Standardized Study - IA de Investigación especializada en el MIT

Estudio estandarizado
Designs, Value Judgments,
and Financial Conflicts of
Interest in Research

Kevin C. eliot
Michigan State University

The potential for ﬁnancial conﬂicts of interest (COIs) to inﬂuence scientiﬁc
research has become a signiﬁcant concern. Some commentators have suggested
that the development of standardized study protocols could help to alleviate
these problems. This paper identiﬁes two problems with this solution: (1) científico-
tiﬁc research incorporates numerous methodological judgments that cannot be
constrained by standardized protocols; y (2) standardization can hide sig-
niﬁcant value judgments. These problems arise because of four weaknesses of
standardized guidelines: incompleteness, limited applicability, selective igno-
rance, and ossiﬁcation. Por lo tanto, the standardization of study designs should
not serve as an alternative to addressing the interests and power relations that
pervade science policy-making. Policy makers should take at least two steps to
prevent powerful interest groups from co-opting standardized guidelines. Primero,
their development and review should be made as transparent as possible and
should be subjected to broadly-based deliberation. Segundo, standardized guide-
lines should be supplemented with efforts to scrutinize the conditions under
which ﬁnancial COIs tend to have the most worrisome effects so that addi-
tional steps can be taken to eliminate and mitigate those conditions.

Introducción

1.
The potential for ﬁnancial conﬂicts of interest (COIs) to inﬂuence scientiﬁc
research in problematic ways has recently become a signiﬁcant topic of dis-
cussion across numerous ﬁelds. The chemical, petroleum, pharmaceutical,
and tobacco industries have all been accused of suppressing evidence that

I am grateful for helpful comments from Adam Kokotovich, Heather Douglas, Fern Wickson,
two anonymous referees, and the attendees at the pre-conference workshop on Science, Política,
and Values at the Society for Philosophy of Science in Practice meeting in 2013 at the Uni-
versity of Toronto.

Perspectives on Science 2016, volumen. 24, No. 5
©2016 by The Massachusetts Institute of Technology

doi:10.1162/POSC_a_00222

529

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530

Diseño, Value Judgment, and Conﬂict of Interest

their products are harmful, producing studies with questionable method-
ologies, generating questionable reinterpretations of studies that challenge
their products, and working with public relations (PR) ﬁrms and front
groups to mislead the public about relevant science (see e.g., McGarity and
Wagner 2008; Michaels 2008; Oreskes and Conway 2010; eliot 2011). En
an effort to address these inﬂuences, government agencies and universities
have instituted various policies, which include requirements to disclose ﬁnan-
cial COIs in publications, the creation of trial registries so that unfavorable
studies cannot be hidden as easily, increased enforcement of COI policies for
participation on government advisory panels, and the development of criteria
for assessing the credibility of research (Conrad and Becker 2011; Resnik 2006;
Resnik and Elliott 2013).

Another approach for addressing ﬁnancial COIs that has drawn recent
attention is the development of standardized study protocols (see e.g.,
Conrad and Becker 2011; Ramachandran et al. 2011). The goal of this
strategy is to standardize the design of policy-relevant research (p.ej., seguridad
studies of new chemicals or pharmaceuticals) so that it is more difﬁcult for
investigators to design studies in a manner that generates predetermined
resultados. The present paper explores the merits of this approach by draw-
ing on literature from the philosophy of science as well as science and tech-
nology studies (STS). This literature is very helpful for thinking through
the complexities of standardizing study designs because it highlights the
methodological judgments involved in scientiﬁc research and the ways in
which those judgments can be made appropriately or inappropriately.

The next section of the paper provides background about the inﬂuences
of ﬁnancial COIs on research and the major proposals for addressing them.
It also introduces the strategy of standardizing study protocols in an effort
to constrain study designs. Sección 3 then highlights two major difﬁculties
with this solution. Primero, scientiﬁc research incorporates so many method-
ological value judgments that it is difﬁcult to constrain them through the
standardization of protocols. Segundo, the standardization of protocols can
hide signiﬁcant value judgments that merit further discussion. The paper
clariﬁes and elaborates on these two difﬁculties by highlighting four poten-
tial weaknesses of standardized study designs: they tend to be incomplete,
they have limited applicability, they promote selective ignorance, y ellos
can easily ossify. Sección 4 argues that some of the potential weaknesses
associated with standards can be alleviated by promoting broadly-based
deliberation about them and about the results of studies. But it also argues
that those who wish to address ﬁnancial COIs in scientiﬁc research would
do well to adopt other strategies, such as identifying the conditions under
which the worst problems occur and attempting to eliminate or mitigate
those conditions. Besides helping to address ﬁnancial COIs, the analysis in

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Perspectives on Science

531

this paper should promote greater understanding of the strengths and weak-
nesses of standardization, which is receiving increasing attention both in
the regulatory environment and in the science-studies literature (see e.g.,
Lampland and Star 2009; Busch 2011).

2. Standardization as a Response to Financial COIs
En años recientes, the inﬂuences of ﬁnancial COIs on scientiﬁc research have
become a topic of increasing social concern. It is now well known that the
tobacco industry produced a great deal of questionable research throughout
the latter half of the twentieth century in an effort to defend the safety of
smoking and exposure to second-hand smoke (Proctor 2012). The industry
also famously employed a variety of related strategies, including cultivat-
ing well-known academics to support their products, employing powerful
PR ﬁrms, and funding think tanks and front groups (McGarity and Wagner
2008; Oreskes and Conway 2010; Proctor 2012). It has now become clear
that other industry groups used similar strategies to defend products like
dirigir, asbestos, and vinyl chloride (Markowitz and Rosner 2002). In their
recent book Merchants of Doubt (2010), Naomi Oreskes and Erik Conway
show that many of the same scientists, PR ﬁrms, and front groups worked
to generate confusion and misleading science about a series of environ-
mental issues, including acid rain, the ozone hole, and climate change (ver
also McCright and Dunlap 2010). David Michaels (2008) points out that
government departments and agencies are prone to engage in some of the
same misleading strategies when they face incentives to do so.

Some of the most enlightening empirical information about the effects
of ﬁnancial COIs on research has come from analyses of the pharmaceutical
industria. Over the past twenty years, a number of studies have compared
the results of research on the effectiveness of particular drugs when the
research is funded by an entity with a ﬁnancial interest in the outcome
(such as the manufacturer of one of the drugs) versus when the research is
funded by an entity without signiﬁcant ﬁnancial interests in the outcome
(such as the National Institutes of Health). An inﬂuential meta-analysis of
eleven of these studies found that, in every single study, research funded
by entities with a ﬁnancial interest in the outcome was more likely to yield
results favorable to those entities than comparable research funded by entities
without obvious ﬁnancial interests (Bekelman et al. 2003; see also Sismondo
2008 and Lundh et al. 2012). By combining data from all eleven studies, el
meta-analysis concluded that research funded by those with a ﬁnancial inter-
est in the outcome was about four times as likely to yield results that favored
the funders. Además, when the primary outcomes of studies are not sta-
tistically signiﬁcant, industry-funded biomedical studies are more likely than
non-industry funded studies to report positive ﬁndings in subgroups (Sol

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Diseño, Value Judgment, and Conﬂict of Interest

et al. 2011). Although less data on ﬁnancial COIs have been gathered outside
the biomedical arena, some similar results have been identiﬁed with chemical
safety studies (see e.g., Fagin et al. 1999, pag. 51; vom Saal and Hughes 2005).
A study of ﬁnancial inﬂuences on nutrition research also found that research
funded by entities with ﬁnancial interests in the outcome was four to eight
times as likely to produce results favorable to the funder as compared to
similar research funded by a disinterested party (Lesser et al. 2007).

