Specimen Science

ISBN: 9780262339711 | Copyright 2017


Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research.

After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators.

ContributorsRebecca A. Anderson, Heide Aungs, Avery Avrakotos, Mark Barnes, Jill Barnholtz-Sloan, Benjamin Berkman, Barbara E. Bierer, Mark A. Borreliz, Jeffrey R. Botkin, Dan Brock, Ellen Wright Clayton, I. Glenn Cohen, Lisa Eckstein, Barbara J. Evans, Emily Chi Fogler, Nanibaa' A. Garrison, Pamela Gavin, Aaron J. Goldenberg, Christine Grady, Kate Gallin Heffernan, Marylana Saadeh Helou, Sara Chandros Hull, Elisa A. Hurley, Steven Joffe, Erin P. Johnson, Julie Kaneshiro, Aaron S. Kesselheim, Isaac Kohane, David Korn, Russell Korobkin, Bernard Lo, Geoffrey Lomax, Kimberly Hensle Lowrance, Holly Fernandez Lynch, Bradley A. Malin, Karen J. Maschke, Eric M. Meslin, P. Pearl O'Rourke, Quinn T. Ostrom, David Peloquin, Rebecca Pentz, Jane Perlmutter, Ivor Pritchard, Suzanne M. Rivera, Erin Rothwell, Andrew P. Rusczek, Rachel E. Sachs, Carol Weil, David Wendler, Benjamin Wilfond, Susan M. Wolf

