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1: Scope of the new regulation - 2: Protection of subjects of experiments - 3: The role of the competent authority and the ethics committee(s) - 4: Procedures for conducting a clinical trial in Belgium - 5: Investigational medicinal products - 6: Special cases : non-interventional trials and non-commercial experiments - 7: Sanctions - 8: Entry into force and transition measures

Pharmacology. Therapy --- Medical law --- Professional ethics. Deontology --- Belgium --- Clinical Trials as Topic --- Randomized Controlled Trials as Topic --- Ethics, Clinical --- Legislation, Drug --- Legislation, Medical --- Biomedical Research --- Human Experimentation --- 34 EU --- 351.84*7 --- 615 <493> --- legislation & jurisprudence. --- organization & administration. --- Rechtswetenschappen.--EU --- Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- Farmacologie. Farmaceutische wetenschappen--België --- Belgium. --- 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- 34 EU Rechtswetenschappen.--EU --- legislation & jurisprudence --- organization & administration --- Clinical Trials as Topic - Belgium --- Randomized Controlled Trials as Topic - Belgium --- Ethics, Clinical - Belgium --- Legislation, Drug - Belgium --- Legislation, Medical - Belgium

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Le consentement informé est la pierre angulaire de l'éthique de la recherche et de la bioéthique elle-même. La recherche actuelle dans le domaine de la santé pose de nouvelles questions en ce qui concerne les essais cliniques et l'emploi des placebos, les études de populations ou les études épidémiologiques. Ce quatrième et dernier volume de L'éthique de la recherche examine ces problèmes et conclut la présente réflexion sur l'éthique de la recherche à partir de perspectives historiques, philosophiques, juridiques et sociales. Une importante bibliographie, surtout de langue anglaise, couvre les sujets des quatre volumes.

Medicine --- Epidemiology --- Human experimentation in medicine --- Informed consent (Medical law) --- Medical ethics. --- Research --- Moral and ethical aspects. --- 17.023.33 --- geïnformeerde vrijwillige toestemming (instemming) --- klinische proef (klinische studie, geneesmiddelenstudie) --- epidemiologisch onderzoek --- biomedisch, medisch-wetenschappelijk onderzoek --- onderzoeksethiek --- -Human experimentation in medicine --- -Informed consent (Medical law) --- Medical ethics --- -17.023.33 --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Physicians --- Biomedical ethics --- Clinical ethics --- Ethics, Medical --- Health care ethics --- Medical care --- Bioethics --- Professional ethics --- Nursing ethics --- Social medicine --- Consent, Informed --- Consent to treatment --- Disclosure, Medical --- Medical disclosure --- Treatment, Consent to --- Consent (Law) --- Medical personnel --- Patient education --- Involuntary treatment --- Patient refusal of treatment --- Experimentation on humans, Medical --- Medical experimentation on humans --- Medicine, Experimental --- Clinical trials --- Diseases --- Public health --- Biologische doeleinden. Bio-ethiek; bioethiek. Übermensch. Medische deontologie --- consentement libre et éclairé --- essai clinique (étude clinique) --- recherche épidémiologique --- recherche biomédicale --- éthique de la recherche --- -Moral and ethical aspects --- Moral and ethical aspects --- Malpractice --- 17.023.33 Biologische doeleinden. Bio-ethiek; bioethiek. Übermensch. Medische deontologie --- Research&delete& --- Health Workforce --- Medicine - Research - Moral and ethical aspects. --- Epidemiology - Research - Moral and ethical aspects. --- Human experimentation in medicine - Moral and ethical aspects.

