2011 Webinar: Improving Informed Consent

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Improving Informed Consent: Innovations in Form and Process, a webinar on Thursday, September 22, 2011, featured an overview of the current practices around informed consent, identify shortcomings, and offer ideas for improvement.

Topics for discussion included:

  • Tensions between an optimally written form and a quality consent process: striking the appropriate balance
  • Regulatory constraints associated with limited English language proficiency and low-literacy populations: preparing to meet the needs of these groups
  • Innovations in consent forms: using the Short Form and exploring developments of the Association of American Medical Colleges (AAMC) and National Cancer Institute (NCI) working groups
  • A case study on oral consent: identifying common assumptions about comprehension and assessing the subject’s understanding
  • A case study on institutional review board (IRB) review of a consent form: identifying IRB responsibilities, including ensuring consistency between the consent form and consent process


The topic of this webinar was of interest to human research protections program (HRPP) professionals, IRB members, IRB staff, administrators, researchers, research staff, patient advocates, community leaders, and anyone working with human subjects.


Margo Michaels, MPH
Margo Michaels is the executive director and founder of Education Network to Advance Cancer Clinical Trials (ENACCT). Over the last 15 years, Ms. Michaels has developed numerous innovative programs to educate cancer advocates, community leaders, and health care professionals about cancer clinical trials. She also initiated the first national training program to help cancer researchers improve their recruitment and accrual processes to be more responsive to community needs. As the founder of ENACCT, Ms. Michaels is considered a national expert in community-based education efforts around cancer clinical research. Prior to starting ENACCT, Margo served as chief of the public and survivor education branch of National Cancer Institute (NCI); as the lead consultant to the Clinical Research: Affiliates Funding Trials (CRAFT) program at the Susan G. Komen Breast Cancer Foundation (now Komen for the Cure) in Dallas, TX; and as the director of the National Breast Cancer Coalition's Project LEAD. Margo began her career as a community organizer around reproductive health issues and occupational health. She holds an MPH in health behavior/health education from the University of North Carolina School of Public Health.

Heather Pierce, JD, MPH
Heather Pierce, JD, MPH, is senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges (AAMC). Heather serves as AAMC’s leader on issues related to conflicts of interest, human subjects protection, regulatory compliance, and interactions between industry, government, and academia in biomedical research. Prior to joining AAMC, Heather was an attorney in the health care group of the law firm of Ropes & Gray in New York. Her practice focused on regulatory compliance issues including research with human subjects, medical information privacy and security, and fraud and abuse counseling. She worked with a wide range of clients including academic medical centers, hospitals, universities, and pharmaceutical and device manufacturers. She earned her JD at New York University and her MPH at Boston University. Prior to becoming a lawyer, Heather worked in development and public education for an academic medical center and as a freelance writer.

Certificates of Attendance

Certificates of Attendance
Certificates of Attendance for the Improving Informed Consent: Innovations in Form and Process webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining Continuing Education Credits (not Continuing Medical Education Credits) from professional associations. Note that guidelines concerning Continuing Education Credits may differ, and you should consult the appropriate professional association representative for further guidance.

Continuing Education (CE) Credit for CIP® Recertification
Webinar participants holding the CIP credential who wish to apply credits from Improving Informed Consent: Innovations in Form and Process toward CIP recertification may submit a Certificate of Attendance as documentation of participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.