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Samenvatting OM3-De Deyn-Ethiek

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Onderzoeksmethodologie En Statistiek 3

Institution
Universiteit Antwerpen (UA)

OM3 Lessen de deyn over ethiek

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Number of pages 52
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de deyn
om3
ethiek

Institution
Universiteit Antwerpen (UA)
Education
Kinesitherapie En Revalidatiewetenschappen
Course
Onderzoeksmethodologie En Statistiek 3

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OM3-De Deyn-Ethiek Loranne den Otter

Commissies medische ethiek
1. What is an ethics committee?
Also called ‘institutional review board’ or IRB, consists of members with a broad competency in
biomedical sciences and ethics. It reviews the ethical aspects of an experiment, develops guidelines
and gives advice in individual problems (‘ethical consultations’)

2. Why ethics committees?
 To safeguard the rights, safety and well-being of research subjects
 Pay special attention to vulnerable populations
 To support health workers confronted with ethical decisions in hospital practice
 Ethisch comittee voor het evalueren van wetenschappelijke protocols
– Niet goed onderbouwd  niet ethisch verantwoord
3. Basic texts on ethics in clinical research
 Nuremberg Code (1947) - voluntary consent to participate in research
 World Medical Association - Declaration of Helsinki (1964, later modified many times)
 National Research Act (USA, 1974) The Belmont Report, 1978
– Respect for persons (integrity, autonomy)
– Beneficience - non-maleficience
– Justice

3.1. Nuremberg code
 Voluntary consent
 Fruitful results for the good of society
 Anticipated results justify experiment
 Avoid all unnecessary suffering
 No experiment if death or disabling injury could occur
 Degree of risk should not exceed importance of problem
 Proper preparations to protect experimental subject
 Conducted by scientifically qualified persons
 Person should be at liberty to bring experiment to an end
 Scientist in charge must be prepared to terminate experiment

3.2. The declaration of Helsinki (1975)
 Conform to generally accepted scientific principles
 Experimental protocol reviewed by committee independent of investigator and sponsor
 Conducted by scientifically qualified persons. Responsibility with medically qualified person.
 Importance of experiment in proportion to inherent risk.
 Careful assessment of predictable risk
 Right of research subject to safeguard his/her integrity should be respected.
 Cease any investigation if hazards outweigh potential benefits (ook met interim analyses).
 In publication, preserve the accuracy of the results.
 Each potential subject should be informed about the aim, methods, potential benefits and
potential hazards and any discomfort.
 Subject should have the right to abstain from participation and withdraw his/her consent at
any time.

,OM3-De Deyn-Ethiek Loranne den Otter

3.3. Participation in clinical trials
 Decision making capacity: P moet zelf in staat zijn om deel te nemen
 Voluntariness
 Communication
 Selection of research subjects: vergoeding van vrijwilligers?  kunnen niet minder ziek zijn
 Assessment of risks and benefits
– Subjects at risk
– Types of risk involved
– Balance of benefits and risks

3.4. Belgian law
 Royal Decree 12 August 1994: every hospital or –group needs to have a recognized
ethics committee
 Organization
– 8-15 members
– Majority of MD’s affiliated with the hospital
– ≥ 1 GP not affiliated
– ≥ 1 nurse - jurist - Not allowed: director, medical director (hoofdgeneesheer),
president of medical council, director nursing
– Standard operating procedures, mandate 4 years, renewable, ≥ 1 meeting per
trimester, yearly report
 Assignment
– Advisory function with respect to the ethical aspects of hospital care
– Supportive function in decisions concerning individual ethical problems
– Advisory function with respect to all protocols concerning experiments in human trial
subjects – 4 MAY 04 became ‘decisive’
 Advice is (was) confidential, not compulsory, written, individual and if necessary, can reflect
the individual opinions of the committee members
 Questions from any member of personnel and any physician

4. EEC guidelines
 Directive 2001/20/EC of the European parliament and of the Council of 4 April 2001
 Scope
 Definitions: investigator, protocol,...
 Protection of clinical trial subjects
 Clinical trials on minors
 ... on incapacitated adults (vulnarable (patient) populations
 Ethics committees, this considers:
– Relevance of trial
– Benefits and risks
– Protocol
– Suitability of investigator and staff
– Investigator’s Brochure
– Quality of facilities
– Adequacy of written patient information
– Provision for indemnity = voorziening voor vrijwaring
– Rewarding or compensation of investigators and trial subjects

