Symposium: Bioethics in Scientific Research:

Conflicts between Subject’s Equitable Access to

Participate in Research and Current Regulations

Conducting Research in Developing Countries: Experiences of the Informed

Consent Process from Community Studies in Peru1
Hilary Creed-Kanashiro,2 Beatriz Oré, Marı́a Scurrah,* Ana Gil, and Mary Penny
Instituto de Investigación Nutricional, Apartado 18-0191, Lima-18, Peru and *International Potato Center
(CIP), PO Box 1558, Lima-12, Peru

ABSTRACT This article discusses the process for obtaining genuine informed consent for the participation of
human subjects in research in developing countries. We discuss the consent process in the light of recently
published guidelines, the experience of nutrition and health research projects, and the ethics review process of the
Instituto de Investigación Nutricional with peri-urban and rural populations in Peru. We discuss the cultural context

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in relation to (i) who should be involved in the decision for participation, especially for research in children and in
community settings; (ii) when to use written or verbal consent; (iii) the format and presentation of the consent form
to ensure understanding by the target population; and (iv) the process of how and by whom information is given
and consent is obtained. Common concerns of participants with regard to their involvement in research studies are
presented, as well as aspects that participants find difficult to understand. Some specific concerns of conducting
research with Indigenous Peoples are discussed. We recommend future research to further understand and
implement informed consent processes to assure genuine and voluntary consent in different developing country
contexts. J. Nutr. 135: 925–928, 2005.

KEY WORDS: ● ethics ● developing countries ● consent process ● children ● indigenous peoples

The assurance of ethical conduct for research related to
health care in developing countries has been the subject of
much recent discussion, particularly with the increase of
research in these countries and the need to address their
high burden of disease (1– 4). Recent publications give
helpful guidelines addressing these specific ethical issues for
developing countries: Nuffield Council on Bioethics. the ethics
of research related to healthcare in developing countries (5), The
Council for International Organizations of Medical Sciences
1
Presented as part of the symposium “Bioethics in Scientific Research:
Conflicts between Subject’s Equitable Access to Participate in Research and
Current Regulations” given at the 2004 Experimental Biology meeting on April 19,
2004, Washington, DC. The symposium was sponsored by the American Society
for Nutritional Sciences and the Community and Public Health Nutrition and
Nutrition Education Research Interest Sections, and supported in part by an
unrestricted grant from the Dannon Institute. The proceedings are published as a
supplement to The Journal of Nutrition. This supplement is the responsibility of
the Guest Editors to whom the Editor of The Journal of Nutrition has delegated
supervision of both technical conformity to the published regulations of The
Journal of Nutrition and general oversight of the scientific merit of each article.
The opinions expressed in this publication are those of the authors and are not
attributable to the sponsors or the publisher, editor, or editorial board of The
Journal of Nutrition. The Guest Editors for the symposium publication are Ann M.
Ferris, Center for Public Health and Health Policy and the Department of Nutri-
tional Sciences, University of Connecticut, Storrs, CT, and Grace S. Marquis,
Department of Food Science and Human Nutrition, Iowa Sate University,
Ames, IA.
2
To whom correspondence should be addressed.
E-mail: hmcreed@iin.sld.pe.
(6), and WHO-CINE Indigenous Peoples and participatory
health research (7). Some elements that are generally ac-
cepted as essential include the relevance of the research to
the local situation and to national and community priori-
ties, an understanding and a sensitivity to the local cultural
context (1), often involving different ethical and types of
knowledge expectations to the Western model (8), and the
feedback to the community or population, and actions
taken after the research has finished. A critical element of
conducting research is the process of obtaining informed
consent. Populations with limited resources are particularly
vulnerable. They are often already living under high-risk
health conditions, which can affect both the researchers
and the study population’s assessment of risk:benefit of the
research (5). The cultural context may limit truly indepen-
dent consent and may also be distorted through the giving
of incentives in populations with limited economic circum-
stances. However, there are few studies describing practical
experiences in the consent process for participation in
research studies in developing countries (9,10). This article
discusses specific aspects of the consent process in the light
of the experiences of nutrition and health research projects
and of the ethics review process of the Instituto de Inves-
tigación Nutricional (IIN) with peri-urban and rural pop-
ulations of Peru, with a view to contribute to finding ways
to ensure voluntary and genuine informed consent.

