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As planning and coordination for 2023 is underway, it’s imperative that study Sponsors, CROs, principal investigators (PIs), and Institutional teams understand FDA’s recently released Notices of Proposed Rulemaking (NPRMs) and pediatric research guidance and their potential impacts on clinical research. In late 2022, the FDA released two NPRMs to help standardize and streamline clinical trials in the US.

These NPRMS cover two general categories relevant to research sites and sponsors:

  • Single IRB Review for multisite trials
  • New required elements of informed consent and informed consent document organization

FDA has also released a draft guidance that directs how IRBs should assess the relative risks and potential benefits of pediatric research, a process that differs from the same assessment in adults.

This webinar discusses the details of these three documents and outline the actions that need to be taken now to ensure utmost compliance and continued efficiency for trial stakeholders.

In this article


Our experts answer your research ethics and oversight questions, and share the (anonymized) answers as a resource for our industry.

Do you have an upcoming study that could benefit from expert reviews?

As the most experienced and trusted IRB in the industry, WCG IRB is proud to serve its clients with the highest ethical standards and world class service. To learn how you can accelerate your study timelines, get in touch now!

Frequently Asked Questions

Expand the sections below to read answers to common questions related to NPRMs.

Please note: The Notices of Proposed Rule-Making (NPRMs) and draft guidance do not represent final regulations or final guidance, and they may change during the finalization process, or not be released at all.  The information below is based on these proposed/draft documents, and may change. This content will be updated when new information becomes available. When these regulations and guidances are finalized, we expect to provide more information (webinars, etc.).

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