Massive data sets are being generated on an unprecedented scale in the academic and private sectors through wearable health devices, online educational courses, social media, and more. “Big data” has great potential for scientific advances in both biomedical and social, behavioral, and education research (SBER), and in recent years, institutional review boards (IRBs) have seen an influx of research involving large data sets. As our society as a whole and the research community continue to produce and utilize large data sets, IRBs need to know how to best protect human subjects when reviewing a protocol that involves big data.
Using case studies from SBER and biomedical research, presenters shared best practices for how to review research protocols that either create or use large data sets, with a focus on maintaining the value of the data while protecting human subjects. During this intermediate-level webinar, presenters discussed considerations for IRB review from the perspectives of an assistant IRB director at an academic institution and a data security expert at a commercial research firm. The following topics were discussed:
What will I learn?
After attending this webinar, attendees were able to:
Who should attend?
This intermediate-level webinar was useful for IRB members and professionals, institutional officials, data scientists, and investigators who conduct research involving large data sets.
Betsy L. Draper, MBA, CIP, serves as the assistant director of IRB administration at Harvard University’s Committee on the Use of Human Subjects (CUHS). For human subjects research matters, she serves as an advisor to the HarvardX Research Committee, and on the IRB-IT Task Force, Harvard Catalyst, The Harvard Clinical and Translational Science Center. Betsy received her bachelor of music education degree from Florida State University, and her master of divinity degree from Southwestern Theological Seminary in Fort Worth, Texas, prior to her service as one of the university chaplains at MIT. She left MIT after almost 15 years to complete her master of business administration at Simmons College in Boston, and has been with the IRB at Harvard University since 2006.
Sean Owen, CISSP, CAP, CRISC, is the director of the client cybersecurity center at Abt Associates Inc. and has more than 12 years of experience developing, assessing, and auditing security requirements and compliance for federal and commercial clients. He has held positions with KPMG, Department of Labor, Department of Energy, and Department of Commerce with a specialty in Federal Information Security Management Act (FISMA) compliance, certification and accreditation, Federal privacy requirements including Privacy Impact Assessment, and National Institute of Standards and Technology 800 series special publications. Mr. Owen currently serves as a member of Abt’s IRB and is a member of Abt’s Information Risk Management initiative. He holds the Certified Information System Security Professional (CISSP), Certified Authorization Professional (CAP), and Certified in Risk and Information Systems Control (CRISC) certifications.
Certificates of attendance will be 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 (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.
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CE Credit for Certified IRB Professional (CIP®) RecertificationWebinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.
For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.
Additional information about CIP® recertification can be found here.
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