In accordance with 45 CFR 408(b), the IRB may determine that a parent`s permission is sufficient to conduct searches under 45 CFR 46.404 or 45 CFR 46.405. If the search is conducted under 45 CFR 46.406 or 45 CFR 46.407, permission from both parents must be obtained unless one parent is dead, unknown, incompetent, or not reasonably available, or only one parent has legal responsibility for the care and custody of the child. Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient cannot communicate and no substitute decision-maker is available. Not all procedures require explicit informed consent either. For example, measuring a patient`s blood pressure is part of many medical treatments. However, a discussion of the risks and benefits of using a blood pressure monitor is usually not necessary. 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. Some scholars adopt a strictly libertarian, even anarchist, position on these questions: political authority is legitimate only to the extent that it is based on the explicit consent of the persons concerned by its exercise.
Others allow certain measures to be taken as evidence of implied consent, but emphasize the importance of real, express or implied consent. Other scholars argue that hypothetical consent is sufficient to confer legitimacy on fundamental principles of the political order, and that consent is not required for certain laws and policies: as long as effective means of redress and reform are available, citizens must comply with certain legitimate laws if they are compatible with a basic constitutional structure that allows consent to be more reasonable and sufficiently lit. I would like to ask the Commissioner whether he is aware of the fact However, critics question whether such hypothetical consent can really generate real obligations. Still other researchers suggest that legitimacy and commitment are ultimately not based on consent, but on the deeper narratives of moral free will and the good life that make consent seem so important in the first place. 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). It can be difficult to assess whether a patient has really understood the information provided and often little information is stored (see chapter Practical aspects). This leaves physicians in doubt as to whether their patient`s consent is truly informed.
Consent based on partial information may be invalid, but this may go unnoticed by the patient and the attending physician. 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 informed consent process is the essential communication link between the potential human subject and a researcher, beginning with a researcher`s first approach to the potential subject (e.g., through a pamphlet, brochure, or advertisement for the research study) and ending with the end of the research study. For purposes of HHS regulations in 45 CFR Part 46, “investigators” are individuals who conduct research involving humans, including individuals directly involved in obtaining voluntary consent from potential subjects.