As various ﬁgures have noted, one needs to be careful about how to interpret
these correlations between funding sources and research outcomes, because they
can be generated by a variety of different causal processes. Arthur Schafer dis-
cusses at least four potential causes for the correlations that have been identiﬁed
in pharmaceutical industry publications: (1) industry might be good at rec-
ognizing in advance which products are likely to be most effective; (2) ensayos
sponsored by industry might be of poor quality (yielding results favorable to
their products); (3) the industry studies might be biased (either consciously or
unconsciously); o (4) there might be publication bias (Schäfer 2004, pag. 18).
Schäfer (2004) argues that the ﬁnal two causes are more plausible than
the others and that there is already signiﬁcant evidence for publication bias.
En otras palabras, pharmaceutical companies are most likely to publish studies
that are favorable toward their products, and they are less likely to publish
ﬁndings that are unhelpful for their marketing goals. This is part of a
broader “publication planning” effort on the part of these companies. Ellos
work with professional publication planners to determine what kinds of
papers would be most helpful for promoting their products, which aca-
demics would be most inﬂuential to have as authors, and which “key opinion
leaders” should be cultivated to spread the word about their ﬁndings (eliot
2004; Sismondo 2007). As part of this effort, Richard Smith (former editor of
the British Medical Journal ) argues that the pharmaceutical industry has
become very skilled at designing studies and interpreting data in ways that
do not appear obviously biased to peer reviewers but that are likely to gen-
erate preferred results (Herrero 2005; see also Michaels 2008).

Desafortunadamente, developing adequate approaches for alleviating these in-
ﬂuences of ﬁnancial COIs on scientiﬁc research is no easy matter. I have
previously argued that scientiﬁc practice is permeated by so many different
subtle methodological judgments that it is very difﬁcult to identify and
manage all the problematic ways that ﬁnancial COIs can affect research
(eliot 2008; see also de Melo-Martin and Intemann 2009). Actualmente,
perhaps the most common approach for addressing COIs is to require that
investigators disclose any relevant ﬁnancial ties when they publish their
trabajar. But a fascinating body of psychological research indicates that this
solution is likely to be fairly unhelpful and perhaps even counterproductive.
Psychologists have found that those who receive information about COIs

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Perspectives on Science

533

are very poor at determining how much to discount the quality of the infor-
mation that they receive, and those who disclose COIs may actually provide
more biased information than they otherwise would (Cain et al. 2005;
Loewenstein et al. 2012; see also de Melo-Martin and Intemann 2009).

Other proposed solutions face similar challenges. Por ejemplo, otro
common suggestion for addressing ﬁnancial COIs is to fund more research
on policy-relevant issues via government agencies that do not have a sig-
niﬁcant stake in the results (p.ej., the US National Science Foundation or
the National Institutes of Health) (see e.g., Angell 2005; APHA 2003;
Shrader-Frechette 2007; eliot 2011). While this proposal might be
promising in principle, it faces major practical difﬁculties. Namely, indus-
try currently funds about two-thirds of scientiﬁc research and development
in the US, including the vast majority of safety studies for new products
(Conrad and Becker 2011; eliot 2011, pag. 6). Given that most govern-
ments are skeptical of increased spending, it would be very difﬁcult to re-
place much of this industry research with science funded by government
agencias. Other commentators have suggested that individual researchers
might be able to counteract the effects of ﬁnancial COIs by developing
virtuous character traits that enable them to minimize biasing inﬂuences
(Curzer and Santillanes 2012). But this proposal faces at least two difﬁcul-
corbatas. Primero, people tend to overestimate the extent of their objectivity and
their ability to resist the inﬂuences of COIs (Cain et al. 2005; Loewenstein
et al. 2012). Segundo, many of the ﬁgures paid by interest groups to obtain
speciﬁc sorts of scientiﬁc results do not appear motivated to resist these
inﬂuences (see e.g., Michaels 2008; Oreskes and Conway 2010).

Given the difﬁculties associated with these common approaches for
responding to ﬁnancial COIs, some authors have suggested that the stan-
dardization of study protocols could be a promising alternative solution.
This was a central recommendation in the concluding report of a group
at the University of Minnesota that received National Science Foundation
(NSF) funding for a four-year project to study potential oversight struc-
tures for research on nanotechnology (Ramachandran et al. 2011). Basado
on an analysis of ﬁve previous oversight experiences with emerging tech-
nologies in the United States (involving genetically engineered foods,
pharmaceuticals, medical devices, workplace chemical exposures, and gene
therapy), they concluded that common weaknesses in these systems include
“low transparency, little public input, prominent conﬂicts of interest, y
limited ﬁnancial resources” (Ramachandran et al. 2011, pag. 1352).

In order to alleviate the limited ﬁnancial resources available to regulatory
agencias, the Minnesota group suggested that industry should play a major
role in generating safety data for new nanotechnologies. They acknowledged
that this could exacerbate the problem of conﬂicts of interest, pero ellos

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Diseño, Value Judgment, and Conﬂict of Interest

suggested a two-pronged approach for addressing these conﬂicts. Primero, ellos
suggested that standardized protocols and procedures should be developed
that both manufacturers and regulatory agencies can follow. Segundo, ellos
suggested that a coordinating agency could provide external review and
vetting of the safety data produced. Part of the idea behind standardizing
study protocols is that it makes it more difﬁcult for investigators to take steps
to generate preferred outcomes. Por ejemplo, the standards could prevent
investigators from running studies for too short a period of time or using
too few animals or using an inappropriate feed or using various other tactics
that can mask toxic effects (Shrader-Frechette 2007).

This emphasis on using standardized study protocols to constrain study
designs can also be found in a recent article in Environmental Health Perspec-
tives that attempted to synthesize various criteria for assessing the credibil-
ity of scientiﬁc studies. Los autores, James Conrad and Richard Becker
(2011), focused especially on assessing the credibility of chemical safety
studies performed for regulatory purposes. They acknowledged that many
people have become suspicious of these studies because the overwhelming
majority of them are funded by those who manufacture or use the chemicals
under investigation. Sin embargo, Conrad and Becker suggest that it makes
more sense to evaluate the credibility of these studies based on criteria that
do not appeal to the studies’ sources of funding.

Conrad and Becker’s paper (2011) provides ten criteria, such as whether
ﬁnancial COIs have been disclosed, whether principal investigators are
legally guaranteed freedom to publish and interpret results, whether data
and methods are publicly disclosed, and whether the study has undergone
peer review or some other form of external review. I have previously argued
that many of these criteria are relatively unhelpful, but one of their most
promising criteria is whether the study has a transparent research objective
and an appropriate design for achieving that objective (eliot 2014). Para
the purposes of the present paper, the crucial point is that Conrad and
Becker appeal to standardized study protocols in order to determine
whether this criterion is met. They argue that those evaluating studies
should consider whether the studies meet Good Laboratory Practice
(GLP) or Good Epidemiological Practice (GEP) guidelines and whether
they are performed according to agency-approved study protocols that
are typically generated by the Organization for Economic Cooperation
and Development (OECD). The goal of this paper is to consider how well
these standards can indeed serve the goal of ensuring study credibility.

