Nonexempt clinical trials (as defined by 45 CFR 46.102(b)) conducted or supported by HHS, initially approved by an IRB on or after January 21, 2019.Ĭategory 2. Posting is required for two categories of clinical trials:Ĭategory 1. Which studies must satisfy the posting requirement at 45 CFR 46.116(h)? The Basics of Complying with 45 CFR 46.116(h) 1. General Instructions on Complying with 45 CFR 46.116(h) of the 2018 Requirements A. While the submission of information other than consent forms to is not required by the Common Rule, the submission of this additional information is required by the final rule, which implements the provisions of section 402(j) of the Public Health Service Act (42 U.S.C.
CONSENT FORM TRIAL
If the clinical trial is not already registered with, then as part of registration, information about the trial must be submitted 4Īnd other requirements may be triggered. If is selected, a consent form can only be uploaded if the clinical trial is also registered with that website. The awardee or the federal department or agency conducting the clinical trial may select either website to satisfy the posting requirement. Where the document describes suggested compliance procedures or nonbinding agency guidance, it generally uses the terms “should” or “recommended” to describe them.Īt this time, two federal websites have been identified as places where consent forms can be posted to satisfy 45 CFR 46.116(h): 2Īnd a designated docket folder on (Docket ID: HHS-OPHS-2018-0021). While this document is described as “Instructions,” it includes numerous references to statutory and regulatory requirements, which are generally described as procedures that “must” or “shall” be followed.
CONSENT FORM HOW TO
This document provides general instructions on how to comply with 45 CFR 46.116(h). These instructions apply to clinical trials that are conducted or supported by HHS.Īt 45 CFR 46.102(b), a clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. The revised Common Rule (also referred to as the 2018 Requirements) 1Īt 45 CFR 46.116(h) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial. NOTE : These instructions are consistent with the 2018 Requirements (i.e., the revised Common Rule) I. General Instructions on the Informed Consent Posting Requirement (45 CFR 46.116(h))
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