Research ethics
Jan Deckers
School of Medical Education
1
Objectives
• To reflect on what ethics is.
• To develop your skills as an ethical researcher.
• To prepare yourself to apply for ethical approval
from research ethics committees.
• To stimulate your ethical thinking in relation to
‘consent’ and your research projects.
2
What is ‘ethics’?
• Ethics ‘deals with the standards and principles of moral
reasoning’. (Rachels, 1998, 15)
• Internet Encyclopedia of Philosophy: ‘ethics (or moral
philosophy) involves systematizing, defending, and
recommending concepts of right and wrong behaviour’
3
so, what is ‘ethics’?
• a theory of
– how we ought/ought not to act
– which values or principles ought (not) to guide
our actions
• ethics is about evaluating/justifying particular
actions
4
What is ‘meta-ethics’?
• the study of the status/meaning of ethical
theories
• the study of moral justification
5
Three meta-ethical positions: e.g. ‘X is wrong’
• Moral absolutism
– ‘I know that X is wrong (and anyone who
disagrees is wrong).’
• Moral relativism
– ‘X might seem wrong to you, but what is right
and wrong is entirely subjective (nothing but a
matter of taste).’
• Pyrrhonian moral scepticism
– ‘I believe/think that X is wrong (but those who
disagree may be right).’
6
‘Pyrrhonian’ moral scepticism
• A school of thinking named after Pyrrho
– a Greek philosopher who lived from c. 360 to
c. 270 BC
7
Why do we need ethics?
• Many people feel the
need to:
= subjective aspect
– justify their behaviour
– to explain why their
behaviour is
(un)acceptable
• These explanations often
relate actions to
principles.
• A theory is an account of
which principles should be
followed, and how to
balance them against
each other.
• Many (or all?) things
deserve moral
= objective aspect
8
objective dimension: What sorts of
things should we value?
• key questions
– Which things are proper objects of ‘moral
consideration’?
– How much ‘relative moral significance’ should we give
to different things?
• key distinction
– intrinsic value: value for oneself
≠
– instrumental/use value: value for others
9
What is bioethics, and what is research
ethics?
• bioethics = the study of how human actions that
affect biological organisms can or can’t be
justified.
• research ethics = the study of ethical issues that
pertain to research.
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two dimensions
• 1. law and professional guidelines
• 2. reflection
11
How does it work?
• 1. establishing knowledge of the relevant legal
and professional guidelines
• 2. exercising your ability to reflect........
– how?
12
the tools of the trade
• clarity
• the principle of non-contradiction
• the use of analogies and thought experiments
13
clarity: the importance of defining concepts
• reportive definitions
– = lexical definitions
– to reflect the existing meaning of a term
• stipulative definitions
– to assign new meaning to a term
• clarifying definitions
– may combine the above
– to give more precise meaning to a term
14
rationale for emphasising clarity
• the ‘what do you mean?’ question may resolve a lot of
moral disputes
15
Example: a simple disagreement between James and
John
• James: Animal research is unacceptable.
– P (P= premise) 1 (major): Inflicting pain is unacceptable.
– P2 (minor): Animal research causes pain.
– Conclusion: Animal research is unacceptable.
• John: Animal research is not necessarily unacceptable.
– Agrees with James about P1, but does not accept P2 as not all
research inflicts pain.
– Conclusion: Animal research is not necessarily unacceptable.
16
How to resolve this dispute?
• James may come to agree with John that not all
animal research is unacceptable as he may
question P2, e.g. after John has explained to
him that his definition of ‘animal research’
includes studies that merely observe animals in
nature.
17
the importance of defining concepts = the
virtue of clarity
• aiming for clarity may help you to:
– scrutinise what you think before you say something.
– scrutinise what others say before you decide to
(dis)agree with it.
18
the principle of noncontradiction/consistency
• example:
a researcher who carries out research on
patients with advanced dementia says the
following:
“I believe that researchers who want to carry out
research on patients should only proceed if patients
give their voluntary, informed consent to taking part
in the research.”
