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Write an explanation of the ethical issues illustrated in the article (attached). Imagine that you obtained secondary epidemiological data that support a policy change that may positively impact your community. Now, you learn that the data were obtained unethically. Explain what action you might take. Support your position using scholarly resources.APA FORMAT
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Policy & practice
Ethical challenges in cluster randomized controlled trials:
experiences from public health interventions in Africa and Asia
David Osrin,a Kishwar Azad,b Armida Fernandez,c Dharma S Manandhar,d Charles W Mwansambo,e
Prasanta Tripathy f & Anthony M Costello a
Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled
trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and
Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of
public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the
ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular
challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by
individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of
public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the
debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the
intervention under test.
Une traduction en français de ce résumé figure à la fin de l’article. Al final del artículo se facilita una traducción al español. .‫الرتجمة العربية لهذه الخالصة يف نهاية النص الكامل لهذه املقالة‬
Introduction
“I am because we are and because we are I am. A person is not
a separated and isolated individual but a community of related
individuals. Despite all this, an individual has the right to
self determination and authorization.”
Joseph Mfutso-Bengo, Malawian bioethicist.1
This paper describes ethical discussions arising from our attempts to improve public health evidence in low-income
settings. It considers two overlapping issues: the ethics of testing social interventions and the ethics of cluster randomized
controlled trials (RCTs). We are not ethicists but public health
practitioners who work on maternal and newborn survival,
and our interest in ethics arises from operational challenges.
We started our first cluster RCT a decade ago, and currently
work on six: one in Bangladesh, two in India, one in Malawi,
and two in Nepal (Table 1).
Ethics of public health research in lowincome countries
Recent papers on public health ethics in the Bulletin of the
World Health Organization identify a need to reconcile the
claims of individual and mass approaches,2–4 a need encapsulated in the quotation with which this paper begins. The current emphasis of research guidelines on individual autonomy
– the protection of the vulnerable – is primarily a reaction to
historical tragedies.5–9 It draws on the ethical tradition of de-
ontological morality: the question of whether research treats
participants as they ought to be treated or as they have a right
to be treated.5,10 This accords with the Hippocratic obligation
to benefit the individual patient and its hallmarks are consent
to participation and the right to non-interference.11–14 There
are other possible perspectives. Public health research lends
itself to utilitarian morals within which it should maximize
health or happiness for the greatest number of people: 5 an
action may be justified by its overall results rather than by its
effects on the individual participant. This perspective, known
as consequentialism,10 is attractive but difficult because it
reminds us of the very abuses that led to the drafting of the
existing guidelines. Nevertheless, a focus restricted to individual self-determination does not necessarily resonate with
our experience of social life, the connectivity between people
and the public health agenda. We hesitate to generalize but
it is worth floating the idea that the individualistic perspective
is at least partly a product of European enlightenment thinking and that this may not always coincide with traditions of
thought in other societies.
Discussions about research ethics in low-income countries have been dominated recently by concerns about trials
of drug regimens to prevent mother-to-child transmission of
HIV.15 Contentious issues include the use of placebo control
groups, the testing of interventions that are likely to be less
effective than current best practice (with substantial discussion on how far best practice implies a global standard of care)
and post-trial access to therapy.16–19 Although the resulting
University College London, Institute of Child Health, 30 Guilford Street, London WC1N 1EH, England.
Perinatal Care Project, Diabetic Association of Bangladesh, Dhaka, Bangladesh.
c
Society for Nutrition, Education and Health Action (SNEHA), Dharavi, Mumbai, India.
d
Mother and Infant Research Activities (MIRA), Kathmandu, Nepal.
e
Department of Paediatrics, Kamuzu Central Hospital, Lilongwe, Malawi.
f
Ekjut Project, Chakradharpur, Jharkhand, India.
Correspondence to David Osrin (e-mail: [email protected]).
(Submitted: 14 January 2008 – Revised version received: 10 October 2008 – Accepted: 6 January 2009 – Published online: 24 July 2009 )
a
b
772
Bull World Health Organ 2009;87:772–779 | doi:10.2471/BLT.08.051060
Policy & practice
Ethical challenges in cluster randomized controlled trials
David Osrin et al.
