Revista Română de Bioetică, Vol. 13, Nr.1, January - March 2015
THE APPLICATION OF CERTAIN
ETHICAL ASPECTS OF BIOMEDICAL
SCIENCE IN SOCIAL RESEARCH ON
MENTAL HEALTH: RESULTS OF A
PILOT STUDY
Liliana Mondragón Barrios*, América Castellanos*,
Alberto Jiménez*, Andrea Figueroa*
Abstract
The ethical requirements that have guided social studies on health issues are those postulated by
biomedical research. The provisions of the international codes and declarations on ethics are
relevant; however, little is known about their application in social research on mental health.
For this reason, the purpose of this paper is to describe how social scientists apply some of the
aspects mostly recommended by international documents for studies with human subjects. These
ethical aspects include the informed consent, the favorable risk/benefit proportion and the fair
selection of subjects. Therefore, the research conducted forms part of a descriptive study in
which a pilot survey was conducted by applying an electronic questionnaire. The questionnaire
was completed by a group of social scientists, both men and women, who work in various fields
of mental health research (violence, addictions or suicide), with prior informed consent. The
results indicate that most of the researchers in this sample considered the application of
informed consent, the risk/benefit proportion and the fair selection of subjects in social research
to be admissible. However, there are certain particular elements of social studies that may
question the application of these ethical components. As a result, the inter-relationships that
arise in a studied social context must be considered in order to clarify a pertinent application.
Keywords: Ethical aspects, social research, mental health
Corresponding author : Liliana Mondragón Barrios- [email protected]
* Instituto Nacional de Psiquiatría, México DF, México
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the Declaration of Helsinki and the
Belmont Report, which have stated the
ethical aspects that must be followed in
all clinical studies with human subjects
(7).
There are certain ethical cautions
born in biomedical science that have
been adapted and used in social
science to encompass mental health
issues; for example, participating in an
informed
investigation (informed
consent), maximizing the potential
benefits, and minimizing the risk for
the persons who take part in the study
(favorable risk/benefit proportion) or
maintaining the confidentiality of the
personal information about the
research subjects.
However, it is known that the
application of ethical components
requires "a practical interpretation and
a specification that will depend
intrinsically on the context” (7, p 91).
This means that its practical use lies in
its interpretation depending on the
scenario in which it is applied, which
may represent a difference between
biomedical and social research in terms
of the way of using them (8,9, 10).
For instance, the requirement for
the format and the signing of the
informed consent in the clinical
precinct are essential because the
express permission of the participant,
duly certified with the signed form, is
needed. However, this is difficult in
social research due to the interactions
that occur in the diversity of scenarios.
An example of this is evident in
ethnographic or observational studies
of subjects, in which the researcher
must insert into and interact naturally
with the study population, which
establishes a very different relationship
from that seen in the clinical scenario
(10).
The aim of this paper is to describe
INTRODUCTION
The knowledge about how the
ethical elements of biomedical
sciences are applied in social research
on mental health is limited. Research
in this field presents ethical challenges
inherent to the study of phenomena
such as violence, addictions, and
suicide. This is because work is being
conducted with vulnerable populations
or who have limited mental functions
and because sensitive information of
the subjects is processed that implies
indirect or less tangible risks, which
may lead to, whether due to omission,
ignorance or prejudice, stigma or
discrimination that could cause the
breach of the participants' rights or the
trampling of their dignity.
The singularity of the ethical
challenges that arise in social research
on mental health generates a necessary
reflection on the ethical requirements
applied in this area. Some of these
requirements in social sciences are the
importance of conceiving research as
being dependent on the context and the
cultural process where it is carried out
(1), revaluing the obtaining of a free
and informed consent to participate
(2), using incentives correctly to
recruit subjects (3,4), protecting
interviewees from breaches of their
privacy (5) and legal processing (such
as in cases of studies on drug abuse)
and, finally, maintaining the safety of
the work team in the field (6).
However, social research has
adapted the ethical requirements that
have guided most of the studies
conducted on human subjects to the
sensitive nature of its context. These
requirements have been postulated by
the main guiding sources in biomedical
research, such as the Nuremberg Code,
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how social scientists apply some of the
ethical aspects mostly recommended in
international documents [such as the
Nuremberg Code, the Declaration of
Helsinki and the Belmont Report] in
studies involving human subjects (10)
and that have arisen in the biomedical
area, such as the informed consent, the
favorable risk/benefit proportion and
the fair selection of subjects.
they represent the ethical aspects most
used for studies involving human
subjects from the biomedical area.
