- 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
De minimis Risk: A Suggestion for a New Category of Research Risk
De minimis Risk: A Suggestion for a New Category of Research Risk
- Chapter:
- (p.31) 2 De minimis Risk: A Suggestion for a New Category of Research Risk
- Source:
- Human Subjects Research Regulation
- Author(s):
Rosamond Rhodes
- Publisher:
- The MIT Press
This chapter argues for establishing de minimis risk as a new sub-category of research risk. It regards informed consent as an important consideration in human subject research, but not an absolute requirement. Instead it urges a more nuanced and contextual approach to determining when informed consent must be obtained. The level of risks and harms involved in participation, as well as the burdens, costs and feasibility of providing the information all have to be considered. For some studies, robust informed consent from the participant should be the standard. For others, such as biobank research, agreement based on less than full information will be adequate. And in some circumstances, such as registry and public health research, no consent is required at all. This proposal puts the focus of research ethics where it belongs, on an assessment of risks and benefits, and reduces unreasonable obstacles that have inhibited research. Allowing studies to proceed under the category of de minimis risk would strike a reasonable balance between advancing biomedical science and societal health, and the importance of respecting persons.
Keywords: informed consent, biobanks, registry, public health, risk, benefit, respect
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- 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