Cluster randomized
controlled trials
The use of RCTs to test public health
interventions is increasing, a predictable
development given their importance
as a source of evidence. The defining
feature of a cluster RCT is that the unit
of allocation is a group rather than an
individual.21 Cluster trials are important to public health for four reasons.
Many public health interventions are
delivered to groups, areas, institutions
or systems collectively rather than individually; testing the delivery of an intervention to an individual might raise
concerns if others are not included;
individually-delivered interventions
might spread among family, friends or
the wider community; and we are often
interested in the mass effectiveness of
interventions that will be rolled out to
the public with varying degrees of quality, uptake, adherence and response,
Fig. 1. A women’s group in Dhanusha, Nepal
David Osrin
controversy has been beneficial – airing
concerns about “North–South” relationships and inequity – it gives a limited
impression of public health research
partnerships in low-income countries.
It is easy to see that trials of public
health interventions involve a tension
between individual autonomy and potential public benefit.20 Some interventions leave little option for voluntary
participation, others more. Our work,
for example, aims to improve the experience and outcomes of maternity. Much
of it involves testing the effects of community women’s groups on morbidity,
care seeking and mortality (Fig. 1). The
intervention model is a cycle in which
the groups discuss maternal and child
health, identify problems and successes
they and their neighbours have faced,
prioritize issues for action, design strategies to address them, enact the strategies
(either as groups or within the wider
community) and evaluate their success
(Fig. 2). The intervention is made on a
background of sub-optimal health-care
provision and usage, the point being
that we are testing strategies to improve
quality and uptake of appropriate care
in a situation where health system best
practice is an aspiration rather than a
reality. The intervention requires participants to opt in: individuals have to
make an effort to access it by joining
and attending a community group and
involving themselves in its activities.
even if they have been shown to be
efficacious in individual cases.22 We
will not discuss the issues of design,23
analysis 21,24,25 and reporting of cluster
RCTs,26–28 but we think that researchers have an ethical responsibility to
be aware of them, to seek advice and
to report on the basis of appropriate
analyses.27,29–31
Challenges and responses
Group consent
Cluster RCTs involve two levels of consent: 28 for the involvement of the group
and the individual. Commonly, local
guardians or representatives – elected
leaders, community elders or group
heads – act as cluster guardians who
consent to participation. In communities in which collective decision-making is customary, communal leaders
may express the collective will. To do
this, they have to decide that participation is in the best interest of the
community, a utilitarian judgement
that may also be contested given that
communities are usually amalgams of
smaller communities.29,32 In a complex
society, how do we identify individuals
– or groups – who speak for the many?
How far can we say their guardianship
extends to such a decision? We need to
bear in mind that representatives will
almost never have been appointed for
the context in which we seek their
assent and so their fitness for this role
may be questionable.
Bull World Health Organ 2009;87:772–779 | doi:10.2471/BLT.08.051060
We have found group consent
challenging. At the minimum, we need
to document the choice of representatives and the reasons for approaching
them.33 In all our trials, we have tried
to make the process of cluster consent
as open as possible. Since it is unlikely
that one type of person can represent
a community, we have sought agreement from a range of stakeholders. In
most cases we have held community
meetings at which the idea of the trial
has been discussed and consent for it
sought (Table 1 and Box 1). This has
not always been written consent, which
tends to have been reserved for elected
representatives and village heads, but it
has at least been inclusive.
Three examples provide food for
thought. When the MIRA Makwanpur
trial began in rural Nepal, we were able
to engage the district development
committee and village development
committees in the process of cluster selection, randomization and allocation.
