The Resource Acceptable Risk in Biomedical Research : European Perspectives, by Sigmund Simonsen, (electronic resource)

Acceptable Risk in Biomedical Research : European Perspectives, by Sigmund Simonsen, (electronic resource)

Label
Acceptable Risk in Biomedical Research : European Perspectives
Title
Acceptable Risk in Biomedical Research
Title remainder
European Perspectives
Statement of responsibility
by Sigmund Simonsen
Creator
Author
Author
Subject
Language
  • eng
  • eng
Summary
This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research
Member of
Is Subseries of
http://library.link/vocab/creatorName
Simonsen, Sigmund
Dewey number
344.04/196
http://bibfra.me/vocab/relation/httpidlocgovvocabularyrelatorsaut
gY6OelJtQj4
Language note
English
LC call number
  • QH332
  • R724-726.2
Literary form
non fiction
Nature of contents
dictionaries
Series statement
International Library of Ethics, Law, and the New Medicine,
Series volume
50
http://library.link/vocab/subjectName
  • Medical ethics
  • Public health laws
  • Medicine
  • Theory of Medicine/Bioethics
  • Medical Law
  • Biomedicine general
Label
Acceptable Risk in Biomedical Research : European Perspectives, by Sigmund Simonsen, (electronic resource)
Instantiates
Publication
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
1. Introduction -- 2. Method and material -- 3. Initial conceptual clarifications -- 4. Origins of the requirement of proportionality -- 5. The purpose of the requirement of proportionality -- 6. Introduction: Part II -- 7. Which risks, burdens and potential benefits are relevant? -- 8. How to estimate risks, burdens, and potential benefits -- 9. The requirement of proportionality – initial clarifications -- 10. Therapeutic research -- 11. Nontherapeutic research -- 12. Nontherapeutic research on “vulnerable” participants -- 13. Non-interference with necessary clinical interventions and the no harm rule -- 14. Especially on randomised clinical trials, including placebo controlled clinical trials -- 15. Acceptable Risks and Burdens to Others than the Participant -- 16. Later developments during the course of the research -- 17. Legal effects of the requirement of proportionality -- 18. Summary of results -- 19. Recommendations -- 20. Perspectives -- 21. Appendix.-
Dimensions
unknown
Edition
1st ed. 2012.
Extent
1 online resource (291 p.)
Form of item
online
Isbn
9786613576590
Media category
computer
Media type code
c
Other control number
10.1007/978-94-007-2678-9
Specific material designation
remote
System control number
  • (CKB)2670000000537313
  • (EBL)886159
  • (OCoLC)779202322
  • (SSID)ssj0000609022
  • (PQKBManifestationID)11973892
  • (PQKBTitleCode)TC0000609022
  • (PQKBWorkID)10607799
  • (PQKB)10188736
  • (DE-He213)978-94-007-2678-9
  • (MiAaPQ)EBC886159
  • (EXLCZ)992670000000537313
Label
Acceptable Risk in Biomedical Research : European Perspectives, by Sigmund Simonsen, (electronic resource)
Publication
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
1. Introduction -- 2. Method and material -- 3. Initial conceptual clarifications -- 4. Origins of the requirement of proportionality -- 5. The purpose of the requirement of proportionality -- 6. Introduction: Part II -- 7. Which risks, burdens and potential benefits are relevant? -- 8. How to estimate risks, burdens, and potential benefits -- 9. The requirement of proportionality – initial clarifications -- 10. Therapeutic research -- 11. Nontherapeutic research -- 12. Nontherapeutic research on “vulnerable” participants -- 13. Non-interference with necessary clinical interventions and the no harm rule -- 14. Especially on randomised clinical trials, including placebo controlled clinical trials -- 15. Acceptable Risks and Burdens to Others than the Participant -- 16. Later developments during the course of the research -- 17. Legal effects of the requirement of proportionality -- 18. Summary of results -- 19. Recommendations -- 20. Perspectives -- 21. Appendix.-
Dimensions
unknown
Edition
1st ed. 2012.
Extent
1 online resource (291 p.)
Form of item
online
Isbn
9786613576590
Media category
computer
Media type code
c
Other control number
10.1007/978-94-007-2678-9
Specific material designation
remote
System control number
  • (CKB)2670000000537313
  • (EBL)886159
  • (OCoLC)779202322
  • (SSID)ssj0000609022
  • (PQKBManifestationID)11973892
  • (PQKBTitleCode)TC0000609022
  • (PQKBWorkID)10607799
  • (PQKB)10188736
  • (DE-He213)978-94-007-2678-9
  • (MiAaPQ)EBC886159
  • (EXLCZ)992670000000537313

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