backWe are offering a Webinar or in person option for the Roundtable.
Join us for a discussion about the challenges and risks facing healthcare providers and IRBs, as well as pharmaceutical and medical device innovators, as they conduct clinical research involving human biospecimens and related private information that is potentially identifiable. As healthcare facilities participate in clinical studies and biobanks to advance innovation in precision medicine, state-of-the-art science raises major new issues regarding informed consent and privacy protections for the research participant, public and federal scrutiny, and litigation. This program will address why these are hot button issues, the rapidly changing expectations for informed consent and protection of privacy, and the implications of the new proposed rule that would amend the Federal Policy for the Protection of Human Subjects (the "Common Rule"). We will present hypothetical examples to illustrate potential practical approaches to identify and navigate risks related to the conduct of the research as well as contractual relationships with other parties. Our discussion will include the following:
- How new practices at the National Institutes of Health are reshaping today's approaches to future research uses of biospecimens and linked personal data.
- How the proposed rule would introduce a new category of broad consent for future uses of biospecimens and require extensive new disclosures to human subjects.
- Recent litigation and its implications for research uses of biospecimens by your institution and outside partners.
- Enhanced concern for "informational risks," including the new regime for maintaining privacy and security of "identifiable private information."
King & Spalding Presenters:
- Rob Keenan
- Beverly Lorell, MD
- Christina Markus
You do not have to be a client to attend, and there is no charge.
General information on our practice is available in our electronic publications Serving the Healthcare Industry, Around the Corner and Serving the Life Sciences Industry. If you would like to be included on our regular pharmaceutical manufacturers, medical device manufacturers or healthcare provider mailing lists to receive notices of other events and written updates, you can be added by submitting your full contact information to healthcare@kslaw.com and specifying the list you wish to join.
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Questions
If you have questions concerning this Roundtable Webinar, e-mail healthcare@kslaw.com.