Specimen science : ethics and policy implications
(Book)

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.