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Medical law --- Human rights --- Professional ethics. Deontology --- Droits de l'homme --- Ethique philosophique --- Europese Unie --- Geneeskunde --- Mensenrechten --- Médecine --- Union européenne --- Wijsgerige ethiek --- Human experimentation in medicine --- Human reproduction --- Patients --- Informed consent (Medical law) --- Law and legislation --- Legal status, laws, etc --- Human Rights. --- Bioethics. --- Legislation as Topic. --- 351.84*7 --- -Human reproduction --- -Informed consent (Medical law) --- -Patients --- -#RBIB:gift.1998.3 --- Academic collection --- #A0006A --- 674 Gezondheidsrecht --- 252 Mensenrechten --- Verdrag tot bescherming van de rechten van de mens en de waardigheid van het menselijk wezen met betrekking tot de toepassing van de biologie en de geneeskunde, Oviedo, 4 april 1997 (Verdrag inzake de mensenrechten en de biogeneeskunde) --- biogeneeskunde --- bio-ethiek (medische, biomedische ethiek, bio-ethische aspecten) --- mensenrechten (rechten van de mens) --- patiëntenrechten (rechten van de patiënt) --- Belgisch Raadgevend Comité voor Bio-ethiek --- commissie voor medische ethiek (ethisch comité, CME) --- voorafgaande wilsverklaring (voorafgaande negatieve wilsverklaring, levenstestament, euthanasieverklaring) --- menselijk genoom --- recht op niet weten (recht op weten) --- Europa --- Rechten van de patiënt --- Medische ethiek --- Rechten van de mens --- 601.7 --- biomedische ethiek --- ethiek (gez) --- mensenrechten (gez) --- patiëntenrecht (gez) --- recht (gez) --- Consent, Informed --- Consent to treatment --- Disclosure, Medical --- Medical disclosure --- Treatment, Consent to --- Consent (Law) --- Medical ethics --- Medical personnel --- Patient education --- Involuntary treatment --- Patient refusal of treatment --- Human physiology --- Reproduction --- Reproductive health --- Reproductive rights --- Experimentation on humans, Medical --- Medical experimentation on humans --- Medicine --- Medicine, Experimental --- Clinical trials --- Constitutional Amendments --- Laws and Statutes --- Legislation, Health --- Model Legislation --- Population Law --- Statutes and Laws --- Health Legislation --- Amendment, Constitutional --- Amendments, Constitutional --- Constitutional Amendment --- Law, Population --- Laws, Population --- Legislation, Model --- Population Laws --- Biomedical Ethics --- Health Care Ethics --- Ethics, Biomedical --- Ethics, Health Care --- Ethics, Medical --- Ethicists --- Equal Rights --- Equal Right --- Human Right --- Right, Equal --- Right, Human --- Rights, Equal --- Rights, Human --- Social Justice --- Human Rights Abuses --- Persons --- Sick --- Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- -Legal status, laws, etc --- -Convention pour la protection des droits de l'homme et la dignité de l'être humain à l'égard des applications de la biologie et de la médecine, Oviedo, 4 avril 1997 (Convention sur les droits de l'homme et la biomédecine) --- biomédecine --- bioéthique (éthique médicale, biomédicale, aspects bioéthiques) --- droits de l'homme --- droits du patient --- Comité consultatif de Bioéthique de Belgique --- comité d'éthique médicale (comité d'éthique, CEM) --- testament de vie (directive anticipée) --- génome humain --- droit de ne pas savoir (droit de savoir) --- Europe --- Droits du patient --- Ethique médicale --- Droits de l'Homme --- Malpractice --- Research --- Europe. --- Northern Europe --- Southern Europe --- Western Europe --- Conferences - Meetings --- Legal status, laws, etc. --- 351.84*7 Medisch recht. Gezondheidsrecht. Wetgeving i.v.m. ziekenhuizen --- Bioethics --- Human Rights --- Legislation as Topic --- #RBIB:gift.1998.3 --- Health Legislation as Topic --- Convention pour la protection des droits de l'homme et la dignité de l'être humain à l'égard des applications de la biologie et de la médecine, Oviedo, 4 avril 1997 (Convention sur les droits de l'homme et la biomédecine) --- Collective Human Rights --- Linguistic Rights --- Right