It is an international scientific guide that reflects good clinical practices in the field of health research.
24/5/2022.- The clinical trial conducted under the PROCARE initiative has recently been included in the ‘Good Clinical Practices Network’, an international scientific guide to good clinical practices in the field of health research.
Specifically, this guideline is an international standard of ethical and scientific quality applicable to the design, conduct, registration and reporting of clinical trials involving human participants. It is a guide developed along the lines of the good clinical practices currently being carried out in the European Union, Japan, the USA and Australia, and under the guidelines of the World Health Organization (WHO).
The PROCARE initiative, led by the professor of the University of Jaén (UJA), Luis Joaquín García, has provided free help to more than 1,500 schoolchildren at risk of suffering emotional problems, and to their families. Through this clinical trial, it has contributed significantly to the promotion of mental health and emotional well-being of young people between 12 and 18 years of age in different parts of the country.
In addition, PROCARE is characterized by being the first transdiagnostic selective prevention program under the framework of personalized medicine, which is aimed at young people in the current stage of psychosocial difficulties marked by the pandemic and post-pandemic.
After learning of the inclusion of PROCARE in this relevant guide, Luis Joaquín García points out that “compliance with this standard provides a public guarantee of the protection of the rights, safety and well-being of the subjects participating in the clinical trial in accordance with the principles of the Declaration of Helsinki, and, in turn, guarantees the credibility of the data collected”.
The PROCARE initiative is a national project, which has involved the work of professionals from the Psychology Department of the UJA, the Rovira i Virgili University, the Miguel Hernández University of Elche and the University of Miami (USA). In addition, the Youth Institute (INJUVE) of the Ministry of Social Rights and Agenda 2030, the Spanish Association of Mutual Help against Social Phobia and Anxiety Disorders (AMTAES), the Confederation of Organizations of Psychopedagogy and Guidance of Spain (COPOE), the FELGTBI+ Youth group of the State Federation of Lesbians, Gays, Trans and Bisexuals (FELGTB) and the Youth Council of Spain (CJE) are part of the project’s External Advisory Council.
