Reviewers must use written informed consent approved by the IRB when documenting informed consent in accordance with 21 CFR 50.27, except as provided in 21 CFR 56.109(c). Therefore, the IRB should consider the relevance and appropriateness of all the wording of consent documents, as well as the overall length and presentation of the information. Informed consent forms that are long, complex, legalistic and have a high reading level39 can overwhelm potential topics and interfere with reading the full document and understanding relevant information. (2) A brief written certificate of consent attesting that the elements of informed consent required by section 50.25 were presented orally to the subject or the subject`s legal representative. If this method is used, a witness must attend the oral presentation. In addition, the IRB approves a written summary of what is to be said to the subject or representative. Only the short form itself must be signed by the person concerned or his representative. However, the witness must sign both the summary form and a copy of the summary, and the person actually receiving consent must sign a copy of the summary. A copy of the summary is provided to the subject or representative in addition to a copy of the summary form. 2.
Alternative methods of obtaining informed consent For clinical trials that are not “applicable clinical trials”, the sponsor or principal investigator may voluntarily record and report the results to the database, subject to Title VIII of the LAAA. If a sponsor or principal investigator plans to voluntarily submit study results, nothing would prevent a researcher, sponsor or IRB from informing potential plan subjects from submitting this information appropriately. Informed consent forms can direct subjects to www.ClinicalTrials.gov where subjects can receive some overall results of the study. Investigators and sponsors may describe alternative plans to inform subjects of the results of the clinical trial in the consent document. Name the sponsor(s) of the study. The IRB requires that all consent forms indicate that agencies or institutions (e.g., National Institutes of Health, Department of Defense, government agencies), cooperative groups (CALGB, COG, ACTG), foundations, or industry sponsors are funding the research or providing drugs or equipment for the study. 25. For more information, see FDA guidance, “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” ClinicalTrials.gov Registration: The FDA has issued a final rule that consent forms for applicable drug and product clinical trials include a specific statement that clinical trial data will be entered into ClinicalTrials.gov. The required language can be found in the Biomedical and Cancer Control Consent Form template.
§ 46.116 – The IRB may approve an informed consent process that does not contain or amend some or all of the elements of informed consent set out in this section, or waive the requirements for obtaining informed consent, provided that it determines and documents that: The figure below shows the five elements identified as key information proposed in the preamble to the revised final rule. When obtaining informed consent, informed consent must be documented by a signed and dated written consent form, except in two specific circumstances described in FDA regulations in 21 CFR 56.109(c). 28 (21 CFR 50.27.) If written informed consent is required, the use of electronic signatures, including digital signatures, is permitted by FDA regulations, provided it complies with applicable regulations. 29 Sponsors often provide clinical researchers with an informed consent sample that can be tailored by the clinical investigator to local needs. When the consent form is submitted to the FDA for review, FDA comments are usually directed to the sponsor. See Section IV.D.1, New Drug and Investigational Biologics, and Section IV.D.2, Investigational Medical Devices. The sponsor should promptly provide FDA comments to the clinical investigator so that changes can be made to informed consents. Since the clinical investigator must obtain IRB approval prior to the start of the clinical trial (see 21 CFR 312.66 and 21 CFR 812.110(a)), the sponsor should work closely with the clinical investigator to ensure that the amended informed consent is reviewed and approved by the IRB. The FDA recommends that the clinical investigator provide the sponsor with a copy of the IRB-approved consent form. For all FDA-regulated clinical trials (except as provided in 21 CFR 50.23 and 50.24-5), effective informed consent must be obtained from the subject or his or her legal representative.
Informed consent must meet the requirements of 21 CFR 50.20 and contain the basic information required by 21 CFR 50.25(a). If appropriate for the clinical trial, one or more of the additional pieces of information must also be addressed in accordance with 21 CFR 50.25(b). For “applicable clinical trials” initiated on or after March 7, 2012, an additional element of informed consent is required under 21 CFR 50.25(c). 6 (ii) A statement that the subject`s information or biological samples collected in the course of the research, even if the identifiers are removed, will not be used or distributed for future research studies. Signature of the person receiving consent: To ensure that subjects have a record of who explained the study to them, add lines for the signature of the specific person receiving consent and the date of signature. In the case of a biomedical study, a copy of the experimental subject`s Bill of Rights must also be provided. Attach a copy of the current version of the UCSF Bill of Rights to the consent form. The registration of individuals with partial disabilities may require changes to informed consent and the process so that they can consent on their own behalf. If a participant`s ability to give consent is impaired to such an extent that the participant is unable to give effective informed consent, the participant shall be admitted only if his or her legal representative consents.
(21 CFR 50.3(L) and 50.20.) 52. This fact sheet is available at Guidelines for Institutional and Clinical Investigator Review Committees: Pre-Enrolment Screening Tests. (5) The person who actually obtains consent shall sign a copy of the English version of the long-form form approved by the IRB. The FDA notes that informed consent should be considered an ongoing process during a subject`s participation in research. Therefore, the FDA recommends that whenever subjects who do not understand English are involved in the research, appropriate interpretation services are provided throughout the research. FDA regulations require the investigator to obtain legally valid consent from subjects or ensure that it is obtained. 45 If the investigator delegates this responsibility, the FDA recommends that the person to whom responsibility is delegated be qualified by education, training, and experience to perform this activity. The person obtaining informed consent should be aware of the clinical trial and have appropriate training and qualifications; and the investigator should have a detailed plan for the supervision and supervision of the clinical trial, including the informed consent process. 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 welfare of subjects during the clinical trial (21 CFR 312.60 and 21 CFR 812.100).
(2) For FDA-regulated research, the investigator shall promptly receive a translated copy of the IRB-approved English version of the detailed form that served as a written summary.