Ethics and Law summary
S. van de Vorst
Contents
Introduction and ethical models...................................................................3
Introduction...............................................................................................3
Values and norms......................................................................................3
Models.......................................................................................................4
IRR &AD.......................................................................................................6
Background...............................................................................................6
Case study................................................................................................7
Biobanks......................................................................................................8
What is a Biobank.....................................................................................8
Children in research: overview..................................................................9
Need for paediatric tissue samples...........................................................9
Children in biobanks: ethical issues..........................................................9
Conclusion & Discussion.........................................................................10
Polygenic Risk Scores in Healthcare Contexts............................................10
Scientific background.............................................................................10
PRS in healthcare context.......................................................................11
Normative considerations (systemic reviews).........................................11
Scientific integrity......................................................................................13
Research integrity...................................................................................13
Importance of misconduct and integrity?...............................................14
Guidance.................................................................................................14
What should be done?............................................................................15
General introduction: Delineating the boundaries of the discipline...........15
What is the evolution in the law’s engagement with health and
biomedical research?..............................................................................15
Law in biomedical research in a multi-layered legal order......................15
Clinical research and biomedicine..............................................................16
Some possible exam questions...............................................................16
Concerns of health lawyers with clinical research..................................16
1
, EU’s general research and technological development policy: the
“framework programmes”......................................................................16
Research on human beings and the Clinical Trial Regulation 536/2014
(before: Clinical Trial Directive)...............................................................17
Biomedical research and the Biotechnology directive...............................20
Some possible exam questions...............................................................20
1. Using patents to encourage/discourage research...............................20
2. European patent Convention..............................................................20
3. Biotechnology directive adopted after almost ten years of debate
(98/44/EC)...............................................................................................20
4. Health law implications of the Biotechnology Directive......................20
Law/directives/regulations.........................................................................24
ETHICS
2
, Introduction and ethical models
Introduction
Research comes with delicate ethical dilemmas such as whether it is good or allowed to do certain
kinds of research. These dilemmas will be viewed via moral experience such as intuitions and will be
hard to argue against with logic/arguments. This moral experience can be coloured by the negative
contrast experiences that lead to abhorrent behaviour and experience of plenitude that leads to
wanting to follow a role model/good example. These moral experiences are shaped by your
environment.
Professional ethics uses rational arguments to defend moral standpoints. On the other hand, there are
legal regulations that uses Deontology which are the professional codes of ethics. Although these
deontological codes are not hard law, when violating these, accountability is expected.
There are three approaches in ethics:
1. Descriptive ethics
a. Research on the actual norms and values in a specific community
b. 2 steps:
i. Empirical study of the ethos (moral)
ii. Hypothesis to explain observations
c. E.g. Why more euthanasia cases in Flanders compared to Wallonia?
2. Normative ethics: core of ethics (based on norms)
a. First level of abstraction: assessing whether a practice/action is ethically acceptable
b. Through elaboration from a theoretical standpoint: prescriptive ethics
c. Arguments why one positions is to be preferred over another
d. The core/heart of ethics
e. E.g. Is euthanasia ethically acceptable?
3. Meta-ethics
a. The critical study of the concepts and methods used in normative ethics
b. E.g. what is acceptable?
Values and norms
Most lay people use values and norms interchangeably, but there is an important distinction. Values
are qualities that we experience as positive. It can also be that there are conflicting values. There are
absolute values that should always be respected and fundamental values that should always be
respected except when it conflicts with other fundamental values.
These values are translated into norms which is what you use to judge an action. This can be either
concrete guidance (future) or criterion for evaluating an action (past). Norms are not universal and
can constantly change. Additionally, there can be different norms for the same values. Norms are often
formulated in a negative way to allow freedom.
These values and norms are evaluated via an anthropological view. The reference point is the ideal
person. To assess a situation ethically, it compares to the reference point. This leads to the ultimate
criterium “What is good from the perspective of a human person?”. However, this reference point
depends on the values and
norms that someone holds.
Thus, the view on the full
human person (anthropology)
depends on the ranking of
values.