However, as the crisis of governance
associated with Nepal’s Maoist insurrection developed, the legitimacy and
responsibilities of these institutions
were contested. By degrees, the realities
of running a trial in an area with two
governments – each considered illegitimate by the other – became clear. We
speculate that politics embodies the
idea of cluster guardianship writ large,
since it involves claims that individuals,
parties and movements speak for larger
groups. Indeed, the suggestion that a
given leader might not be able to give
773
Policy & practice
Ethical challenges in cluster randomized controlled trials
consent for the involvement of his or
her constituency could be seen as an
affront to such claims.
Difficult though this issue is, it becomes more confusing if the definition
of a “cluster” is not based on existing
geopolitical demarcations. In Mumbai, India, we work within vulnerable
urban slum areas. This means that the
boundaries of clusters are not obvious
and they do not necessarily represent
existing political or sociocultural spaces.
Who gives consent for the inclusion in a
trial of part of an urban agglomeration
of densely packed but diverse humanity? Certainly, we have consent from
municipal health service providers but,
since one of the intrinsic problems is the
lack of access to their services, it would
be hard to say that they speak for a cluster. We have to fall back for permission
on political and cultural leaders, elected
members and community organizations, bearing in mind that it is always
best to avoid associating public health
interventions with specific political
incumbents.
And what if the intervention under
test aims to change the status quo? The
Ekjut intervention in Jharkhand, India,
tries to help women in underserved
communities to take charge of their
health needs. The process itself raises
(at least conceptual) notions of empowerment and agency that could be seen
as socio-politically destabilizing. How
would potential cluster guardians deal
with this possibility? More provocatively, how ethical is it to take consent
from (mostly male) guardians who embody the social structure within which
the participants will be manoeuvring?
On balance, we feel that the opt-in nature of the interventions under test relieves us of at least some of the burden
of anxiety. Cluster guardianship is less
critical if individuals are able to decide
for themselves whether to be physically
involved in the trial; but perhaps this
allows us to skirt the issue.
Individual consent
Group consent is not a substitute for
individual consent, which we think
should follow similar lines to individualized studies. Participation may be
related to the intervention itself and to
data collection. Community members
should be made aware of the trial and
asked if they would like to participate.
An individual’s right to refuse to participate should be respected, despite
774
David Osrin et al.
Fig. 2. Example of an intervention model: sequence of community group activities in
the City Initiative for Newborn Health, Mumbai, India
Phase 4
Dreaming
2 meetings
Visions of group’s role
in community development
and how they visualize
future change
Phase 3
Energy
6 meetings
Deciding on individual
and community strengths
and identification
of local themes
Phase 5
Designing
4 meetings
Development and
planning of strategies
for community action
Phase 1
Discovery
5 meetings
Sharing women’s
experiences in pregnancy,
delivery, postpartum
and childcare
Phase 2
Perception
11 meetings
Creating awareness
of behaviours
and problems
in maternity
and newborn care
consent at the representative level,32
and trial documentation should clarify
the opportunities for cluster members
to avoid the risks associated with an
intervention.33
All our trials require verbal consent
for data collection. Participants are informed of the reasons for the exercise,
the scope of the questions involved and
the likely time required for an interview,
as well as the fact that the decision not
to participate will not be penalized. We
have not so far been concerned about
verbal consent in this context. From
the intervention perspective, things are
less concrete. In the Ekjut trial, for example, the agenda of the first women’s
group meeting is to seek consent for
future meetings. This is obtained after
explaining the approach that will be
followed, that participation in meetings is voluntary and groups can decide
not to meet. In the MaiMwana trial,
Malawi, women’s informed voluntary
participation in intervention activities
is considered to imply consent. We
confess to some variation in the degree
to which participants in women’s group
activities are aware of the study design
or the existence of control groups.
They tend to be invited to participate
in the unmasked intervention and
are informed that they are involved in
testing a new approach which will be
Phase 6
Delivery
6 meetings
Implementing strategies
and designing
indicators of success
Phase 7
Evaluation
4 meetings
Group assessment
of the participatory
process and achievements
compared with other areas that do not
have women’s groups.
