Greater Columbus Chapter: Webinar Replay: Waiving or Altering Consent for Minimal Risk Trials

When:  Oct 12, 2018 from 2:00 PM to 3:00 PM (CT)
Associated with  ACRP Greater Columbus Chapter

Webinar Replay:
Waiving or Altering Consent for Minimal Risk Trials


Speakers:
Glenda Guest

Program Agenda:

  • 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.


Registration Cost: 

  • $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

Location

Online Instructions:
Url: http://zoom.us/meeting/register/4a22b92c80d26a0166858a512be5123a
Login: See instructions in registration email
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