Breakthroughs in genomics research and technology hold the potential for significant and wide-reaching clinical, scientific, and societal benefit. As genetic sequencing and testing become increasingly accessible and prevalent, so too has the ability to share vast amounts of genomic information. Such advances have disrupted traditional notions of identifiability and have introduced new considerations for IRBs, researchers, and research subjects regarding the attendant risks and benefits presented by genomics research. A primary example of the effort to acknowledge the quickly evolving nature of genomics research is the revised Common Rule, which calls for periodic assessments of identifiability standards for information and biospecimens—meaning the current definitions of “human subject” and “identifiable” will be re-evaluated in the coming years.
IRBs and researchers should employ forward-thinking strategies in order to be prepared for these potential changes, and for the accompanying shifts in risk-benefit assessment that may come as a result. At the same time, it is critical that stakeholders assess risk within a realistic, evidence-based framework, and that concerns about privacy breaches, re-identification, and bad actors, are not overestimated.
During this 90-minute webinar, presenters Jiayan Chen, JD and Suzanne Rivera, PhD offer a framework to help IRBs adapt to the shifting landscape of genomics research. Presenters will discuss:
- Key regulatory developments and implications for different types of genetic information, and the specific sensitivities associated with various types of genetic information
- Mechanisms IRBs and researchers can employ to inform research subjects about the risks and benefits of participation in genomics research, including outreach, education, and the consent process
- Recommendations for researchers, including how to enhance data discipline and leverage data architecture to bolster privacy protections for research in the age of genomics and big data
- Important considerations regarding return of research results, including challenges presented by conflicting federal regulatory regimes
- Thought-provoking questions to help IRBs avoid the pitfalls of overestimating risks involved with genomics research
What will I learn?
After attending this webinar, you will be able to do the following as it relates to genomics research:
- Comprehend the regulatory and legal factors underlying the shift in notions of identifiability and privacy
- Implement forward-looking strategies for IRB review that protect subjects and take potential future changes into consideration
- Understand the potential clinical and societal benefits of genomics research and be aware of the pitfalls of overestimating risks
Who should attend?
IRB staff, IRB members, compliance personnel, institutional officials, researchers, and research staff involved with (or who will be involved with) reviewing and conducting genomics 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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