3. Challenges of Standardization
The main argument of this section is that when one reﬂects on the myriad
ways in which value judgments pervade scientiﬁc practice, it becomes

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Perspectives on Science

535

apparent that the standardization of study design faces signiﬁcant dif-
ﬁculties as a response to ﬁnancial COIs. Numerous STS scholars, en-
cluding many philosophers of science, have recently elucidated the
value-laden character of scientiﬁc reasoning (see e.g., Kitcher 2001;
Longino 2002; douglas 2009; Kourany 2010; eliot 2011). According
to these scholars, scientists have to make methodological decisions
that cannot be decided in a simple rule-governed fashion; ellos tienen
to weigh the importance of various desiderata when deciding what
questions to ask about a particular phenomenon, how to design studies
to investigate it, what terminology or categories to employ for describ-
ing it, what background assumptions to adopt, how to interpret ambig-
uous results, and what standards of evidence to demand when drawing
conclusions.

Because of all these methodological choices, scientiﬁc reasoning be-
comes value-laden in at least two different senses. Primero, as noted in the
previous paragraph, scientists are forced to weigh a range of desiderata
(es decir., valores) when making methodological choices. Segundo, when these
methodological choices have social consequences, such as determining
whether particular products are determined to be harmful or whether
particular groups of people receive compensation for being harmed, ellos
become value-laden in an additional (ethical and political) sense. Como
Heather Douglas (2009) has argued, scientists have responsibilities to
consider the potentially harmful social consequences of their methodo-
logical decisions, and therefore they need to include ethical reasoning
about these consequences among the other desiderata that they factor into
their decisions. Admittedly, making methodological choices (like decid-
ing what strain of rats to use in a toxicology study) is not as explicitly
normative as deciding what level of risk people should be exposed to.
Sin embargo, these issues start to blur together once one recognizes that
subtle methodological choices can determine whether a chemical is deemed
to have a high level of risk or not, and therefore whether it ends up being
regulated (douglas 2009; eliot 2011).

The prevalence of these methodological value judgments throughout
scientiﬁc reasoning poses two problems for using standardized study pro-
tocols to address ﬁnancial COIs. Primero, it is unrealistic to expect standard-
ized study guidelines to prevent the wide array of potential inﬂuences of
ﬁnancial COIs on all these judgments. Segundo, standardized guidelines can
hide signiﬁcant value judgments, insofar as they impose design features
that are appropriate in some scientiﬁc contexts but not in others. Por lo tanto,
they can be exploited (either intentionally or unintentionally) to advance
the goals of speciﬁc interest groups (see e.g., Ottinger 2010). In order to
highlight and illustrate these two problems, it is helpful to reﬂect on

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Diseño, Value Judgment, and Conﬂict of Interest

four potential weaknesses of standardized protocols: incompleteness, limitado
applicability, selective ignorance, and ossiﬁcation.

Primero, standardized protocols are often incomplete, in the sense that they
are typically insufﬁcient to ensure that studies actually have the qualities
that are desired in a particular context. A perfect example of this sort of
incompleteness comes from Conrad and Becker’s (2011) suggestion that
those evaluating the credibility of studies should consider whether they
have been performed according to GLP guidelines. The problem with this
dependence on GLP standards is that they were developed by the U.S.
Food and Drug Administration (FDA), and later adopted by the Environ-
agencia de protección mental (EPA), as a response to industry abuses in which
researchers falsiﬁed or fabricated their data (Myers et al. 2009). Por lo tanto,
they focus primarily on documenting procedures so as to ensure that all
reported results actually reﬂect what was done in the lab. They do not
ensure that these procedures are actually appropriate for answering the
questions under investigation. Por ejemplo, a number of researchers argued
that the U.S. FDA and the European Food Safety Authority gave too much
weight to industry-funded GLP studies when they evaluated the safety of
bisphenol A, even though those GLP studies may not have employed the
best new techniques for identifying potential health hazards (Myers et al.
2009).

Conrad and Becker (2011) would presumably respond that when GLP
studies are performed for regulatory purposes, the protocols followed by
investigators are typically those that have been speciﬁed and approved
by agencies such as the FDA or the EPA. These protocols are often pro-
posed by international bodies such as the OECD, and they undergo vali-
dation to ensure that they are appropriate for answering the regulatory
questions under consideration. Por lo tanto, even though GLP guidelines
themselves are incomplete, in the sense that they do not ensure that appro-
priate protocols are followed, they are conjoined with other standards that
address this source of incompleteness.

Desafortunadamente, even these agency-approved protocols are often in-
complete, in the sense that they are insufﬁcient to prevent questionable
value judgments from inﬂuencing studies. Por ejemplo, these protocols
typically give investigators the freedom to choose which of several spe-
cies or strains of animals to employ (Elliott and Volz 2012). Esto es
understandable, because it could be problematic for the standards to
be overly rigid in specifying the details of study designs in all cases.
Sin embargo, this allows those with an interest in obtaining particular
resultados (p.ej., obtaining evidence that a chemical is not particularly
harmful) to choose experimental animals that are more likely to yield
those results (p.ej., choosing particularly insensitive animals) (see e.g.,

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Perspectives on Science

537

Vandenberg et al. 2012, pag. 393; vom Saal and Hughes 2005). simí-
mucho, the guidelines for regulatory ecotoxicity tests provide signiﬁcant
latitude for investigators to choose desired dose levels and statistical
analyses in their experiments, which can have significant effects on the
calculation of safe exposure levels for the chemicals under investigation
(Chapman et al. 1996; Isnard et al. 2001). Finalmente, these guidelines typically
only specify a minimal amount of information that must be reported to reg-
ulators, which allows those performing the studies to make signiﬁcant value
judgments about what additional information to report or not (Elliott and
Volz 2012).

A second potential problem with standardized protocols is their limited
applicability. En otras palabras, they apply in some circumstances but not in
otros, and there are often signiﬁcant value judgments involved in decid-
ing where they do and do not appropriately apply. Por ejemplo, David
Michaels (2008) notes that Good Epidemiological Practice (GEP) guía-
lines require high standards of evidence in order to infer that a particular
substance contributes causally to a hazard. This demand for high standards
of evidence makes sense in many scientiﬁc contexts, and it serves the inter-
ests of those who produce and use the substance in question. But in some
casos (p.ej., where the use of a potentially hazardous substance could have
dire social consequences and where there are reasonable alternatives), él
might make sense to infer that a substance is harmful based on much more
limited evidence (Elliott and Resnik 2014). To take another example,
David Andow and Angela Hilbeck (2004) note that OECD guidelines rec-
ommend that chemical pesticides be tested on a set of “universal indicator
species” (such as an algae, a water ﬂea, and a ﬁsh) in order to predict their
likely toxicity on a wide range of other species. Sin embargo, value judg-
ments are needed about how widely to generalize the results of these stud-
es, because these indicator species are not likely to serve as reliable
indicators for effects on nontarget species or on “higher-level” entities such
as populations and ecosystems (Andow and Hilbeck 2004).

Another excellent example of the limited applicability of standards
comes from a recent article by Fern Wickson and Brian Wynne (2012).
They discuss recent debates about a safety study of a genetically modiﬁed
(GM) insect-resistant corn (maize) that expresses a protein from the bacte-
rium Bacillus thuringiensis (Bt) (see Bøhn et al. 2008). The study provided
evidence that water ﬂeas fed this GM maize suffered increased mortality,
lower sexual maturation, and lower egg production (Bøhn et al. 2008,
pag. 584). According to critics of the study, one reason for challenging its
results is that it ran too long; whereas OECD Directive 211 for reproduc-
tion tests with Daphnia magna (the water ﬂea used for the experiment) calls
for tests to be 21 days long, the Bøhn et al. (2008) study ran for 42 días.