19
arguing by reductio ad absurdum (reduction to
absurdity)
• 1. Start from the assumption that X is right.
• 2. Try to find a counterexample.
• 3. If a counterexample can be found, conclude that X
cannot be right.
20
example
• Premise A: Research that involves research subjects
should not happen unless subjects give their consent.
• Premise B: If no research was done with people who
suffer from advanced dementia, people with this
condition might be excluded from medical progress.
• Conclusion: People with advanced dementia should not
be excluded and premise A should be rejected/modified.
21
the use of analogies
• example:
– When a research project is likely to kill me
(healthy), research should not proceed.
↓
– When a research project is likely to kill healthy
others, research should not proceed.
• What is at work here is the principle of
universalisability/generalisability
– Is this a valid analogy?
22
the use of analogies
• example:
– When a research project is likely to kill human
research subjects, research should not proceed.
↓
– When a research project is likely to kill nonhuman
research subjects, research should not proceed.
• Is this a valid analogy?
23
the use of thought experiments
• A thought experiment is an analogy between a real case
and an imaginary case whereby the latter is claimed to
shed light on how to handle the former.
24
the use of thought experiments
• example: Julian Savulescu (2002)’s leukaemia
case:
– Imagine: A nuclear reactor has exploded, leaving your
child exposed to nuclear fall out. Numerous children
develop leukaemia, including your own. Bone marrow
can be generated most successfully by
reprogramming brain cells from children.
Unfortunately, a child must be killed, as no brains
from those who have deceased are available. The
extracted stem cells could then be reprogrammed to
treat ten children.
25
• Since a one in eleven chance of certain death
seems preferable to a one hundred percent
chance of imminent death, the question is:
– Would you enter your child into a lottery and risk a
1/11 chance of your child being sacrificed (by being
killed to treat others), or refrain from entering your
child into such a lottery (which would mean certain
death for your child)?
– If you do, Savulescu claims that you should also enter
all human embryos into a similar lottery as the real
world would be similar to this imaginary world: the
real world is a world that lacks the great benefits that
we would have had if there had been less objection to
embryonic stem cell research.
26
Why use analogies and thought experiments?
• Rachels (1998, p. 22): ‘like cases should be
treated alike and different cases differently’
27
some common ethical theories
• consequentialism
• deontology
• principlism
28
consequentialism
• focus on consequences
example:
utilitarianism: consequences are measured in
terms of whether or not they produce happiness
29
deontology
• focus on duties (following rules)
30
principlism
= the ‘four principles’ approach:
1. autonomy (self-determination)
2. beneficence (well-being)
3. non-maleficence (no harm)
4. justice
(1&4 are deontological?; 2&3 are
consequentialist?)
= a very popular approach in bioethics
ref: Beauchamp & Childress, 2001.
31
Why is research ethics important?
• Many people would agree that ‘not everything goes’ in
relation to research.
• some examples:
– Tuskegee syphilis experiment
• For 40 years (between 1932 and 1972) 399 black men with
advanced syphilis were told they were treated for ‘bad blood’
by the US Public Health Service. They were never told they
had syphilis, and never received treatment for it. The aim of
the study was to examine the effect of syphilis on the human
body. The data were collected from the autopsies.
– the TGN1412 trial
32
Ryan Wilson, one of the victims (picture from:
http://news.bbc.co.uk/1/hi/health/5121824.stm)
33
the TGN1412 trial
• a phase 1 clinical trial conducted in 2006 by Parexel, an
independent clinical trials unit based in London
• £ 2000 paid to 6 healthy volunteers
• All ended up in hospital.
• 4 developed multiple organ dysfunction and suffered
from a cytokine storm
34
applying the four principles
• 1. Did it respect the autonomy of research
participants?
– Could the fact that a financial incentive was provided have
undermined their autonomy?
• 2. Did it promote beneficence?
– There may be little doubt that the research was done with the
aim to promote the well-being of future patients, but how
important was this motive compared to the motive to make a
profit? Does it matter which was the primary motive?
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• 3. Was it non-maleficent?
– The research caused harm. Could this harm have been avoided?
