Original research
J Med Ethics: first published as 10.1136/medethics-2018-104966 on 18 September 2018. Downloaded from http://jme.bmj.com/ on 22 September 2018 by guest. Protected by copyright.
1
Bioethics Centre, School of
Medical and Surgical Sciences,
University of Otago, Dunedin,
New Zealand
2
Department of Primary Health
Care and General Practice,
University of Otago, Dunedin,
New Zealand
Correspondence to
Dr Angela Ballantyne,
Department of Primary Health
Care and General Practice,
University of Otago, Dunedin
9016, New Zealand;
​angela.​ballantyne@​otago.​ac.n​ z
Received 22 May 2018
Revised 8 August 2018
Accepted 22 August 2018
© Author(s) (or their
employer(s)) 2018. No
commercial re-use. See rights
and permissions. Published
by BMJ.
To cite: King M,
Ballantyne A. J Med Ethics
Epub ahead of print: [please
include Day Month Year].
doi:10.1136/
medethics-2018-104966
Donor-funded research: permissible, not perfect
Mike King,1 Angela Ballantyne1,2
Abstract
Donor-funded research is research funded by private
donors in exchange for research-related benefits, such
as trial participation or access to the trial intervention.
This has been pejoratively referred to as ’pay to play’
research, and criticised as unethical. We outline three
models of donor-funded research, and argue for their
permissibility on the grounds of personal liberty, their
capacity to facilitate otherwise unfunded health research
and their consistency with current ethical standards for
research. We defend this argument against objections
that donor-funded research is wrongly exploitative, unfair
and undermines the public good of medical research.
Our conclusion is that, like all human subjects research,
donor-funded research should be regulated via standard
health research legislation/guidelines and undergo
Research Ethics Committee/Institutional Review Board
and scientific peer-review. We expect that, measured
against these standards, some donor-funded research
would be acceptable.
Introduction
Demand for biomedical research funding outstrips
supply from current funding bodies. Only a small
percentage of promising drugs ever make it into
drug trials to test their efficacy and safety. Deci-
sions regarding which drugs to take from discovery
to proof of concept involve a considerable amount
of guesswork. This provides a prima facie incen-
tive to find new ways to fund biomedical research.
One option is raising money from private donors,
in exchange for their receipt of some research-re-
lated benefit. This is not a new idea; historically
patronage funded much of science and the arts.
However, in modern biomedical research there are
some potentially important differences: the internet
enlarges the pool of potential donors accessible to
researchers, and facilitating aggregation of donors
for a study, and donors may have an interest in
being a participant in the research, rather than
merely funding it.
Donor-funded research is proposed, and has been
used, as a way to overcome traditional research
funding limitations.1 2 The recent ‘plutocratic
proposal’ (PP) presented in this journal by Masters
and Nutt is a relevant example.1 A related model
is one in which private donors would be offered
the opportunity to try the experimental interven-
tion without participating in the trial.2 We call this
‘pay to try’ (PTT) research. Previous literature has
explored a similar idea, under the terminology
‘pay to play’ or ‘pay to participate’ (PTP) research,
where all participants pay for access to the trial.3–5
A common feature of the models we focus on is that
private donors are offered an opportunity to partic-
ipate in clinical trials they fund, or otherwise access
to the experimental intervention. Hereafter, we will
King M, Ballantyne A. J Med Ethics 2018;0:1–5. doi:10.1136/medethics-2018-104966
refer to these three models or their use collectively
as donor-funding models or donor-funded research.
We argue that they deserve serious consideration.
Our approach in this article is to assess these
proposals against broadly accepted minimal stan-
dards of research ethics to determine whether it
is reasonable to prohibit donor-funded research.
This standard ensures consistency with how other
clinical research is reviewed and assessed. Our
concern is that previous critiques have measured
donor-funding against higher, perhaps aspira-
tional, research ethics standards. We conclude that
donor-funded research is prima facie permissible,
and ought to be regulated through Research Ethics
Committee/Institutional Review Board (REC/IRB)
review and oversight like other research.
Argument for donor-funded research
Both liberty and public good can ground a prima
facie argument for the permissibility of donor-
funded research. First individuals hold a prima facie
right to engage in free exchanges of goods, based
on personal liberty interests, or personal autonomy.
