Samenvattende nota's / summary bio-ethics in experimental medicine

BIO-ETHICS IN HUMAN RESEARCH
Introduction ........................................................................................................................................2
General ethics .....................................................................................................................................4
Medical ethics .....................................................................................................................................6
Ethics in medical research ................................................................................................................. 10
Dual use research of concern (DURC) ................................................................................................. 25
Protection of essential rights of patients ............................................................................................. 27
Protection of essential rights of minors ............................................................................................... 31
Medical ethics committee and other instances.................................................................................... 34
Research and the GDPR ..................................................................................................................... 42
Big data and AI in healthcare .............................................................................................................. 47




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,INTRODUCTION

 Learning outcomes
 Scientist
 Communicator: societal implications and ethical limitations of biomedical research
 Professional: (inter)national regulations
 Researcher: code of conduct
! adhere to code of scientific integrity during all phases of research
o COVID-19 pandemic
- Research on COVID-19
= moral obligation to learn as much as possible – as quickly as possible
= diagnosis – transmission – treatment – prevention
 Interventional studies
 Treatment
 Blood testing
 Feasibility of online training/coaching
 Vaccine studies
 Epidemiological studies
 Effect of COVID-19 infection in chronic disease
 Registration of affected persons – survival – herd immunity
! Needs ethical approval
 Balance expediting research with
maintaining protection of participants
e.g. sharing data of patients and research subjects
exposing immunized individuals to live virus
participation of children
 Pressure might encourage subversion of regulations
and speed up review process at expense of quality
= protocol deviations and adaptation of ICF
- Non-COVID-19 clinical research
 Problems to access the hospital/trial site
 Study on hold by the sponsor
 Telecommunication + home physician + home drug-delivery
- Stages to consider when defining care for patients in a pandemic
! can raise moral distress for healthcare providers
 Conventional care: all patients admitted – quality of care as usual
 Contingency care: alternative capacity – quality of care as usual
 Crisis care: capacity exceeded – quality of care not guaranteed
! most appropriate prognostic scoring system
 Quality of care  disability discrimination
 Survival to hospital discharge  prediction based
 Long-term survival  disability discrimination
 Clinical scoring system
- Lessons learned
 Fast and safe authorisation for protocols on COVID-19 therapeutics
 Coordinated review between member states by CTR
 Shortened timelines for validation – assessment – notification




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, Definition
 Ethics
o Branch of philosophy
o Systematizing – defending – recommending concepts of right and wrong
 Bio-ethics
o Advances in biology – medicine – technology
o Issues: philosophical – social – legal
 Bio-ethics in humans
o Principles of medical ethics
- Autonomy
- Beneficence
- Non-maleficence
- Justice




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, GENERAL ETHICS




Less visible – makes sure the reasoning doesn’t ‘collapse’


 Scientific statement: pv = constant ≈ measurement
 moral statements: abortion is morally wrong ≈ taste
≠ ethics (should be in between) ≈ judgement
 Any rational procedure by which we determine what individual human beings ‘ought’ to do or
what is ‘right’ for them to do – or to try to bring about by voluntary action
 Rational procedure: aim for consistency – extrapolation – counterexamples – refining – …
= universalisation
o Ethical reasoning involves claims that transcend individual case
o Applicable in similar situations
! Method or test to evaluate more specific rules or norms
 Ought and right
o Careful not to go immediately from description to prescription
E.g. it is not because a treatment extents life  that it is ‘the best’ (more side effect)
Smoking significantly increases risk of lung cancer  you shouldn’t smoke
o Ethical arguments are meant to bridge the gap between the two
 Normative: prescribe + include principles – values – norms

TYPES OF ETHICAL REASONING

 Different ways of looking at problems
 Ethical intuition comes naturally
 Intuition comes with a cost
 Accidental – unargued


CONSEQUENTIALISM
 Tackles ethical questions by looking at the consequences of one’s actions
 Utilitarianisms = most well-known subtype
 Actions should maximize good effects and avoid negative effects
 Greatest good for the greatest number
E.g. organ donation – reuse of research data –
kill 1 person (trolley problem) i.l.o. allowing 5 to be killed
 No distinction between doing and allowing
 Advantages
 Consequences are easier to judge than intentions
 Impartial: everyone is treated as one – and no more than one
 Easy: since there is only one general rule = maximize good outcomes and minimize bad ones

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