• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Plans New Regulations on Informed Consent Waivers, IRB Approval and IND Reporting

FDA Plans New Regulations on Informed Consent Waivers, IRB Approval and IND Reporting

July 13, 2020

A final FDA rule allowing IRBs to waive or alter certain informed consent requirements for minimal-risk clinical trials is expected this December, according to the agency’s spring regulatory agenda.

The FDA’s plan, which provides only broad target dates, also lists five new proposed rules for clinical research, including one on cooperative research that would require U.S. institutions participating in multisite trials to use a single IRB for approval of any research conducted in the U.S. This rule was expected to be released in June, but still has not been published.

This month, the agency plans to release two proposed rules: one on annual IND reporting that would add a new requirement to submit a development safety update report to the FDA; and one intended to harmonize FDA human subject protection rules with the requirements of the Common Rule. A proposed rule on clinical holds of medical device trials is planned for September.

A proposed rule altering IND regulations for initiating and conducting clinical trials is expected in April 2021. The proposed rule, which would require additional documentation and reporting from investigators, is intended to help reduce study misconduct, enhance protection of subjects and ensure the reliability and integrity of clinical trial data, the FDA says.

To read the FDA regulatory agenda, click here: https://bit.ly/2W2NgfX.

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing