or whether they continue to participate in research. The informed consent process should ensure that all critical information about a study is fully disclosed and that potential subjects or their legally authorized representatives adequately understand the research so that they can make informed decisions. Definition of childrenThe definition of “children” also takes into account the particular treatments or procedures involved in the proposed research; For example, in some places, sixteen-year-olds may accept certain medical treatments under the law, and if the participation of human subjects in a proposed research activity consists of those treatments, they may be considered adults for that purpose. However, if a proposed activity includes something for which the subject has not yet reached the legal age of consent, that person should be considered a child. If a written form of consent or parental authorization is used that contains some or all of the elements of informed consent required by the regulations of 45 CFR 46.116, the regulations only require that the informed consent or parental authorization document be provided by the subjects or legally authorized representatives of the subjects or by the parents of children, the subjects are (45 CFR 46,117 (a)) and 45 CFR 46,408 (d)). Only in cases where a short form is used indicating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject`s legal representative or to the parents of a child who is a subject, that there are additional requirements for signatures (45 CFR 46.117(b)(2)).

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)). For the consent or parental authorization procedure using the short form, the regulation states that there must be a witness at the oral presentation, who then signs both the short form and a copy of the written summary approved by the IRB of what the subject or legally authorized representative of the subject or the parents of a child who is a subject, that is. The subject or the subject`s legally authorized representative or parents must sign the short form, and the person who actually receives the 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 subject or legally authorized representative or the parents of a child who is a subject, the person who receives the consent and the witness. HHS regulations of 45 CFR 46.116 state that no examiner may include a human as a subject unless the examiner has obtained the legally effective informed consent of the subject or his or her legally authorized representative. However, under the conditions set out in the regulations in paragraph 46.116(c) or (d) of 45 CFR, an IRB may approve a consent process that does not include or modify some or all of the elements of informed consent under 45 CFR 46.116. In some cases, an IRB may also waive the obligation to obtain (45 CFR 46,116 (c) and (d)). In addition, under the conditions set out in the 45 CFR 46.117 Regulation, an IRB may also waive the requirement to document informed consent.

(It should be noted that the regulations in paragraph 46,408(c) of 45 CFR also allow the IRB to waive parental authorization.) The person providing information to the participant or the LAR during the consent process must provide that information in a language understandable to the participant or his/her representative. One of the main considerations when recruiting subjects with severe cognitive or psychiatric impairment is to establish procedures to determine which individuals are able to give their legal consent and which are not. HHS regulations state: “An examiner may obtain such consent only in circumstances that give the subject or potential representative sufficient opportunity to consider participating or not and that minimize the possibility of coercion or undue influence” (45 CFR 46.116). This requirement applies to all non-exempt research involving human subjects that is not eligible to waive consent requirements. The informed consent process has three main features: (1) disclosure of information necessary for an informed decision to potential researchers; (2) facilitate the understanding of what has been disclosed; and (3) promote the voluntary nature of the decision to participate or not in the research. Informed consent must be legally effective and obtained prospectively. HHS regulations 45 CFR 46.116 and 45 CFR 46.117 describe the requirements for informed consent. When obtaining the consent of a legally authorized representative (surrogate mother), the IRB usually requires that the subject`s consent be obtained. Unless the IRB waives the requirement that the examiner obtain a signed consent form or authorization form based on HHS regulations 45 CFR 46.117(c), the subjects or legally authorized representatives of the subjects or the parents of the subjects who are children must have a written form of consent or permission, which can be an electronic version, and signed by them. Some form of consent document must be provided to subjects or parents of subjects who are children in a format that they can keep.

The OHRP would allow the electronic signature of the document if these signatures are legally valid in the jurisdiction in which the search is to be conducted. The HHS regulations of 45 CFR Part 46 on the Protection of People in Research require an investigator to obtain the legally effective informed consent of the subject or his or her legally authorized representative, unless (1) the research is exempted under 45 CFR 46,101(b); (2) the IRB determines and documents that informed consent may be waived (45 CFR 46.116(c) or (d)); or (3) the IRB determines and documents that the research meets the requirements of the waiver to the HHS Secretariat under paragraph 46.101(i) of the CFR, which allows for the derogation of the general requirements for obtaining informed consent in a limited category of research in emergency situations. If informed consent is required, it must be obtained prospectively and documented to the extent required by hhstherapeuvring regulations under 45 CFR 46.117. [Food and Drug Administration (FDA) regulations of 21 CFR Part 50 may also apply if the research involves an FDA-regulated clinical trial.] The IRB`s regulatory requirements for review and approval also state that, in order to approve research covered by HHS regulations, the IRB must ensure that “if some or all subjects are likely to be likely to be subject to coercion or undue influence, such as children, prisoners, pregnant women, people with mental disabilities, or economically or educationally disadvantaged people, additional protective measures were included in the study, protecting the rights and well-being of these subjects” (45 CFR 46,111(b)). As a result, incentives that would normally be acceptable in certain populations may become unreasonable influences for these vulnerable groups. In 1996, pursuant to 46.101(i) of the 45 CFR, the Secretary of HHS announced a waiver from the applicability of the regulatory requirement to obtain and document informed consent for a strictly limited category of research, that is, research that can be conducted on human subjects who require emergency treatment and for those who are subject to the subjects` state of health and the unavailability of legally authorized representatives of the subjects. no legally effective informed consent can be obtained. This derogation applies to research with adults or children, but not to research with pregnant women, human fetuses, newborns whose viability is uncertain and non-viable newborns or prisoners.

An LAR is required to conduct research in the Commonwealth of Virginia with a person who is an adult who is unable to make an informed decision, as defined in Virginia Code § 54.1-2982, at the time consent is required….