• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Kids v Cancer

Changing the landscape of pediatric research

DONATE
  • Who We Are
    • About Us
    • About Jacob
    • Mission and Impact
    • Press Kit
    • Contact
  • Policy Development
    • RACE for Children Act / PREA
    • Creating Hope Act / Pediatric Priority Review Vouchers
    • Kids’ Eligibility for Trials
  • For Doctors & Families
    • COMPASSIONATE USE NAVIGATOR
    • Brain Tissue Donation
  • News & publications
    • News
    • Pediatric Cancer Legislative Yearbook 2021
    • Pediatric Cancer Research Consortia 2019
    • Kids v Cancer End of Year Letter 2017
    • Blog
  • Youth Programs
    • All programs
    • Climb the Hill Youth Advocacy Day Sign Up
    • Video and photo gallery
    • Kids v Cancer Youth Board
  • Our stories
  • Get involved
    • Donate
    • Our Parent Council
    • Happy Day Gift
    • Become a Corporate Partner

Waiver of Informed Consent

Waiver of Informed Consent

FDA may authorize (21 CFR 50.23 (a) access for an individual patient without written consent if you and a physician not involved in clinical investigation of the drug you are applying for certify in writing that:

• The patient is in a life-threatening situation.
• The physician cannot communicate with the patient.
• Time is not sufficient to obtain consent from the patient’s legally authorized representative.
• No alternative method of approved or generally recognized therapy is available that provides equal or greater likelihood of saving the patient’s life.

If immediate use of a drug is needed to preserve the patient’s life, and there is no time to obtain a determination from a second physician that the conditions described above are met, you as the treating physician may administer the treatment. You must have the written determination reviewed and signed by an independent physician within 5 working days after emergency use of the drug.


Apply to a Drug Manufacturer | Apply for FDA Authorization | Apply to IRB | Safety Reports Requirements | Request Our Help

  • Compassionate Use Navigator
  • Request Our Help
  • Information for Families
    • Application Steps
  • Information for Physicians
    • Expanded Access Explained
    • Apply to a Drug Manufacturer
    • Apply for FDA Authorization
    • Apply to IRB
    • Safety Reports Requirements
    • Handout — All Application Steps
  • Forms and Templates
  • Precision Medicine Clinical Trials Involving Pediatric Patients
  • Reports, Legislation, Articles
  • Advisory Council
  • Contribute to Our Outcomes Database
  • Compassionate Use News
link to Information for Families
Information for Families

 

Information for Physicians

  • Facebook
  • Twitter

DONATE CONFLICT OF INTEREST SUBSCRIBE

Kids v Cancer · 3500 Macomb Street NW · Washington D.C. 20016 · 646-361-3590 · contact

© 2021 Kids v Cancer · All Rights Reserved a 501(c)(3) nonprofit organization · EIN 27-1427784 · Privacy Policy · Terms of Use · Sitemap