Timing of consent
Consent after randomization is common in cluster RCTs. Because of the
scale of work, it is often easier to choose
a population, define and draw a random
sample of clusters in which the trial
will be done, randomize the allocation,
then seek consent from cluster guardians.34 This conforms in general terms
with Zelen’s approach to individually
randomized designs, in which consent
is taken after randomization.35,36 In an
individualized trial, we seek consent for
participation and explain the process of
randomization so that the participant is
aware that she may or may not receive
the intervention under test. Presumably a similar approach should apply to
clusters: we should seek consent from
cluster guardians for inclusion in the
trial and explain that data collection
will be done across all study clusters,
but that allocation will be random.
Table 1 shows that we have sought
cluster guardian consent pre-allocation
in several cases, but not in all. In our
experience, community representatives
have been able to grasp the idea of
randomization easily: stakeholders in
Makwanpur rapidly conceived the trial
design as a lottery. One way of looking
Bull World Health Organ 2009;87:772–779 | doi:10.2471/BLT.08.051060
Policy & practice
Ethical challenges in cluster randomized controlled trials
David Osrin et al.
Table 1. Six cluster randomized controlled trials conducted by the partnership for Population Science of Maternal and Child Survival
Perinatal Care
Project
Ekjut Project
City Initiative for
Newborn Health
MaiMwana
Project
MIRA Makwanpur
MIRA Dhanusha
Country
Bangladesh
India
India
Malawi
Nepal
Nepal
Area
Bogra, Maulvi
Bazaar and
Faridpur
districts
Jharkhand and
Orissa states
Mumbai municipality
Mchinji district
Makwanpur district
Dhanusha district
Population
480 000
228 000
300 000
170 000
170 000
417 000
Clusters
(intervention:
control 1:1)
18
36
48
48
24
60
Cluster
population
25 000
6333
6250
3500
7000
7000
Cluster
parameters
Villages
making up
a union
8–10 villages
1000–1500
Residents
households in
classified as
vulnerable slum area
tribal or other
backward castes
Aggregated villages
and group village
headman areas
Village development
committee
Village development
committee
Project
partners
Diabetic
Association of
Bangladesh
(DAB)
Women and
Children
First (United
Kingdombased charity)
Ekjut
Government
of India
PRADAN
(national
voluntary
organization)
UCL Centre for
International
Health and
Development
Society for Nutrition
Education and Health
Action (SNEHA)
Municipal corporation
of Greater Mumbai
ICICI Centre for Child
Health and Nutrition
UCL Centre for
International Health
and Development
MaiMwana
Malawi Government
Ministry of Health
Lilongwe Central
Hospital
UCL Centre for
International Health
and Development
Mother and Infant
Research Activities
(MIRA)
Nepal Government
Ministry of Health
District Development
Committee
District Public Health
Office
UCL Centre for
International Health
and Development
Mother and Infant
Research Activities
(MIRA)
Nepal Government
Ministry of Health
Local Development
Committee
District Public Health
Office
UCL Centre for
International Health
and Development
Source
of ethical
approval
DAB Ethical
Committee
Independent
Mumbai Independent
ethics committee Ethics Committee
Malawi National
Health Sciences
Research Committee
Institute of Child
Health Ethics
Committee
Nepal Health
Research Council
Institute of Child
Health Ethics
Committee
Nepal Health
Research Council
Institute of Child
Health Ethics
Committee
Pre- or postallocation
consent
Post-allocation Post-allocation
Pre-allocation
Pre-allocation
Pre-allocation
Pre-allocation
UCL, University College London.
at – and presenting – the situation is
as a pilot test of an intervention in the
first phase of roll-out. It is undoubtedly
true that some representatives of control
areas have been unenthused by the fact
that their areas are not to receive the
intervention under test until a later
date, and it would be disingenuous of
us to claim that the process has been
smooth sailing. However, if the idea of
the RCT is rendered overt, consensus
can usually be reached.
Ethical approval
We have faced two particular challenges
to ethical review.13,15 First, it may not
be easy to find an ethical committee to
which to put the case for an RCT. This is
not the usual business of governmental
public health. For example, although
the City Initiative for Newborn Health
was undertaken in partnership with
the …
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