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Acceptable Risk in Biomedical Research (Record no. 16385)

000 -LEADER
fixed length control field 03615nam a22004575i 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20140310145543.0
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
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number QH332
Classification number R724-726.2
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 610.1
Edition number 23
Classification number 174.2
Edition number 23
264 #1 -
-- Dordrecht :
-- Springer Netherlands,
-- 2012.
912 ## -
-- ZDB-2-SHU
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Simonsen, Sigmund.
Relator term author.
245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE
Title Acceptable Risk in Biomedical Research
Medium [electronic resource] :
Remainder of title European Perspectives /
Statement of responsibility, etc by Sigmund Simonsen.
300 ## - PHYSICAL DESCRIPTION
Extent XVI, 296 p.
Other physical details online resource.
440 1# - SERIES STATEMENT/ADDED ENTRY--TITLE
Title 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.
Topical term or geographic name as entry element Medical ethics.
Topical term or geographic name as entry element Public health laws.
Topical term or geographic name as entry element Medicine & Public Health.
Topical term or geographic name as entry element Theory of Medicine/Bioethics.
Topical term or geographic name as entry element Medical Law.
Topical term or geographic name as entry element Biomedicine general.
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
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://dx.doi.org/10.1007/978-94-007-2678-9
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Item type E-Book
Copies
Price effective from Permanent location Date last seen Not for loan Date acquired Source of classification or shelving scheme Koha item type Damaged status Lost status Withdrawn status Current location Full call number
2014-04-03AUM Main Library2014-04-03 2014-04-03 E-Book   AUM Main Library610.1