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Description

The use of technologically interconnected products and services continues to revolutionize the design and conduct of human subjects research. From smartphones and smartwatches, tablets, fitness trackers, to virtual assistants, and even smart medical devices, these technological innovations raise important legal, regulatory, and ethical questions for IRBs.

In order to adequately address these emerging issues, ensure protection of human subjects, and accurately apply the regulatory criteria for approval, IRBs should incorporate Information Technology (IT) expertise throughout their work. This webinar reviews the critical intersection between IRBs and IT and can help equip IRBs in managing the need for IT expertise on their boards.

 

Learning Objectives

  • Identify the regulatory basis for including IT expertise on the IRB.
  • Discuss considerations for risk assessment of emerging technologies.
  • Describe how to encourage collaboration between existing IRB and IT offices/personnel and how to build institutional partnerships.
  • Recognize what to consider when reviewing consent forms that include technology.
  • Examine strategies for including IT expertise on the IRB.

 

Audience

Graduate Students, HRPPs, IRB Members and Administrators, Institutional Officials, Researchers

 

Meet the Presenters

Kimberley Serpico, MEd, CIP – Harvard T.H. Chan School of Public Health
Kim Serpico is the Associate Director of IRB Operations for the Harvard School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine, and Co-Chair of the Harvard Catalyst Emerging Technologies, Ethics, and Research committee.

 

 

 

Joseph Zurba, CISSP, CISA – Harvard Medical School
Joseph Zurba is the Information Security & IT Compliance Officer at Harvard Medical School. As the chief security professional at HMS, he is responsible for building and staffing the Information Security program, developing strategy, and managing risk for all information security and compliance across the school.

 

 

Tonya Ferraro, MEd – Boston Children’s Hospital
Tonya Ferraro is the Senior IRB QI Consultant at Boston Children’s Hospital’s (BCH) Education and Quality Improvement Program. Her responsibilities include educational outreach, internal reviews and audits, and supporting BCH’s reaccreditation effort. She holds a BA from Northeastern University and an interdisciplinary MEd from the University of Vermont focusing on research methodologies.

 

 

Aaron Kirby, MSc – The Harvard Clinical & Translational Science Center
Aaron Kirby is the Director of Regulatory Affairs Operations for the Regulatory Foundations, Ethics and Law Program at Harvard Catalyst and SMART IRB. Aaron has led regulatory knowledge initiatives related to research ethics, data safety and quality, protection of human subjects, and education outreach.