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Diseño, Value Judgment, and Conﬂict of Interest

Wickson and Wynne challenge the critics by pointing out that one could
plausibly interpret the OECD Directive as calling for tests to be a minimum
de 21 days rather than a maximum of 21 días. Además, they point out
that there are signiﬁcant judgments involved in deciding when a 21-day
test is superior to a 42-day test (Wickson and Wynne 2012, pag. 327). Ellos
note that if one desires to investigate the potential for chronic effects or
for effects over the entire lifecycle of the organism, 42-day tests could
be superior. De este modo, whereas a 21-day test may be preferable in some circum-
posturas, this standard may not be appropriate for answering other impor-
tant questions about the safety of GM maize.

A third potential problem with standardized protocols is their ten-
dency to promote selective ignorance (eliot 2013). En otras palabras, ellos
focus investigators on collecting some forms of information about poten-
tial hazards, which may decrease attention to other relevant threats or
forms of information. This problem is related to the previous one (limitado
applicability), in the sense that both are caused by the tendency of
standardized guidelines to constrain the sorts of information that are col-
lected. Sin embargo, the focus of the two problems is somewhat different.
The limited applicability problem emphasizes that the information col-
lected is helpful only for addressing certain sorts of questions in a speciﬁc
range of contexts. The focus of the selective ignorance problem is that,
insofar as standardized protocols yield only speciﬁc forms of information,
scientists and policy makers can lose sight of other forms of information
that would be valuable for them to collect in order to inform their decision
haciendo.

Wickson and Wynne’s discussion of GM maize also provides an ex-
ample of selective ignorance. They note that another criticism of the
study by Bøhn et al. (2008) has been that it used GM maize ﬂour as
the test material that was fed to the water ﬂeas. Una vez más, this violated
the OECD standards supported by industry and the European Food
Safety Authority (EFSA) (see Wickson and Wynne 2012, pag. 329). El
standard material fed to water ﬂeas in order to test the safety of this GM
maize is puriﬁed Bt protein taken directly from Bacillus thuringiensis. Un
advantage of this standardized approach is that it is much easier for
investigators to obtain puriﬁed Bt protein from bacteria than from the
maize that has been genetically engineered ( Wickson and Wynne 2012,
pag. 329). But this approach also promotes a signiﬁcant form of ignorance.
Namely, it uncovers only the toxic effects caused by the Bt protein itself.
It does not identify any toxic effects that might be caused by the maize
plant as a result of its genetic modiﬁcation, and it does not uncover any
harmful ways in which the Bt protein might have been modiﬁed in the
maize plant ( Wickson and Wynne 2012). De este modo, this case shows how

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Perspectives on Science

539

standards can incorporate signiﬁcant judgments and assumptions about
what sorts of information are and are not important to collect.1

Some of the features of the selective ignorance illustrated by the Bt maize
case are common across many areas of standardized regulatory science. En
particular, it is common for standardized approaches to simplify the com-
plexity of real-life situations signiﬁcantly for the sake of generating more
replicable and easily interpretable data. In order to minimize the potential
to obtain confusing results as a result of feeding test organisms the actual
ﬂour from GM maize, researchers typically assume that the hazards asso-
ciated with the maize can be isolated to the Bt toxin and that the toxin
is no different in the maize than in Bt bacteria. In a somewhat analogous
manner, researchers simplify the vast majority of toxicity tests for regulatory
purposes so that they are performed with individual chemicals, even though
people are exposed to mixtures of chemicals in real life (Eggen et al. 2004).
Similarmente, toxicity tests are typically performed on a small number of well-
understood model organisms or indicator species, even though these may
not provide complete information about the effects of the chemicals on
other species or ecosystems (Andow and Hilbeck 2004). Studies are also
commonly performed in carefully controlled laboratory conditions, con
puriﬁed samples and a minimum of potential confounding factors. All these
common features of standardized regulatory studies maximize the possi-
bility of obtaining replicable results that are easy to interpret, pero ellos
lessen the chance of uncovering new and previously unknown hazards.

A fourth potential problem for standardized study protocols can be
called “ossiﬁcation.” The worry about ossiﬁcation is that it can be very
difﬁcult and time-consuming to develop and change standardized proto-
cols, which can prevent the introduction of new techniques or perspectives.
Por ejemplo, en 1996 Congress tasked the U.S. EPA with developing a
screening program to identify endocrine disrupting chemicals, y el
Tier 2 assays for the testing process have still not been fully validated and
approved.2 Similarly, the ecotoxicity studies currently required for testing
pesticides in the United States were based on draft guidelines for sixteen

1. This case illustrates many features of a more general clash between two frameworks
for risk assessments of non-target impacts from GM crops (p.ej., unintended effects on the
natural predators of the pests that are actually targeted by the GM crops). The “eco-
toxicological” approach relies on substantial equivalence testing as evidence that the modiﬁed
and un-modiﬁed plants are similar in all ways except the inserted toxin, thereby justifying
their focus on direct effects and use of laboratory studies. The “ecological” approach argues
that semi-ﬁeld and ﬁeld studies are best suited to test for the potential effects on non-target
organisms caused by indirect pathways and unpredicted changes in the modiﬁed plant (ver
Kokotovich 2014).

2. See http://www.epa.gov/endo/pubs/assayvalidation/status.htm.

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540

Diseño, Value Judgment, and Conﬂict of Interest

años, until they were ﬁnally approved in 2012.3 They have still been
criticized for failing to identify subtle, indirect ecological effects caused
by some pesticides (Calow and Forbes 2003). With such a slow process
for creating and approving standardized study guidelines, one can hardly
expect them to be based on the best cutting-edge scientiﬁc innovations.

An additional and related problem associated with the ossiﬁcation of
standards is that it can be exploited by interest groups for rejecting cutting-
edge scientiﬁc research that conﬂicts with their goals. ya hemos visto
how regulatory decisions regarding bisphenol A were based on studies that
employed standardized study protocols, even though a number of scientists
argued that those study protocols were out-of-date (Myers et al. 2009).
Similarmente, the Bøhn et al. (2008) study was dismissed for failing to follow
standardized guidelines that may not have been essential (and that may
inappropriately constrain scientiﬁc investigations). Gwen Ottinger (2010)
has also discussed how standards can be used as “boundary-policing” devices
to block citizen involvement in science. While citizens can sometimes
gain legitimacy for their work by following the standardized practices
recommended by experts, sometimes these same standardized practices can
block innovative new methodologies or forms of data suggested by citizens
(Ottinger 2010). Por supuesto, it is crucial to remember that standardized
study guidelines can sometimes be valuable for blocking inappropriate study
methodologies; the point is that there are signiﬁcant value judgments
involved in deciding whether new methodological approaches are valuable
or not in particular contexts.

Having looked at these four potential weaknesses of standardized study
pautas, it should now be clear how they contribute to the two major
problems with using these guidelines to address ﬁnancial COIs. Primero,
given the incompleteness and limited applicability of standardized study
protocols, it is unrealistic to expect standardized guidelines to prevent the
wide array of potential inﬂuences of ﬁnancial COIs on methodological
value judgments. Standards cannot fully constrain all the decisions associ-
ated with experimental design, and the more they did constrain those de-
decisiones (thereby eliminating the problem of incompleteness), the narrower
their applicability would be (thereby exacerbating the problem of limited
applicability) (see also Douglas 2012, 146). Segundo, given the potential for
standards to promote selective ignorance and to ossify, they can be strate-
gically employed by interest groups to hide signiﬁcant value judgments
that serve their needs. Por ejemplo, we have seen how standardized guide-
lines can prevent the collection of information that could point to new and
unknown hazards. We have also seen that those with vested interests in

3. See http://www.epa.gov/ocspp/pubs/frs/publications/ Test_Guidelines/series850.htm.

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Perspectives on Science

541

dismissing particular scientiﬁc ﬁndings can appeal to the fact that they are
based on non-standardized study designs (even if those designs represent
cutting-edge advancements in scientiﬁc methodology or legitimate starting
points for further investigations).

