60. The exception in Article 21 cfR 50.23 concerns certain life-threatening situations where there is no appropriate alternative treatment and there is insufficient time to obtain informed consent, military operations and public health emergencies. The exception in 21 CFR 50.24 is for emergency research. Obtaining informed consent in medicine is a process that should include: (1) a description of the proposed intervention, (2) a focus on the patient`s role in decision-making, (3) discussion of alternatives to the proposed intervention, (4) discussion of the risks of the proposed intervention, and (5) highlighting the patient`s preference (usually by signature). In this context, the discussion of all risks is of the utmost importance for informed consent. Most consents include general risks, procedural risks, risks of non-treatment, and alternatives to treatment. In addition, many declarations of consent express that there is no guarantee that the proposed procedure is a remedy for the problem being addressed. An IRB may approve a short form for use in appropriate situations where the elements of informed consent required by 21 CFR 50.25 are presented orally to the subject or his or her legally authorized representative. (21 CFR 50.27(b)(2).) For example, IRBs may consider approving the use of a short form in situations where the subject or his or her legally authorized representative cannot read due to illiteracy or blindness (see Section V.C, Low Literacy and Numeracy Subjects, and Section V.D, Subjects with Physical Disabilities). While a competent person who does not read and write well may give informed consent and enroll in a clinical trial, the sponsor, clinical investigator and IRB should consider whether changes to the informed consent procedure are necessary to ensure that the informed consent procedure is understandable. The IRB-HSBS General Informed Consent Model has been revised to include new “key information” and other elements required to meet the requirements of the 2018 Common Rule.
Download the revised template for use. Additional templates will be released as soon as they are updated to meet the new requirements. The use of the short form requires that a witness be present at the oral presentation of the information before the subject or the legally authorized representative of the subject. (21 CFR 50.27(b)(2).) The FDA recommends that an impartial third party who is not otherwise associated with the clinical trial (for example. B clinical staff not involved in the research or a patient advocate) act as a witness. The FDA recommends that the witness be present throughout the consent process (physically or otherwise, para. B telephone or videoconference), and not only when signing the consent form. The purpose of the witness is generally to confirm the voluntary nature of the subject`s consent and the appropriateness of the consent procedure by ensuring that the information has been transmitted correctly and that the subject`s questions have been answered. (2) A brief written declaration of consent indicating that the elements of informed consent required by § 50.25 have been submitted orally to the subject or to the subject`s legal representative. If this method is used, a witness must be present at the oral presentation. In addition, the IRB approves a written summary of what to say to the subject or representative.
Only the short form itself must be signed by the subject or representative. However, the witness signs both the short form and a copy of the summary, and the person who actually receives the consent signs a copy of the summary. A copy of the abstract is provided to the subject or representative in addition to a copy of the summary form. The following may be made available to potential subjects if the IRB determines that the information is essential to the potential subjects` decisions to participate: (5) The person who actually receives consent shall sign a copy of the English version of the detailed form approved by the IRB. If the patient`s record does not contain the basic information necessary to determine if the patient is eligible for the clinical trial, additional information may be required from the potential subject. Before obtaining the additional information, informed consent may be required. Please refer to the FDA`s fact sheet “Pre-Registration Screening Tests,”52 for a discussion of when informed consent would be required under the regulations. The FDA recommends that potential subjects first be informed of the care a patient would likely receive if they were not part of the research, and then receive information about the research.
This sequence allows potential subjects to understand how the research differs from the care they might otherwise receive. The description should include tests or procedures that would be part of the usual care that would not be performed, as well as those that are required under the protocol and would not be part of their treatment outside of research, e.B. collecting blood samples for a pharmacokinetic study. The information provided should also inform potential subjects of the possible consequences of these differences in care. Note that all experimental procedures must be marked as such. (21 CFR 50.25(a)(1).) Procedures that relate exclusively to research (p.B. protocol dosage versus individualized dose, randomized assignment for treatment, blinding of subjects and investigator, and receipt of placebo if the study is placebo-controlled) should be explained. For clinical trials that are not “applicable clinical trials” subject to Title VIII of the FDAAA, the sponsor or principal investigator may voluntarily register and report the results to the database. If a sponsor or principal investigator intends to voluntarily submit the results of the study, nothing would prevent an investigator, sponsor or IRB from informing potential subjects of the plan in order to submit this information appropriately. Declarations of consent can redirect subjects to www.ClinicalTrials.gov, where subjects can get some overall results from the study.
Investigators and sponsors may describe other plans in the informed consent form to inform participants of the results of the clinical trial. Provides up-to-date information on cancer and cancer treatment, life with cancer, clinical trials and research This element requires subjects to be informed that they may refuse to participate in the clinical trial or terminate participation at any time without penalty or loss of benefits to which subjects are entitled. (21 CFR 50.25(a)(8).) Formulations limiting the subject`s right to refuse to participate or withdraw from the clinical trial shall not be used. If specific procedures for the withdrawal of the subject from the clinical trial are followed, the procedures of the consent procedure should be described and explained (21 CFR 50.25(b)(4), see Section III.C.4, Consequences of the Decision to Withdraw the Subject). Also note that subjects are not allowed to remove data collected about them before their revocation, as described in section V.I, Data Storage when subjects are taken over. Katz AL, Webb SA, Bioethics Committee. .