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Contents (pg. vii)
Series Foreword (pg. xi)
Acknowledgments (pg. xiii)
Introduction (pg. 1)
References (pg. 17)
I Background and Foundations (pg. 19)
Introduction (pg. 21)
1 Legal and Regulatory Issues in Biospecimen Research: National and International Perspectives (pg. 25)
United States (pg. 25)
Europe (pg. 36)
China (pg. 38)
Brazil (pg. 39)
India (pg. 40)
Challenges in International Biobanking (pg. 41)
Conclusion (pg. 42)
Notes (pg. 43)
References (pg. 45)
2 Property Rights and the Control of Human Biospecimens (pg. 47)
Tissues as Chattels (pg. 47)
The Information Within (pg. 49)
The Transfer of Property Rights (pg. 51)
Compensation (pg. 55)
The Complicating Interaction of Informed Consent Law and Privacy Concerns (pg. 59)
Conclusion (pg. 61)
Notes (pg. 62)
References (pg. 63)
3 Research with Biospecimens: Tensions, Tradeoffs, and Trust (pg. 67)
Informed Consent (pg. 69)
Privacy and Identifiability (pg. 73)
Conclusion (pg. 78)
Notes (pg. 79)
References (pg. 79)
II Roots of the Debate: Autonomy, Justice, and Privacy (pg. 85)
Introduction (pg. 87)
References (pg. 90)
4 Research on Human Tissue Samples: Balancing Autonomy vs. Justice (pg. 91)
Background (pg. 91)
Balancing Autonomy with Justice (pg. 95)
The Legal Landscape (pg. 99)
Sustaining Public Support through Rigorous Oversight and Enforcement of Standards (pg. 102)
Conclusion (pg. 104)
References (pg. 104)
5 Biospecimens, Commercial Research, and the Elusive Public Benefit Standard (pg. 107)
Is the Bias against Commercial Research Rational? (pg. 108)
Ethics of Access to Identifiable Biospecimens (pg. 111)
The Missing Public Benefit Standard in Current Regulations (pg. 114)
Clarifying the Public Benefit Standard for Research (pg. 116)
Conclusion (pg. 120)
Note (pg. 120)
References (pg. 121)
6 What Specimen Donors Want (and Considerations That May Sometimes Matter More) (pg. 125)
Why Donors Give Specimens (pg. 125)
Barriers to Donation (pg. 128)
Must (Can) We Always Honor Donors’ Wishes? (pg. 130)
Discussion (pg. 133)
Conclusion (pg. 135)
Notes (pg. 135)
References (pg. 136)
7 Assessing Risks to Privacy in Biospecimen Research (pg. 143)
What Is Involved in Re-identifying Biospecimens from Which Traditional Identifiers Have Been Removed? (pg. 144)
Understanding the Likelihood of Re-identification (pg. 146)
The Contributions of Modeling (pg. 149)
What Needs to Happen to Achieve a More Appropriate Balance of Risk and Benefit for Research Using Biospecimens and Associated Data (pg. 151)
Notes (pg. 153)
References (pg. 153)
III Consent and Its Implications (pg. 159)
Introduction (pg. 161)
8 Broad Consent for Research on Biospecimens (pg. 167)
Changing Regulations and Guidance (pg. 168)
Ethical Reasons in Favor of Consent for Research with Biospecimens (pg. 169)
Empirical Support for Consent for Research with Biospecimens (pg. 170)
Considering Costs and Burdens of Obtaining Consent (pg. 172)
Objections to Broad Consent (pg. 173)
Proposal for Broad Consent (pg. 174)
Need for Future Research and Debate (pg. 178)
Conclusion (pg. 178)
Note (pg. 179)
References (pg. 179)
9 Evolving Consent: Insights from Researchers and Participants in the Age of Broad Consent and Data Sharing (pg. 185)
Genetic Research with Tribes (pg. 185)
Data Sharing and Tribal Sovereignty (pg. 190)
Changes to the Common Rule (pg. 192)
Broad Consent, Data Sharing, and Trust (pg. 193)
Participants’ Perspectives on Broad Consent (pg. 195)
Conclusion (pg. 196)
References (pg. 197)
10 The Ethics of the Biospecimen Package Deal: Coercive? Undue? Just Wrong? Or Maybe Not? (pg. 201)
The Belmont Report, Current Regulations, and OHRP Guidance (pg. 202)
OHRP Compliance Actions (pg. 203)
Does Identifiability of Biospecimens Matter? (pg. 204)
Are Package Deals Coercive? (pg. 205)
Do Package Deals Create Undue Influence? (pg. 207)
Do Package Deals Inhibit Voluntary Informed Consent? (pg. 213)
Conclusion (pg. 214)
Notes (pg. 216)
References (pg. 216)
IV Special Populations and Contexts (pg. 219)
Introduction (pg. 221)
11 Biorepositories and Precision Medicine: Implications for Underserved and Vulnerable Populations (pg. 225)
Background: Previous Scholarship on Research and Underserved Populations (pg. 226)
Biorepository/Cohort Design and Participant Recruitment (pg. 228)
Biorepository Maintenance and Management (pg. 231)
Research Use and Translation of Results (pg. 233)
Conclusions (pg. 237)
References (pg. 238)
12 The Ethical Management of Residual Newborn Screening Bloodspots (pg. 243)
Public Attitudes (pg. 247)
Professional Statements (pg. 248)
Changes in Federal Policy (pg. 249)
Conclusions (pg. 252)
Notes (pg. 253)
References (pg. 253)
13 Informed Consent for Genetic Research on Rare Diseases: Insights from Empirical Research (pg. 257)
Broad vs. Specific Consent (pg. 258)
Systematic Reviews of Public Attitudes about Broad Consent (pg. 260)
Attitudes of Persons with Rare Diseases and Their Family Members (pg. 262)
Discussion (pg. 268)
Notes (pg. 270)
References (pg. 270)
14 Considerations for the Use of Biospecimens in Induced Pluripotent Stem (iPS) Cell Research (pg. 273)
Unique Ethics Policy Considerations (pg. 275)
Donor Consent (pg. 277)
Previously Banked Research Specimens (pg. 284)
Conclusion (pg. 285)
References (pg. 286)
V Governance, Accountability, and Operational Considerations (pg. 291)
Introduction (pg. 293)
Note (pg. 297)
15 Governance Issues for Biorepositories and Biospecimen Research (pg. 299)
The UK Biobank and the Road to Governance (pg. 300)
What Should Biospecimen Repository Governance Look Like? (pg. 303)
The Biospecimen Repository Landscape in the United States (pg. 306)
The PMI-CP Governance Model: Raising the Bar for Biospecimen Repository Governance? (pg. 307)
Conclusion (pg. 311)
Notes (pg. 312)
References (pg. 312)
16 The Rise of Patient-Driven Research on Biospecimens and Data: The Second Revolution (pg. 317)
The History of Excluding Patients from Biospecimen Research (pg. 318)
The Patient and Family Revolution (pg. 324)
Evolving New Models for Research and Biospecimen Resources (pg. 326)
Conclusion (pg. 329)
Note (pg. 329)
References (pg. 330)
17 Informing the Public and Including It in Discussions about Biospecimens (pg. 335)
Patients’ Understanding of Biospecimen Research (pg. 337)
Donor and Patient Education (pg. 338)
Perception vs. Reality (pg. 339)
Donation Utility (pg. 340)
Empowered Patient Involvement (pg. 342)
Informed Consent (pg. 343)
Summary (pg. 348)
References (pg. 349)
18 Investigator’s Commitment during the Consent Process for Biospecimen Research (pg. 353)
Ever-Changing Purpose of Consent (pg. 358)
Awareness and Accountability (pg. 358)
Inconsistent Nature of Biospecimen Research (pg. 359)
Similarities and Differences with Clinical Care (pg. 360)
Components of the Investigator Oath (pg. 361)
Discussion (pg. 361)
Conclusion (pg. 364)
References (pg. 364)
19 Biospecimen Repositories in the Era of Precision Medicine: Perspectives from a Biobanker “in the Trenches” (pg. 367)
Biobanking 101: The Consenting Process, Participant Information, and Data Sharing (pg. 368)
Biobanking Governance and the IRB (pg. 370)
Assuring Quality in Biospecimen and Data Collection (pg. 370)
Disease-Team Collaboration for Prioritization of Biospecimen Repository Resources (pg. 373)
Collaboration within and between Institutions (pg. 374)
Biospecimen Annotation and Longitudinal Collection Data of Outcomes Data (pg. 374)
Working toward Long-Term Sustainability of Biobanking (pg. 376)
Conclusions (pg. 377)
Notes (pg. 377)
References (pg. 378)
20 Operationalizing Institutional Research Biospecimen Repositories: A Plan to Address Practical and Legal Considerations (pg. 383)
Planning for an Institutional Biospecimen Repository: Drafting the Protocol and Exploring the Mechanics of Informed Consent (pg. 383)
Planning for Third-Party Interests in Specimens (pg. 390)
Education Efforts (pg. 393)
Conclusion (pg. 397)
Appendix: Biospecimen Repository Planning Checklist for Kickoff Meeting (pg. 397)
Notes (pg. 399)
References (pg. 400)
Contributors (pg. 403)
Index (pg. 409)
Basic Bioethics (pg. B-1)
Books Acquired under the Editorship of Glenn McGee and Arthur Caplan (pg. B-1)
Books Acquired under the Editorship of Arthur Caplan (pg. B-2)