4. Responses
We have seen that there are signiﬁcant potential problems associated with
employing standardized study guidelines to address ﬁnancial COIs in sci-
entiﬁc research. Sin embargo, this solution need not be abandoned
completely. De hecho, it would be unwise to give up on using standards to
help address problems with scientiﬁc research because they are likely to
continue playing a signiﬁcant role in future regulatory science. Además,
if used carefully, standards can actually serve as a useful tool for illuminating
crucial value judgments rather than hiding them. When scientists and
other stakeholders are forced to deliberate about the appropriate protocols
for performing key regulatory studies, they can sometimes develop a better
understanding of key methodological assumptions that would otherwise
have gone unnoticed. In this respect, the strengths and weaknesses of
standardizing study protocols are much like the strengths and weaknesses
of formal decision-making tools like cost-beneﬁt analysis (CBA). In many
casos, CBA can be used to hide crucial value judgments, but under the
right circumstances CBA can also be a valuable tool for making judgments
transparent and promoting deliberation about them (Shrader-Frechette 1985;
Schmidtz 2001).

De este modo, scientists and policy makers need to think about ways to mini-
mize the weaknesses of standardized protocols while maximizing their
fortalezas. This section proposes two broad classes of solutions. One set
focuses on ways to improve the use of standardized protocols so that they
can be a more effective solution to ﬁnancial COIs. The second set of solu-
tions focuses on ways to supplement the use of standardized protocols with
additional strategies for addressing ﬁnancial COIs.

Turning ﬁrst to solutions that attempt to improve on the use of stan-
dardized study guidelines, it is helpful to return to the article written by
the group at the University of Minnesota concerning oversight systems for
nanotechnology (Ramachandran et al. 2011). That group calls for a two-
pronged approach to ﬁnancial COIs: the use of standardized study proto-
cols as well as the vetting of the resulting data by a coordinating agency
(Ramachandran et al. 2011, pag. 1361). En tono rimbombante, they call for the co-
ordinating agency to include members from key agencies, various stake-
holder groups, and the public. This reﬂects a general theme in their
artículo, a saber, that public engagement and transparency are crucial for
successful regulatory regimes. Their emphasis on incorporating public

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Diseño, Value Judgment, and Conﬂict of Interest

engagement and transparency, as well as promoting a dynamic and ﬂexible
regulatory regime, could go a long way toward improving the use of stan-
dardized study guidelines for addressing ﬁnancial COIs.

As intimated by Ramachandran et al. (2011), all four potential weak-
nesses of standardized study guidelines (incompleteness, limited applica-
habilidad, selective ignorance, and ossiﬁcation) could be mitigated by creating
mechanisms for generating broadly based deliberation about the guidelines
and the studies stemming from them (see also NRC 1996). Por ejemplo, if an
appropriate deliberative body could examine the results of regulatory safety
estudios, it could alleviate the problems of incompleteness and limited appli-
cability by identifying at least some of the ways in which the studies might
have been inﬂuenced by ﬁnancial COIs even if they followed standardized
pautas. This sort of body could also alleviate the problem of ossiﬁcation
by calling for revisions to out-of-date guidelines or identifying cases in which
studies that do not follow standardized guidelines should nevertheless be
given signiﬁcant weight in regulatory decision making. Finalmente, the problem
of selective ignorance could be addressed by generating broadly based delib-
eration about the ways in which particular standards do and do not generate
the sorts of information desired by various stakeholder groups (see also
Ottinger 2010).

Desafortunadamente, creating this sort of broadly based deliberation is no easy
asunto. Considerar, Por ejemplo, that current standardized study guidelines
are typically created by the OECD, which operates in a manner that is
limited in its transparency and openness to the public. Por ejemplo, el
process for developing or altering OECD chemical testing guidelines is
controlled primarily by member nations of the OECD (IOCM 2009).
Coordinators from member nations have the authority to submit national
proposals for new or revised standards (IOCM 2009, pag. 19). While con-
cerned scientists, los ciudadanos, and non-governmental organizations (ONG)
can propose new or altered standards, they have to work through a national
coordinator (IOCM 2009, pag. 20). Subsequent review and approval of
the proposals is controlled primarily by the national coordinators and
the members of relevant committees of the OECD (IOCM 2009, pag. 34).
Other scientiﬁc experts and stakeholder groups can sometimes inform the
decision-making process, but their ability to provide input largely depends
on whether they are invited by member nations or ofﬁcials of the OECD
(IOCM 2009, pag. 29). Once one recognizes how standardized study guide-
lines can be employed to advance the goals of particular interest groups, él
becomes clear that this sort of process is likely to exacerbate concerns over
ﬁnancial COIs rather than alleviating them.

En principio, national regulatory agencies could make up for this lack
of transparency by creating deliberative bodies of their own that include

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Perspectives on Science

543

broader representation and that are open to public input. But given the
ﬁnancial constraints faced by most regulatory bodies, this solution would
be challenging to implement on a large scale. And even if agencies did
create deliberative bodies, they would not have the time to examine every
study submitted to the regulatory agency to determine how it might have
been inﬂuenced by ﬁnancial COIs. Además, some of the inﬂuences gen-
erated by ﬁnancial COIs are not easily observable merely by looking at
reports of study data and conclusions (Resnik and Elliott 2013). Por lo tanto,
while it would certainly be valuable to open up the process for generating
study guidelines and scrutinizing study results so that these processes are
more transparent and open to public involvement, this hardly seems suf-
ﬁcient by itself as a solution to ﬁnancial COIs in research.

In previous work, I have suggested an alternative set of solutions to
ﬁnancial COIs that do not depend on standardization of study protocols
(eliot 2014). These solutions are grounded in an attempt to identify con-
ditions under which ﬁnancial COIs are most likely to generate worrisome
effects on scientiﬁc research. By reﬂecting on previous cases in which ﬁnan-
cial COIs appeared to be particularly problematic, I suggested three con-
ditions that appear to play a signiﬁcant role in these sorts of cases (eliot
2014):

(2)

(1) Scientiﬁc ﬁndings are ambiguous or require a good deal of inter-
pretation or are difﬁcult to establish in a straightforward manner.
Individuals or institutions have strong incentives to inﬂuence those
scientiﬁc ﬁndings in ways that damage the credibility of the research.
Individuals or institutions that have incentives to inﬂuence those
scientiﬁc ﬁndings also have adequate opportunities to inﬂuence
a ellos.