– Could paying these participants be considered to have caused
harm? How does it compare with payments for other physical
interventions, e.g.:
• blood donations
• tattoo adverts (Sandel, 2012)
• 4. Was it just?
– Was it legal? Were any legal rights violated?
– + other considersations, e.g.
• moral rights:
• Did it respect the rule to ‘treat like alike’?
– e.g. Would I like to be treated like that? (the “how would you
feel....” test, or “don’t do unto others what you would not want
others to do unto you”)
36
case 1
• James Strong is a researcher who has drafted
an information sheet that he would like to use to
recruit research participants. He includes the
following:
– ‘This research will not expose you to any risks
as previous research has not found any
evidence that the D drug is harmful. This
research merely repeats what has already
been shown by other studies, so you can trust
what we are going to do. This research has
already been funded and it has also been
granted ethical approval from Newcastle
University’s Research Ethics Committee.’
37
case 2
• Claire is working on a research project
aimed at making tomato plants more
resistant to frost. She hopes that isolating
a gene from a flounder fish which can
resist very cold temperatures and inserting
this gene into tomato plants will make
these plants resistant to frost.
38
case 3
• David does not support animal experimentation.
Newcastle University is building a new facility to develop
its research on animals. David wants to stop the
University from building this facility, and speak up for the
plight of animals. David decides to organise a protest in
Newcastle with some like-minded people. They take to
the streets and shout ‘stop the animal lab’. Afterwards,
they go to the pub for a bar meal. David orders a pint of
lager and a lamb pie with chips.
39
Appendix 1: further information in
relation to the principle of autonomy:
• ‘consent’, a cornerstone of good research?
– consent = closely related to ‘autonomy’
• providing consent = giving permission
• Research often requires legal consent from
those who participate in it.
– why?
40
Legal context
• common law duty to obtain consent
• statutory laws, e.g.
– Mental Capacity Act 2005 (MCA)
41
What if consent is compromised?
• criminal law:
– Researchers may be liable to assault/battery:
• battery: ‘an act that directly and either intentionally or
negligently causes some physical contact with the person of
another without that person’s consent’ (McHale & Fox, 2007,
p. 352.)
– Researchers may be liable to criminal (gross/extreme)
negligence in criminal law (= rare).
• civil law:
– Researchers may be liable to trespass to the person (infringing
the bodily integrity or liberty of another) and negligence.
42
the tort of negligence
• a person claiming negligence (= a claimant)
must satisfy:
– that the defendant owed him or her a duty of
care
– that this duty was breached, and
– that the claimant was harmed by this breach
and that this harm was not too remote
ref: Pattinson, 2009, p. 68, 78.
43
three requirements in relation to consent
• The research subject:
– has capacity
– is informed adequately
– gives consent without being coerced (voluntariness)
44
three questions
• What is capacity and what to do if it is lacking?
• What does it mean to be adequately informed?
• Can research subjects give voluntary consent to
participate in research?
45
first question: What is capacity?
• necessary condition for valid consent =
the person in question ‘has capacity’ (is competent)
• legal presumption: every person has capacity
from the age of 16
• if in doubt: assess
– how?
46
Mental Capacity Act 2005
• section 3.1: a person lacks capacity if a person
is unable:
– ‘(a) to understand the information relevant to the
decision,
– (b) to retain that information,
– (c) to use or weigh that information as part of the
process of making the decision, or
– (d) to communicate his decision (whether by talking,
using sign language or any other means).’
• What should be done in situations where adults
lack capacity?
– distinguish between clinical and other research
47
the law related to clinical research
• Medicines for Human Use (Clinical Trials)
Regulations 2004
• The patient’s legal representative can give
permission on behalf of the patient if the clinical
trial has gained ethical approval from a
Research Ethics Committee.
– This person can be
– ‘the doctor primarily responsible for the medical
treatment provided to that adult’ or ‘a person
nominated by the relevant health care provider’,
provided they are not connected with the trial
(Schedule 1, part 1, section 2)
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– This person must
– speak to a member of the research team
about the risks and objectives;
– be provided with a contact point;
– be told that the subject can be withdrawn at
any time;
– either consent or refuse to the subject’s
participation.
