|
Guidance and Resources
Fully informed consent is critical to the ethical conduct of clinical research. Although the consent document is only one component of the entire consent process, its content is defined in regulation and is a critical tool to help potential participants understand the risks and benefits of a research project. Over time, as research has increased in complexity, the informed consent document has become lengthy, complex and difficult to understand. Studies have confirmed that the documents are often written at reading levels considerably higher than that of the majority of the
U.S.
population. Recent research has shown that there can be a large discrepancy between the information in the informed consent document and a participant’s understanding.
An aim of the CRpac program is to develop informed consent resources that will be of assistance to investigators, IRBs, and prospective research participants. Toward that end, the CRpac program will conduct a comprehensive review and assessment of the communication tools that can be used to enhance the informed consent process; this review will include the broad spectrum of products including pamphlets, videotapes, compact discs, web-based programs and other tools that have been evaluated for their effectiveness. Resource materials produced will provide an evidence-based set of recommendations for the informed consent process that takes into account the differing information needs of specific populations, the learning needs of specific groups (such as children and those with limited English proficiency) and the types of clinical research being conducted.
Pertinent Resources, Policies, and Regulations
Department of Health and Human Services:
Food and Drug Administration:
Protection of Human Subjects. Code of Federal Regulations, 21 CFR Parts 50 and 56
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
A Guide to Informed Consent (1998 - This document provides guidance on the informed consent process andthe information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25(b), or studies that are subject to the requirements of the FDA regulations)
Exception from Informed Consent For Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble (1998 - This document provides guidance on the narrow FDA regulatory exception to the requirement for informed consent to allow research on life-threatening conditions for which available treatments are unproven or unsatisfactory, and where it is not possible to obtain informed consent, while establishing additional protections to provide for safe and ethical studies)
Exception From General Requirements for Informed Consent-FDA’s Interim Final Rule at 21 CFR 50.23(e) (The Food and Drug Administration (FDA) issued this interim final rule to amend its medical devices regulations to establish a new exception to the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The exception applies when investigational in vitro diagnostic devices are used and the investigator is unable to obtain timely informed consent from subjects (or their legally authorized representatives) whose specimens are being tested, and delay in diagnosis could be life-threatening to the subject)
Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (This document addresses how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug Administration’s (FDA’s) interim final rule, “Medical Devices; Exception From General Requirements for Informed Consent” (21 CFR 50.23(e)). This guidance only applies to clinical investigations that are conducted or supported by HHS)
National Institutes of Health:
|