Each section of the questionnaire on
these ethical aspects is described as
follows:
Informed Consent (IC): consisted
of 13 questions, five closed with
Yes/No answers options and eight
open; for example, How do you
guarantee that people can consent to
their participation in research? What
are the possible implications for social
research of omitting the participants'
informed consents?
Favorable Risk/Benefit Proportion:
contained nine questions, three with
Yes/No answers options and six open,
such as: In most social research
studies, situations arise in which harm,
discrimination, stigmas, coercion or
intimidation can result. How do you
avoid these situations? What are the
most common benefits in the research
area you are involved in?
Fair Selection of Subjects: included
two open questions: What harm may
be caused to the community when the
selection is made based on its
accessibility? What are the ethical
implications
of
selecting
as
participants in a research project only
those groups or persons in vulnerable
or unequal situations?
MATERIALS AND METHODS
A pilot study was conducted in
Mexico City with social scientists from
various institutions in January and
February 2014. The sample included
male and female social scientists who
have conducted studies on areas of
research on mental health (violence,
addictions or suicide). All of them
agreed to take part in the informed
consent process. The Research Ethics
Committee of the Institution that
implemented the project approved this
research.
The study was cross-sectional; the
data was collected through a survey
that consisted in the application of an
electronic questionnaire sent by e-mail.
The questionnaire contained 127 open
and closed, multiple choice or direct
questions to collect information on the
scientists' experiences and opinions in
terms of the application of ethical
aspects. These included the informed
consent, confidentiality, independent
ethical evaluation, the right to privacy
and withdrawals from studies, as well
as the presentation and publication of
results.
This work only analyzed the
information from the open answers
about the informed consent, the
favorable risk/benefit proportion and
the fair selection of subjects. These
requirements were selected because
RESULTS
14 social scientists were contacted
during the period of the pilot study,
who represented 10% of the total
sample of the national survey (n=137).
The participants were invited to take
part in the on-line survey. They were
informed about the confidentiality of
their participation and the purpose to
describe the current status of the
ethical components included in social
143
research on mental health.
Only 10 (71.4%) answered the
questionnaire.
The
non-response
(28.6%) could have been due to
invitations not received because of
obsolete e-mail addresses or spam
filters. Half (50%) of the respondents
were women, and the sample consisted
mainly of psychologists (30%),
followed by communication and
anthropology professionals. The social
scientists reported education levels of
Masters' (30%), Doctorate (20%),
Major (10%) and were attached to
public institutions.
In terms of research areas, 30%
were involved in violence-related
issues and 10% worked with
addictions, 20% responded as working
in another, unspecified field and 40%
did not answer. In terms of whether or
not they had completed a course,
specialization or training in ethics or
bioethics, only 40% of the respondents
confirmed that they had. The results
are presented in accordance with the
ethical aspects they selected.
of the components of informed consent
(the declaration of intent and
understanding), most respondents
answered that the verbal explanation of
the content of the informed consent
allows the declaration of intent.
However, 10% alluded to that there is
no guarantee of this. The researchers
mentioned that participants have
understood the letter of informed
consent when asked if they have any
doubts or questions about the research
(30%) and that the signing of the letter
is a way of confirming the
understanding of the IC.
Moreover, 20% of the respondents
commented that they have had
problems in applying the IC, mainly
due to participants' refusal to sign the
letter. 10% also mentioned problems
with the design of the format.
In addition, 40% of the sample
responded affirmatively when asked
about whether or not there are
situations in which the subjects'
consent may be requested again in
order to continue with the study. The
condition most commonly referred to
was related to the modifications to the
research,
which
included
new
interviews, contacts for a second
project phase, a detected risk and
changes during the course of the
research.
On inquiring about obtaining the
informed consent, half of the
respondents (50%) affirmed that it was
given for documentary research, 10%
mentioned that the IC is excluded
when the research incurs no risk, for
example,
in
surveys.
Another
respondent answered that the consent
must not be omitted under any
circumstance.
