Contributors

Acknowledgements

Preface

1

The Ethical Parameters of Experimentation / David N. Weisstub

1

2

Bringing Ethics to Human Experimentation: The American Experience / David J. Rothman

35

3

Beyond Consent / M. Gregg Bloche

44

4

Roles in Clinical and Research Ethics / David N. Weisstub

56

5

The Concept of Goodness in Medical Research: An Action-Theoretic Approach / Jan Helge Solbakk

73

6

Drawing the Distinction between Therapeutic Research and Non-Therapeutic Experimentation: Clearing a Way Through the Definitional Thicket / Simon N. Verdun-Jones David N. Weisstub

88

7

The Distinction between "Clinical Practice" and "Research": The Case of Pituitary Derived Hormones and Creutzfeldt-Jakob Disease / Margaret Allars

111

8

"Consensual" Research with Cognitively Impaired Adults: Resolving Legal Shortcomings in Adult Guardianship / George F. Tomossy David N. Weisstub

137

9

French Law and Biomedical Research: A Practical Experiment / Christian Byk

158

10

Consent to Human Experimentation in Quebec: The Application of the Civil Law Principle of Personal Inviolability to Protect Special Populations / Simon N. Verdun-Jones David N. Weisstub

175

11

The Advance Directive in Research: Prospects and Pitfalls / David N. Weisstub Anne Moorhouse

195

12

The Regulation of Human Experimentation: Historical and Contemporary Perspectives / Sev S. Fluss

222

13

International Trends in Research Regulation: Science as Negotiation / Paul M. McNeill

243

14

Models for Regulating Research: The Council of Europe And International Trends / Bernard Starkman

264

15

Research Ethics Committees and the Principle of Justice: Putting Ethics and Law to the Test / Marie-Luce Delfosse

286

16

The Institutional Review Board: Its Origins, Purpose, Function, and Future / Charles R. McCarthy

301

17

The Regulation of Biomedical Experimentation in Canada: Developing an Effective Apparatus for the Implementation of Ethical Principles in a Scientific Milieu / Simon N. Verdun-Jones David N. Weisstub

318

18

Establishing the Boundaries of Ethically Permissible Research with Vulnerable Populations / David N. Weisstub Julio Arboleda-Florez George F. Tomossy

355

19

Biomedical Experimentation with Children: Balancing the Need for Protective Measures with the Need to Respect Children's Developing Ability to Make Significant Life Decisions for Themselves / David N. Weisstub Simon N. Verdun-Jones Janet Walker

380

20

Biomedical Experimentation Involving Elderly Subjects: The Need to Balance Limited. Benevolent Protection with Recognition of a Long History of Autonomous Decision-Making / David N. Weisstub Simon N. Verdun-Jones Janet Walker

405

21

Ethical Research with Vulnerable Populations: The Mentally Disordered / Julio Arboleda-Florez David N. Weisstub

433

22

Ethics in Psychiatric Research with Incompetent Patients / Hanfried Helmchen

451

23

The Conditions of Personhood as Applied to Incompetent Persons / Michel Silberfeld

466

24

Ethical Research with Vulnerable Populations: The Developmentally Disabled / David N. Weisstub Julio Arboleda-Florez

479

25

Ethics in Research with Detained Individuals / Norbert Nedopil

495

26

Prisoners as Subjects of Biomedical Experimentation: Examining the Arguments For and Against a Total Ban / Simon N. Verdun-Jones David N. Weisstub Julio Arboleda-Florez

503

27

Ethical Questions Pertaining to the Use of Placebos / Christian Mormont

531

28

Resolving the Inherent Dissonance between the Doctor's Roles as Healer and Researcher: A Proposal / Dominique Sprumont

547

29

Ethical Issues in Epidemiological Research / Julio Arboleda-Florez David N. Weisstub Heather Holley

557

30

Ethical Guidelines for Epidemiological Research / Povl Riis

588

31

Epidemiology and the Ownership of Health Data: Ethical, Legal and Social Aspects / Claes-Goran Westrin Tore Nilstun

599

Bibliography

609