3
S. van de Vorst
Contents
Introduction and ethical models...................................................................3
Introduction...............................................................................................3
Values and norms......................................................................................3
Models.......................................................................................................4
IRR &AD.......................................................................................................6
Background...............................................................................................6
Case study................................................................................................7
Biobanks......................................................................................................8
What is a Biobank.....................................................................................8
Children in research: overview..................................................................9
Need for paediatric tissue samples...........................................................9
Children in biobanks: ethical issues..........................................................9
Conclusion & Discussion.........................................................................10
Polygenic Risk Scores in Healthcare Contexts............................................10
Scientific background.............................................................................10
PRS in healthcare context.......................................................................11
Normative considerations (systemic reviews).........................................11
Scientific integrity......................................................................................13
Research integrity...................................................................................13
Importance of misconduct and integrity?...............................................14
Guidance.................................................................................................14
What should be done?............................................................................15
General introduction: Delineating the boundaries of the discipline...........15
What is the evolution in the law’s engagement with health and
biomedical research?..............................................................................15
Law in biomedical research in a multi-layered legal order......................15
Clinical research and biomedicine..............................................................16
Some possible exam questions...............................................................16
Concerns of health lawyers with clinical research..................................16
1
, EU’s general research and technological development policy: the
“framework programmes”......................................................................16
Research on human beings and the Clinical Trial Regulation 536/2014
(before: Clinical Trial Directive)...............................................................17
Biomedical research and the Biotechnology directive...............................20
Some possible exam questions...............................................................20
1. Using patents to encourage/discourage research...............................20
2. European patent Convention..............................................................20
3. Biotechnology directive adopted after almost ten years of debate
(98/44/EC)...............................................................................................20
4. Health law implications of the Biotechnology Directive......................20
Law/directives/regulations.........................................................................24
ETHICS
2
, Introduction and ethical models
Introduction
Research comes with delicate ethical dilemmas such as whether it is good or allowed to do certain
kinds of research. These dilemmas will be viewed via moral experience such as intuitions and will be
hard to argue against with logic/arguments. This moral experience can be coloured by the negative
contrast experiences that lead to abhorrent behaviour and experience of plenitude that leads to
wanting to follow a role model/good example. These moral experiences are shaped by your
environment.
Professional ethics uses rational arguments to defend moral standpoints. On the other hand, there are
legal regulations that uses Deontology which are the professional codes of ethics. Although these
deontological codes are not hard law, when violating these, accountability is expected.
There are three approaches in ethics:
1. Descriptive ethics
a. Research on the actual norms and values in a specific community
b. 2 steps:
i. Empirical study of the ethos (moral)
ii. Hypothesis to explain observations
c. E.g. Why more euthanasia cases in Flanders compared to Wallonia?
2. Normative ethics: core of ethics (based on norms)
a. First level of abstraction: assessing whether a practice/action is ethically acceptable
b. Through elaboration from a theoretical standpoint: prescriptive ethics
c. Arguments why one positions is to be preferred over another
d. The core/heart of ethics
e. E.g. Is euthanasia ethically acceptable?
3. Meta-ethics
a. The critical study of the concepts and methods used in normative ethics
b. E.g. what is acceptable?
Values and norms
Most lay people use values and norms interchangeably, but there is an important distinction. Values
are qualities that we experience as positive. It can also be that there are conflicting values. There are
absolute values that should always be respected and fundamental values that should always be
respected except when it conflicts with other fundamental values.
These values are translated into norms which is what you use to judge an action. This can be either
concrete guidance (future) or criterion for evaluating an action (past). Norms are not universal and
can constantly change. Additionally, there can be different norms for the same values. Norms are often
formulated in a negative way to allow freedom.
These values and norms are evaluated via an anthropological view. The reference point is the ideal
person. To assess a situation ethically, it compares to the reference point. This leads to the ultimate
criterium “What is good from the perspective of a human person?”. However, this reference point
depends on the values and
norms that someone holds.
Thus, the view on the full
human person (anthropology)
depends on the ranking of
values.
3
