November 16, 2015 8:30 AM - 5:30 PM
Conferences
2015-2016
8am-12:40pm: Austin Hall North (100); 12:40-5:30pm, Langdell Hall South, Room 272
Harvard Law School, Cambridge, MA

VIDEO: Welcome from Coorganizers I. Glenn Cohen (Petrie-Flom), Holly Fernandez Lynch (Petrie-Flom), Barbara Bierer (Harvard Catalyst and MRCT), Suzanne Rivera (Case Western Reserve University)
VIDEO: Panel 1: Elisa Hurley, "Research with Biospecimens: A Brief History"
VIDEO: Panel 1: David Peloquin, "Legal Considerations and International Perspectives"
VIDEO: Panel 1: Karen J. Maschke, "Governance Issues for Biobanks and Biospecimen Research"
VIDEO: Panel 1: Audience Q & A moderated by Aaron S. Kesselheim
VIDEO: Panel 2: Natasha Bonhomme, "From Patient to Participant: The Evolving Role of Consumers in Biospecimen Research"
VIDEO: Panel 2: Russell Korobkin, "Property Rights and the Control of Human Tissue Samples"
VIDEO: Panel 2: Jill S. Barnholtz-Sloan, "Biobanks in the Precision Medicine Era: Perspectives from a Biobanker in the 'Trenches'"
VIDEO: Panel 2: Kate Gallin Heffernan, "Operationalizing Institutional Research Biorepositories: A Plan to Address Practical and Legal Considerations"
VIDEO: Panel 2: Audience Q & A moderated by Pamela Gavin
VIDEO: Lunchtime Talk: Mark Barnes, "Biospecimens and the NPRM"
VIDEO: Lunchtime Talk: Q & A (Part 1)
VIDEO: Lunchtime Talk: Q & A (Part 2)
VIDEO: Panel 3: Barbara Evans, "Biospecimens, Commercial Research, and the Elusive Public Benefit Standard"
VIDEO: Panel 3: Aaron Goldenberg, "Biospecimen Repositories and Precision Medicine: Implications for Underserved and Vulnerable Populations"
VIDEO: Panel 3: Jeffrey Botkin, "The Ethical Management of Residual Newborn Screening Bloodspots"
VIDEO: Panel 3: Geoffrey Lomax, "Considerations for the Use of Bio-Specimens in Induced Pluripotent Stem (iPS) Cell Research"
VIDEO: Panel 3: Audience Q & A moderated by Mark Barnes
VIDEO: Panel 4: Christine Grady, "Broad Consent for Research on Biospecimens"
VIDEO: Panel 4: Sara Chandros Hull, "Informed Consent for Genetic Research on Rare Diseases: Insights from Empirical Research"
VIDEO: Panel 4: Nanibaa’ A. Garrison, "Evolving Consent: Insights from the Havasupai Case in the Age of Broad Consent and Data Sharing"
VIDEO: Panel 4: Erin Rothwell, "Investigator’s Role for Innovative Consent Methods with Biospecimen Research"
VIDEO: Panel 4: Audience Q & A moderated by Pearl O'Rourke
VIDEO: Panel 5: Rachel E. Sachs, "Human Tissue Samples: Balancing Autonomy vs. Justice"
VIDEO: Panel 5: Ellen Wright Clayton, "Modeling Risk to Privacy in Genomics Research"
VIDEO: Panel 5: Suzanne M. Rivera, "What Specimen Donors Think (and Considerations That May Sometimes Matter More)"
VIDEO: Panel 5: Ivor Pritchard and Julie Kaneshiro, "The Ethics of the Biospecimen Package Deal: Coercive, Undue or Just Wrong?"
VIDEO: Panel 5: Audience Q & A moderated by Steven Joffe

Learn more about the presentations - check out some of our speakers' slides below!

Couldn't attend in person? Join the conversation online: Go to @PetrieFlom on Twitter and use #specimenscience!