Informed Consent (IC)
The questionnaire found that 50%
of respondents use the letter of
informed consent in their research
projects and 30% of them said they did
so because it is required by a legal or
ethics committee. Those who said they
did not use the letter argued that they
were unaware of it, or it had not been
required. However, most respondents
considered that the use of consent is
beneficial for the social research. They
stated that the IC ensures due respect
for the participants' rights, both in
terms of being informed and being able
to decline to take part, as well as to
protect the researcher and to avoid
legal problems.
In terms of the exploration of two
Favorable Risk/Benefit Proportion
80% of the respondents answered
144
that social research poses various risks.
Their answers were grouped into three
categories: 1) breach of confidentiality
due to the misuse of the information
provided by participants (10%); 2)
economic risks (10%); 3) the
consequences of participation such as
psychological discomfort, abuse by
poorly trained researchers, alterations
of their uses and customs and
pathologizing a phenomenon (60%).
We found that 40% of the sample
did follow-ups on participants for the
potential consequences of the research.
The main reasons include the
anonymous nature of the study
information (10%), the insufficient
budget assigned for attendance to the
event
resulting
in
negative
consequences as a result of the study
(10%), 10% channel these persons, and
the remaining 10% mentioned that they
do not work with patients.
Moreover, the researchers mention
that they avoid situations that could
cause harm, stigmas, coercion,
intimidation or discrimination to
participants, and that they achieve this
by questioning their own investigative
work (30%), whether as academics or
in face-to-face conversations. Also,
30% referred to certain ethical
requirements such as the review of the
protocol by an ethics committee in
order to maintain the confidentiality of
the information and the application of
the informed consent. Only 10%
mentioned that these situations do not
usually arise in social research, and if
they do, they are not related to the
research itself.
Among the risks that researchers
know that social research can cause
when working with vulnerable
participants are the coercion and
intimidation
(10%),
unfulfilled
promises to the community (20%),
exposure to psychological problems,
including violence exerted by third
parties (10%), breaches of subjects'
autonomy (20%) and physical or
contextual risks of the study (10%)One respondent mentioned that both
the researcher and participant are at
risk (10%).
Finally,
the
benefits
that
researchers find in their research areas
are the attention to social phenomena
that affect the population (30%), the
participants' search for professional
help (10%), the subjects' own
understanding of the problem (20%),
and knowledge translated into public
policy (20%).
Fair Selection of Subjects
The results show that the
researchers identify the ethical aspects
in the selection of the sample,
specifically when a population is
selected based on its accessibility. In
this case, the harm that can be caused
to the population by an easy and quick
access to them are the biased results
(10%), the impact on subjects' daily
lives (20%), the disclosure of harmful
results (10%) and the lack of
communication of the results by
researchers (30%). Other respondents
explained that the impact was due
rather to inequality than harm (10%). It
was also mentioned that an adequate
statistical sampling would prevent any
harm to the population selected (10%).
Negative responses are related to
the implications of selecting the
participants only from people or
groups in vulnerable or unequal
situations. Negative responses were
found because scientists consider that
participants can accept to take part in
an ongoing investigation without
willing to. Therefore, they will be
exposed to greater physical or
145
psychological risks in exchange for
financial gains, which can lead to
discrimination and stigma. In a
positive sense, the results indicate that
it is important to tackle problems that
affect these populations in order to be
able to solve them or to achieve
favorable changes for them. 10%
mentioned that the concept of
vulnerability should be questioned,
whereas another 10% raised the issue
of the obligations to give credit to the
community and respect confidentiality.
originating in the biomedical area. The
data suggests that the majority of
social scientists who participated in
this study considered the application of
ethical aspects related to the principles
set forth in international regulations,
such as the Belmont Report and in
biomedical research, is admissible.
However, the three precepts reflected
the particular elements of social
research.
Informed Consent (IC)
The surveyed social researchers
continue to perceive the informed
consent as a legal defense instrument
for the researcher. It must be explained
that the IC, as a legal protection
resource, originated in medicine. Its
primordial goal was to counteract
patients' claims and complaints against
medical negligence and that this
representation still surrounds it today.
