The Seville Public Prosecutor’s Office has begun investigating whether a medical team at the Virgen Macarena University Hospital undertook a study with diabetic patients without their informed consent or the approval of the ethics committee. This is confirmed by sources from the Public Prosecutor’s Office consulted by SevillaelDiario.es, after the doctor who had warned of “irregularities and bad practices” by his colleagues in the internal medicine department decided last July to take charge of the case reported by this newspaper.
In his complaint, filed after the hospital decided to close its own internal investigation without collecting a statement, the doctor asked the Public Ministry to try to clarify whether four doctors at the Sevillian hospital took blood samples for investigation purposes from patients admitted for diabetic foot. . without previously informing them as responsible.
Facts that, in the opinion of the complaining doctor, “present indicative characteristics of a crime” against privacy included in the Penal Code, as well as a “violation of the organic law on the protection of personal data and guarantees of digital rights, the law on biomedical research and the general law on health”, as specified in the document to which this newspaper had access.
Today, at the end of the summer, the Public Prosecutor’s Office has begun the procedures with which the investigation begins, which is added to that already started in February by the Andalusian Council for Transparency and Data Protection. This independent entity has agreed to treat the complaint filed by the same doctor from La Macarena in November “as a possible violation of data protection regulations”. The period of “preliminary investigative actions” continues and can last up to 18 months in order to gather information, as data protection sources indicate to this newspaper.
Chronology of the case
The reported events date back to April 2023, when a patient hospitalized for “decompensation and complications due to diabetic foot” asked his doctor about the results of a test that had been carried out. Intrigued, since he himself, as the person in charge, had not prescribed any tests and no one in the department had told him anything about it, he consulted the file and found that, at least since March, as many requests for tests had been made in patients with the same clinical picture admitted under their responsibility.
The doctor who appeared to be the petitioner of all turned out to be one of the authors of the study identified by the acronym BIOEAP, which, according to the complaint, was launched without waiting for the mandatory authorization of the Research Ethics Committee of the Virgen Macarena and Virgen del Rocío Hospitals, the body responsible for giving the green light to proposals for scientific trials in Seville. The complainant bases this statement on the fact that the related opinion was issued three months later, on June 26, and was “unfavorable”, which is why he rejected its implementation.
“This demonstrates the irregularities that were committed in the research project carried out,” the internal medicine specialist maintains in his complaint, stressing that “the study had already been underway since March 2023, as evidenced at least by “the first of the requests for clinical analyses detected on my patients.” At this point in the document, let us recall that the Biomedical Research Act establishes that “all research on human beings must be subject to compliance with ethical standards aimed at preserving the dignity, rights and safety of people, and to the express authorization of the Clinical Committee.” Research Ethics.
All this was brought to the attention of the medical management of the Macarena hospital in writing in October 2023. The center then opened “immediately” an internal investigation that has been completed since March “because the facts reported were not proven,” according to the information. Macarena sources consulted by this newspaper.
The doctor, not satisfied with the file – he insists that no director or manager of the hospital institution contacted him to compare the evidence he reported in his notification – decided to resort to justice, filing a complaint with the Seville Public Prosecutor’s Office on July 19. The Public Prosecutor’s Office will now have to decide whether, as the complainant fears, these biological samples taken without informing the patients or the doctor in charge were carried out in violation of the procedures established by the ethical codes of medical research and current legislation.
