Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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Dr. He Jiankui’s Secret CRISPR Baby Experiment
TOPIC: Dr. He Jiankui’s secret CRISPR baby experiment: a study in non-compliance, uninformed consent, and a leap for glory
Jennifer Doudna’s relatively recent discovery of the bacterial gene-editing system widely known as “CRISPR” has enabled an explosion of research not previously contemplated. Relatively precise and easy to use, the CRISPR technology facilitates research in areas such as gene expression and function, development of animal models for disease, and even gene transfer clinical trials, in which CRISPR’s precision for gene-editing is an improvement over the use of viral vectors for gene delivery. While genome editing of non-human embryos has been implemented in the laboratory, there is a worldwide consensus among scientists that, at this time, clinical trials involving human embryo genome-editing would be premature at best and unethical and irresponsible at worst; these opinions have been published by numerous international scientific bodies, professional societies, and stem cell experts. Nevertheless, a scientist in China, ignoring the well-publicized expert opinion and warnings of colleagues, conducted human genome editing in secret, and two gene-edited babies were born in 2018.
TOPIC DESCRIPTION: In November 2018, the world was stunned by the announcement, from scientist Dr. He Jiankui, that two gene-edited babies had been born in China, the result of implantation of embryos whose genomes were deliberately edited in an attempt to create human beings resistant to HIV and AIDS. In the days and weeks that followed the announcement, not only was the science called into question, but irregularities were exposed regarding the conduct of the research. The research was conducted in violation of an international agreement among stem cell scientists that human embryo genome editing should not yet be attempted, and the research appears to have been in violation of legal, regulatory, and scientific norms and requirements for the conduct of clinical trials. In this presentation, Dr. Jonlin will describe the technology and summarize the fields’ current thinking on diseases for which human genome-editing might eventually be implemented. She will also unravel the now infamous story of the “CRISPR babies,” highlighting the noncompliance, unethical practices, violations of human subjects protection principles, and scientific risks posed by this particular human experimentation.
SPEAKER: Erica C. Jonlin, PhD
SPEAKER BIOGRAPHY: Dr. Erica Jonlin is the regulatory manager for clinical research activities conducted at the University of Washington Institute for Stem Cell and Regenerative Medicine. Her responsibilities include human subjects protection, clinical protocol design, and coordinating and managing the regulatory submission and review processes for clinical research involving products developed from pluripotent stem cells. Dr. Jonlin is also the IRB consultant for the UW Dept. of Pathology, specializing in biospecimens research. She regularly lectures on Good Clinical Practice guidelines, and for thirteen years taught for UW’s Certificate in Clinical Trials program. Early in her career, Dr. Jonlin served as a human subjects review administrator for one of UW’s Institutional Review Boards. Dr. Jonlin was the recipient of an AAAS Science and Diplomacy Fellowship in Washington, D.C., after earning her Ph.D. in Biochemistry at the University of California, Los Angeles.
Fred Hutch Campus Map
WHO: Clinical, regulatory, quality, manufacturing and legal
This meeting includes:
- Coffee and tea
- Pastries and fresh fruit
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification.
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