Description

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.  

This symposium addressed 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 covered 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 will be published as an edited volume by MIT Press in 2017.

Agenda

All panels included time for audience Q & A.

8:30 - 9:00am, Breakfast and Registration

9:00 - 9:05am, Introductory Remarks

9:05 - 10:10, Panel 1: Background and Foundations

  • Elisa Hurley, PRIM&R (and Kimberly Hensle Lowrance and Avery Avrakotos) - Research with Biospecimens: A Brief History

  • David Peloquin, Ropes & Gray LLP (and Barbara Bierer and Mark Barnes) - Legal Considerations and International Perspectives

  • Karen J. 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

  • Natasha Bonhomme, Genetic Alliance - From Patient to Participant: The Evolving Role of Consumers in Biospecimen Research

  • Russell Korobkin, UCLA Law - Property Rights and the Control of Human Tissue Samples 

  • Jill S. Barnholtz-Sloan, Case Comprehensive Cancer Center (and Quinn T. Ostrom) - Biobanks in the Precision Medicine Era: Perspectives from a Biobanker in the 'Trenches'

  • Kate Gallin Heffernan, Verrill Dana LLP (and Mark A. Borreliz, Emily Chi FoglerMarylana Saadeh Helou, and Andrew P. Rusczek) - Operationalizing Institutional Research Biorepositories: A Plan to Address Practical and Legal Considerations

  • Moderator: Pamela Gavin, National Organization for Rare Disorders

11:40am -12:00pm, Lunch Break

12:00 - 12:40pm, Lunch Presentation: "Biospecimens and the NPRM," Mark Barnes, Ropes and Gray LLP

12:40 - 1:00pm, Break

1:00 - 2:20pm, Panel 3: Policy and Practice

  • Barbara Evans, University of Houston Law Center (and Eric M. Meslin) - Biospecimens, Commercial Research, and the Elusive Public Benefit Standard

  • Aaron Goldenberg, Case Western Reserve University (and Suzanne M. 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) - The Ethical Management of Residual Newborn Screening Bloodspots

  • Geoffrey Lomax, California Institute for Regenerative Medicine - Considerations for the Use of Bio-Specimens in Induced Pluripotent Stem (iPS) Cell Research

  • Moderator, Mark Barnes, Ropes & Gray

2:20 - 2:30pm, Break

2:30 - 3:50pm, Panel 4: Consent Issues

  • Christine Grady, National Institutes of Health Clinical Center, Department of Bioethics (and Lisa EcksteinBen BerkmanDan BrockSara HullBernie Lo, Rebecca PentzCarol WeilBenjamin S. Wilfond, and Dave Wendler) - Broad Consent for Research on Biospecimens

  • Sara Chandros Hull, Bioethics Core of the National Human Genome Research Institute - Informed Consent for Genetic Research on Rare Diseases: Insights from Empirical Research

  • Nanibaa’ A. Garrison, Seattle Children’s Research Institute and the University of Washington - Evolving Consent: Insights from the Havasupai Case in the Age of Broad Consent and Data Sharing

  • Erin Rothwell, University of Utah (and Erin Johnson) - Investigator’s Role for Innovative Consent Methods with Biospecimen Research

  • Moderator, Pearl O'Rourke, Partners HealthCare

3:50 - 4:00pm, Break

4:00 - 5:20pm, Panel 5: Ethical Challenges

  • Rachel E. Sachs, Petrie-Flom Center, Harvard Law School (and David Korn) - 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 M. Rivera, Case Western Reserve University (and Heide Aungst) - What Specimen Donors Think (and Considerations That May Sometimes Matter More)

  • Ivor Pritchard, Office for Human Research Protections, U. S. Department of Health and Human Services (and Julie Kaneshiro) - The Ethics of the Biospecimen Package Deal: Coercive, Undue or Just Wrong?

  • 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 (with Isaac Kohane), “Genomic Biobanks in the Era of Patient-Driven Precision Medicine: Revamping Norms, Policies & Practices.”

