Waiving or Altering Consent for Minimal Risk Trials
- 2:00 pm ET – Webinar Replay
Program Description: FDA regulations and the Common Rule share the same definition for “minimal risk,” but while the Common Rule allows a waiver of informed consent for minimal risk
research if specific criteria are met current FDA regulations do not.
FDA indicates that waiver of informed consent for certain FDA-regulated minimal risk clinical
investigations will facilitate investigators’ ability to conduct studies that may
contribute substantially to the development of products to diagnose or treat diseases
or conditions, or address unmet medical needs.
FDA intends to revise its informed
consent regulations in response the 21st Century Cures Act. Learn what the FDA is
requiring, via recent Guidance in order for minimal risk research to be conducted
with an alteration or waiver of informed consent. Be sure you are prepared for the
new opportunities this policy change will open to your research teams
Upon completion of this Seminar, attendees should be able to:
- Describe existing regulatory exceptions to informed consent.
- Define minimal risk as it pertains to waiver or alteration of informed consent
by the IRB
- List the four criteria the IRB must document in order to grant an alteration or
waiver of informed consent.
- $5 Chapter Members
- $10 ACRP Members
- $15 Non-Members
Contact hours: 1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Refunds will only be processed if the event is cancelled by the chapter