to Housing and Shelter --- Rights of Indigenous Peoples --- Human Rights, Collective --- Indigenous Peoples Rights --- Rights, Collective Human --- Rights, Linguistic --- Belgisch Raadgevend Comité voor Bio-ethiek --- commissie voor medische ethiek (ethisch comité, CME) --- patiëntenrechten (rechten van de patiënt) --- patiëntenrecht (gez) --- Rechten van de patiënt --- Comité consultatif de Bioéthique de Belgique --- bioéthique (éthique médicale, biomédicale, aspects bioéthiques) --- biomédecine --- comité d'éthique médicale (comité d'éthique, CEM) --- génome humain --- Convention pour la protection des droits de l'homme et la dignité de l'être humain à l'égard des applications de la biologie et de la médecine, Oviedo, 4 avril 1997 (Convention sur les droits de l'homme et la biomédecine) --- testament de vie (directive anticipée) --- Ethique médicale --- človekove pravice --- derechos humanos --- ľudské práva --- prawa człowieka --- ljudska prava --- δικαιώματα του ανθρώπου --- човешки права --- human rights --- inimõigused --- cilvēktiesības --- rechten van de mens --- lidská práva --- cearta an duine --- ihmisoikeudet --- direitos humanos --- људска права --- emberi jogok --- menneskerettigheder --- човекови права --- drittijiet tal-bniedem --- mänskliga rättigheter --- žmogaus teisės --- të drejtat e njeriut --- diritti umani --- drepturile omului --- Menschenrechte --- kršenje ljudskih prava --- Verletzung der Menschenrechte --- diritti fondamentali dell'uomo --- Verteidigung der Menschenrechte --- nezadatelná práva --- ανθρώπινα δικαιώματα --- nepromlčitelná práva --- pasikėsinimas į žmogaus teises --- фундаментални слободи и права на човекот и граѓанинот --- zaštita ljudskih prava --- porušování lidských práv --- atentado a los derechos humanos --- Schutz der Menschenrechte --- mbrojtje e të drejtave të njeriut --- krænkelse af menneskerettighederne --- cilvēktiesību apdraudējums --- παραβίαση των δικαιωμάτων του ανθρώπου --- violarea drepturilor omului --- aantasting van de rechten van de mens --- porušenie ľudských práv --- Beeinträchtigung der Menschenrechte --- mensenrechten --- emberi jogok védelme --- emberi jogok megsértése --- kränkning av mänskliga rättigheter --- atteinte aux droits de l'homme --- útok na ľudské práva --- ihmisoikeusloukkaus --- προσβολή των δικαιωμάτων του ανθρώπου --- attack on human rights --- protección de los derechos humanos --- cilvēktiesību aizsardzība --- bescherming van de rechten van de mens --- salvaguardia dei diritti dell'uomo --- proteção dos direitos humanos --- tilsidesættelse af menneskerettighederne --- ihmisoikeuksien suojelu --- protezione dei diritti umani --- Конвенција за заштита на човековите права и основните слободи --- skydd av mänskliga rättigheter --- violación de los derechos humanos --- cilvēktiesību pārkāpums --- ochrana ľudských práv --- žmogaus teisių apsauga --- ihmisoikeuksien uhkaaminen --- prava čovjeka --- derechos del hombre --- rispetto dei diritti dell'uomo --- schending van de rechten van de mens --- inimõiguste kaitse --- protecția drepturilor omului --- shkelje e të drejtave të njeriut --- violação dos direitos humanos --- brott mot mänskliga rättigheter --- beskyttelse af menneskerettigheder --- ochrana lidských práv --- inimõiguste ohustamine --- violation des droits de l'homme --- повреда на граѓанските права --- cenim i të drejtave të njeriut --- žmogaus teisių pažeidimas --- cilvēka pamattiesības --- граѓански слободи и права --- προστασία των δικαιωμάτων του ανθρώπου --- ofensa aos direitos humanos --- заштита на правата и слободите на граѓаните --- кршење на човековите права --- human rights violation --- violazione dei diritti umani --- protection of human rights --- inimõiguste rikkumine --- reato contro i diritti dell'uomo --- protection des droits de l'homme --- gezondheidsrecht --- Human experimentation in medicine - Law and legislation - Europe --- Human reproduction - Law and legislation - Europe --- Patients - Legal status, laws, etc - Europe --- Informed consent (Medical law) - Europe