0022-3166/05 $8.00 © 2005 American Society for Nutritional Sciences.

925
926 SYMPOSIUM
Genuine informed consent
The Nuffield Council (5) emphasizes obtaining genuine
informed consent for participation in a research protocol. In
conducting collaborative studies, it is necessary to adapt the
consent form and the process to the local situation, and this
has been a central issue in the review of projects by the ethics
committee of the IIN. As well as the cultural context and
language; the perceptions of the participant population toward
health, illness, life and life processes; the ownership of local
knowledge; and who in the family or the community has the
responsibility for giving consent, need to be considered, as well
as ways of addressing local beliefs, myths, and rumors.
Who gives consent?
In research studies of the IIN, conducted in the community
and especially when children are involved, the consent to
participate is most commonly a family decision: fathers and
grandmothers are frequently influential, and opportunities are
sought by the field personnel presenting the project to talk
with these family members. Our ethics committee recom-
mends that children 7 y and older give their assent to partic-
ipation, although their understanding will be limited (11).
For certain populations and study topics, prior consent by
the community organization is appropriate, depending on the
accepted role of the organization and its representation of the
population (4,7,12). We have found this to be an essential part
of the process in nutrition projects of populations of low
literacy levels in the rural highlands and the rain forest areas
of Peru, and helpful for community support in peri-urban
populations. However, this is not a substitute for individual
and family consent (4,5,9).
Verbal or written/signed consent?
Many collaborative projects insist on a written, signed,
consent form, but this is not always appropriate for developing
country populations (13). For certain protocols, such as epi-
demiological or nutrition surveys, the IIN Ethics Committee
does not require the signing of a form, although it does need to
see and to approve the consent statement presented verbally to
the participant explaining the project. Even with more com-
plex protocols, we have had occasion where signing was un-
acceptable to the study population: members of a rural com-
munity in the highlands of Peru were suspicious of signing a
document they were unable to read because they had “lost land
by signing a document,” and, in this case, participants ac-
cepted participation in a nutrition study involving extended
periods of observation of feeding practices in the home if the
community leaders were in agreement with the project. Thus,
flexibility for written or verbal consent is recommended, ob-
viously depending on the type of study and culture of the
population involved.
The consent form
Consent forms presented to our ethics committee are often
long and complex, especially for clinical trials of pharmaceu-
tical companies. We frequently require modification to facili-
tate genuine informed consent, and we have found that those
responsible for the studies usually accommodate to these re-
quests. The ethics committee has developed a format for
consent forms for use locally, presented in question and answer
form. For example: “what is the study about,” “who can par-
ticipate,” “what do I have to do if I decide to have my child
participate,” “are there any risks to my child if he/she partic-
ipates.” We encourage the use of diagrams and tables in the
consent form where these can facilitate understanding, e.g.,
showing frequency of the visits or of the taking of blood
samples. Experienced field workers review the consent form
and modify wording and expressions for greater clarity before
the final version is approved. In the case of another language,
the consent form, written or oral, is translated, back translated,
and tested to assure fidelity and understanding.
Who explains the study and the consent process?
We consider that the field workers who understand and
identify with the local culture are the best people to explain
the project, even though some protocols require a more senior
member of the team to witness the giving of consent. The field
workers usually explain the study and the procedures in their
own words, as well as reading the form. They do not neces-
sarily read the consent form but do explain each section to be
sure of leaving no surprises of new information for later.
The consent process
The consent process often occurs during several visits to a
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potential participant. The consent form or the information
sheet is explained and is left in the home to allow for consul-
tation with other family members. For more complex studies,
there may be an average of 3 visits. Visual aids, such as a flip
chart or a brochure, are frequently used in projects to facilitate
explanation and understanding.
To check understanding of the consent form, the health
workers use “checking questions.” Examples of these are
