- 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
Toward Human Research Protection That Is Evidence Based and Participant Centered
Toward Human Research Protection That Is Evidence Based and Participant Centered
- Chapter:
- (p.113) 7 Toward Human Research Protection That Is Evidence Based and Participant Centered
- Source:
- Human Subjects Research Regulation
- Author(s):
Michael McDonald
Susan Cox
Anne Townsend
- Publisher:
- The MIT Press
This chapter addresses a fundamental question of whether current research protection systems based on compliance with rules actually do what they purport to do – protect participants without needlessly impeding socially beneficial research. Based on the authors’ prior research, this chapter contends that it is essential to understand 1) how subjects actually experience research participation and (2) how these experiences are interpreted by researchers and research ethics committee members. Using specific examples drawn from subjects' accounts of risk, motivations for research participation, personal responsibility, and benefits/burdens, the authors argue in favour of an evidence-based system based on careful assessment of the actual impacts of research participation on subjects' lives, as opposed to the current rule-compliance system. A key premise of this approach is that the experience of research participants is pivotal to meaningful human subjects’ research protection. In this domain, they are sociologically and ethically “key” informants.
Keywords: Benefits, Burdens, Risk, Motives for research participation, Participant responsibility, Research participant experiences, Evidence based ethics review
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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
