Informed Consent: Understanding Regulatory Flexibilities
Nichelle Cobb Senior Advisor for Strategic Initiatives, Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Nancy Olson IRB Administrator, University of Nebraska Medical Center
Explore how IRBs approach the review of informed consent and make determinations about waivers and alterations of both the process as well as the documentation. Find out what a waiver of informed consent means and if flexibilities can be found in the regulations. Should IRBs work more closely with research teams to identify the most appropriate informed consent approach for a study?
This webinar is designed to help IRB administrators and members think about how they can review informed consent by taking into consideration the nature of a research study while following the regulations.
Ideal for IRB administrators, IRB staff, IRB chairs and members, HRPP personnel, research teams, consent form writers.
Familiarity with the revised Common Rule and other federal regulatory requirements for informed consent is recommended.
After participating in this webinar, attendees will be able to:
- Identify regulatory flexibilities for informed consent
- Examine waivers and alterations of the consent process and waivers of documentation of informed consent
- Discuss how the flexibilities provide an opportunity to tailor the consent process to the scientific goals of the study, while protecting the rights and welfare of human subjects
Participants will receive a certificate of attendance that documents up to 1.25 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
Course participants who hold the Certified IRB Professional (CIP®) credential may apply 1.25 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.