In late 2022, the FDA released two Notices of Proposed Rulemaking (NPRMs) to help standardize and streamline clinical trials in the US. These NPRMS cover two general categories relevant to Institutions, CROs, and Sponsors:

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

It’s imperative that study Sponsors, CROs, principal investigators (PIs), and Institutional teams understand how these NPRMs will impact future trials. This resource center will provide valuable information to help your teams navigate these changes, and our experts are standing by to help you through your trial planning.

By tapping into the expertise and leveraging the site network of WCG, your research will be accelerated to a new level. WCG helps connect the dots between Sponsors, CROs, Institutions, and sites.

Read the most recent updates about the NPRMs and draft guidance.

How May the NPRMs Impact Your Trials?

The federal government has been moving in the direction of requiring a single IRB to oversee multi-site research for several years. The goal of this transition is to reduce the burden on institutions and sponsors so that important research developments can reach the public more quickly without sacrificing ethical oversight.

We recognize that no one understands your local population better than you. That’s why WCG believes in balancing compliance with flexibility – we assimilate your local Standard Operating Procedures while ensuring you meet the FDA’s upcoming requirements. Our experts understand local issues and bring a wealth of board knowledge to the table, ensuring excellent review of your clinical trials.

To learn how the Single IRB NPRM might affect your institution, check out this recent white paper!

Sponsors involved in the review and conduct of federally-funded research have already adopted many of these provisions in 2018 in the Common Rule, and these new informed consent requirements will have less impact. Commercial sponsors and investigators who do not participate in federally-funded research will have to update consent form templates and other documents (required element checklists, etc). Some Sponsors of FDA-regulated research may have already encountered the key information section requirement, if working with a local IRB that applies Common Rule requirements to all research.

However, forward-thinking Sponsors and researchers may want to start updating their informed consent template now, as none of these changes are contradicted by current regulations. WCG IRB’s experts are standing by, ready to help you prepare for these proposed changes!

To understand the biggest impact to Sponsors read this white paper!

Commercial CROs should be prepared to address these new requirements if and when it is implemented, although the change should lead to less administrative burden as only one IRB will review each study. That said, the timeline for adoption of these proposed changes to the FDA regulations is unclear; it could take several months or even several years. However, forward thinking CROs may want to start updating their policies now and work with their clients to amend necessary consent language.

The FDA’s Notice of Proposed Rule Making regarding the single IRB mandate has the potential to streamline clinical trials. Are you ready? With WCG IRB, you can be. Our team of experts is ready to guide you through the process, ensuring your research is compliant and ready for the changes ahead.

Understand the biggest impact to CROs by checking out this white paper!

Understanding FDA’s New Proposed Regulations

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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