Second, assuming this is an informed, consensual,
voluntary transaction between rational parties, each
is better off—the donor prefers exchanging their
money for access to the trial, and the researcher
prefers exchanging some research-related benefit
(these vary in different models, as we later explain)
for funds that enable the trial to occur. Although
neither donor nor researcher may be under a duty
to engage in or offer these transactions, there is pro
tanto reason, based on the benefit of free exchanges,
and the liberty to engage in them, that they not be
prohibited or otherwise thwarted.
Second, clinical research is a public good; it
provides the evidence base for safe and effective
clinical care.6 Populations who are systematically
excluded from, or neglected in, research are worse
off than others, due in part to the lack of evidence
to inform their medical care. Examples include
patients with comorbidities, pregnant women and
people with rare diseases, all of which are neglected
under the status quo of health research funding.7–9
Effects of this can include increased adverse events
and side effects, reduced length or quality of life
due to undertreatment and missing out on inno-
vative therapies. There are strong public interests
in regulating research. Regulation helps ensure
the scientific validity and social value of proposed
research. Moreover, given the history of unethical
medical research, there is a duty to protect potential
research participants from harm.
If these donor-funding models allow
good research to occur when it otherwise would not,
as has been the case,1 then prohibiting this research
forgoes both the internal value of the transaction,
   1
 Original research
and its public good externalities. This provides sufficient reason
to consider such proposals seriously.
Three donor-funding models
Here we outline three donor-funding models, where the donor
pays (wholly or in part) for the costs of running the trial.
Plutocratic proposal
In 2017, Masters and Nutt proposed a model where one donor
funds, wholly or largely, a phase I or phase IIa clinical trial in
exchange for participation by them (or their nominee) in the
trial, thereby receiving the test intervention (trials comparing
interventions are excluded).1 The donor’s transaction with the
researchers is mediated by a ‘matching agency’, overseen by a
medical charity, which screens potential donors against poten-
tial clinical trials for suitability, provides ethical review of trials,
permitting participation only for those donors/nominees that
meet clinical selection criteria for the trial.
Pay to try
An alternative version involves the private funder (or their
nominee) accessing the experimental intervention, not as a
participant in the trial, but through compassionate use exemp-
tion alongside the trial.2 The researchers recruit trial partici-
pants as per standard research practice. We call models with this
feature PTT.
Pay to play/participate
A further variation that has been discussed in the literature
involves individual patients paying a fee for enrolment in a clin-
ical trial, with price varying with research cost. Other details,
such as whether paying enrollees are randomised across control
and treatment arms (if present in the study design) may vary.3–5
These models all rely on private financial donations in
exchange for access to an experimental trial or intervention.
In both PP and PTP, access to the intervention is contingent on
participation in the clinical trial: donors are both funders of,
and participants in, the research. This dual donor-participant
role raises the potential for conflicts of interest. The mediation
structure of PP aims to eliminate potential conflicts of interest by
reducing the power each party could have to act on conflicting
interests.
While the sophisticated PP model is appealing, there is
currently no national or global infrastructure resembling the
proposed matching agency. Much of the appeal of the PP model
relies on the existence of this infrastructure. To the extent that
any other model, such as PTT, may benefit from this or a similar
infrastructure this is also a problem for them, and the estab-
lishment of this infrastructure would be valuable. In the mean-
time, it seems likely that bilateral agreements between donors
and researchers will be a feature of donor-funding models, at
least initially, as was the case for neuroendocrine cancer research
Masters successfully funded using PP.2
Objections
The first objection we consider aims to undermine the value of
the transaction for the donor and researcher: the transaction is
exploitative, and therefore bad for the donor, or morally wrong,
or both. The second objection claims that it is an ethically illegit-
imate transaction; the potential benefits and harms of research
participation ought not to be exchanged for money, and there-
fore distributed among potential participants on the basis of
2 King M, Ballantyne A. J Med Ethics 2018;0:1–5. doi:10.1136/medethics-2018-104966
J Med Ethics: first published as 10.1136/medethics-2018-104966 on 18 September 2018. Downloaded from http://jme.bmj.com/ on 22 September 2018 by guest. Protected by copyright.
wealth. The third objection questions the public good of the
research, due to concerns about the social value of interventions
that would be funded, and concerns about the scientific validity
of such studies. We consider these in turn.
