Advances in digital health applications, tools, and technologies are occurring rapidly and are here to stay. Often, these technologies are designed to be “disruptive” (i.e., to replace current technology or create a new market) and are developed by companies with strong computing and analytics capabilities, but lacking a strong foundation in health care norms. In addition, many of these technologies may not be subject to FDA oversight, and the developers might have focused less on the safety and effectiveness standards and benchmarks required for an FDA process.
IRBs cannot assume digital health tech is developed in compliance with the regulatory and ethical standards well-understood by human subjects protections professionals. In order to take advantage of these promising technologies, IRBs need to be equipped to assess the tool’s suitability to protect the data, privacy, and confidentiality of research subjects who participate in studies involving digital health technologies, and to recognize differences in the study designs and subject characteristics presented by digital health research.
When the appropriate measures are taken, the integration of digital health tools into existing processes and procedures holds the potential to improve some aspects of human subjects research, for example, informed consent and patient reported outcomes.
(Presented on February 8, 2018)
Through sharing of best practices and illustrative examples, the webinar presenters will discuss:
- Differing priorities and goals among developers of digital health technologies and human research protections professionals
- Strategies for IRBs and HRPPs to equip themselves to assess new digital health technologies
- Ways to leverage digital health technologies to improve human subjects protections
- Some promising technologies that are being used in studies that illustrate key considerations for IRB review
This is an advanced-level webinar. Attendees should have a prior understanding of the basic concepts, challenges, and opportunities that arise with digital health technology in research.
What will I learn?
After attending this webinar, you will be able to:
- Identify and implement potential changes to policies, procedures, and practices in their HRPP in order to evaluate digital health-related technologies and research protocols
- Develop institution-specific tools and guides for their IRBs to assess the sufficiency of the data protection mechanisms of digital health tools
- Understand some of the ways in which digital health tools can support and improve human subjects protections
Who should attend?
IRB staff, IRB members, compliance personnel, institutional officials, researchers interested in using digital health technology, and research staff involved with (or who will be involved with) reviewing and conducting digital health research will benefit from attending this webinar.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
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HRP 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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