“What is the study about,” “is everyone who participates going
to receive the supplement,” “how many visits to the health
facility will you have,” “how many blood samples will be
taken,” or, even, “do you have to pay?”
Some common concerns expressed by potential participants
Participants primarily want to know what benefits there
may be to participating in the study, and this has been found
to be the key concern to acceptance. Consequently, the ben-
efits, such as the potential benefit of the “treatment,” or the
health services that are provided during the study, tend to be
stressed by the field or health workers.
There are often negative connotations associated with the
words “investigation” and “study” and a suspicion of “experi-
menting” or “practicing on my child.” When any risks are
presented, this sometimes incites concern that “something bad
will happen to my child.” Participants are concerned about
confidentiality but mainly require the assurance that their
neighbors do not learn of personal information.
Our study populations want to know who is financing the
research. Because it is “cost free,” does that mean that it might
be “harmful?” They need to be assured that there will be no
charge at the end. The clause of “not offering compensation”
in the case of damages unrelated to the study, included in some
clinical trials, often creates concern that harm might occur.
The local knowledge and the reputation of the research insti-
tution influence the decision to participate in the study. We
have found that it is important to share information about the
study with local organizations, e.g., the government health
services, because the population does check with these credi-
ble sources about the research projects.
We have found that it is difficult for potential participants
to evaluate the risk:benefit ratio of participation in a study.
The benefits that they perceive, frequently including access to
 INFORMED CONSENT IN DEVELOPING COUNTRY CONTEXT
good health care, are the strongest influence. In a controlled
clinical trial, such as the testing of a new vaccine, the use of
a placebo is often taken lightly. Participants tend to expect
that they will receive the vaccine rather than placebo, even
though this may be clearly explained. It is not always clear to
participants that they can withdraw from a study at any time
once they have signed the consent form.
Refusals
The most common reason for refusing to participate in a
study is the taking of blood samples, especially in the case of
young children, due to a fear that it will “weaken” the child,
or even that “they are selling our blood.” Refusals are fre-
quently due to the opinion of a close family member other
than the mother, particularly the father.
Continued participation
Once subjects have been enrolled, strategies to maintain
their voluntary participation need to be considered and re-
viewed by the ethics committee. In projects of the IIN, strat-
egies have included additional home visits and educational
and social activities. Special consideration to avoid coercion is
needed in certain circumstances, such as pressure to enroll in
a defined period of time, competitive enrollment rates between
sites, or payment to an investigation team for the number of
subjects enrolled, and this has to be carefully monitored.
The consent process with indigenous peoples
There are specific ethical concerns when conducting re-
search with Indigenous Peoples, and useful guidelines have
recently been published by WHO-CINE (Center for Indige-
nous Peoples Nutrition and the Environment) (7). These are
special ethnic groups that have been discriminated against and
that often have a suspicion toward outsiders due to previous
colonizing experiences, as do many populations of developing
countries. It is often harder to explain what is being investi-
gated with social science or descriptive research and how the
results will be used. As with other research in developing
countries, it is essential that the research addresses the com-
munity’s priorities. Sharing of collective knowledge requires a
collective agreement, for example, for studying the perceptions
of the nutritive value and the use of traditional foods, or the
medicinal properties of plants. In the experience of our recent
work with Indigenous Peoples in Peru, in collaboration with
the CINE, we have had a three-level consent process: a re-
search agreement with the Indigenous Peoples’ organization; a
research agreement with each of the communities, presented
and discussed in their community meetings; and, finally, indi-
vidual and family consent for the individual interview. The
research agreement includes similar elements to an individual
consent process but, in addition, specifically includes the re-
sponsibilities of the researchers and the community, the com-
munity participation in the study, the use of the information
by the researchers and the community, and the dissemination
outside of the community (7).
DISCUSSION
The Nuffield Council (5) and the Council for International
Organizations of Medical Sciences (6) stress the importance of