Exploitation
Emanuel et al argue that "pay-to-play research is less likely to
be a collaborative partnership than a psychological exploitation
of individuals desperate to do anything to save their own or a
loved one’s life[…] Although willingness to pay might indicate
understanding and voluntariness by participants, it might also
reveal unrealistic expectations and undue pressure. The chances
for success of early-phase experimental drugs are much smaller
than either researchers or laypeople think."3
There are two related concerns here. First that donors may
be especially vulnerable to the ‘therapeutic misconception’,
thereby undermining or invalidating consent. Second that even
if consent is valid, donors may be exploited because they do not
receive sufficient benefit from the experimental intervention, in
exchange for their considerable investment.
The therapeutic misconception is a problem, but this problem
is not unique, nor necessarily worse, in donor-funded research.
Empirical work shows the therapeutic misconception remains
deeply problematic in research, especially in cancer research and
research with terminal patients. Many studies show a high expec-
tation of therapeutic benefit that likely reflects both misunder-
standing and optimistic attitude.10 11 One study found that 68%
of patients with cancer in phase I trials of experimental drugs did
not understand that they were involved in research rather than
receiving standard clinical care.12 Another study found that 89%
of early phase oncology trials participants ranked the drugs’
potential to help fight their cancer as a major reason for partic-
ipation.13 In fact, many researchers also share this misconcep-
tion; in one study, fewer than half of research providers surveyed
recognised that the main purpose of clinical trials is to benefit
future patients.14 Informed consent and patient understanding is
challenging in all oncology trials, and in donor-funded models.
We suggest that the risk of therapeutic misconception might
be higher than average in PTP research. Healthy volunteers
correlate research risk to the amount of payment they receive for
participation—volunteers assume higher payment means riskier
research.15 We might extrapolate that if participants pay to
participate, they may be more likely to believe that the interven-
tion is beneficial, despite advice to the contrary. Sipp has made
a related claim that payment for participation will increase the
perceived value of the trial by the participant, thereby increasing
placebo effect proportionally and threatening the trial method-
ology.4 While Sipp seems primarily worried about the impact on
the scientific validity of the trial, overestimating the benefit of
the intervention can also amount to therapeutic misconception
and thereby threaten consent.
Is the risk of therapeutic misconception sufficient reason to
prevent PTP research? Given that we permit phase I cancer
trials with terminal patients, where we know the therapeutic
misconception affects around three-quarters of participants, it is
inconsistent to prohibit PTP research on the speculative grounds
that therapeutic misconception could be higher in these cases.
We support the conclusion by Miller and Joffe that while these
empirical data suggest the need for enhanced informed consent
processes, it does not invalidate consent nor necessitates prohibi-
tion of phase I oncology trials.16 Consistency would demand the
same approach for PTP research.
Furthermore, the risk of therapeutic misconception seems
vastly reduced in PTT and PP models where only one, or a small

number of, funders are involved and they are paying signif-
icant amounts, close to £1 million, to enable the trial. With a
small number of funders, researchers or the matching agency
can spend more time ensuring they understand the nature of
the research. Rather than paying to participate in a pre-existing
trial, the funder(s) are actually funding the trial to get it off the
ground. They are explicitly wearing a research funding hat, in
addition to a patient or participant hat.
The second concern was that such research might exploit the
donor by failing to deliver sufficient benefit. The concern here
is that the psychological vulnerability of donors may be wrong-
fully taken advantage of (intentionally or not) for the benefit of
researchers, and research. First, we should note that potential
donor participants will not necessarily be in ill-health (especially
at the start of a study), and some may have established medical
options still available to them.i Second, the value of the chance
to try an experimental intervention is subjective—depending in
part on the donor’s available resources and their level of risk
aversion. Just as standard research subjects must assess a trial
to see if for them the potential benefits outweigh the potential
burdens; so too must donor participants make this calculation.
Even if the donor benefits less than the researcher, it is not
clear why this imbalance is sufficient to allow others to prohibit
the transaction. Where exploitation is mutually beneficial and
consensual it should not necessarily be prohibited, because to
prohibit such transactions would make the vulnerable party even
worse off, compounding their disadvantage.17 18
Neither concerns about therapeutic misconception nor
concerns about exploitation are sufficient to rule out donor-
funded research.
Fair subject selection
Emanuel et al refer to concern about ‘fair subject selection’ in
relation to PTP research funding: “selection of research subjects
should be based on the goals of the research study, including
maximising internal validity and generalisability and on the
obligation to minimise risk”, and not on ability to pay.3 This
can be interpreted as a concern about scientific validity (which
we address later) or about justice and fair eligibility criteria.
