- 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
What Is This Thing Called Research?
What Is This Thing Called Research?
- Chapter:
- (p.285) 18 What Is This Thing Called Research?
- Source:
- Human Subjects Research Regulation
- Author(s):
Zachary M. Schrag
- Publisher:
- The MIT Press
This chapter explores various ways of distinguishing research that should and should not be covered by human subjects regulations. Aligning regulations to the underlying statute, which only covers “biomedical and behavioral research,” would return scrutiny to the areas of concern identified by Congress. Alternatively, defining “human subjects” more narrowly as those people in the power of an investigator might focus energy on the prevention of the abuse of power. By contrast, relying on distinctions between generalizable knowledge and nongeneralizable knowledge is the very worst strategy, for in three decades policy makers have proved unable to agree on what this distinction means.
Keywords: Biomedical research, Behavioral research, Social Science, Human Subjects, Generalizability, Regulations
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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