The reason scientists use the IC is to
make the participants aware of and
understand their rights. In this sense,
the respondents mentioned that they
respect the participants' right to be
informed and to decline
their
participation. This context is mostly
representative for the ethical aspects of
the IC and less for the legal ones,
which came about with the emergence
of both human and patients' rights.
The IC takes on a different function
in social research. Its core element in
social research is the plural and
intercultural dialog that emerges from
it, but contextual standards also govern
it, both cultural and social (13).
The fact that 28.6% of respondents
mentioned having had problems in
applying the IC makes more sense
because its management is particularly
difficult in social research. These types
of investigations are susceptible to
methodological designs and data
DISCUSSION AND
CONCLUSIONS
The
social
sciences
have
regulations that govern the social
research and professional associations
have codes of ethics that impose
obligations on researchers in this field.
These regulations and codes apply to
works on mental health (violence,
addictions or suicide). Researchers are
required to comply with the regulations
for studies with human subjects, but
the research ethics committees
evaluate their projects based on the
ethical aspects stipulated by these
standards.
This dynamic has resulted in
various problems for the social
research. The ethical regulation relies
on biomedical practices, which departs
from the adequate understanding of
social life and constricts it to a
procedural evaluation (1.3, 9, 10 and
12).
The objective of this paper is to
establish how social scientists apply
the informed consent, the favorable
risk/benefit ratio and the fair selection
of subjects. These are ethical
components
recommended
by
international documents for studies
with
human
subjects,
mainly
146
collection processes, which do not
match the predictable and explainable
information contained in the IC of a
research project obtained before its
commencement. For example, in
ethnographies, the work can be kept
out of sight, which implies difficulties
for the application of the IC (12).
Another possible explanation is
that for social studies, it is essential to
establish social relationships with the
potential participants. This process
takes
time
and
cannot
be
predetermined with the ultimate
purpose of being registered with one
signature in a single document (12).
Finally, another clarification is that
the application of the IC has been
prioritized as complementary to the
principle of autonomy. This without
considering that the current design and
execution of the research and the basic
ethical principles often come into
conflict because the application of the
latter requires the weighting of one
principle over the other (9) and the
context in which the research is
conducted is not considered. Fisher (9)
mentions that the National Health
Insurance (11) recommends that
researchers and ethical evaluation
committees pay more consideration to
the specific context of the investigation
in which the principles are to be
applied.
On the other hand, besides the
context, the difficulty of applying the
IC revolves around the requirement to
request a signature to confirm the
consent. In this sense, the IC has been
reduced to a mere device; a piece of
paper bearing the signature of the
subject who participates in an
investigation. This action does not
seem to be questioned in the
biomedical
area.
Since
1957,
signatures have been requested for
medical attention and research in the
United States (10). Interventions
require the participants' physical
presence
in
order
to
take
anthropometric measurements, the
extraction of corporal fluids (saliva,
blood, urine, etc.,) or for the
prescription of medicines. However,
this reduction can be complicated in
social research. The signature on the
IC has been considered to be
indispensable as requested by ethics
committees in terms of the inherent
declaration of the study’s ethics. This
situation imposes such a procedure on
the entire investigation, even in social
sciences (8), regardless of the
particular details of the studies.
Simmerling, et al., mention that “if
the "man in the street" had to choose
between participating anonymously or
signing a consent form, it is most
likely that the majority would feel
more secure by not having to sign
anything. Most subjects are sufficiently
intelligent to realize that when they
are asked to sign something, in
general, it is for the benefit of the
person or organization that requests
them to sign, and not for their own
benefit” (10, p851). These experiences
have been reported at least in studies of
addictions (9), in opinion polls and
ethnographies (8,10).
The use of the IC by social
scientists seems to be completely
conventional. They conceive it as a
document that can legally and ethically
protect both the researcher and the
participant or as a complementary
element to ensure the respect for the
research subjects' rights. However, it
seems that the social field inherited
this ordinary use of the IC from the
biomedical field.
This is how researchers apply the
IC where there seem to be aspects
147
inherent to the social sciences. The
importance of the context in which the
research is carried out, which is an
ethical element by itself, but also in the
praxis of ethics in the investigation
with a biomedical or behavioral view
is rarely valued or accepted.
