(1) An examiner who requests informed consent, if necessary with the assistance of an interpreter, shall provide verbally to the subject the elements of informed consent required by FDA regulations under 21 CFR 50.25, as well as any additional relevant information contained in the English version of the IRB-approved long form. This presentation may be an oral translation of the English version of the IRB-approved long form. The oral presentation must be in a language understandable to the subject (21 CFR 50.20). The investigator, if necessary with the help of an interpreter, answers all the questions of the potential subject. A witness to the oral presentation must be present, who must not be the person requesting informed consent (21 CFR 50.27(b)(2)). In addition, the witness must be fluent in the language of the oral presentation. Applicant`s signature: Unless the IRB approves a waiver of signed consent (i.e., the use of an information sheet instead of a consent form), add lines for the subject`s signature and the date of signature. The subject must date the form personally. Many states use the “reasonable patient standard” because it focuses on what a typical patient would need to know to understand the decision to be made. However, it is the sole duty of the provider to determine which approach is appropriate for a particular situation.     The informed consent procedure shall indicate, where applicable, the approximate number of subjects who will participate in the clinical trial. (21 CFR 50.25(b)(6).) For example, a subject`s decision may be influenced by the fact that they know that the clinical trial is a small initial trial of the product (p.
ex. B a phase 1 or 2 clinical trial of a drug, or a clinical trial on the feasibility of an instrument in which only a small number of subjects participate). Important Note: The California Medical Experiments Act requires a certificate attesting that the consent form has been signed and dated by someone other than the participant or the participant`s guardian or a legally authorized representative who can confirm that the informed consent requirements have been met. At UCSF, the investigator`s signature is used for this purpose, unless an impartial witness is required as described above. In the event that a IRB waives the requirement for written documentation of informed consent (pursuant to 21 CFR 56.109(c)(1)), the FDA recommends that elements of informed consent be reviewed orally with the subject or his or her legally authorized representative. In addition, the IRB may require the investigator to provide subjects with a written statement of a clinical trial. (21 CFR 56.109(e).) The FDA recommends that if a IRB waives the documentation requirement for informed consent in cases where there is minimal risk of harm, as permitted by 21 CFR 56.109(c)(1), the consent process and discussion are described and noted in clinical trial records. 30 49. For the purposes of this document, unless otherwise specified, all references to “drugs” or “drugs” include drugs for human use and biologics that are also drugs. With the prior approval of the IRB, other methods of transmitting study information may be used to complete the consent process or, more rarely, to replace a consent form.
These approaches include the use of audiovisual material, brochures, drawings and information published on a specific website. Number the pages of each consent document, preferably in a format such as “1 of 2”, “2 of 2”, in the footer of the document. In research with children, consent considerations – both process and documentation – become more complex than in adult subjects. The IRB`s Guidelines on Children and Minors in Research provide information on the documentation required for the consent of children and parents and use the consent and consent form templates for examples of drafting age-appropriate forms. Traditionally, informed consent was obtained through a personal interview using paper-based consent forms. New technologies are becoming available that can serve as an alternative to paper consent in the consent process. Parties interested in researching other methods to obtain informed consent are encouraged to contact the FDA. 31 Currently, the FDA is considering other methods that use these new technologies and would be interested in commenting on these alternative methods. If the IRB determines that consent is required, it must also determine whether and how consent should be documented. (21 CFR 50.55 (g).) Some of the above considerations in determining children`s ability to give consent should be taken into account when deciding whether consent should be given in writing or orally.
If the IRB determines that oral consent is appropriate, the consent process should be described and noted in the subject`s record of the clinical trial. For clinical trials involving children for which the IRB has given written consent, an approval form is required in accordance with the regulations of 21 CFR 50.20 and 50.25 for parents to grant permission, and the FDA recommends that a child consent form be used describing the clinical trial. FDA regulations explicitly identify “people with mental disabilities” as a vulnerable category of subjects in clinical trials for which CIRs may need to take on more responsibility. (21 CFR 56.107(a) and 56.111(b).) When reviewing studies of, for example, “persons with mental disabilities” who may be subject to coercion or undue influence, IRBs must ensure that additional safeguards have been included in the study, which may include a change in the informed consent process to protect the rights and well-being of subjects. (21 CFR 56,111(b).) Verbal notifications are acceptable for minor changes unless the sponsor or the SFVAMC requires all subjects to be notified in writing and sign an additional consent report for all changes. After this verbal notification, document in the topic`s search record that you had a consent discussion. As noted earlier, there is a deficit in providing the necessary information to patients when they receive informed consent. Providers should be trained by experts on routine procedures and procedures and should be able to share this information with patients as well as other members of the healthcare team. Members of the healthcare team, such as nurses and patient caregivers, should also be informed of any possible side effects so that they can identify them and notify a provider so that any immediate intervention required can be performed in a timely manner.
Members of the healthcare team caring for a patient should also be informed of procedures and interventions, as they can be used as witnesses to obtain informed consent. They would be able to assess whether the patient received all the necessary information and provide any information that the provider might have forgotten when obtaining consent. A person who is physically disabled (i.B s or physically unable to speak or write or who has a hearing or visual loss) may enroll in a clinical trial if they are competent and able to give consent if it is in accordance with applicable state law. Clinical trial records must include documentation of the informed consent process (21 CFR 50.27), except as set out in 21 CFR 56.109(c). The FDA recommends that the subject`s medical history include a description of the specific means by which the potential subject communicated their consent to participate in the clinical trial and how the questions were answered. The FDA recommends that researchers meet the specific needs of the study population. For example, depending on the degree of impairment of the visually impaired, the examiner could use a tape with the content of the declaration of consent or a form with an enlarged font. Unless otherwise requested, the exempt category search does not require a signature line. .