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.
Jiayan Chen, JD is a partner at McDermott Will & Emery, LLP. Ms. Chen counsels clients on a range of regulatory and strategic issues that arise in the context of biomedical innovation and data sharing initiatives. She also has extensive experience advising life sciences companies and their collaborators on state and federal “Sunshine” and gift ban requirements. In her regulatory practice, Ms. Chen advises clients on regulatory and strategic considerations attendant to the development of research collaborations, data sharing initiatives, quality improvement endeavors, and biospecimen and data repositories, including in the context of personalized medicine and secondary use. In this regard, she has experience counseling a broad array of clients, including health systems, information technology companies, professional associations and biotechnology companies. Ms. Chen regularly assists clients in navigating requirements under the Health Insurance Portability and Accountability Act (HIPAA), the Common Rule, state research and privacy laws, and Food and Drug Administration (FDA) requirements relating to clinical investigations and human subject protections. She has extensive experience designing and implementing complex data sharing strategies, quality improvement initiatives, and research collaborations including in the preparation of protocols, project proposals and other IRB submissions, as well as in drafting and negotiating complex affiliation, collaboration and research agreements. Ms. Chen’s practice also includes counseling clients on state and federal “Sunshine” and gift ban laws by analyzing proposed arrangements, determining compliance obligations, and evaluating proposed corporate organizational structures in view of managing potential reporting obligations. While in law school, Ms. Chen was the articles selection coordinator for the Michigan Journal of Gender & Law.
Suzanne Rivera, PhD, MSW is the vice president for research and technology management at Case Western Reserve University in Cleveland, Ohio. She also is a faculty member in the Department of Bioethics at the CWRU School of Medicine and serves as the institutional official for human research protections. Her scholarly interests include research ethics, health disparities, and science policy. Dr. Rivera has served on the US Department of Health and Human Services Secretary's Advisory Committee on Human Research Protections (SACHRP) and the Environmental Protection Agency's Human Studies Review Board (HSRB). Lately, her research focus has been on the ethical and policy implications of biospecimen collection, biobanking, and use of specimens in research. In addition to writing numerous journal articles and book chapters, Dr. Rivera co-edited the book Specimen Science, which was published by MIT Press in 2017. Dr. Rivera received a Bachelor of Arts degree in American Civilization from Brown University, a Master's degree in social welfare from the University of California-Berkeley, and a doctoral degree in public policy from the University of Texas. She joined the PRIM&R Board of Directors in 2018 and is a member of the Nominations and Elections Committee.
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