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Clinical trials in Honduras: ethical considerations
Ensayos clínicos en Honduras: consideraciones éticas
Jhiamluka Solano
, Orlando Garner
, Jalileh García
, Mary L. Vallecillo-Zúniga
Department of Internal Medicine, Royal Oldham Hospital, Greater Manchester, United Kingdom
Asociación de Educación Médica Hondureña, AEMH, Tegucigalpa, Honduras
Department of Critical Care, Midland Memorial Hospital, Midland, Texas, United States
Department of Internal Medicine, Texas Tech University Health Sciences Center at the Permian Basin, Texas, United
School of Geography and Environment, University of Oxford, Oxford, United Kingdom
Department of Pathology, Brigham and Women´s Hospital, Harvard Medical School, Boston, Massachusetts, United
Clinical trials represent the penultimate step in the
hierarchy of scientific evidence and are crucial in
developing new therapies. Therefore, rigorous design and
ethical considerations must be implicit in all scientific
inquiry's construction and review process. During scientific
research, the ethical component is crucial and must be
prioritised over any other interest. When designing a study
and in its subsequent evaluation, the ethics committee must
independently assess the ethical justification of the study. In
other words, the result of the ethical review must be framed
using human rights standards, must be independent and
complete, regardless of the country where the study is
carried out.
Low-middle income countries (LMIC) represent a
challenging scientific environment for developing and
executing clinical trials, for which their implementation
must be strictly monitored. The barriers include lack of
funding and trained human resources, lack of a scientific
research environment, operational barriers, and obstacles in
the regulatory and ethical systems (Alemayehu et al., 2018).
The absence of robust ethical systems has led some
researchers in high-income countries (HIC) to develop
clinical trials in LMIC, which has deep regulatory and
ethical implications.
Scientific research and ethics
Throughout history, scientific research on humans has
borne great accomplishments for the benefit of humanity.
For example, vaccinology first arose in the late 18th century
when most of the world population was afflicted with
smallpox, except for those who tended cattle. These
observations culminated in Edward Jenner inoculating an 8-
year-old boy with cowpox, rendering him immune to
smallpox. This represented an advance against viral
diseases; however, Edward Jenner's approach would not be
allowed in current times due to possible ethical and legal
On the other hand, there are also studies with negative
outcomes. This is due to the interest in acquiring scientific
knowledge divorced from ethical principles or rooted in
racist doctrines and knowledge acquired in the pursuit of
economic profit. In 1946, 23 German doctors were charged
with war crimes for scientific experimentation on
concentration camp victims. Consequently, the Nuremberg
Code was created, which stipulates that the voluntary
consent of the human subject is absolutely necessary in any
scientific study. Subsequently, the World Medical
Association (WMA) published the Declaration of Helsinki
stipulating that significant in vitro and in vivo findings must
precede human research. In addition, an independent
committee must review research protocols, informed
consent of the participants must be safeguarded, and the
benefit of the research must be greater than the risk of the
J. Solano, et al.
INNOVARE Revista de Ciencia y Tecnología Vol. 11, No. 3, 2022
Table 1
The Belmont Report is a guide about the various ethical issues that may be encountered during scientific research.
Respect for people
Informed consent
-Individuals should be treated as autonomous agents.
-People with reduced autonomy must be protected.
-To the degree of their capacity, the individuals should be given the
opportunity to understand what is going to happen or not happen to
-Consent must have three elements:
*Being volunteer
Risk and benefit evaluation
-Humans must not be harmed.
-Research should maximise benefits and minimise harms.
-The nature and the scope of the risk and benefit must be evaluated
Subject selection
-The benefits and risks of research must be fairly distributed.
-There must be fair procedures and outcomes in selecting research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979).
The relevance of ethical considerations in any study lies
in protecting the individuals under study, since the
participants may be part of vulnerable populations (e.g.,
low-income, with physical or mental disabilities, children,
incarcerated people, among others). Between 1932-1972
(Tuskegee, Alabama, United States), four hundred low-
income African Americans, who were purposely infected
with syphilis, were monitored to evaluate the natural course
of the disease, without being offered any penicillin
treatment. Likewise, in 1942 (Guatemala), the government
of the United States of America (USA) conducted studies on
696 marginalised people by inoculating a quarter of them
with syphilis without their knowledge. These experiments,
together with those carried out by the Nazis and the
Willowbrook Hepatitis Study (New York, USA), resulted in
the creation of the Belmont Report (Table 1), which serves
to help guide different ethical questions of the scientific
process (Mandal et al., 2011).
Human rights standards and scientific
Human rights standards and principles were created to
safeguard people's dignity. These principles are closely
related to ethical considerations when carrying out scientific
research since both seek to protect all people involved,
especially those who may be considered vulnerable. It is
important to remember that states have the responsibility
and obligation to safeguard the rights of people, making sure
that neither the state nor third parties (i.e., individuals,
companies, etc.) violate them.
