Acceptable Risk in Biomedical Research (Record no. 285747)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03980nam a22005415i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-94-007-2678-9 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20160615110940.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 120102s2012 ne | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9789400726789 |
| -- | 978-94-007-2678-9 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-94-007-2678-9 |
| Source of number or code | doi |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Alfaisal Main Library |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | QH332 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | R724-726.2 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PSAD |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MB |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED050000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 610.1 |
| Edition number | 23 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 174.2 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Simonsen, Sigmund. |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Acceptable Risk in Biomedical Research |
| Medium | [electronic resource] : |
| Remainder of title | European Perspectives / |
| Statement of responsibility, etc | by Sigmund Simonsen. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Place of production, publication, distribution, manufacture | Dordrecht : |
| Name of producer, publisher, distributor, manufacturer | Springer Netherlands, |
| Date of production, publication, distribution, manufacture | 2012. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XVI, 296 p. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content Type Term | text |
| Content Type Code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media Type Term | computer |
| Media Type Code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier Type Term | online resource |
| Carrier Type Code | cr |
| Source | rdacarrier |
| 347 ## - | |
| -- | text file |
| -- | |
| -- | rda |
| 490 1# - SERIES STATEMENT | |
| Series statement | International Library of Ethics, Law, and the New Medicine, |
| International Standard Serial Number | 1567-8008 ; |
| Volume number/sequential designation | 50 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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.-. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical ethics. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical laws and legislation. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine & Public Health. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Theory of Medicine/Bioethics. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical Law. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biomedicine general. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Printed edition: |
| International Standard Book Number | 9789400726772 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | International Library of Ethics, Law, and the New Medicine, |
| -- | 1567-8008 ; |
| Volume number/sequential designation | 50 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://ezproxy.alfaisal.edu/login?url=http://dx.doi.org/10.1007/978-94-007-2678-9">http://ezproxy.alfaisal.edu/login?url=http://dx.doi.org/10.1007/978-94-007-2678-9</a> |
| 912 ## - | |
| -- | ZDB-2-SHU |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Koha item type | eBooks |
No items available.