A well-accepted premise of ethical research is that research
risk and benefits should be fairly distributed.19 Participants or
populations should not be unfairly excluded from research,
nor overly burdened with research participation. PTP research
restricts places on trials to those who can pay, and PTT research
allows donors to avoid the risk of allocation to a control group.
Before we address this objection, it is worth noting a potential
tension between the previous two concerns. On the one hand,
potential donors are characterised as sick, desperate, vulnerable
and open to the therapeutic misconception. On the other hand,
they are characterised as wealthy, powerful and able to purchase
the benefits of research participation that are unfairly denied to
poorer patients. It is, however, possible that donors could be
vulnerable in regard to their health, but simultaneously powerful
in terms of the resources they have available.ii The point here
is that no single simplistic characterisation of donors or the
donor-researcher relationship is plausible. Therefore, arguments
about the permissibility of the these funding models should
not be dependent on the accuracy of these assumptions about
donors.
i 
We thank an anonymous reviewer for this suggestion.
ii 
We thank an anonymous reviewer for this observation.
King M, Ballantyne A. J Med Ethics 2018;0:1–5. doi:10.1136/medethics-2018-104966
Original research
J Med Ethics: first published as 10.1136/medethics-2018-104966 on 18 September 2018. Downloaded from http://jme.bmj.com/ on 22 September 2018 by guest. Protected by copyright.
Should trial places or research-related risk be traded for money?
The distribution of research risk and benefit between communi-
ties based on financial resources is common. Clinical research
is increasingly outsourced to contract research organisations in
low-income to middle-income countries to make use of large
patient populations that lack access to standard medical care.20
Outsourcing research essentially allows wealthy communities to
buy their way out of research risk. Their families and children
do not undertake the risks of drug development, yet still benefit
from successfully developed interventions. On the reverse, high-
tech, cutting-edge research, such as surgical robotics, is likely to
be conducted in tertiary hospitals in high-income countries and
rural patients are unlikely to have equal access to this. Research
conducted in private allied health facilities is often restricted to
those who can pay to purchase the clinical services (eg, sleep
clinics, physiotherapy, weight management). In all these cases,
access to research participation and distribution of research risk
depends in part on the potential participants’ socioeconomic
circumstances. We do not believe donor-funding models are
more commodifying than research practices we already allow.
It would be inconsistent to prohibit them while permitting the
others.
Public good: social value
A further concern with donor-funding models is that they may
undermine the social value of research by skewing the research
agenda: “pay to play research would prioritise research needs of
the wealthy and their aliments”.3
But all pharmaceutical industry-funded research, currently
three-quarters of all clinical research, prioritises the needs of the
patients in wealthy markets.21 The global poor bear the greatest
burden of disease, and have the least economic resources with
which to buy healthcare at profitable prices; they therefore
represent a poor market. Only roughly 1% of total research and
development funding is directed towards neglected diseases, and
seven to eight times the funding for clinical research is directed
towards diseases affecting those from high-income countries,
compared with low-income and middle-income countries.21 If
Emanuel et al are right that skewing the research agenda towards
those who can pay is sufficient to prohibit research that deviates
from the perfectly just pattern of distribution, much more than
donor-funded research ought to be prohibited.
Furthermore, current examples of these donor-funding
models have focused on rare diseases that do not rank highly for
social utility reasons or according to the size of the market, and
therefore do not appeal to either public or private sponsors. The
PP has explicitly been developed by Masters and Nutt to address
the gap in clinical research funding by focusing on neglected or
orphan diseases, and used successfully for this purpose.1
There will be an irreducible element of chance. Of two equally
worthy potential drugs, only one may receive PTT or PP funding
because there happens to be a wealthy affected funder. While
funding of any specific drug may be random in this manner, it
is not clear that this would be unfair, as opposed to unlucky.
Given the vast scale of the total global investment in research
and development, about 90% of which is from corporate and
public funding,21 we doubt overall that donor-funding models
would skew the global research agenda. Even if they did have an
impact, it is not clear that this would render the research agenda
more unjust.
Moreover, if donor-funding models did objectionably skew the
research agenda, it is not clear that the free exchange of goods
that they constitute ought to be prohibited. As Nozick argued,
voluntary, permissible, exchanges can disrupt any patterned
3
 Original research
distribution.22 It is not straightforward that the solution to this is
to override individual liberty in the relevant domain, as opposed
to other options such as funding or incentivising other research
to re-orientate the agenda. Prohibition in this case would be
an example of pre-emptive levelling down, preventing valid
research from being conducted.
