1. Introduction

The objective of scientific research is to achieve an impartial and true knowledge of the surrounding reality to guide it in favor of the transformation of man and his environment. In this way, safe and reliable information will be obtained to understand, correct, verify or apply an understanding or judgment (by means of a controlled, critical and systematic reflexive process) in the discovery of new facts, relations and laws ⁽¹⁾.

The development of progress has caused changes in the perspectives of research (mainly clinical) to be presented in an accelerated manner, with sometimes unforeseeable consequences, which has resulted in an authentic ethical and legal revolution that in some cases is difficult to specify ⁽²⁾.

In every project carried out, the protection of life, health, integrity, self-determination, privacy and confidentiality of the participants and their responsibility must be considered ⁽³,⁴⁾. The goal of all clinical research is to respect human rights and human dignity ⁽⁵⁾.

Clinical research should be based on basic knowledge of biology, physiology, medicine and ethics to improve the understanding of patients’ health-disease processes ⁽⁴⁾. In the case of the disease itself, it constitutes an existential and biological twist for people; therefore, research should have a comprehensive understanding of the act of contracting and caring for them. Most of these studies (as the frequent activities of medicine in general) are influenced by techniques that lead to base practices exclusively on objective facts, leaving behind the subjective perceptions of the integral understanding of the disease processes that not only affect the physical body but the totality of people ⁽⁶⁾.

Bioethics is closely linked to clinical research to contribute to the development of humanity and is based on the moral values of individuals. If ethical values were appreciated in the same way as scientific-methodological values, studies would have to be re-evaluated for the impact they have on people ⁽⁷⁾. Thus, the conception of bioethics in research should provide protection for the primordial value of human dignity ⁽⁸⁾.

This framework makes it clear that the human being is the fundamental component of clinical research, so that his or her freedom, respect, integrity and fair treatment without discrimination constitutes the dignity of persons, which substantially increases the value of the knowledge obtained from them.

2. Person and dignity

To speak of dignity in persons, its concept must first be explained through several approaches:

This person is an individual who possesses a superior cognitive capacity, not only about himself, but also about his surroundings, both in the present, past and most probably in the future, considering himself as a persistent, constant and unique subject throughout his life ⁽¹⁴⁾. It is not possible to conceive of treating a person without considering the rights entailed by the dignity he represents by his nature and being.

Dignity could be considered as a principle bearing social and individual values and rights of men, which make the person more than an object, affirming his social relations among human beings and reaffirming his autonomy ⁽¹⁵⁾. In this sense, society has the obligation to respect the dignity of everyone that forms the society it governs.

Currently, and specifically at the level of clinical research, the notion of dignity of persons plays a double role in its conformation:

It should be noted that dignity has two types of conceptions:

Man is worthy as such, not only as a basis for legislation but also in his bodily nature, with or without rationality expressed in his body (ontological dignity), with his own free behavior to the extent of the essence of being human (moral dignity), before the enjoyment of their physical and psychological capacities that develop their personality, under norms and rights that regulate their behavior (legal dignity) ⁽¹⁸⁾.

This conception of dignity in people is fundamental to consider in research studies, first, to preserve their inalienable human rights of respect for the life of the human being and above all in the holistic conception of the individuals who are going to participate.

3. Dignity and axiological values

The principle of dignity in persons in scientific research studies has a reference within the axiological framework of international bioethics, rights, guarantees and constitutional and doctrinal legislations in order not to violate their conceptions as human beings ⁽¹⁹⁾.

The relevant values of dignity are based on its sanctity, freedom, responsibility, duty and service to one’s fellow human beings. Moreover, a person’s health and well-being are essential to live as full a life as possible ⁽²⁰⁾.

Dignity is a sum of values that constitute persons and distinguish them from other living beings, which can confer social goods ⁽¹²⁾. It is an absolute right that is supported by the values of freedom, justice, peace, honor, respect for property and security, so that both the powerful and the miserable should be protected in their rights ⁽²¹⁾.

It would not be possible to conceive the dignity of people without their freedom, to unleash their intellectual and physical potentials in their cultural and social coexistence and in terms of education, justice, peace and other values granted by the state. It is a sovereignty without pressure or conditioning of each person over his life and behavior. However, this freedom is conditioned to the responsibility of individuals, the duties and rights of their existence ⁽¹²⁾. Respect for oneself and for others is preponderant and is established when the human being must be treated as such and not seen from the point of utilitarianism. On the other hand, respect must also be included in the fulfillment of basic human needs according to their biological context, so that men are aware of themselves ⁽¹²⁾, as a psychic maturation that translates into considerations to others, with tolerance, composure and waiting capacity to regulate the behavior of human beings ⁽²²⁾.

Justice in dignity is related to the public and private context of each person, both commutatively and distributive and unquestionably legal. Every person has the right to social security, to the satisfaction of his economic, social and cultural rights indispensable for his dignity and the development of his personality ⁽¹²,²³,²⁴⁾. Dignity must be inherent to justice, which generates respect, openness, gratitude, gentleness and helpfulness.

The honor is determined by the moral authority to be considered socially as examples of the community and deserves esteem and recognition ⁽¹²⁾. On multiple occasions, honor has evolved to be esteemed as a representation of dignity for the achievement of identity recognition claims ⁽²⁵⁾.

From the axiological point of view of dignity, this should be considered as the supreme value that individuals have, which provides them with the rights of freedom, justice, peace, honor and autonomy necessary for this subject to be part of the research on his person and on his health-disease data.

