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Introduction / Suzanne M. Rivera, Barbara E. Bierer, I. Glenn Cohen, Holly Fernandez Lynch
I. Background and foundations. Introduction / Aaron S. Kesselheim
Legal and regulatory issues in biospecimen research : national and international perspectives / David Peloquin, Mark Barnes, and Barbara E. Bierer
Property rights and the control of human biospecimens / Russell Korobkin
Research with biospecimens : tensions, tradeoffs, and trust / Elisa A. Hurley, Kimberly Hensle Lowrance, and Avery Avrakotos
II. Roots of the debate : autonomy, justice, and privacy. Introduction / Steven Joffe
Research on human tissue samples : balancing autonomy vs. justice / David Korn and Rachel E. Sachs
Biospecimens, commercial research, and the elusive public benefit standard / Barbara J. Evans and Eric M. Meslin
What specimen donors want (and considerations that may sometimes matter more) / Suzanne M. Rivera and Heide Aungst
Assessing risks to privacy in biospecimen research / Ellen Wright Clayton and Bradley A. Malin
III. Consent and its implications. Introduction / P. Pearl O'Rourke
Broad consent for research on biospecimens / Christine Grady, Lisa Eckstein, Benjamin Berkman, Dan Brock, Sara Chandros Hull, Bernard Lo, Rebecca Pentz, Carol Weil, Benjamin S. Wilfond, and David Wendler
Evolving consent : insights from researchers and participants in the age of broad consent and data sharing / Nanibaa' A. Garrison
The ethics of the biospecimen package deal : coercive? Undue? Just wrong? Or maybe not? / Ivor Pritchard and Julie Kaneshiro
IV. Special populations and contexts. Introduction / Pamela Gavin
Biorepositories and precision medicine : implications for underserved and vulnerable populations / Aaron J. Goldenberg and Suzanne M. Rivera
The ethical management of residual newborn screening bloodspots / Jeffrey R. Botkin, Erin Rothwell, Rebecca A. Anderson, and Aaron J. Goldenberg
Informed consent for genetic research on rare diseases : insights from empirical research / Sara Chandros Hull
Considerations for the use of biospecimens in induced pluripotent stem (iPS) cell research / Geoffrey Lomax and Heide Aungst
V. Governance, accountability, and operational considerations. Introduction / Barbara E. Bierer
Governance issues for biorepositories and biospecimen research / Karen J. Maschke
The rise of patient-driven research on biospecimens and data : the second revolution / Susan M. Wolf and Isaac S. Kohane
Informing the public and including it in discussions about biospecimens / Jane Perlmutter and Heide Aungst
Investigator's commitment during the consent process for biospecimen research / Erin Rothwell and Erin Johnson
Biospecimen repositories in the era of precision medicine : perspectives from a biobanker "in the trenches" / Quinn T. Ostrom and Jill S. Barnholtz-Sloan
Operationalizing institutional research biospecimen repositories : a plan to address practical and legal considerations / Kate Gallin Heffernan, Emily Chi Fogler, Marylana Saadeh Helou, and Andrew P. Rusczek.
I. Background and foundations. Introduction / Aaron S. Kesselheim
Legal and regulatory issues in biospecimen research : national and international perspectives / David Peloquin, Mark Barnes, and Barbara E. Bierer
Property rights and the control of human biospecimens / Russell Korobkin
Research with biospecimens : tensions, tradeoffs, and trust / Elisa A. Hurley, Kimberly Hensle Lowrance, and Avery Avrakotos
II. Roots of the debate : autonomy, justice, and privacy. Introduction / Steven Joffe
Research on human tissue samples : balancing autonomy vs. justice / David Korn and Rachel E. Sachs
Biospecimens, commercial research, and the elusive public benefit standard / Barbara J. Evans and Eric M. Meslin
What specimen donors want (and considerations that may sometimes matter more) / Suzanne M. Rivera and Heide Aungst
Assessing risks to privacy in biospecimen research / Ellen Wright Clayton and Bradley A. Malin
III. Consent and its implications. Introduction / P. Pearl O'Rourke
Broad consent for research on biospecimens / Christine Grady, Lisa Eckstein, Benjamin Berkman, Dan Brock, Sara Chandros Hull, Bernard Lo, Rebecca Pentz, Carol Weil, Benjamin S. Wilfond, and David Wendler
Evolving consent : insights from researchers and participants in the age of broad consent and data sharing / Nanibaa' A. Garrison
The ethics of the biospecimen package deal : coercive? Undue? Just wrong? Or maybe not? / Ivor Pritchard and Julie Kaneshiro
IV. Special populations and contexts. Introduction / Pamela Gavin
Biorepositories and precision medicine : implications for underserved and vulnerable populations / Aaron J. Goldenberg and Suzanne M. Rivera
The ethical management of residual newborn screening bloodspots / Jeffrey R. Botkin, Erin Rothwell, Rebecca A. Anderson, and Aaron J. Goldenberg
Informed consent for genetic research on rare diseases : insights from empirical research / Sara Chandros Hull
Considerations for the use of biospecimens in induced pluripotent stem (iPS) cell research / Geoffrey Lomax and Heide Aungst
V. Governance, accountability, and operational considerations. Introduction / Barbara E. Bierer
Governance issues for biorepositories and biospecimen research / Karen J. Maschke
The rise of patient-driven research on biospecimens and data : the second revolution / Susan M. Wolf and Isaac S. Kohane
Informing the public and including it in discussions about biospecimens / Jane Perlmutter and Heide Aungst
Investigator's commitment during the consent process for biospecimen research / Erin Rothwell and Erin Johnson
Biospecimen repositories in the era of precision medicine : perspectives from a biobanker "in the trenches" / Quinn T. Ostrom and Jill S. Barnholtz-Sloan
Operationalizing institutional research biospecimen repositories : a plan to address practical and legal considerations / Kate Gallin Heffernan, Emily Chi Fogler, Marylana Saadeh Helou, and Andrew P. Rusczek.