Sponsors often provide clinical investigators with a model declaration of consent that can be adapted by the clinical investigator to local needs. When the consent form is submitted to the FDA for review, the FDA`s comments are usually directed to the sponsor. See Section IV.D.1, New Investigational Drugs and Biologics, and Section IV.D.2, Investigational Medical Devices. The sponsor must promptly provide the FDA`s comments to the clinical investigator so that changes can be made to the consent forms. Since the clinical investigator must obtain IRB approval prior to the commencement of the clinical trial (see 21 CFR 312.66 and 21 CFR 812.110(a)), the sponsor must work closely with the clinical investigator to ensure that the amended consent is reviewed and approved by the IRB. The FDA recommends that the clinical investigator provide the sponsor with a copy of the informed consent form approved by the IRB. An impairment in the ability to consent may include partial depreciation, depreciation that fluctuates over time, or complete depreciation. For example, the ability to consent can be affected by a variety of disorders and conditions such as dementia, stroke, traumatic brain injury, developmental disorders, serious mental illness, intoxication and delirium. The 21st Century Cures Act, passed by the 114th U.S.
Congress in December 2016, allows researchers to waive the requirement for informed consent when clinical trials «present minimal risk» and «involve appropriate safeguards to protect the rights, safety, and well-being of the human subject.»  (2) Upon obtaining informed consent, the subject shall be provided with the translated short form approved by the IRB and a copy of the English version of the detailed form approved by the IRB, which will serve as a written summary. If you have decided to refuse treatment or diagnostic tests, your doctor can inform you of the risks or likely outcomes of this choice so that you can make an informed rejection (which means that you understand what could happen to your health by rejecting the recommended treatment, but you still do not want the treatment). In this case, you may be asked to sign a form stating that you have received this information and that you have always chosen not to be processed. * The use of a legally authorized representative (surrogate mother) to obtain consent from minors or cognitively or medically incapacitated persons requires the prior approval of the IRB. Informed consent is a collaborative process that allows patients and health care providers to make decisions together when there is more than one reasonable alternative, taking into account the patient`s unique preferences and priorities, as well as the best available scientific evidence. The general requirements for informed consent, found in 21 CFR 50.20, 21 CFR 50.25 and 21 CFR 50.27, apply to parental authorization. (21 CFR 50.55(e).) When obtaining parental permission, if a child`s parents do not understand English, parental permission must be obtained and documented in a language that is understandable to the parents. (21 CFR 50.20.) The FDA recommends that a child not be used as a translator, even if they are fluent in English and may be able to accept.
If a child`s consent is required, the information given to the child must be in a language that is understandable to the child. For other research, the time frame for registering a subject that does not understand English may not allow sufficient time for the IRB to prepare and review appropriately translated consent documents. In the event of an emergency in this situation, many CISRs have begun translating a generic short form into multiple languages that meets the requirements of FDA regulations under 21 CFR 50.27(b)(2) and have prospectively approved the use of these short forms for the registration of subjects who do not understand English, as required for any research protocol. In such circumstances, the FDA considers procedures that include the following consecutive steps to be an acceptable way to obtain and document the subject`s informed consent: For clinical investigations that pose more than minimal risk, the consent process should describe all compensation and medical treatment available to subjects in the event of injury. 20 (21 CFR 50.25(a)(6).) Since the compensation and medical treatment available may vary depending on the medical situation of the individual concerned or the policies of the institution, the consent process should include an explanation of individuals where they can obtain additional information. An example of an appropriate statement is «The sponsor has planned to pay for the medical expenses associated with the research-related injuries,» followed by an explanation of how to obtain more information. If no compensation is available, the consent process should include statements such as 21 FDA regulations that require the investigator to obtain the legally effective consent of the subjects or ensure that the legally effective consent of the subjects is obtained. 45 Where the investigator delegates this responsibility, the FDA recommends that the person to whom responsibility is delegated be qualified by education, training and experience to carry out that activity. The person requesting informed consent should be aware of the clinical trial and should have the appropriate training and qualifications; and the investigator should have a detailed plan for the monitoring and surveillance of the clinical trial, including the informed consent procedure.
46 Even if a task is delegated to another person, the investigator remains responsible for ensuring that the clinical trial is conducted in accordance with applicable FDA regulations and for protecting the rights, safety, and well-being of subjects during the clinical trial (21 CFR 312.60 and 21 CFR 812.100). Complaints reasonably foreseeable for the subject should also be described. (21 CFR 50.25(a)(2).) For example, the consent form should reveal the severity and duration of pain caused by surgery or discomfort from prolonged immobilization for MRI. If FDA review services have specific concerns about the suitability or compliance of consent documents with 21 CFR Part 50 after reviewing the consent documents, details of those concerns will generally be communicated to the sponsor in writing. In rare cases, the FDA may conclude that a consent form is misleading, inaccurate, or incomplete, so informed consent is insufficient and non-compliant with Part 50 of 21 CFR, leaving subjects at an unreasonable and significant risk of illness or injury. In these cases, the FDA may require specific revisions to address concerns before the clinical trial can proceed (21 CFR 312.42). To answer this question, in addition to the laws of the jurisdiction in which the research is conducted, the HHS regulations of 45 CFR Part 46 should be consulted. If an adult is unable to consent, for example because of trauma, intellectual retardation, certain forms of mental illness or dementia – whether temporary, progressive or permanent – only a legal representative of that adult may give consent to participate in the research, unless the IRB waives the requirement to obtain informed consent in accordance with the requirements of paragraph 46.116(d) of 45 CFR, or pursuant to emergency waiver provisions authorized under the supervision of the HHS Secretary under 45 CFR 46.101(i). . .