(21 CFR 50.25(c).) If the clinical investigation is conducted or supported by the Department of Health and Human Services (HHS) and involves an FDA-regulated product, then the study is subject to both 45 CFR part 46 and 21 CFR part 50, meaning that both sets of regulations must be followed. 2 The informed consent requirements in 21 CFR part 50 are not intended to preempt any applicable Federal, State or local laws that require additional information to be disclosed for informed consent to be legally effective. These regulations apply to clinical investigations regulated by FDA. To the extent that issues presented in this draft guidance intersect with the Common Rule FDA plans to coordinate with other relevant federal agencies to facilitate consistency across policies.įDA's informed consent requirements are set forth in FDA's regulations on Protection of Human Subjects ( 21 CFR part 50). The changes under consideration can be found in in the JFederal Register in an ANPRM titled " Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators." FDA issues this draft guidance while the agencies continue to explore potential changes to the Common Rule. Before developing proposed changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research. Department of Health and Human Services announced in 2011 that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. This guidance document was developed as a part of these efforts. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research. This guidance, when finalized, will supersede " A Guide to Informed Consent," issued in September 1998, by the Office of Health Affairs, FDA.
This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA's informed consent regulations. Reporting Aggregate Results of the Clinical Investigation Data Retention upon the Withdrawal of Subjects Subject Participation in More Than One Clinical Investigation Investigational New Drugs and BiologicsĬ. Considerations for Multicenter Clinical Investigationsġ. Identification of Revised Consent Formsġ. Adequacy and Appropriateness of WordingĤ. Review of All Informed Consent MaterialsĪ.
Forms for Documentation of Informed Consent Alternative Methods of Obtaining Informed ConsentĤ.
Requirement for Written Documentation of Informed ConsentĢ. Element of Informed Consent for Applicable Clinical Trialsġ. Providing Significant New Findings to Subjectsĭ. Consequences of Subject's Decision to Withdrawĥ. Involuntary Termination of Subject's ParticipationĤ. Additional Elements of Informed ConsentĢ. Compensation and Medical Treatments in Event of InjuryĬ. Language Understandable to the Subject or the RepresentativeĦ. General Requirements for Informed Consentģ. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSIONĪ. This guidance document is being distributed for comment purposes only. To communicate facts by way of accusation against to denounce as, two persons came to the magistrate, and informed against A.Center for Biologics Evaluation and Research
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