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further conditions for participation:
• par. 6: ‘The subject has received information
according to his capacity of understanding
regarding the trial, its risks and its benefits.’
• par 9: ‘There are grounds for expecting that
administering the medicinal product to be tested
in the trial will produce a benefit to the subject
outweighing the risks or produce no risk at all.’
50
• par. 11: ‘The clinical trial relates directly to a lifethreatening or debilitating clinical condition from
which the subject suffers.’ (Schedule 1, part 5)
• Subjects who refuse to participate when they still
have capacity cannot be entered once they have
lost capacity.
51
the law related to other research
• for non-clinical research with adults, the Mental
Capacity Act 2005 should be applied: Research
on adults who lack capacity is possible if:
– It involves minimal risk;
– relates to the person’s condition;
– cannot be done as effectively on people who have
capacity;
– (unpaid) carers or nominated third parties are
consulted;
– the person is not entered or is withdrawn if any
resistance is shown;
– and the research project has been approved by an
appropriate body, such as a Research Ethics
Committee.
52
the law related to clinical research with
children
• normally, a person with parental responsibility
should be asked to give consent.
• legal representatives should only be used in
emergencies.
• consent from a person with parental
responsibility is required even if children are
deemed to have capacity. (Schedule 1, part 4)
53
the law related to non-clinical research with
children
• Apply common law:
– Children may be able to give consent if they
are ‘Gillick competent’.
– Children who are not Gillick competent may
be able to give their assent.
– Children must be informed, even if they lack
competency.
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second question: What does it mean to
be informed adequately?
• three different views:
– professional practice standard (legal standard in
criminal law)
• Bolam test: ‘a doctor is not guilty of negligence if
he has acted in accordance with a practice
accepted as proper by a responsible body of
medical men’ (Bolam v. Friern Hospital
Management Committee [1957] 1 W.L.R. 538)
55
– reasonable/prudent person standard (legal standard
in civil law)
• Bolitho v. City & Hackney Health Authority [1998]
A.C. 232 (HL) at 243: a court can reject medical
opinion if it is not ‘reasonable or responsible’
(emboldening mine)
• Chester v Afshar [2004] UKHL 41; [2005] 1 AC
134.
56
– individual person standard
• J. Bridson et al., 2003 (p. 1160; emboldening
mine): ‘The professional standard is paternalistic,
emphasising what clinicians consider appropriate
to disclose rather than what patients want
disclosed. The reasonable patient standard is
inherently hypothetical, upholding the autonomy
only of patients who behave like the typical patient.
It asks what risks should be disclosed to a
‘reasonable’ patient in the particular patient’s
position, not what risks the particular patient
would regard as important.’
57
Are we moving closer towards the
individual patient standard?
• The “test of materiality is no longer restricted to
what the reasonable person in the patient's
position would consider significant: it now
includes the added refinement that a risk is also
material if ‘the doctor is or should reasonably be
aware that the particular patient would be likely
to attach significance to it’.” (Heywood, R. 2015. RIP
Sidaway: Patient-oriented disclosure – a standard
waiting for? Montgomery v Lanarkshire Health Board
[2015] UKSC 11. Medical Law Review, 23 (3): 455-466,
p. 460: with reference to Montgomery [2015] UKSC 11 at
87)
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third question: how to ensure research
subjects give their voluntary consent? A case:
• Miss Jackson is paid by a drug company for
participation in their trial of the new Alzheimer’s
drug. She is keen to contribute to the possibility
of making a scientific breakthrough that could
much improve the quality of life of patients
suffering from Alzheimer’s. Miss Jackson thinks
it is appropriate that her patients are paid a
small amount as well.
• Are there any ethical issues here?
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Appendix 2: Some practical advice for
your research projects
• Some useful questions to ask in relation to personal
research projects
– What is the aim of my research?
– What are the implicit assumptions about what science
is or should be?
– Whose interests will be served by my research?
– What are the risks?