5:20 - 5:30pm, Closing Remarks

5:30pm, Adjourn

Learn More!

Couldn't attend the event? Check out some of the speakers' slide presentations!

 

This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University 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 was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.  

Videos

VIDEO: Welcome from Coorganizers I. Glenn Cohen (Petrie-Flom), Holly Fernandez Lynch (Petrie-Flom), Barbara Bierer (Harvard Catalyst and MRCT), Suzanne Rivera (Case Western Reserve University)
VIDEO: Panel 1: Elisa Hurley, "Research with Biospecimens: A Brief History"
VIDEO: Panel 1: David Peloquin, "Legal Considerations and International Perspectives"
VIDEO: Panel 1: Karen J. Maschke, "Governance Issues for Biobanks and Biospecimen Research"
VIDEO: Panel 1: Audience Q & A moderated by Aaron S. Kesselheim
VIDEO: Panel 2: Natasha Bonhomme, "From Patient to Participant: The Evolving Role of Consumers in Biospecimen Research"
VIDEO: Panel 2: Russell Korobkin, "Property Rights and the Control of Human Tissue Samples"
VIDEO: Panel 2: Jill S. Barnholtz-Sloan, "Biobanks in the Precision Medicine Era: Perspectives from a Biobanker in the 'Trenches'"
VIDEO: Panel 2: Kate Gallin Heffernan, "Operationalizing Institutional Research Biorepositories: A Plan to Address Practical and Legal Considerations"
VIDEO: Panel 2: Audience Q & A moderated by Pamela Gavin
VIDEO: Lunchtime Talk: Mark Barnes, "Biospecimens and the NPRM"
VIDEO: Lunchtime Talk: Q & A (Part 1)
VIDEO: Lunchtime Talk: Q & A (Part 2)
VIDEO: Panel 3: Barbara Evans, "Biospecimens, Commercial Research, and the Elusive Public Benefit Standard"
VIDEO: Panel 3: Aaron Goldenberg, "Biospecimen Repositories and Precision Medicine: Implications for Underserved and Vulnerable Populations"
VIDEO: Panel 3: Jeffrey Botkin, "The Ethical Management of Residual Newborn Screening Bloodspots"
VIDEO: Panel 3: Geoffrey Lomax, "Considerations for the Use of Bio-Specimens in Induced Pluripotent Stem (iPS) Cell Research"
VIDEO: Panel 3: Audience Q & A moderated by Mark Barnes
VIDEO: Panel 4: Christine Grady, "Broad Consent for Research on Biospecimens"
VIDEO: Panel 4: Sara Chandros Hull, "Informed Consent for Genetic Research on Rare Diseases: Insights from Empirical Research"
VIDEO: Panel 4: Nanibaa’ A. Garrison, "Evolving Consent: Insights from the Havasupai Case in the Age of Broad Consent and Data Sharing"
VIDEO: Panel 4: Erin Rothwell, "Investigator’s Role for Innovative Consent Methods with Biospecimen Research"
VIDEO: Panel 4: Audience Q & A moderated by Pearl O'Rourke
VIDEO: Panel 5: Rachel E. Sachs, "Human Tissue Samples: Balancing Autonomy vs. Justice"
VIDEO: Panel 5: Ellen Wright Clayton, "Modeling Risk to Privacy in Genomics Research"
VIDEO: Panel 5: Suzanne M. Rivera, "What Specimen Donors Think (and Considerations That May Sometimes Matter More)"
VIDEO: Panel 5: Ivor Pritchard and Julie Kaneshiro, "The Ethics of the Biospecimen Package Deal: Coercive, Undue or Just Wrong?"
VIDEO: Panel 5: Audience Q & A moderated by Steven Joffe

Tags

bioethics   genetics   health information technology   health law policy   human subjects research   human tissue   pediatrics   privacy   research   stem cells