The problems of applying the IC in
social research do not mean that this
ethical aspect is inadequate or should
be disregarded in these types of
studies. Instead, they demonstrate a
different approach, which proposes
“the powerful need to implement a tool
to structure the technical rules,
practical advice, and moral standards”
(14, p 20). This tool would have an
impact on policies and practices that
significantly reflect the ethical ideal of
consent by itself: respect for people,
which is perceived as the obligation of
researchers to ensure that participation
is informed, rational and voluntary and
that the participants' privacy is
protected (9). In this sense, the
application of the IC should consider
the sensitivity of the contextual nature
(8.9) in the different scenarios of social
research.
described the repercussions caused by
the investigation since the former refer
to the likelihood of causing harm, and
the latter are the results that could
follow an event. However, all of them
agree on the usual risks of social
research.
The researchers alluded to the risks
that can be caused by social research
when the work is conducted with
participants in vulnerable situations,
such as the breach of the subjects'
autonomy (18.2%) and the promises
made to the community that are broken
(18.2%). This latter point agrees with
what Fisher (9) found in a study of
drug addicts, which mentioned that
some participants assumed that the
researchers had sworn to maintain the
confidentiality as part of their
professional duties: "when you make a
promise, you must keep it"; and,
therefore, if "one works in their
career", one has to "maintain [one's]
oath". Other respondents tried to
prioritize their compliance with
promises (9, p 8); however, this issue
seems to reflect more consequences
than risks.
The social scientists in this study
mentioned that, despite their goodwill
when making promises to the
community, it is impossible to keep
them. The promise sets a commitment
"to continue with or to avoid certain
actions or lines of conduct" (16, p
152). Breaking the promise is a breach
of the social and moral obligation that
it represents. The fulfilment of the
promise takes on an enormous ethical
significance. It can arise in the
framework of the process of social
relationships in the social field and,
although they seem to form part of the
benefits offered by researchers, this
risk should be understood as beyond an
event that can be predetermined and
Favorable Risk/Benefit Ratio
Occasionally, social research has
been mentioned as not generating risks
or that the risks it does generate are
minimum (15). However, it is known
that all social research imply risks,
perhaps not physical as in biomedical
studies, but of social or emotional
nature. The results showed that more
than half of researchers mentioned the
consequences of participation as the
main
risk
of
social
studies
(psychological discomfort, abuse by
poorly trained researchers, alterations
of their uses and customs and
pathologizing a phenomenon). In
addition to these risks, the researchers
148
predicted in a proportion of risks and
benefits. This means that social
research seems to lie more in terms of
values than of procedures (12).
The
social
scientists
who
participated in this study said that in
order to avoid situations that could
cause
harm,
stigma,
coercion,
intimidation or discrimination to the
participants, one would have to resort
to certain ethical requirements. These
requirements include the review of the
protocol by an ethics committee, as
well as questioning the investigative
work itself, whether as academics,
working on the themes of the study or
in dialogs with peers. This last point
stands out. According to Gergen (17),
a critical reflection on own activities,
using the same rationales that
legitimize these activities, becomes
complicated because one can barely do
anything else but rationalize the status
quo. However, it is essential to
implement deliberative processes that
include the historical and cultural
aspects of the reality that are taken for
granted and that make room to other
voices in cultural dialogs.
The survey respondents mentioned
that it is difficult to follow-up on
participants in social research due to
the possible consequences of the
investigation, the anonymous nature of
the information and the lack of budget
to look after subjects in these cases.
Protecting the welfare of the
participants, including any eventuality
caused by the study, is often included
as an obligation of benefit, which is
conducted to the latter in the
biomedical environment. It is not the
same in the social scenario, where
there are no conditions to ensure
compliance with that obligation (9).
Regarding the benefits found by
researchers in their research fields,
they mentioned the attention to social
phenomena that affect the population
(27.3%). This approach coincides with
the application of the benefit, which
indicates as a principle, the researchers'
obligation to generate a valid a
scientific investigation to promote the
public well-being (9).
These results concur with the
conception of the benefit that includes
an integral approach. It considers the
values and concerns of the subjects of
investigation and how they can be
supported by the ethical procedures of
the investigation.
