Webinar: SBER Across Borders: IRB Considerations and Cases for International Studies

Tuesday, February 20, 2018 | 1:00-2:30 PM ET

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IRBs and ethics committees that review research conducted in international settings face particular challenges. The reviewing IRB must possess adequate knowledge of laws and regulations in the country where the research is taking place. The IRB should also be sensitive to the area’s cultural norms and have a thorough understanding of the appropriateness of the study design. Social, behavioral, and educational research (SBER) protocols in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. How can IRBs ensure subjects are protected while continuing to support research on important issues around the globe?

During this 90-minute webinar, speakers will discuss the following issues as they relate to SBER conducted internationally:

  • Regulatory requirements for international SBER under the Common Rule
  • Potential impact of the revised Common Rule (specifically exemption category 2), with an informed discussion of remaining questions and areas of uncertainty
  • Best practices for IRB composition, policies, and processes
  • Considerations for subject recruitment and informed consent
  • Identifying and mitigating risks
  • Case studies that focus on common challenges, including inclusion of minors, stigmatized populations, and conflicts with local review boards

What will I learn?

After attending this webinar, attendees will be able to:

  • Identify various challenges presented by international research collaborations
  • Implement strategies for eliminating or mitigating these challenges
  • Understand and implement best practices for IRBs with respect to policies and procedures around international SBER with human subjects

Who should attend?

IRB staff, IRB members, compliance personnel, institutional officials, and researchers involved with SBER conducted in international settings will benefit from attending this webinar.

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 »


John BaumannJohn R. Baumann, PhD is the associate vice president for research compliance at Indiana University, including the Bloomington and Indianapolis campuses, as well as the five regional campuses and affiliated hospitals. He earned his PhD in sociology from the Graduate Center of the City University of New York. In addition to his position at Indiana University, Dr. Baumann serves as a site visitor for AAHRPP, Inc., has just finished a six-year term on its Council of Accreditation and chairs the social-behavioral IRBs of the National Development and Research Institutes and the American Academy of Family Physicians. Prior to joining Indiana University, Dr. Baumann was vice provost for research at the University of Missouri-Kansas City and, before that, deputy executive director of the National Development and Research Institutes, a private, not-for-profit behavioral science research institute in New York, NY, with a primary focus on substance abuse, HIV/AIDS, and related social problems.

Kelly O'KeefeKelly O’Keefe, MPH currently works as the research ethics board manager for Population Services International (PSI), an international public health organization. Prior to joining PSI, Ms. O’Keefe worked at Children’s National Medical Center in Washington, D.C. as a senior IRB analyst, and she established and maintained a human subjects program at the Center for Court Innovation in New York City. Ms. O’Keefe also served as a community member on John Jay College of Criminal Justice’s IRB. In addition to human subjects work, Ms. O’Keefe has conducted research in the areas of mental health, gender-based violence, and problem-solving courts. Ms. O’Keefe served as a Peace Corps volunteer in Morocco, received her MPH from University of North Carolina Chapel Hill, speaks conversational French, and is fluent in Moroccan Arabic.

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.

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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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