Dra. Ruth Varela Valencia | CIF Project Manager
Experimental clinical studies or trials are strategies designed to evaluate the efficacy of a treatment in humans, they have to follow certain international and national regulations in order to protect the rights and well-being of the participants (Calva-Mercado, 2000: 4). The development of research for health must address ethical and scientific aspects that guarantee the dignity and well-being of the person subject to research; it requires the establishment of technical criteria and clear guidelines to regulate the application of the procedures (Pacheco et al, 2016:175).
Figure 1. Own elaboration based on Frank et al, 1987. Timeline of international publications issued on clinical trials in humans.
Over time, publications on regulation in clinical trials have emerged. The Nuremberg codes of ethics (1947), the norms dictated by the Helsinki declaration, and the appearance of the Institutional Review Boards (IRB) -see figure-. However, these international declarations were not enough to safeguard the rights of people in the framework of clinical research. There are four research projects in humans that have been considered paradigmatic in this regard:
- New York. 1956: Mentally retarded children infected with hepatitis. Parents gave consent under duress.
- New York. 1963: Cancer cells were injected into 22 elderly patients, without their consent.
- Tuskegee, Alabama. 1932-1972: 200 black patients with syphilis, no treatment allowed.
- Europe, Asia and the Middle East. 1962: More than 10,000 children are born with teratogenic effects after taking Thalidomide by their mothers during pregnancy.
All this led the main organizations dedicated to drug control to more strictly regulate clinical research more, such as those issued by OPRR (Office for the Protection from Research Risks) and FDA (Food and Drug Administration). In 1990, the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) was created, which is the International Council for the harmonization of technical requirements for the registration of medicines for human use. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed, registered and maintained in the most efficient manner.
Currently, the human research process is governed by an international standard of Good Clinical Practices (GCP), which is a standard for the design, conduct, performance, analysis, and reporting of clinical studies that provide confidence in data and reporting of results to be credible and accurate and to protect the rights, integrity, and confidentiality of subjects participating in the research” (Hutchinson, 1997). These guidelines are used in most countries and serve as a reference for conducting clinical trials.
At the national level, there is a specific legal framework applicable to conduct clinical trials, which involves their authorization, monitoring, control, and surveillance. Compliance with these guidelines, agreements and regulations ensures the protection of the dignity, human rights, safety and well-being of the participants in the clinical study, since the general aspects for the development of research in the country as well as the ethical aspects are established. of research in human beings, the investigation of new prophylactic, diagnostic, therapeutic and rehabilitation resources; Criteria are established for the execution of clinical studies, topics such as: the presentation and request for authorization before the competent authority of a research project; how should be the follow-up and partial technical report and technical report of study closure; It also speaks of the physical and legal security of the research subject; and the confidentiality of the information.
As has been detailed, both national and international regulations have as their main purpose to ensure that the research subject is protected, and that the conduct of clinical studies contributes to the search for better ways to prevent, detect and treat diseases and conditions with negative impact. in health as well as promoting scientific and technological development by publicizing the results of medical importance through the publication of articles in journals, debates or medical and scientific meetings and by means of communication that promote the stimulation of the operation of public-private establishments intended for research and the training of health personnel in the field of research on human beings.
REFERENCES
- Calva-Market J. J (2000). Experimental clinical studies, Public Health of Mexico. (42), p.4.
- Frank, I.,Ruley Riley A., Murray P (1987). Conducting Clinical Trials, Plenum Medical Book Company. New York and London.
- Hutchinson David BS (1977) The Trial Investigator’s GCP Handbook a practical guide to ICH requirements. Brookwood Medical publications.UK.
- López-Pacheco, M.C. (et, al) (2016). Regulations that govern clinical research in human beings and requirements that a research center must meet to participate in a clinical study in Mexico. Acta Pediatr Mex, 37 (3), pgs. 175-182.
- Harmonization for better health (2020). Sharing of ICH Perspectives. https://www.ich.org/