The researchers referred to the
application of the benefit in terms of
the obligation to protect the health and
the well-being of the participants and
others who may be beyond the context
of the investigation, but also affected
by it. The assessment is more
consistent with the conception of the
benefit based on the idea that human
subjects need assets or tangibles and
are vulnerable to harm (9). This
appreciation is congruent with the idea
of benefit having a greater scope for
application in the social sciences and
not reduced to the risk-benefit
calculation for the participants in the
investigation. Such assessment cannot
have sufficient scope for diverse assets
and harm that legitimately arise in the
different contexts of social works.
Fair Selection of Subjects
Among the implications of
selecting the participants only from
persons or groups in vulnerable or
unequal situations, it was mentioned
that there are groups that may accept to
participate against their real will.
Therefore, they are exposed to greater
physical or psychological risks in
exchange for the benefits. This
perception indicates that vulnerable
149
subjects (disabled patients, ethnic and
racial minorities, children, the elderly
or institutional patients) should not be
included in scientific studies on an ongoing basis (10, 11). They are easy to
manipulate due to their conditions or
socio-economic
situation,
their
autonomy and their reduced capacity to
consent.
The Belmont Report (11) mentions
that the selection of subjects should be
fair depending on the purpose and the
objectives of the research. It also
applies to the foreseen or expected
burden of risks and benefits. In all
cases, if the groups are vulnerable,
they are entitled to protection.
The researchers in this study
explained that studying the problems
that affect vulnerable populations is a
relevant issue in order to solve them or
achieve a change for their benefit. This
result concurs with the insights found
in the life stories and the narratives of
patients with dementia and in
investigations with victims of sexual
abuse and their opportunity to talk
about their traumas in more details
with others (in this case, the
researchers), which could be beneficial
and therapeutic for them (10, 18).
It is worth emphasizing that 9.1%
commented on the obligations to give
credit to the community and respect
confidentiality when working with
vulnerable groups. Both aspects, but
mainly the latter, have been described
in the literature as being obvious and
relevant for social research (19, 20),
for example, in observational studies.
The scientists also alluded to
questioning
the
concept
of
vulnerability. The fair selection of
subjects in social research on mental
health presents a reassessment of the
moral
responsibility
and
the
commitment of social science as a
reflexive way to understand the
construction of the knowledge gained
from social research (5). For example,
fairness in the selection of participants
cannot coexist with the moral
judgments that suppose or qualify
those participants. Such is the case of
vulnerability. The latter, as a concept,
should focus more on conditions or
contexts rather than on people. The
greater good as a justification for the
inclusion of subjects and communities
in research, often serves more to
satisfy the private interests of the
financial backers or researchers and is
reduced to a single criterion of utility.
The social sciences have proposed
to treat ethical dilemmas as socialrelated problems or as the result of
social processes (21), where the
actions taken over those dilemmas is
the most important aspect. This study
underlines that the epistemological,
ontological
and
methodological
contexts distinguish different nuances
in the application of certain ethical
components between one science and
another. It would seem that social
scientists apply the informed consent,
the favorable risk/benefit ratio and the
fair selection of subjects in a
conventional manner. However, the
tone that makes it appear to be rather
more a reflexive contextual and
relational effort (9) is based on social
practices, without providing any
answers regarding the procedural
aspect.
Social research should be linked to
ethical analysis, where the principles,
concepts, assumptions, results and
procedures of the research itself will be
questioned and discussed from their
methodological and epistemological
points of view. Thus, the application of
the IC should contemplate the context
in which the research is carried out.
150
The benefit should not be reduced to
the risk-benefit calculation for the
participants in the investigation. In
social studies, the representation of
assets and harm that are declared in
different social and cultural contexts
should also be considered. Finally, it is
important to reflect on the meaning of
fairness in the selection of participants
by proposing situations or contexts,
and not just people.
Psiquiatría Ramon de la Fuente Muñiz
(INPRFM). The project was funded by
the Consejo Nacional de Ciencia y
Tecnología (CONACyT-169226). It
also had the support of the
Scholarships
for
Women
in
Humanities and Social Sciences 2012
of the Mexican Academy of Sciences,
CONACYT,
Science
Advisory
Council of the Presidency of the
Republic (CCC). Special thanks to
Victor Hugo Jorge Plascencia for his
assistance in the search for information
and to María de Jesús for her careful
reading.
Acknowledgements
This work was possible thanks to the
"Analysis of ethical components for
social research in mental health"
project of the Instituto Nacional de
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