4. Dignity and human rights

Dignity is not only a principle or a constitutional value, but it should also be considered as the cornerstone of people’s lives and a fundamental right. This principle is a parameter of the activity of society as an open concept based on criteria, instruments and patterns of interpretation in favor of individuals ⁽²⁶,²⁷⁾. Dignity should be considered as the power of individuals to act autonomously, with the right to create conditions to favor the development of their personality, but also as a restriction in the relations of individual freedom conditioned to general reasons ⁽²⁷⁾.

Dignity in human rights is historically conferred as a juridical expression to allow and guarantee their respect not only because of their condition of living being, but also because of their nature or their own characteristics ⁽²⁸⁾.

We could establish indispensable human rights for clinical research, such as the following:

Law and bioethics must be considered to keep in mind the vulnerability of people when they are involved in research relationships ⁽³⁸⁾.

Human rights focused on the integrity and dignity of persons emphasize the need to see each person as the central core of research and not to obtain knowledge. Research studies should not be conceived where the subjects are objects of study and are not conscious and valid active subjects from whom benefit is obtained.

5. Dignity in clinical research

It can be established that all ethical regulations and norms are carried out to protect the values of respect and dignity of the participants in research studies, safeguarding their human rights ⁽³⁹,⁴⁰⁾.

Although dignity has been considered as a futile concept that should only be linked to the autonomy of research participants, claiming that if we were to eliminate the reason for which we would consider each of them (due to loss of physical or mental aptitudes), their dignity would disappear and, therefore, their autonomy would lose its justification ⁽⁴¹⁾. Undoubtedly, the self-determination of persons constitutes a key element to ensure their dignity, but the latter must be conceptualized from a much broader point of view, as a source of human rights in persons, the result of the exercise of their intelligence, free will, and capacity for self-pity, expression of their ethical and moral values ⁽¹⁷⁾. This autonomy must be freely exercised to accept or reject any form of participation in research studies ⁽⁴²⁾.

Respect for human dignity implies balancing scientific freedom with the autonomy and well-being of the people who participate in research ⁽¹⁷⁾.

The dignified treatment of the participant is not only conditioned to the research activity itself, but the physical environment, the attitude of the participants, the behavior of the personnel, the culture of the people and, above all, the independence that the individuals may have ⁽⁴³⁾.

In clinical research, the rights of patients should be preserved as best as possible, in order to provide them, as far as possible, with the basic individual guarantees of health, integrity, respect for life, and non-inhumane treatment. Participants in research studies should be guaranteed dignified treatment of their person and belongings.

6. Dignity in clinical research through the principlism approach

The principlism trend, which began with the introduction of the Belmont report ⁽⁴⁴,⁵¹⁾, has sought to preserve the dignity of the participants in clinical research. The use of the four principles of bioethics (principlism approach) in any type of clinical research is indisputable ⁽⁴⁵⁾:

The principle of justice is based on the balance between the demand for benefit and protection against improper activities. Justice must be evaluated from two perspectives: a) social (distinction between the classes of subjects who should or should not participate, the capacity of their members and the possibility of receiving such activities) and b) individual (fairness about benefits and risks), as in the case of vulnerable groups, so that the selection of subjects must be equitable. On the other hand, an understanding of the balance of direct or indirect benefit on the vulnerability of the participants and their risk is required. Fairness must be present in the access of individuals when there is a direct benefit to them, to ensure that the resulting information is not only restricted in its application but also beneficial to society ⁽⁵¹,⁵⁴,⁵⁵⁾.

Most likely, an analysis of each of the principles will affect more than one question in the development of any clinical research.

There are additional principles that are considered in the research process: protection of health, welfare and respect for populations and the right to self-determination, protection of vulnerable populations and equitable distribution of benefits ⁽³²,⁵⁶⁾.

The principlism apporach instituted since the Belmont Report ⁽⁴⁴⁾ was originated as a response to the dignified treatment that should prevail in clinical research participants. This report and later the expansion to the 4 basic principles, protect people by giving preponderance to their autonomy as human beings, to preserve justice in the fairness of activities and charity, placing the participants as the purpose of improvement and pointing out the non-maleficence as an event that, if sometimes it cannot be separated from the studies, is appropriately weighted in the risk benefit of each one.

7. International Standards Protecting the Dignity of Clinical Research Participants

International regulations seek to support the dignity of participants in various bioethical approaches. The main agreements, guidelines, conventions and conferences highlighting the importance of the dignity of clinical research participants are listed below.

8. Conclusions

For the future of medical knowledge, it is essential to continue conducting competent clinical research both from the methodological point of view and about the support of bioethical concepts.

The person is the central part of clinical research, it is not possible to think from the bioethical point of view to carry it out without considering his/her dignity as an indispensable part of its execution.

Throughout history and especially nowadays, the failure to consider the dignity of persons has brought immense harm to human beings in research. This lack of dignity in studies has caused many people to have negative repercussions on their body, mind and everything related to their existence.

At the international level, there are norms and regulations that protect the dignified treatment of people; it is the duty of the researcher, the work and research center, the institutions and the government, to respect these laws in order to protect individuals who aspire to participate in clinical research. In them, it must be considered that people are the end and not the means to achieve the expected technological advances. Respecting the dignity of individuals in clinical studies is a central part of this, so respecting it means that research must be integral and contribute to the progress of science in a holistic manner.