(3)

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I argued that the elimination or mitigation of any one of these conditions is
likely to decrease the likelihood that ﬁnancial COIs will inﬂuence research
in problematic ways. Por lo tanto, one can arrive at a promising set of poten-
tial solutions by exploring ways to eliminate each of these three conditions.
Consider ﬁrst the possibility of avoiding scientiﬁc ﬁndings that are
ambiguous or that require a good deal of interpretation. It is obviously
not possible to eliminate uncertainty in scientiﬁc research, but it is pos-
sible to formulate science policy in a manner that depends less on highly
uncertain scientiﬁc ﬁndings. By doing so, one can eliminate much of the
pressure for interest groups to manipulate this research in ways that serve
their interests. The Massachusetts Toxic Use Reduction Act of 1989 pro-
vides an excellent example of this sort of creative policy making. Bastante
than promoting endless debates over the question of whether speciﬁc sub-
stances were toxic enough to be banned, this legislation merely identiﬁed a

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number of chemicals that appeared likely to be problematic. Entonces, bastante
than banning the substances, the legislation required companies that used
large quantities of them to publicly report how much they were using and
to document any alternatives to the use of those substances. This policy
approach placed relatively little emphasis on obtaining detailed results
from scientiﬁc studies; en cambio, it focused on incentivizing the pursuit of
alternatives to potentially harmful activities. A pesar de (or perhaps because of )
avoiding extensive debates about scientiﬁc results, this policy appeared to
have very beneﬁcial results, including large reductions of toxic chemical
emissions as well as economic savings for industry (Tickner 1999, pag. 178).
Another set of solutions for alleviating ﬁnancial COIs can be developed
by attempting to eliminate the second condition above, a saber, eso
individuals or institutions have strong incentives to inﬂuence scientiﬁc
ﬁndings in ways that damage the credibility of the results. In many areas
of science, this condition is not a signiﬁcant problem; en cambio, those who
fund research have an interest in obtaining highly credible results. Para
ejemplo, when the failures of a new technical innovation will be obvious
to consumers, there are strong incentives for the manufacturers to produce
highly credible research to make sure the innovation works. It is when
product failures—or human and environmental health threats caused by
the products—are more difﬁcult to identify that manufacturers end up
with incentives to produce shoddy research that covers up those problems
(eliot 2014).

One way to alter these incentives for producing high-quality research
(and therefore to mitigate or eliminate the second condition described
arriba) is to tweak tort policies so that it is easier for plaintiffs to obtain
damages when they are harmed by faulty or dangerous products (McGarity
and Wagner 2008; Cranor 2008). Another approach is to impose more
severe penalties for manipulating science for the purposes of introducing
harmful products to the market (McGarity and Wagner 2008). Carl Cranor
(2011) argues that some incentives for producing questionable science
could also be eliminated by creating a pre-market approach to regulatory
policy rather than a post-market approach. He suggests that once com-
panies have already introduced a product to the market they are likely
to ﬁght strenuously—including, en algunos casos, by using questionable
research—to keep it on the market.

A ﬁnal set of solutions for alleviating ﬁnancial COIs are directed toward
eliminating the third condition above, a saber, that the individuals or
institutions with incentives to inﬂuence research also have opportunities
to do so. One approach to lessening opportunities for inﬂuencing research
is to put various oversight mechanisms in place (Resnik and Elliott 2013).
Por ejemplo, in the biomedical context, most journals now require prior

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545

registration of clinical trials in a database as a condition for publication,
and some journals require an individual independent from industry to take
responsibility for data integrity and data analysis (DeAngelis et al. 2005;
DeAngelis and Fontanarosa 2008). Another approach is to create institu-
tional barriers between those who have incentives to inﬂuence research and
those who have opportunities to do so. Por ejemplo, a governmental or
inter-governmental agency could take charge of designing and contracting
out regulatory studies of new products (perhaps with direct or indirect
ﬁnancial support from relevant industry groups), thereby largely eliminat-
ing opportunities for the makers of the products to inﬂuence research on
a ellos (see e.g., Krimsky 2003; Schäfer 2004; Volz and Elliott 2012).

Another promising approach for lessening opportunities to damage the
credibility of research (and thereby to eliminate the third condition men-
tioned above) is to create collaborative research endeavors. Rather than
using institutional barriers to insulate the research process from those with
an interest in obtaining particular results, the collaborative approach
attempts to bring together an adequate range of interested parties so that
they can work together to develop a mutually acceptable research process.
An advantage of this approach is that it has the potential to create greater
trust among a diverse range of stakeholders, whereas some of these stake-
holders might remain suspicious that the creation of institutional barriers
is inadequate to keep those with deep pockets from surreptitiously inﬂuenc-
ing research. Heather Douglas (2005) has drawn attention to a case where
a highly contentious risk assessment of the Alaskan oil trade in Prince
William Sound received widespread support because a major local citizens’
grupo (the Regional Citizens’ Advisory Council or RCAC) collaborated in
the creation of the risk assessment with the oil industry (see also Busenberg
1999). Similarmente, after evidence emerged that pollen from Bt corn plants
might be harmful to monarch butterﬂies, the US Department of Agri-
cultura (USDA) helped organize a collaborative research effort guided by
individuals from industry, academia, environmental groups, and govern-
mento. This collaborative effort helped to generate research that was widely
respected even though it addressed a highly contentious topic (Pew Initiative
on Food and Biotechnology 2002).

En suma, there are a variety of available strategies for addressing the
effects of ﬁnancial COIs on research. Given that the standardization of
study protocols is likely to keep playing a signiﬁcant role in science policy
haciendo, it is very important to pursue efforts of the sort proposed here to
make this approach more transparent and responsive to public input. Pero
even if the standardization process is improved, we have seen that it is not
likely to be a sufﬁcient solution to ﬁnancial COIs. Por lo tanto, it is worth
considering approaches for eliminating the conditions that make ﬁnancial

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546

Diseño, Value Judgment, and Conﬂict of Interest

COIs most worrisome. Many of these suggestions are likely to prove
politically challenging to implement (p.ej., altering tort policies or creating
institutional barriers that keep those with signiﬁcant interests in research
from inﬂuencing it). But while efforts are made to institute these sorts of
cambios, other strategies (such as the creation of collaborative research
efforts) hold promise for addressing some of the challenges posed by ﬁnan-
cial COIs.

5. Conclusión
This paper has argued that the standardization of study protocols is limited
in its ability to address problematic inﬂuences of ﬁnancial COIs on scien-
tiﬁc research. The difﬁculties with employing standardized study protocols
are two-fold. Primero, there are so many methodological value judgments
involved in research that it is not feasible to constrain them all using stan-
dardized guidelines. Segundo, the use of standardized protocols can actually
hide important value judgments. In cases where there should be discussion
about what methodology best serves the needs of a particular research
contexto, appeals to standardized protocols can shut down this discussion.
These two problems were highlighted and illustrated in Section 3 por
examining four potential weaknesses of standardized guidelines. Primero, ellos
suffer from incompleteness, insofar as they do not constrain all the meth-
odological decisions that must be made in research. Segundo, they have lim-
ited applicability; en otras palabras, the guidelines apply in some cases but
can actually be misleading or problematic in other research contexts.
Tercero, they promote selective ignorance, insofar as they direct researchers
toward collecting some pieces or kinds of information about a problem
rather than others. Cuatro, they tend to ossify, meaning that they are
difﬁcult to develop and change and can therefore enforce outdated or prob-
lematic methodologies. It is signiﬁcant that there can often be tradeoffs
between these weaknesses. Por ejemplo, efforts to alleviate the incomplete-
ness of standards or the selective ignorance that they generate by making
them more elaborate can exacerbate their limited applicability and their
ossiﬁcation.

An overarching lesson of the paper is that the standardization of study
designs cannot serve as an alternative to addressing the interests and power
relations that pervade science policy making. In this respect, the practice of
standardization is much like the practice of cost-beneﬁt analysis or the use
of any other formal tool; such practices can be very helpful under some
circumstances, but they can also be wielded strategically by powerful
interest groups to advance their goals (Shrader-Frechette 1985; Ottinger
2010; Busch 2011). Por lo tanto, standardized study guidelines should
continue to be employed, but policy makers should take at least two steps

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Perspectives on Science

547

to supplement them and to prevent powerful interest groups from co-
opting them. Primero, the development and review of standardized guidelines
should be made as transparent as possible and should be subjected to
broadly-based deliberation (NRC 1996). Segundo, science policy makers
should scrutinize the conditions under which ﬁnancial COIs tend to have
the most worrisome effects and take additional steps to eliminate and
mitigate those conditions.

