Terms such as “passive” or “implied” consent are not mentioned in HHS regulations. However, the OIG recognizes that these terms are sometimes used by investigators or IRBs to describe a process in which parental consent or authorization requirements have been modified or abandoned, or for which the requirement to document parental consent or permission has been waived. HHS regulations state that “an examiner may obtain such consent only in circumstances that give the prospective subject or representative ample opportunity to consider whether or not to participate and to minimize the possibility of coercion or undue influence” (45 CFR 46.116). This requirement applies to all non-exempt human research that does not qualify for an exemption from the consent requirements. It is the IRB`s responsibility to determine, in a particular case, whether some or all of the above additional elements should be included in the consent process for a particular study. The IRB should make this decision based on the nature of the research and its knowledge of the local research context. If the IRB determines that additional elements are appropriate for the research study, this additional information must be considered important along with the eight basic elements of informed consent described in the HHS regulations in 45 CFR 46.116(a). Click on the section below to receive emails when new items are available. 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. 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. HHS regulations in 45 CFR 46.116 state that no examiner may involve a human being as a subject unless the examiner has obtained the legal consent of the subject or the subject`s legally authorized representative. However, under the conditions set out in 45 CFR rules 46.116(c) or (d), an IRB may approve a consent process that does not include or modify some or all elements of informed consent under 45 CFR 46.116. In some cases, an IRB may also waive consent (45 CFR 46.116(c) and (d)). In addition, an IRB may also waive the requirement to document informed consent under the conditions set out in 45 CFR 46.117. (Note that 45 CFR 46.408(c) regulations also allow an IRB to waive parental authorization.) In the case of young children who cannot yet read, the documentation must be made in an appropriate form to record consent. The IRB may also decide that documentation of consent is not warranted. A: A witness signature is generally not required. The witness` task is to verify that the patient (or their representative) has signed the form.
The informed consent process has three main features: (1) disclosure of information about potential research topics necessary for an informed decision; (2) facilitate the understanding of what has been disclosed; and (3) promote the voluntary nature of the decision to participate in research.
