Expressão de preocupação: CONTROLE SOCIAL, TRANSPARÊNCIA, INTEIREZA CIENTÍFICA E RESPONSABILIDADE EM PESQUISAS MÉDICAS

Flávio Dantas

doi:10.1590/SciELOPreprints.5289

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Flávio Dantas Federal University of Uberlândia https://orcid.org/0000-0002-2756-2412

DOI:

https://doi.org/10.1590/SciELOPreprints.5289

Keywords:

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

Abstract

Expression of Concern

The SciELO Ethics Office, following an assessment conducted by an ad hoc Working Group composed of researchers and editors with expertise in research ethics and scholarly communication, identified concerns regarding the preprint "Social Oversight, Transparency, Research Integrity, and Accountability in Medical Research". The assessment was conducted with reference to the SciELO Good Practices Guide and the guidelines of the Committee on Publication Ethics (COPE).

The Working Group identified conceptual inconsistencies and deficiencies in the manuscript's supporting rationale and recommended that the author revise the manuscript to bring it into compliance with accepted standards of academic rigor. In accordance with COPE's editorial practices, the author was formally notified and invited to respond to the recommendations put forward.

However, the author chose not to address the substance of the requested revisions within the allotted timeframe. In light of the author's refusal to cooperate with the editorial review process, and because the concerns raised remain unresolved, the SciELO Ethics Office hereby issues this Expression of Concern.

The purpose of this notice is to ensure transparency in the editorial process and to inform the readership that substantive, unresolved concerns have been identified regarding this work. This statement reaffirms the SciELO Program's commitment to the integrity of scholarly communication.

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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 implements the protection of participants. The 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 the 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, Federal University of 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.