Strange and new Informed consent in human embryonic stem 奇怪的和新的知情同意在人类胚胎干细胞.pptVIP

The role of IRBs in Ethical Interventional Stem Cell Research 6th Annual Columbia University IRB Conference Boston, MA Patrick Taylor Children’s Hospital Boston, Harvard Medical School, Petrie-Flom Center, Harvard Law School Agenda Describe some problems you won’t have. Describe some problems you still will have in different form, but with special resources to manage them. Describe some new ideas to help manage risks. What will we see? We fear Pseudoscientific stem cell human research protocols presenting great risks, unknowably larger than the known risks of cancer, and uncertain benefit; Desperate patients for whom the voluntariness of consent is questionable, yet also presenting an extremely strong sort of claim for respect for autonomous choices Nondeterminative, or no, preclinical data And little regulatory guidance With industry trial issues and regulatory judgments confidential and inaccessible to others. But actually the area has been preparing: Ethics Generally recognized ethical separation between donation/derivation and uses of derived lines for research purposes. disputed ethical issues are outside IRB review is Consensus standards on most ethical issues involving the original donation, informed consent, and provenance – the criteria for IRB acceptance and reliance including the elements of informed consent (literature, NIH, ISSCR and NAS). Registries and stem cell distributional banks using those ethical criteria to collect, and making data and certifications available to investigators and IRBs. Ethical standards for use of animals and chimeras useful in translational context. Scientific path; regulatory + ethical integration Connecting the dots scientifically from pluripotency to differentiation to controlled applications of derivatives Direct attention to genes and factors affecting cancer risks and uncontrolled development Development of pluripotent alternatives w select oncogene deletions for iPS cells Agreement on certain elements of “producti