- Title Pages
- Basic Bioethics
- Dedication
- Series Foreword
- Acknowledgments
- Introduction
-
1 Setting the Stage: The Past and Present of Human Subjects Research Regulations - Introduction to Part I—Regulation of Risk
-
2 De minimis Risk: A Suggestion for a New Category of Research Risk -
3 Risk Level, Research Oversight, and Decrements in Participant Protections - Introduction to Part II—Protection of Vulnerable Populations
-
4 Classifying Military Personnel as a Vulnerable Population -
5 Children as Research Partners in Community Pediatrics -
6 Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1 -
III Redefining the Participant–Researcher Relationship and the Role of IRBs -
7 Toward Human Research Protection That Is Evidence Based and Participant Centered -
8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors? -
9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves? -
10 Democratic Deliberation and the Ethical Review of Human Subjects Research -
11 IRBs and the Problem of “Local Precedents” -
IV Specimens, Data, and Privacy -
12 Biospecimen Exceptionalism in the ANPRM -
13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water? -
14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement -
15 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens -
16 Considering Privacy Protections for Human Research -
17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data -
V aradigm Shifts in Research Ethics -
18 What Is This Thing Called Research? -
19 What's Right about the “Medical Model” in Human Subjects Research Regulation -
20 Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity -
21 Protecting Human Research Subjects as Human Research Workers -
22 Getting Past Protectionism: Is It Time to Take off the Training Wheels? - Appendix: Regulatory Changes in the ANPRM
- Comparison of Existing Rules with Some of the Changes Being Considered
- Contributors
- Index
Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement
Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement
- Chapter:
- (p.221) 14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement
- Source:
- Human Subjects Research Regulation
- Author(s):
Carol Weil
Hilary Shutak
Benjamin Fombonne
Nicole Lockhart
- Publisher:
- The MIT Press
The use of human biological samples in medical research has the potential to transform our understanding of health and disease in the age of the genome, but the collection and banking of samples for currently unknowable future research purposes presents both ethical and legal challenges. Given the primacy of biospecimens in genomic research, it is critical to develop regulatory policies that appropriately balance public preferences about privacy and consent with the scientific imperatives of investigator access and broad data sharing. The Advanced Notice of Proposed Rulemaking (ANPRM) proposes a requirement for written informed consent for research uses of previously collected human biological samples. This chapter explores the impact of that regulatory proposal with respect to the ethics and operations of research involving biospecimens. It describes specific shortcomings of the current federal regulations protecting human biospecimens and associated data used in research, explains how proposed changes to consent procedures in the ANPRM could address these limitations while at the same time pose new challenges for health care institutions, and finally, sets forth the thesis that enhanced education and collaboration with participant communities would greatly improve implementation of the ANPRM’s written consent requirement for secondary uses of biospecimens in research.
Keywords: Informed consent, Biobanking, Genomics research, Community engagement, Secondary research with tissue
MIT Press Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.
Please, subscribe or login to access full text content.
If you think you should have access to this title, please contact your librarian.
To troubleshoot, please check our FAQs, and if you can't find the answer there, please contact us.
- Title Pages
- Basic Bioethics
- Dedication
- Series Foreword
- Acknowledgments
- Introduction
-
1 Setting the Stage: The Past and Present of Human Subjects Research Regulations - Introduction to Part I—Regulation of Risk
-
2 De minimis Risk: A Suggestion for a New Category of Research Risk -
3 Risk Level, Research Oversight, and Decrements in Participant Protections - Introduction to Part II—Protection of Vulnerable Populations
-
4 Classifying Military Personnel as a Vulnerable Population -
5 Children as Research Partners in Community Pediatrics -
6 Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1 -
III Redefining the Participant–Researcher Relationship and the Role of IRBs -
7 Toward Human Research Protection That Is Evidence Based and Participant Centered -
8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors? -
9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves? -
10 Democratic Deliberation and the Ethical Review of Human Subjects Research -
11 IRBs and the Problem of “Local Precedents” -
IV Specimens, Data, and Privacy -
12 Biospecimen Exceptionalism in the ANPRM -
13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water? -
14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement -
15 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens -
16 Considering Privacy Protections for Human Research -
17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data -
V aradigm Shifts in Research Ethics -
18 What Is This Thing Called Research? -
19 What's Right about the “Medical Model” in Human Subjects Research Regulation -
20 Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity -
21 Protecting Human Research Subjects as Human Research Workers -
22 Getting Past Protectionism: Is It Time to Take off the Training Wheels? - Appendix: Regulatory Changes in the ANPRM
- Comparison of Existing Rules with Some of the Changes Being Considered
- Contributors
- Index