Referencias
Andow, D. y un. Hilbeck. 2004. “Science-Based Risk Assessment for

Nontarget Effects of Transgenic Crops.” BioScience 54: 637–649.

Angell, METRO. 2005. The Truth about the Drug Companies: How They Deceive Us

and What to Do about It. Nueva York: Random House.

APHA (American Public Health Association). 2003. Supporting Legislation
for Independent Post-marketing Phase IV Comparative Evaluation of Pharma-
céuticos. Washington, corriente continua: APHA.

Bekelman, J., Y. Sotavento, and C. Bruto. 2003. “Scope and Impact of Financial
Conﬂicts of Interest in Biomedical Research.” Journal of the American
Medical Association 289: 454–465.

Bøhn, T., R. Primicerio, D. Hessen, t. Traavik. 2008. “Reduced Fitness of
Daphnia Magna Fed a Bt-transgenic Maize Variety.” Archives of Environmental
Contamination Toxicology 55: 584–592.

Busch, l. 2011. Standards: Recipes for Reality. Cambridge, MAMÁ: CON prensa.
Busenberg, GRAMO. 1999. “Collaborative and Adversarial Analysis in Environ-

mental Policy.” Policy Studies 32: 1–11.

Cain, D., GRAMO. Loewenstein, y D. moore. 2005. “The Shortcomings of
Disclosure as a Solution to Conﬂicts of Interest.” Pp. 104–125 in
Conﬂicts of Interest: Challenges and Solutions in Business, Law, Medicamento,
and Public Policy. Edited by D. moore, D. Cain, GRAMO. Loewenstein, y
METRO. Bazerman. Nueva York: Prensa de la Universidad de Cambridge.

Calow, PAG. and V. Forbes. 2003. “Does Ecotoxicology Inform Ecological
Risk Assessment?” Environmental Science and Technology 37: 146A–151A.
Chapman, PAG., METRO. Crane, j. Wiles, F. Noppert, mi. McIndoe. 1996. “Improv-
ing the Quality of Statistics in Regulatory Ecotoxicity Tests.” Ecotoxicology 5:
169–186.

Conrad, j. y r. Becker. 2011. “Enhancing Credibility of Chemical Safety
Estudios: Emerging Consensus on Key Assessment Criteria.” Environmental
Health Perspectives 119: 757–764.

Cranor, C. 2008. Toxic Torts: Ciencia, Law, and the Possibility of Justice. Nuevo

york: Prensa de la Universidad de Cambridge.

Cranor, C. 2011. Legally Poisoned: How the Law Puts Us at Risk from Toxicants.

Cambridge, Masa.: Prensa de la Universidad de Harvard.

D
oh
w
norte
oh
a
d
mi
d

F
r
oh
metro
h

t
t

pag

:
/
/

d
i
r
mi
C
t
.

metro

i
t
.

mi
d
tu
pag
oh
s
C
/
a
r
t
i
C
mi
–
pag
d

F
/

2
4
5
5
2
9
1
7
9
0
2
0
9
pag
oh
s
C
_
a
_
0
0
2
2
2
pag
d

b
y
gramo
tu
mi
s
t

oh
norte
0
8
S
mi
pag
mi
metro
b
mi
r
2
0
2
3

548

Diseño, Value Judgment, and Conﬂict of Interest

Curzer, h. y G. Santillanes. 2012. “Managing Conﬂict of Interest in
Investigación: Some Suggestions for Investigators.” Accountability in Research
19: 143–155.

de Melo-Martin, I. and K. Intemann. 2009. “How Do Disclosure Policies

Fail? Let Us Count the Ways.” FASEB Journal 23: 1638–1642.

DeAngelis, C., j. Drazen, F. Frizelle, C. Haug, j. Hoey, R. Horton, S. Kotzin,
et al. 2005. “Is This Clinical Trial Fully Registered? A Statement from
the International Committee of Medical Journal Editors.” New England
Journal of Medicine 352: 2436–2438.

DeAngelis, C. y P. Fontanarosa. 2008. “Impugning the Integrity of Medical
Ciencia: The Adverse Effects of Industry Inﬂuence.” Journal of the American
Medical Association 299: 1833–1835.

douglas, h. 2005. “Inserting the Public into Science.” Pp. 153–169 in Democ-
ratization of Expertise? Exploring Novel Forms of Scientiﬁc Advice in Political
Decision Making. Edited by S. Maasen and P. Weingart. Dordrecht: Saltador.
douglas, h. 2009. Ciencia, Política, and the Value-Free Ideal. pittsburgh: pittsburgh

Prensa universitaria.

douglas, h. 2012. “Weighing Complex Evidence in a Democratic Society.”

Kennedy Institute of Ethics Journal 22: 139–162.

Eggen, R. et al. 2004. “Challenges in Ecotoxicology.” Environmental Science

and Technology 38: 59A–64A.

eliot, C. 2004. “Pharma Goes to the Laundry: Public Relations and the
Business of Medical Education.” Hastings Center Report 34: 18–23.
eliot, k. 2008. “Scientiﬁc Judgment and the Limits of Conﬂict-of-Inter-

est Policies.” Accountability in Research 15: 1–29.

eliot, k. 2011. Is a Little Pollution Good for You? Incorporating Societal
Values in Environmental Research. Nueva York: prensa de la Universidad de Oxford.
eliot, k. 2013. “Selective Ignorance and Agricultural Research.” Science,

Tecnología & Human Values 38: 328–350.

eliot, k. 2014. “Financial Conﬂicts of Interest and Criteria for Research

Credibility.” Erkenntnis 79: 917–937.

eliot, k. y D. Resnik. 2014. “Science, Política, and the Transparency of

Values.” Environmental Health Perspectives 122: 647–650.

eliot, k. y D. Volz. 2012. “Addressing Conﬂicts of Interest in Nano-
technology Oversight: Lessons Learned from Drug and Pesticide Safety
Testing.” Journal of Nanoparticle Research 14: 664–668.

Fagin, D., METRO. Lavelle, and the Center for Public Integrity. 1999. Toxic

Deception, 2nd edn. Monroe, Maine: Common Courage.

IOCM (Inter-Organization Programme for the Sound Management of
Chemicals). 2009. Guidance Document for the Development of OECD Guide-
lines for the Testing of Chemicals. París: OECD. Disponible en: http://www.
oecd.org/env/ehs/testing/49803789.pdf (accessed on July 25, 2013)

D
oh
w
norte
oh
a
d
mi
d

F
r
oh
metro
h

t
t

pag

:
/
/

d
i
r
mi
C
t
.

metro

i
t
.

mi
d
tu
pag
oh
s
C
/
a
r
t
i
C
mi
–
pag
d

F
/

2
4
5
5
2
9
1
7
9
0
2
0
9
pag
oh
s
C
_
a
_
0
0
2
2
2
pag
d

b
y
gramo
tu
mi
s
t

oh
norte
0
8
S
mi
pag
mi
metro
b
mi
r
2
0
2
3

Perspectives on Science

549

Isnard, PAG., PAG. Flammarion, GRAMO. Roman, METRO. Babut, PAG. Bastien, S. Bintein, l.
Essermeant, et al. 2001. “Statistical Analysis of Regulatory Ecotoxicity
Tests.” Chemosphere 45: 659–669.

Kitcher, PAG. 2001. Ciencia, Truth, y democracia. Nueva York: Oxford Univer-

sity Press.

Kokotovich, A. 2014. Contesting Risk: Ciencia, Gobernancia, and the Future of
Plant Genetic Engineering. PhD dissertation, University of Minnesota.
Kourany, j. 2010. Philosophy of Science after Feminism. Nueva York: Oxford

Prensa universitaria.

