Check out the latest news from the Petrie-Flom Center!

Check out the October 30 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Specimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday, November 16, 2015, 8:00 AM – 5:00 PM
8-11:45am: Austin Hall North (100);
11:45am-5:30pm, Langdell Hall South, Room 272
Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery. The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others. Conference papers eventually will be published as an edited volume with a major academic press.

Agenda

All panels will include time for audience Q & A.

8:30 – 9:00am, Breakfast and Registration, Austin Hall, North Classroom (100)

A continental breakfast will be provided.

9:00 – 9:05am, Introductory Remarks, Austin Hall, North Classroom (100)

9:05 – 10:10, Panel 1: Background and Foundations, Austin Hall, North Classroom (100)

Elisa Hurley, PRIM&R (and Kimberly Hensle Lowrance, and Avery Avrakotos) – Research with Biospecimens: A Brief History
Barbara Bierer, MRCT Center at Harvard University and Harvard Catalyst (and Mark Barnes) – Legal Considerations and International Perspectives
Karen Maschke, The Hastings Center – Governance Issues for Biobanks and Biospecimen Research
Moderator, Aaron S. Kesselheim, Harvard Medical School

10:10 – 10:20am, Break

10:20 – 11:40am, Panel 2: Constituent Perspectives, Austin Hall, North Classroom (100)

Natasha Bonhomme, Genetic Alliance – From Patient to Participant: The Evolving Role of Consumers in Biospecimen Research
Russell Korobkin, UCLA Law – Conflicts Between Patients and Researchers in Biospecimen Research
Jill Barnholtz-Sloan, Case Comprehensive Cancer Center (and Quinn Ostrom) – Biobanks in the Precision Medicine Era: Perspectives from a Biobanker in the ‘Trenches’
Kate Gallin Heffernan, Verrill Dana LLP (and Andrew P. Rusczek, Emily Chi Fogler, Mark A. Borreliz, and Marylana Saadeh Helou) – Operationalizing Institutional Research Biorepositories
Moderator: Pamela Gavin, National Organization for Rare Disorders

11:40am -12:00pm, Lunch Break, Austin Hall, North Classroom (100)

Lunch will be provided. Attendees can pick up lunch in the lobby outside the North Classroom.

NEW! 12:00 – 12:40pm, LATE BREAKING LUNCH PRESENTATION: “Biospecimens and the NPRM,” Mark Barnes, Ropes and Gray, Austin Hall, North Classroom (100)

12:40 – 1:00pm, Break, Move to Langdell Hall South, Room 272

1:00 – 2:20pm, Panel 3: Policy and Practice, Langdell Hall South, Room 272

Barbara Evans, University of Houston Law Center (and Eric M. Meslin) – Biospecimen Research and For-Profit Companies
Aaron Goldenberg, Case Western Reserve University (and Suzanne Rivera) – Biospecimen Repositories and Precision Medicine: Implications for Underserved and Vulnerable Populations
Jeffrey Botkin, University of Utah (and Erin Rothwell, Rebecca Anderson, and Aaron Goldenberg) – Ethical and Policy Issues in Biobanking of Residual Bloodspots from Newborn Screening
Geoff Lomax, California Institute for Regenerative Medicine – Lessons Learned in the Collection, Use, and Sharing of Biospecimens in Stem Cell Research and Regenerative Medicine
Moderator, Mark Barnes, Ropes & Gray

2:20 – 2:30pm, Break

2:30 – 3:50pm, Panel 4: Consent Issues, Langdell Hall South, Room 272

Sara Hull, Bioethics Core of the National Human Genome Research Institute (and David Wendler,Benjamin Berkman) – The Empirical Study of Informed Consent for Genetic Research with Biospecimens: Insights and Limitations
Christine Grady, National Institutes of Health Clinical Center, Department of Bioethics – Broad Consent for Future Research on Stored Biospecimens
Nanibaa’ A. Garrison, Vanderbilt University School of Medicine – Evolving Consent: Broad and Informed Consent Challenges in the Age of Data Sharing
Erin Rothwell, University of Utah (and Erin Johnson) – Innovative Consent Methods in Biospecimen Research
Moderator, Pearl O’Rourke, Massachusetts General Hospital

3:50 – 4:00pm, Break

4:00 – 5:20pm, Panel 5: Ethical Challenges, Langdell Hall South, Room 272

David Korn, Massachusetts General Hospital (and Rachel E. Sachs) – Human Tissue Samples: Balancing Autonomy vs. Justice
Ellen Wright Clayton, Vanderbilt Law School (and Bradley A. Malin) – Modeling Risk to Privacy in Genomics Research
Suzanne Rivera, Case Western Reserve University (and Heide Aungst) – We Think We Know What Specimen Donors Want, but Under What Circumstances Should We Care?
Ivor Pritchard, Office for Human Research Protections, U. S. Department of Health and Human Services (and Julie Kaneshiro) – The Ethics of Mandating Biobanking for Future Unspecified Research: Coercive or Compelling?
Moderator, Steven Joffe, University of Pennsylvania

Please note: Susan Wolf, University of Minnesota, will not present at the conference, but will contribute a chapter to the planned edited volume on the topic, “Genomic Biobanks in the Era of Precision Medicine.”

5:20 – 5:30pm, Closing Remarks, Langdell Hall South, Room 272

5:30pm, Adjourn