000			03832nam a22005055i 4500
001			978-94-007-2678-9
003			DE-He213
005			20140220083342.0
007			cr nn 008mamaa
008			120102s2012 ne | s |||| 0|eng d
020			_a9789400726789 _9978-94-007-2678-9
024	7		_a10.1007/978-94-007-2678-9 _2doi
050		4	_aQH332
050		4	_aR724-726.2
072		7	_aPSAD _2bicssc
072		7	_aMB _2bicssc
072		7	_aMED050000 _2bisacsh
082	0	4	_a610.1 _223
082	0	4	_a174.2 _223
100	1		_aSimonsen, Sigmund. _eauthor.
245	1	0	_aAcceptable Risk in Biomedical Research _h[electronic resource] : _bEuropean Perspectives / _cby Sigmund Simonsen.
264		1	_aDordrecht : _bSpringer Netherlands, _c2012.
300			_aXV, 293p. 1 illus. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
490	1		_aInternational Library of Ethics, Law, and the New Medicine, _x1567-8008 ; _v50
505	0		_a1.      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			_aThis 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	_aMedicine.
650		0	_aMedical ethics.
650		0	_aPublic health laws.
650	1	4	_aMedicine & Public Health.
650	2	4	_aTheory of Medicine/Bioethics.
650	2	4	_aMedical Law.
650	2	4	_aBiomedicine general.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9789400726772
830		0	_aInternational Library of Ethics, Law, and the New Medicine, _x1567-8008 ; _v50
856	4	0	_uhttp://dx.doi.org/10.1007/978-94-007-2678-9
912			_aZDB-2-SHU
999			_c104540 _d104540