Krimsky, S. 2003. Science in the Private Interest. Lanham, Maryland: Rowman and

Littleﬁeld.

Lampland, METRO. and S. Star. 2009. Standards and Their Stories: How Quanti-
fying, Classifying, and Formalizing Practices Shape Everyday Life. Ítaca,
Nueva York: Prensa de la Universidad de Cornell.

Menor, l., C. Ebbeling, METRO. Goozner, D. Wypij, D. Ludwig. 2007. “Relation-
ship between Funding Source and Conclusion among Nutrition-Related
Scientiﬁc Articles.” PLoS Med 4: e5.

Loewenstein, GRAMO., S. Sah, y D. Cain. 2012. “The Unintended Conse-
quences of Conﬂict of Interest Disclosure.” Journal of the American Medical
Asociación 307: 669–670.

Longino, h. 2002. The Fate of Knowledge. Princeton: Princeton Univer-

sity Press.

Lundh, A., S. Sismondo, j. Lexchin, oh. A. Busuioc, y yo. Bero. 2012.
“Industry Sponsorship and Research Outcome.” Cochrane Database of
Systematic Reviews 12: MR000033.

Markowitz, GRAMO. y D. Rosner. 2002. Deceit and Denial: The Deadly Politics
of Environmental Pollution. berkeley: University of California Press.
McCright, A., y r. Dunlap. 2010. “Anti-Reﬂexibility: The American
Conservative Movement’s Success in Undermining Climate Science and
Policy.” Theory, Cultura & Sociedad 27: 100–133.

McGarity, t. and W. Wagner. 2008. Bending Science: How Special Interests
Corrupt Public Health Research. Cambridge, MAMÁ: Harvard University
Prensa.

Michaels, D. 2008. Doubt Is Their Product: How Industry’s Assault on Science

Threatens Your Health. Nueva York: prensa de la Universidad de Oxford.

miers, J., F. vom Saal, B. Akingbemi, k. Arizono, S. Belcher, t. Colborn,
I. Chahoud, et al. 2009. “Why Public Health Agencies Cannot Depend
on Good Laboratory Practices as a Criterion for Selecting Data: El
Case of Bisphenol A.” Environmental Health Perspectives 117: 309–315.
NRC (National Research Council). 1996. Understanding Risk: Informing
Decisions in a Democratic Society. Washington, corriente continua: National Academies
Prensa.

D
oh
w
norte
oh
a
d
mi
d

F
r
oh
metro
h

t
t

pag

:
/
/

d
i
r
mi
C
t
.

metro

i
t
.

mi
d
tu
pag
oh
s
C
/
a
r
t
i
C
mi
–
pag
d

F
/

2
4
5
5
2
9
1
7
9
0
2
0
9
pag
oh
s
C
_
a
_
0
0
2
2
2
pag
d

b
y
gramo
tu
mi
s
t

oh
norte
0
8
S
mi
pag
mi
metro
b
mi
r
2
0
2
3

550

Diseño, Value Judgment, and Conﬂict of Interest

Oreskes, norte. and E. Conway. 2010. Merchants of Doubt. Nueva York: Bloomsbury

Prensa.

Ottinger, GRAMO. 2010. “Buckets of Resistance: Standards and the Effec-
tiveness of Citizen Science.” Science, Tecnología, and Human Values 35:
244–270.

Pew Initiative on Food and Biotechnology. 2002. Three Years Later: Genetically
Engineered Corn and the Monarch Butterﬂy Controversy. http://www.pewtrusts.
org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/
vf_biotech_monarch.pdf (accessed on July 26, 2013)

Proctor, R. 2012. Golden Holocaust: Origins of the Cigarette Catastrophe and

the Case for Abolition. berkeley: University of California Press.

Ramachandran, GRAMO., S. Lobo, j. Paradise, j. Kuzma, R. Sala, mi. Kokkoli,
y yo. Fatehi. 2011. “Recommendations for Oversight of Nano-
biotechnology: Dynamic Oversight for Complex and Convergent Tech-
nology.” Journal of Nanoparticle Research 13: 1345–1371.

Resnik, D. 2006. The Price of Truth: How Money Affects the Norms of Science.

Nueva York: prensa de la Universidad de Oxford.

Resnik, D. and K. eliot. 2013. “Taking Financial Relationships into Account

When Assessing Research.” Accountability in Research 20: 184–205.

Schäfer, A. 2004. “Biomedical Conﬂicts of Interest: A Defense of the
Sequestration Thesis—Learning from the Cases of Nancy Olivieri and
David Healy.” Journal of Medical Ethics 30: 8–24.

Schmidtz, D. 2001. “A Place for Cost-Beneﬁt Analysis.” Philosophical Issues

11: 148–171.

Shrader-Frechette, k. 1985. Science Policy, Ethics, and Economic Methodology.

Dordrecht: Reidel.

Shrader-Frechette, k. 2007. Taking Action, Saving Lives: Our Duties to Protect
Environmental and Public Health. Nueva York: prensa de la Universidad de Oxford.
Sismondo, S. 2007. “Ghost Management: How Much of the Medical Lit-
erature is Shaped Behind the Scenes by the Pharmaceutical Industry?"
PLoS Medicine 4: e286.

Sismondo, S. 2008. “Pharmaceutical Company Funding and Its Consequences:
A Qualitative Systematic Review.” Contemporary Clinical Trials 29: 109–113.
Herrero, R. 2005. “Medical Journals Are an Extension of the Marketing Arm
of Pharmaceutical Companies.” PLoS Med 2 (5): e138. doi:10.1371/
journal.pmed.0020138.

Sol, X., METRO. Briel, j. W.. Busse, j. j. You, mi. A. Akl, F. Mejza, et al. 2011.
“The Inﬂuence of Study Characteristics on Reporting of Subgroup Anal-
yses in Randomized Controlled Trials: Systematic Review.” British Medical
Diario 342: d1569.

Tickner, j. 1999. “A Map Toward Precautionary Decision Making,"
Pp. 162–186 in Protecting Public Health & the Environment: Implementing

D
oh
w
norte
oh
a
d
mi
d

F
r
oh
metro
h

t
t

pag

:
/
/

d
i
r
mi
C
t
.

metro

i
t
.

mi
d
tu
pag
oh
s
C
/
a
r
t
i
C
mi
–
pag
d

F
/

2
4
5
5
2
9
1
7
9
0
2
0
9
pag
oh
s
C
_
a
_
0
0
2
2
2
pag
d

b
y
gramo
tu
mi
s
t

oh
norte
0
8
S
mi
pag
mi
metro
b
mi
r
2
0
2
3

Perspectives on Science

551

the Precautionary Principle. Edited by C. Raffesnperger and J. Tickner.
Washington, corriente continua: Island Press.

Vandenberg, l. et al. 2012. “Hormones and Endocrine-Disrupting Chemicals:
Low-Dose Effects and Nonmonotonic Dose Responses.” Endocrine Reviews
33: 378–455.

Volz, D., and K. eliot. 2012. “Mitigating Conﬂicts of Interest in Chem-
ical Safety Testing.” Environmental Science and Technology 46: 7937–7938.
vom Saal, F., and C. abrazos. 2005. “An Extensive New Literature
Concerning Low-Dose Effects of Bisphenol A Shows the Need for a
New Risk Assessment.” Environmental Health Perspectives 113: 926–933.
Wickson, F., y B. Wynne. 2012. “Ethics of Science for Policy in the
Environmental Governance of Biotechnology: MON810 Maize in Europe.”
Ethics, Política & Environment 15: 321–340.

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w
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.

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.

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