SOCIAL CONTROL, TRANSPARENCY, ACCOUNTABILITY AND SCIENTIFIC INTEGRITY IN MEDICAL RESEARCH

Flávio Dantas

doi:10.1590/SciELOPreprints.9447

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Flávio Dantas Departamento de Clínica Médica, Faculdade de Medicina da Universidade Federal de Uberlândia https://orcid.org/0000-0002-2756-2412

DOI:

https://doi.org/10.1590/SciELOPreprints.9447

Keywords:

Ethics, Research, Human experimentation, Informed consent, Consent forms, Formal social control, Scientific Misconduct, Ethics Committees, Research

Abstract

The CEP/CONEP System, submitted to social control, is responsible for the ethical approval of research in Brazil to protect research participants. The Informed Consent Form (ICF) is the public document that enforces the protection of participants. This paper presents two cases of medical research in the Amazon region on malaria and the use of chloroquine for treating COVID-19. The participants were uninformed in the ICF on relevant aspects of the two studies, with serious health risks. For the sake of increasing transparency and social control, it is proposed that there should be mandatory publication of the ICF in studies supported by public funds, presentation of an objective summary of the study at the beginning of the ICF, publication of central elements of the protocol of clinical trials in open access Brazilian virtual platforms, and promulgation of a dedicated law to improve scientific and ethical integrity in Brazilian medical research.

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Author Biography

Flávio Dantas, Departamento de Clínica Médica, Faculdade de Medicina da Universidade Federal de Uberlândia

Medical Doctor (Federal University of Rio Grande do Norte, 1976) and Lawyer (Federal University of Uberlândia,1992), Master in Organizational Theory and Behavior (Business Administration School/Getúlio Vargas Foundation-SP,1981) and Ph.D. (Federal University of São Paulo,2006). Privat-Docentz in Clinical Homeopathy (UNIRIO,1991) and Postdoctoral Fellow (The Royal London Homeopathic Hospital, 1995-7), with scholarships from CAPES and CNPq. Specialization Course in Hospital Administration and Occupational Medicine and certified as specialist in Internal Medicine, Homeopathy and Acupuncture by The Brazilian Medical Association. Expertise in Law (Diffuse and Collective Rights) and past Coordinator of the Specialisation Course in Medical and Hospital Law at Paulista Law School. Consultant in organizational development, mainly in the areas of conflict resolution, communication and organizational change. Technical director of TEMPO Consulting (1978-1981). Teaching experience in elementary and higher education since 1971. Professor in the Department of Clinical Medicine, Federal University of Uberlândia and Visiting Professor in Clinical Medicine at the Federal University of São Paulo. Delegate of the Regional Council of Medicine of São Paulo. Member of the Technical Chamber of Homeopathy (CREMESP) and Committees of Medical Law and of Biotechnology and BioLaw (OAB-SP). Full Member of the State Health Council of São Paulo State. Development of professional activities in the areas of Conciliation, Mediation and Arbitration, Medical Ethics / Bioethics, Biomedical and Health Law, Homeopathy, Medical Education, Educational Evaluation and Clinical Epidemiology.