Public good: scientific validity
As we have seen, some of the critiques levelled at donor-funding
models have concerned potential threats to the scientific validity
of the study, for example, that patients who fund trials may
attempt to influence aspects of the study design, such as eligi-
bility criteria, the use of placebos and randomisation.
Scientific validity is an essential value of ethical research. If
the study does not generate valid results it will (at best) not add
to knowledge, and (at worst) cause harm to participants and the
public by distorting the knowledge base. As with other clinical
research, donor-funded research must undergo research ethics
review and scientific peer-review. If reviewers are not confident
that the study can be designed and administered to achieve valid
result, then they should not approve the study. It is not clear that
donor-funding model designs are so risky as to be automatically
precluded from REC/IRB consideration.
Of all the potential models, PTT seems the least risky in this
respect as the funder accesses the experimental drug outside the
trial. PTP designs present the highest risk, as all participants are
also funders and therefore the potential for them to put pressure
on the research methodology is maximised.5
Minimal standards as an ethical benchmark
Throughout this paper we have used minimal standards of
research ethics (rather than ideal or aspirational standard) as
the benchmark by which we measure proposed donor-funded
research. We have argued by analogy that these donor-funding
models should be permitted because they are consistent with
much existing permissible research—a conservative argument
from consistency. Critics have argued that donor-funding
should be prohibited because of fundamental ethical concerns
about scientific validity, social value, therapeutic misconcep-
tion, exploitation and fair subject selection. But the nature of
the concerns levelled at donor-funding models are not qualita-
tively, nor in many cases quantitatively, different from features of
currently permitted health research.
There are two alternative conclusions that are worth consid-
ering. A radical conclusion is that both donor-funded research
and much of the current medical research are unethical, and
should be prohibited (eg, the large proportion of pharmaceuti-
cally funded research outsourced to lower middle-income coun-
tries). In our view, the radical consistency argument would be a
legitimate (if somewhat ambitious) response. Alternatively, one
could conclude that consistency should not be the determining
factor. With so much medical research of questionable ethical
status already occurring, why introduce more?iii We think this is
a relevant consideration and worthy of further debate.
But note that neither of these arguments have been levelled
at donor-funding models in the literature. If these critics value
consistency, they ought to acknowledge and defend the radicalism
iii 
A similar argument is made in relation to legalising recreational drugs,
for example, ‘marijuana may be less harmful than alcohol, but given
alcohol is already legal we ought not to legalise additional harmful
substances’. For discussion of this view, see Wolff J. Ethics and Public
Policy: A Philosophical Inquiry, Routledge 2011, pp. 78–79.
4 King M, Ballantyne A. J Med Ethics 2018;0:1–5. doi:10.1136/medethics-2018-104966
J Med Ethics: first published as 10.1136/medethics-2018-104966 on 18 September 2018. Downloaded from http://jme.bmj.com/ on 22 September 2018 by guest. Protected by copyright.
of their argument. The alternative critical approach is to reject
consistency, and provide argument to justify this rejection.
Conclusion
We have argued for the permissibility of donor-funding models
on the grounds of personal liberty, the facilitation of otherwise
unfunded health research and consistent application of ethical
standards. Our concern is that the initial criticisms of private
donor research funding models appear to assess these against
aspirational rather than real-world ethical standards. There is a
compelling public obligation to ensure the scientific validity and
social value of research. All human subjects research should be
regulated via standard health research legislation/guidelines and
undergo IRB/REC and scientific peer-review. We expect that,
measured against these standards, some donor-funded research
would be acceptable. Regarding all of the potential concerns,
the PP does the best job of minimising risks; and PTT is less
risky than PTP (due to the smaller number of donors and there-
fore less chance for therapeutic misconception and conflicts of
interest). In our view, there is nothing inherently unethical about
these forms of donor-funded research and no good reason to
outright prohibit them.
Acknowledgements  The authors would like to thank the audience of the
Asian-Australasian Association of Bioethics and Health Law Conference, and an
anonymous referee for their helpful feedback on this work.
Contributors  MK and AB made a substantial, and equal, contribution to
the conception of the work, each draft, revision and approval of final content.
Both authors agree to be accountable for all aspects of the work and ensure
that questions related to the accuracy or integrity of any part of the work are
appropriately investigated and resolved.
Funding  This research received no specific grant from any funding agency in
thepublic, commercial or not-for-profit sectors.
Competing interests  None declared.
Patient consent  Not required.
Provenance and peer review  Not commissioned; externally peer reviewed.
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