Specimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday, November 16, 2015, 8:30 AM – 5:00 PM
8:30am-12:40pm: Austin Hall North (100);
12:40-5:30pm, 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.
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.
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
This event is free but space is limited. Register now!
This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University andUniversity Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from theNational Human Genome Research Institute.