Mr. Director,
With great surprise we have been informed that the Undersecretary of Public Health, Dr. Paula Daza, in Ord N°14/3140 of August 30, 2021, affirmed that “the Scientific Ethics Committees must focus on the analysis of studies or clinical trials in the area of biology, not corresponding to them to address studies in the field of social sciences”.
As former members of the Advisory Commission on Ethics of Scientific Research of Fondecyt, which worked in CONICYT (today ANID) until December 2019, we want to express our emphatic disagreement with this statement, for the following reasons:
Law 20,120, which regulates scientific research in the country and its regulations, establishes the obligation of ethical evaluation of biomedical research, meaning by these “any physical or psychic intervention or interaction with human beings, with the aim of improving the prevention, diagnosis, treatment, management and rehabilitation of people’s health or increasing the biological knowledge of the human being, including in this activity, the use of human material or identifiable available information.” By including “psychic intervention or interaction with human beings,” biomedical research includes social health research (e.g., psychology, sociology, anthropology, epidemiology, among others), which coincides with the definition accepted by the scientific community of health as a “complete state of physical, mental, and social well-being.”
The regional ministerial secretariats of health, from 2013 to date, have accredited 64 Scientific Ethics Committees in the country. These committees operate within the framework defined by the Health Authority, which includes the evaluation of social research. Some of the committees accredited by this authority evaluate only research in the field of social sciences. The Ordinary in question, then, does not know the work that the Health Authority itself has been carrying out for several years.
It has been recognized for several decades that social research can involve significant risks, for example, in the area of mental health, health discrimination and many others. The evaluation carried out by the scientific ethics committees has as its main objective to analyze these risks according to the expected benefits, and thus protect the health, well-being and rights of the participants. Omitting the ethical evaluation requirement for social research means leaving the people who participate in this research unprotected.
The Undersecretary of Public Health has given a broad response with great implication, in reference to scientific research with human beings, which undoubtedly goes beyond the field of health, ignoring consensus and international standards agreed by the scientific community on the basic requirements for research of excellence that protects the well-being and rights of the participants. It is also unknown that, for any publication in a prestigious scientific journal and with peer evaluation, a basic requirement is that all studies with human beings have the prior approval of a Scientific Ethics Committee.
We consider that the answer provided is not consistent with the level reached by research in our country and that it means a setback to the development of this. Moreover, the scientific ethical review must continue to advance towards all research carried out in the social sciences, humanities and also with animals.
For the above, and for the confusion it generates in all the actors involved in scientific research, in particular in researchers in training, we peremptorily request that the aforementioned Ordinary be corrected and clarified.
Dr. Hedie Bustamante, Mag. Animal Health, PhD Biomedical and Veterinary Sciences
Dr. Marcela Ferrer L., MHSc in Bioethics, PhD in Public Health
Dr. Emilio Herrera V, PhD Biomedical Sciences
Dr. María Elena Gronemeyer F., PhD in Social Communication
Dr. Juan Alberto Lecaros, PhD in Philosophy
Dr.M. Ximena Luengo Ch., Mg Public Health
Dr. Eva Madrid A, Ph.D. in Medicine