– What are the opportunity costs?
• The answers to these questions must feed into
the overall ethical evaluation of your research.
60
Some golden advice?
• ‘a/ write early and write often;
• b/don’t get it right, get it written’ (Delamont,
Atkinson, and Parry, 1997, p. 121)
61
In defence of ‘write early and write often’
• ‘1. The more you write, the easier it gets.
• 2. If you write every day, it becomes a habit.
• 3. Tiny bits of writing add up to a lot of writing.
Break the writing up into small bits. Write 100
words on X, 200 words on Y, and file them
safely. It all mounts up
• 4. The longer you leave it unwritten the worse
the task becomes.’ (Delamont, Atkinson, &
Parry, 1997, p. 121)
62
In defence of ‘don’t get it right, get it written’
• ‘1. Until it is on paper no one can help you to get
it right. Draft, show the draft to people, redraft.
• 2. Drafting is a vital stage in clarifying thought
• 3. Start writing the bit that is clearest in your
head: not the introduction, but Chapter 4, or the
appendixes, or the conclusions, or the methods.
As you draft, other bits become clear.
• 4. Drafting reveals the places where ‘it’ isn’t right
(yet) in ways that nothing else does.’ (Delamont,
Atkinson, & Parry, 1997, p. 121)
63
What makes for a good piece of written work?
• The words ‘making a contribution’ and ‘originality’ appear
frequently (Delamont, Atkinson, and Parry, 1997, p. 113114)
• For the Newcastle PhD: ‘show distinct ability in
conducting original investigations and in testing ideas,
whether the candidate’s own or others’. (…) ‘The
exposition of the work in the thesis must be clear and
must show that the candidate understands the
relationship of the work embodied in the thesis and the
theme of that work to a wider field of knowledge’ (Doctor
of Philosophy by Thesis Examination Conventions, p.
149;
http://www.ncl.ac.uk/regulations/docs/PhDExamConvTh
esis1112.pdf)
64
References and recommended further
reading
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Beauchamp, T. and Childress, J., Principles of Biomedical Ethics, 5th edition, New
York/Oxford: Oxford University Press, 2001.
Bridson, J., et al., Making Consent Patient Centred, in BMJ 2003; 327: 1159-1161.
Deckers J., The New EU Directive on the Use of Animals for Research and the Value
of Moral Consistency, in Journal of Bioethical Inquiry 2012; 9: 377-379.
Delamont, S., Atkinson, P., Parry, O., Supervising the PhD: A Guide to Success,
Bristol: Open University Press, 1997.
Internet Encyclopedia of Philosophy (http://www.iep.utm.edu/ethics/)
Jamieson, D., Method and Moral Theory, in Singer, P. (ed.), A Companion to Ethics,
Oxford: Blackwell, 1993, pp. 476-490.
Knight, A. The Costs and Benefits of Animal Experiments. Palgrave MacMillan, 2011.
McHale, J., & Fox, M., Health Care Law, Second edition, Sweet and Maxwell, 2007.
Nuffield Council on Bioethics, The Ethics of Research Involving Animals, London,
2005.
Pattinson, S., Medical Law and Ethics, Second edition, Sweet and Maxwell, 2009.
Rachels, J., Ethical Theory and Bioethics. In Kuhse, H. & P. Singer (eds.), A
Companion to Bioethics, Oxford: Blackwell, 1998, pp. 15-23.
Sandel, M., What Money Can’t Buy. The Moral Limits of Markets, Allen Lane, 2012.
Savulescu, J., The Embryonic Stem Cell Lottery and the Cannibalization of Human
Beings, in Bioethics 2002;16: 508-529.
65
Conclusions
• Ethics is about the attempt to justify particular
actions.
• Logic and the making of valid analogies are the
tools of the trade.
• In bioethics, the focus is on biological organisms.
• Research ethics focuses on ethical issues in
research.
• Various formal theories exist on what ethics should
be about, including consequentialism, deontology,
and the 4 principles approach.
• Many institutions have ‘research ethics committees’
and demand approval from them before research
projects can commence.
66