The International Covenant on Economic, Social and
Cultural Rights (ICESCR) of 1966 is a binding international
human rights instrument that establishes that the States
Parties recognise the right of everyone to "enjoy the benefits
of scientific progress and its applications." This entails
respect for ethical principles in scientific research. In its
General Comment No. 25 (Alto Comisionado de las
Naciones Unidas para los Derechos Humanos [ACNUDH],
2022), the five interrelated principles regarding the
advancement of science were established (availability,
accessibility, quality, acceptability, and protection of
academic freedom). Additionally, it was noted that scientific
research must "incorporate ethical standards to ensure its
integrity and respect for human dignity, such as the
standards proposed in the Universal Declaration on
Bioethics and Human Rights" (ACNUDH, 2022).
Therefore, although enjoying the benefits of a clinical trial
is a right, this scientific progress cannot override the other
rights that violate or could violate the dignity of people.
Honduras, scientific research, and ethics
In Honduras, clinical trials have been carried out that
have contributed to scientific development during difficult
times. During the COVID-19 pandemic, Honduras
participated in a study aimed at identifying existing drugs
that could be used to manage patients afflicted with COVID-
19. The conclusion was that these drugs had little or no
effect on patients hospitalised for COVID-19 (WHO
Solidarity Trial Consortium, 2021).
Despite this, some of these drugs (e.g.,
J. Solano, et al.
INNOVARE Revista de Ciencia y Tecnología Vol. 11, No. 3, 2022
hydroxychloroquine) were integrated into national protocols
and continue to be used in managing COVID-19 patients in
Honduras. Likewise, preliminary studies that motivated
health personnel to prescribe treatments, such as ivermectin,
have been retracted in the absence of significant evidence
that its administration benefits patients with COVID-19.
More than two years after the pandemic, no clinical or
toxicological studies, among others, have been conducted to
assess the impact on both tissues and organs caused by the
intake of repurposed and new drugs.
Currently, there are 64 clinical trials of drugs or other
interventions registered in Honduras, according to the US
National Library. Additionally, other identified trials have
not been registered. Some of these trials study treatments for
diseases such as Human Immunodeficiency Virus (HIV). It
is unknown if there is monitoring by Honduran regulatory
institutions such as the Sanitary Regulatory Agency
(ARSA), which is the state entity that regulates and controls
clinical trials in humans and biological samples.
Given that the main objective of developing therapies
focused on implementing clinical trials is to ensure the
safety and protection of the subjects participating in the
study, scientific rigor and research ethics must prevail
throughout this process. The United States Food and Drug
Administration (FDA) as a regulatory agency requires
compliance with numerous regulations to maintain high
ethical values in clinical trials, good clinical practices and,
above all, protection of the individuals participating in them.
Honduras has socioeconomic characteristics that limit
scientific development at all levels. One of them is the
percentage of investment in research and development of the
Gross Domestic Product (GDP), scientific production per
million inhabitants, and the limited number of ethics
committees (9) registered in the Portal of the Network of
Ethics and Research Committees of Honduras with irregular
coverage, directly influencing quality scientific production
and evaluation times of research protocols. Undoubtedly,
these conditions represent a challenge for researchers, ethics
committees and regulatory agencies so that the development
of clinical trials adheres to all ethical standards.
Ethical evaluation processes implicit in research are a
fundamental part of the scientific development of any
country. These offer safe environments for the subjects and
facilitate the implementation of solutions that result from
them, offering benefits to humanity. In Honduras, the
limited scientific production affects most of the population
when it is difficult to discern between misinformation, the
need, and the hope of obtaining treatment for a certain
disease and what science shows us with evidence.
It is essential to ensure that the scientific production
carried out in Honduras is accompanied by regulations and
rigorous ethical principles that respect the human rights of
each person involved without taking advantage of their
vulnerability conditions. To this end, it is imperative to
create and promote independent ethics committees, invest in
research, professionalisation, and training of researchers,
and promote the regulation and constant monitoring of state
and academic organisations.
Author Contributions
JS conceptualised the idea of the article. All authors
carried out the literature review and wrote the manuscript,
as well as read and approved the latest version of the
Conflicts of Interest
The authors declare no conflict of interest.
Bibliographic References
Alemayehu, C., Mitchell, G., & Nikles, J. (2018). Barriers for conducting
clinical trials in developing countries- a systematic review.
International Journal for Equity in Health, 17(1), 1-11.
Alto Comisionado de las Naciones Unidas para los Derechos Humanos
[ACNUDH]. (2022). Observaciones generales. Órganos de los
Mandal, J., Acharya, S., & Parija, S. C. (2011). Ethics in human research.
Tropical Parasitology, 1(1), 2-3.
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research. (1979). The Belmont report: Ethical
principles and guidelines for the protection of human subjects of
research. U.S. Department of Health and Human Services.
WHO Solidarity Trial Consortium. (2021). Repurposed antiviral drugs for
Covid-19 - Interim WHO Solidarity Trial Results. The New England
Journal of Medicine, 384(6), 497511.
*Received: 8 August 2022. Revised: 1 September 2022. Accepted: 23
November 2022. Published: 8 December 2022