INNOVARE CIENCIA Y TECNOLOGÍA VOL. 11, NO. 3, 2022

Disponible en CAMJOL

INNOVARE Ciencia y Tecnología

Sitio web: www.unitec.edu/innovare/

Autor corresponsal: jhiamv@gmail.com, Royal Oldham Hospital, Greater Manchester, United Kingdom

Disponible en: http://dx.doi.org/10.5377/innovare.v11i3.15359

Opinion

Clinical trials in Honduras: ethical considerations

Ensayos clínicos en Honduras: consideraciones éticas

Jhiamluka Solano

a,b,1

, Orlando Garner

c,d

, 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

States

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

States

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

implications.

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

research.

J. Solano, et al.

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Table 1

The Belmont Report is a guide about the various ethical issues that may be encountered during scientific research.

Principle

Application

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

them

-Consent must have three elements:

*Information

*Understanding

*Being volunteer

Beneficence

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

systematically.

Justice

Subject selection

-The benefits and risks of research must be fairly distributed.

-There must be fair procedures and outcomes in selecting research

individuals.

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

research

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.,

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J. Solano, et al.

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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.

Conclusions

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

manuscript.

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.

https://dx.doi.org/10.1186/s12939-018-0748-6

Alto Comisionado de las Naciones Unidas para los Derechos Humanos

[ACNUDH]. (2022). Observaciones generales. Órganos de los

tratados. https://www.ohchr.org/es/treaty-bodies/general-comments

Mandal, J., Acharya, S., & Parija, S. C. (2011). Ethics in human research.

Tropical Parasitology, 1(1), 2-3. https://dx.doi.org/10.4103/2229-

5070.72105

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.

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-

the-belmont-report/index.html

WHO Solidarity Trial Consortium. (2021). Repurposed antiviral drugs for

Covid-19 - Interim WHO Solidarity Trial Results. The New England

Journal of Medicine, 384(6), 497–511.

https://dx.doi.org/10.1056/NEJMoa2023184

*Received: 8 August 2022. Revised: 1 September 2022. Accepted: 23

November 2022. Published: 8 December 2022

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