Webinar: Capacity to Consent to Research: Assessing and Improving your HRPP’s Strategy

January 18, 2018 | 1:00-2:30 PM ET

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When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent enhancements, safeguards, and support may be required by the IRB. AAHRPP Standard II-4 requires IRBs to provide additional protections for vulnerable subjects in research, including policies and procedures to protect subjects whose capacity to consent is potentially absent, diminished, or fluctuating. The regulations, however, are generally silent on the specifics of these additional protections. What strategies, best practices, and resources exist for HRPP professionals to address this issue on an institutional level and ensure proper safeguards?

The University of Minnesota and Mayo Clinic recently developed and implemented robust sets of policies and procedures to enhance protections for these vulnerable subjects. During this advanced-level webinar, IRB professionals from these two institutions will discuss:

  • The ethical and regulatory background regarding capacity to consent to research
  • A framework for introducing new or revised policies and procedures for capacity to consent issues
  • Different approaches and lessons learned regarding best practices, oversight, education and outreach, and community engagement
  • How to effectively adapt strategies to your own institution’s needs and constraints

What will I learn?

After attending this webinar, you will be able to do the following regarding research with subjects who have limited capacity to consent:

  • Understand the necessity for identifying additional safeguards
  • Explain some of the various institutional approaches that exist
  • Apply guidance and strategies to develop, implement, and monitor these policies and procedures at your own institution
  • Identify ways to engage the community in the development of policies and procedures
  • Identify relevant education and training activities for IRB members, staff, and the research community

Who should attend?

This advanced-level webinar will be beneficial for IRB chairs, members, and staff; institutional officials; researchers and research staff; and other compliance personnel.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »


Tamyra ArmbrustTamyra Armbrust, CIP, is the IRB education coordinator in the Office of Human Research Protection at Mayo Clinic. She is responsible for coordinating training and education for the Mayo Clinic IRB staff and members. She also conducts classes on research regulation and consent for the Mayo Clinic Research Community as well as department-requested research education throughout the institution. Ms. Armbrust received a Bachelor of Arts degree in Organizational Behavior from the College of St. Scholastica. She received her CIP credential in 2008 and became a Certified Clinical Research Professional (CCRP) in 2015.

Courtney JarboeCourtney Jarboe, MA, MS, CIP, is the education and outreach specialist at the University of Minnesota, leading the university's human research ethics education and outreach activities. She has eight years of experience leading and managing IRBs, as well as developing, delivering, coordinating and evaluating education and outreach efforts for human research protection programs. Previously, she led the management and function of Capella University's IRB and IRB staff. Mrs. Jarboe actively volunteers as a mentor in PRIM&R’s Mentoring Program, and is the ombudsman for Solutions IRB. She holds the CIP certification and has a Master's of Science degree in Research Ethics from Union Graduate College-Icahn School of Medicine at Mount Sinai.

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background Reading:

National Institutes of Health. (2009). Research Involving Individuals with Questionable Capacity to Consent: Points to Consider.

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HRP Consulting Group

HRP Consulting LogoHRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.

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