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. Because individuals receiving urgent or urgent medical care may often be vulnerable to coercion or undue influence, even temporarily, additional safeguards may be required to ensure that the subject`s consent to participate in research is truly voluntary and sought in circumstances that minimize the possibility of undue coercion or influence (45 CFR 46.111(b), (45 CFR 46,116). In addition, in some cases it may be possible to obtain the consent of a legal representative (e.g. in the case of persons incapable of making decisions). In certain emergency situations, the Secretariat`s waiver of informed consent under 45 CFR 46.101(i) may apply.
It should be noted that if the research is regulated by the FDA, the waiver of the Secretariat allows the research to be conducted under a similar provision. Obtaining informed consent from these groups is extremely complex. An amicable procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could be an accessible place. Reimbursement of candidates` travel expenses may be a valid solution to obtain a representative sample for clinical research. Clear and plain language emphasizing confidentiality, with the help of professional interpreters, can encourage migrants to sign the consent form. Finally, the possibility of getting something in return for their contribution can allow migrants to be successfully enrolled in research [31]. Under 46.116(c) of 45 CFR, an IRB may waive the requirement to obtain informed consent or parental permission, or authorize a parental consent or authorization process that omits or amends some or all elements of informed consent, provided that the IRB determines and documents that both of the following criteria are met: The document must also have at least two signatures and date lines: one for the participant and one for the health professional conducting the informed consent interviews with the participant. Informed consent is an ongoing process that must take place prior to the conduct of clinical trial procedures. The process includes documentation and a series of interviews between the clinical trial participant and the principal investigator and, if applicable, designated health professionals. The IRB`s regulatory review and approval requirements also specify that the IRB – in order to approve research covered by HHS regulations – must ensure that « if some or all subjects are likely to be subject to coercion or undue influence, such as children, prisoners, pregnant women, persons with mental disabilities or persons economically or educationally disadvantaged, additional safeguards were included in the study to protect 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 undue influences for these vulnerable thematic groups.
For example, if potential subjects include individuals whose primary language is not English or populations with low literacy levels, the IRB should pay particular attention to ensuring that oral presentations and consent or approval forms are understandable to all subjects or parents of subjects who are children. Subjects who do not speak English must receive a consent or authorization document in a language they understand. The Bureau strongly recommends the use of such a document whenever possible. (See Office of Human Resources Protection guidelines on this subject, see www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html; For more information on children`s consent requirements, see the FAQ on Research with Children.) The Office of Human Resources Protection does not prescribe any specific method of electronic signature. Rather, the International Human Resources Search Office allows IRBs to adopt these technologies as long as they have considered applicable issues, such as how the electronic signature is created, whether the demonstrable legitimacy of the signature is demonstrated, and whether the consent or approval document can be submitted on paper for verification by the prospective individual. One method for electronic signatures to be acceptable in some jurisdictions is to use a secure electronic or digital signature system that provides an encrypted and identifiable « signature ». If obtained correctly, an electronic signature may be considered an « original » for the purposes of registration. Once approved by the Institutional Review Board (IRB) or an independent ethics board, it is mandatory to obtain the consent of each individual before participating in a clinical trial [5]. However, if certain circumstances occur, informed consent may be waived and « research without consent » is possible, allowing patients to be admitted without their consent under strict regulations [7].
For research without consent to be considered defensible, the following three conditions must be met: 1) it is impractical to obtain consent, 2) the research does not violate the principle of self-determination, and 3) the research has significant clinical relevance [8]. HHS regulations do not require documentation of consent. The IRB has the discretion to determine the appropriate way to document the child`s consent. Based on considerations such as the child`s age, maturity and literacy level, the IRB should decide which form of document, if any, is most appropriate. If adolescents are involved in research where informed consent would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document a young person`s consent. (See notice of waiver in the Federal Register.) If the subject regains or develops the capacity to consent, consent must be obtained for any further research, as the consent of the legal representative is no longer valid. The information provided to the IRB should identify and justify the proposed amount and purpose of the remuneration, which should also be clearly stated in the attached consents. The consent process and its documentation should be reviewed if deficiencies in its accuracy or completeness are identified, if new information on reasonably foreseeable risks and potential benefits becomes available, or if other additional information becomes known that improves the consent process.