genuine informed consent before participation in a research
study. The U.S. regulatory procedures focus on the informed
consent document itself (13), often to cover legal aspects of
the study. Whereas the IIN ethics committee places consider-
927
able importance on the document, especially for language,
length, format, and presentation for clarity of understanding
by the target population, there is equal concern for the con-
sent process, such as educational aids, who presents the study
and to whom, who takes the decisions, and the number of
home visits (9,10).
We have found that verbal rather than written consent is
appropriate in some populations, depending on the type of
study, as long as the consent process is reviewed by the ethics
committee. This flexibility has been suggested for research in
developing countries in certain circumstances (13). It has
been proposed that the development of guidelines for this
would be helpful, especially for collaborative studies (14).
Our experiences of the consent process are similar to studies
reported from Africa and Latin America (9,10,15). The prime
motivation for subject participation was the expected health
benefits from the treatment and the health care to be received,
and which tended to color the assessment of risk:benefit.
Similarly, knowledge and trust for the research agency and in
the health workers influenced acceptance.
Repeated visits to the home to give information before
obtaining consent and the use of print material and visual aids
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have been helpful in our experience. In the African studies, in
2 vaccine trials with young children (9,10), there was difficulty
in understanding randomization to vaccine or to placebo, and
double blinding. Different methods of informing the popula-
tion were used. In Senegal, presenting the study to the com-
munity before individual consent and using comparisons with
agricultural situations, was helpful for understanding, for shar-
ing in community consensus, and for facilitating interest to
participate (9). In The Gambia study, there was greater un-
derstanding of the placebo group when an information sheet
was left with the family before consent, allowing for family
consultation, although the mother was the prime decision
maker. In fact, participants in this study recommended home
visits to allow more private discussion (10). Illiterate women
enrolled in an iron supplementation trial in Bangladesh re-
ported being informed of the objectives of the trial, but many
did not understand that they were free to decline or could
choose to leave the study (16). Thus, experiences indicate that
seeking ways for giving maximum information in the home
and for allowing time for family discussion is favorable.
We found that the principal motives for refusal include the
blood sampling in small children and a distrust of “experi-
ments,” similar to The Gambia study, where a distrust of the
product for babies and insufficient information were also men-
tioned (10). Experience has been gained in the IIN in con-
tinuing the consent process after the initial acceptance and
throughout the life of the project, an important aspect to be
considered in the implementation of research (17) and not
only when “things go wrong.” We have found that conducting
research studies in the communities with which we work, and
specifically through the consent process, has given opportuni-
ties for enhancing knowledge in the population about their
health and nutrition.
Community involvement can often facilitate the research
when this is built into the project from the beginning; both in
the approval process and implementation (4); in Senegal, this
was central to participation (9). We have found this to be an
important part of the information and consent process in
peri-urban, rural, and indigenous Peruvian communities.
Setting up of community advisory boards (12) or inclusion
of community members on research study steering commit-
tees has been successful in assuring community relevance of
research goals and the cultural appropriateness of interven-
928 SYMPOSIUM
tions (4), and it influences how researchers relate to par-
ticipants (12).
Finally, we recommend that further research be undertaken
to understand and to find ways of implementing the consent
process in populations of differing circumstances and contexts
in a variety of developing countries, to assure genuine and
voluntary informed consent. Specifically, we need examples of
best practices on how to help potential participants under-
stand the study and to assess true risk:benefit, aspects that
motivate initial and ongoing participation, and how and when
to involve the community organizations.
ACKNOWLEDGMENTS
We thank Enrique Morales, Eduardo Verne, Aldo Maruy, and
Enrique Massa, colleagues of the IIN Ethics Committee and to the
personnel of the Canto Grande field site, for sharing their experiences
of the consent process with participants of many IIN projects in the
community.
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