,OM3-De Deyn-Ethiek Loranne den Otter

– Arrangements for recruitment of subjects
 Conduct of a clinical trial
 Exchange of information
 Suspension of trial or infringements
 Investigational products
 Labeling
 Compliance with GCP and GMP
 Notification of adverse events
 Notification of serious adverse events
 Guidance concerning reports
 ...

4.1. Protocol
 Synopsis
 Rationale for experiments
 Detailed description of experiments
 In- and exclusion criteria
 Potential side effects or risks for study subjects
 Statistical plan
 Stopping rules (and or rescue interventions)

5. ICH guidelines for IRB-CME
 Conduct continuing review of each trial appropriate to the degree of risk, but at least once a
year
 Should ask more information if this adds meaningfully to the protection of subjects
 When non-therapeutic trial, IRB should assess that the protocol adequately addresses
relevant ethical concerns
 When no prior informed consent possible, should determine that the protocol adequately
addresses ethical concerns
 Should ensure that payments to subject do not coerce or otherwise unduly influence
subjects. Payments should be prorated and not depend on completion of the trial.

6. The Belgian Implementation

, OM3-De Deyn-Ethiek Loranne den Otter

6.1. Belgische wet 7 mei 2004

Art. 2, 4° “ Ethisch comité”
 In ziekenhuizen (cfr. K.B.1994, één commissie per fusieziekenhuis), en buiten ziekenhuizen
(WVVH, SSMG, medische faculteiten, te erkennen door de minister)
 Samenstelling : cfr. K.B. 1994
 Minstens 20 protocollen per jaar vanaf 01.01.06 (alle protocollen die onder de wet vallen)
 Belangenconflicten

Art.2,7° “Klinische proef”: interventionele studie met een geneesmiddel (zoals in de Europese
richtlijn), met eudraCT-nummer

Art. 2,11° “Experiment”: “elke op de menselijke persoon uitgevoerde proef, studie of onderzoek,
met het oog op de ontwikkeling van de biologische of medische kennis”
 P.S. Het “Belgische” (niet-eudraCT)-nummer
 De Belgische wet gaat dus over “experimenten op de menselijke persoon” , met onder
andere de interventionele studies met geneesmiddelen (“klinische proef” of “proef” in de
Belgische wet), waarvoor bijkomende eisen bestaan

Art.2,21° “Opdrachtgever”: “een persoon, bedrijf, instelling of organisatie die de
verantwoordelijkheid op zich neemt voor het starten, het beheer en/of de financiering van een
experiment”
 P.S. Er moet voor alle experimenten (ook niet-commerciële) een opdrachtgever zijn, en die
heeft plichten !

Art.2,23° “De menselijke persoon”: “De geboren, levende en levensvatbare persoon. Experimenten
met embryo’s in vitro, met lichaamsmateriaal of lijken vallen niet onder het toepassingsgebied van
deze wet”
 P.S. Retrospectief onderzoek van dossiers evenmin, maar toch advies van een commissie
voor ethiek
 P.S. De definitie van niet-interventioneel onderzoek

Art.10 Begin van een experiment
 Voor alle “experimenten”: pas na gunstig advies van een commissie voor ethiek
 Voor “klinische proeven”(interventionele studies met geneesmiddelen): ook “geen bezwaar”
van de minister (d.w.z. directo- raat-generaal Geneesmiddelen) nodig – nu nog nieuwe
europese regelgeving geïmplementeerd – zie later
 Voor “klinische proeven” (interventionele studies met geneesmiddelen) is er dus een
parallelle procedure
– Onderzoeker: aanvraag bij de commissie voor ethiek
– Opdrachtgever : aanvraag bij de minister, d.w.z. het directoraat-generaal Genees-
middelen (i.v.m. de kwaliteit van het middel, maar ook ivm de preklinische ge-
gevens, cfr. Programmawet Dec.2004)

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