HUMAN BEINGS, ETHICS, AND CLINICAL RESEARCH

Clinical research has been consolidated as a basic means of responding to the global health problems that affect humanity, identifying a range of actors in the continual search for drugs to alleviate diseases that do not yet have cures, for vaccines to prevent new and emerging pathologies with high morbidity and mortality, and for nonpharmacological treatments to treat or palliate other illnesses. But in this pursuit, which involves diverse private and collective interests, the incorporation of human beings in the processes forces researchers to perform constant critical self-reflection, which is mirrored in their actions and decision-making.

A first element for reflection is how to render researchers’ thinking and acting fully conscious, acknowledging actual practice in Mexico and other underdeveloped countries. This has led to arid and contradictory discussion, owing to diverse factors that condition the development of clinical research. The most delicate matter remains the fact that there are still no clear and concrete mechanisms to ensure that the ethical assumptions established on various levels regarding the participation of human beings in research have permeated activity in the field. Apart from the benefits of research for participants, the scientific community, and society in general, there are still prejudices that can condition the wellbeing and quality of life of those involved.

Viewed from the perspective of human participants in the research, various motives can be identified: the desire to cure or palliate their diseases, to prevent new illness, or to prolong their lives with quality. It is unfortunate that, for some researchers, these desires are used for the purposes of experimentation and in order to obtain social, economic, or institutional recognition, without due importance being given to the scope and safety of the research, the physical integrity of the participants, the emotional context of their involvement, and its relation with society.

In considering the integrity of human beings who participate in clinical trials, the epistemological vigilance of the researchers is of enormous relevance, this being understood as a process whereby they constantly view themselves critically, examining the effects they themselves may have on the trials, the different forms of relationship in play and their impact on the participants, and their own discourses, interpretations, and behaviors, among other aspects. All this is important to ensure that they do not incur in ethical, legal, or methodological inconsistencies during the course of the research.

This surveillance is developed mainly within the relationship established by the researcher with the object of study and the participants of the research, and goes beyond the necessary rigor in the correct application of techniques. It also involves a constant review of one’s ontological position in the operative field, that is, the question of when exactly one ceases to be a health worker and becomes a researcher. Likewise, there is the consideration of when the human being ceases to be a patient and becomes a “research subject,” putting at risk adherence to one of the most important ethical postulates established in the health sciences: the free autonomy of clinical trial participants.

The second element of consideration is informed consent, an element of tangible expression of respect for the autonomy of persons not only in the field of health care, but also in that of medical research. Informed consent is not simply a document, but rather a continuous and gradual process, beginning with the first steps in explaining the intentions and objectives of the study. It is an opportunity for reflection and for the potential research participants to inform themselves, corroborate their knowledge, and resolve doubts regarding the manner of their participation, the processes to be undertaken, the possible effects and treatments to be developed as a result of the research, and the consequences of the signatures of both participants and witnesses. Thereafter, it is important to maintain vigilance regarding the fulfillment of what has been agreed on.

For the National Commission on Bioethics in Mexico, informed consent is a process whereby an individual, after receiving the necessary information, makes a voluntary decision to participate in a clinical trial or not to do so. The same institution emphasizes that informed consent is recorded by means of a document, signed and dated, and that it consists of two parts, in the first of which information is provided about the proposed research, and in the second of which the research subject formally accepts, by means of his or her signature, to participate in the research.

The use of informed consent in research merits reflection and analysis, with special attention to particular situations where it may be more demanding than usual: working with minors or incarcerated persons, experimentation on people with serious mental illness, the involvement of unconscious patients, and particularly issues concerning research with women (owing to the permanent discrimination they suffer in many countries, as well as to the possibility of their being pregnant).

Informed consent must also ensure that explanations have been clear, without any doubts or misunderstanding about the procedures to be performed, as for example the taking of biological samples, the photographing of private images or of certain lesions, the evolution of certain dermatological pathologies when new treatments are applied, video recordings of new surgical techniques, voice recordings, or interviews about experiences with new pharmacological management, among others. It is common that, once a process is underway, researchers begin investigating other elements that were not considered at the beginning.

Research subjects should not only have an understanding of the procedures to be performed, but also of why they are performed and how they are managed, as well as safeguards regarding the use that will be made of them in the future, the time spans involved, and the identity of those who will be responsible for these matters. In relation to images and/or photographs, they should also know how many images will be taken and how their own personal integrity and identities will be protected in the process, whether the images are going to be exhibited or shown (and in what medium: poster, magazine, slide show, etc.), and, in some cases, how long this will be the case.

In order to render possible the fulfillment of the two assumptions we have analyzed, their application and understanding must begin with educational institutions, in the training of human resources for health, comprising all the disciplines related to the attention of living beings. This will allow professionals to acquire an understanding of and consideration for the well-being, personal integrity, and integral health of the research subjects, apart from any scientific progress that may be expected from a clinical trial. In this way, the incorporation of human beings in clinical research will be based on constant critical selfreflection on the part of researchers and the quality of their research will be guaranteed, insofar as this is possible, by respect for the dignity and human rights of the research subjects.

Dr. Jorge Laureano Eugenio

Researcher of the Secretary of Health Jalisco.

Dra. Elisa Gil Hernández

Advisor and promoter of research at the Secretary of Health Jalisco.