Private hospitals should participate in research: Conbioethics

In the intricate world of medical research, where science, morality, and ethics are intertwined, the National Bioethics Commission (Conbioética) has a crucial role: ensuring that scientific trials in Mexico do not compromise patients' rights. Its current director, Dr. Patricio Santillán, is stirring up trouble by seeking to restore order. He has generated discontent over the slow pace of authorizations and renewals of research ethics committees (RECs), a process that, for some, slows the pace of scientific progress.

We spoke with Dr. Santillán, who explained why RECs should not operate as isolated approval offices but rather be integrated into a medical-scientific ecosystem. To achieve this, he proposes extending the validity of REC registrations from three to five or six years, adjusting the regulation that allows clinics to register as "health care establishments" (because it creates the potential for committees that operate under precarious conditions), and encouraging private hospitals, many of which already train residents or perform transplants, to join RECs.

He points out the error of considering healthcare, education, and research as separate spheres, as this limits Mexico's potential for producing scientific knowledge. Among the inconsistencies he points out is the case of private hospitals that aspire to perform transplants, a high-level procedure, but lack a CEI, arguing that they don't do research. Santillán questions this position: "If you have residents, the university will ask you for research projects. That's good for your patients, your doctors, and even for business."

Santillán recounts cases of committees with bombastic names, such as the "Southeast Biomolecular Research Institute," located at addresses that Google reveals as houses with garages or tire repair shops next door. These committees approve Phase 1 protocols, the riskiest ones, without ensuring adequate oversight. "The law says that the CEIs must review what is being done in their surroundings, not 5,000 kilometers away," he emphasizes.

To address these irregularities without hindering research, Santillán proposes a reorganization that balances agility and rigor. This includes strengthening the oversight of RECs, promoting agreements between hospitals and research organizations, and educating the private sector about the importance of integrating research as part of their mission. "Ethics is non-negotiable," he states. Conbioethics, aware of the complaints from the private sector, seeks to facilitate processes without sacrificing patient safety, a principle that must prevail over any commercial interest.

Private hospitals, with their growing influence, have a unique opportunity to lead this change by integrating IRBs that not only comply with regulations but also drive ethical innovation.

With 32 years of history, Conbioethics, founded in 1989 as a study group driven by figures such as Dr. Manuel Velasco Suárez, was formalized in 1992 under the General Health Council. Its mission: to ensure ethical and robust clinical research.

Bioethics, a term that will barely be a century old since the German philosopher Fritz Jahr coined it in 1927, gained relevance in the 1970s, when the techno-scientific boom transformed medicine. Innovations such as mechanical ventilators, which saved the lives of polio patients, or hemodialysis, which gave hope to those suffering from kidney failure, brought with them profound ethical dilemmas. Who deserves access to renal replacement therapy when machines are scarce? When should a patient be disconnected from the brain? These questions, which at one time even reached the Vatican, gave rise to the RECs, charged with overseeing research protocols to ensure that scientific progress does not violate human rights, as occurred in the dark experiments at Nazi concentration camps or in studies in the United States where the rights of participants were ignored.

In Mexico, the General Health Law establishes that hospitals conducting research must have a CEI (Regulatory Committee). However, of the 1,200 registered hospital bioethics committees, only 383 are CEIs. This deficit reflects a misperception: many hospitals, especially private ones, view themselves solely as healthcare facilities, not research spaces. But it's time they knew: "Clinical research is an ethical duty," Santillán emphasizes.

Between the urgency to innovate and the need to protect

Conbioética sees a critical problem in bioethics committees operating in consulting rooms or as contract research organizations (CROs) and approving protocols that are executed thousands of miles away, without the necessary follow-up. This practice, in addition to violating local registration regulations, poses risks to patients and creates conflicts of interest, as some committees charge for each review, creating incentives to do business rather than safeguard ethics. In response to pharmaceutical industry executives who express frustration over delays in CEI authorization, hindering key projects, from new drug trials to multicenter studies, Santillán argues: "It's not about looking for a committee that will approve quickly, but rather about working with researchers at solid institutions, such as established hospitals, and presenting protocols that comply with regulations."

An artificial heart developed in Mexico

And speaking of national innovation, today a highly specialized medical development is being presented to cardiologists that inspires inspiration and hope: a ventricular assist device with the absolute seal of Made in Mexico, which, in this case, is the first artificial heart developed from scratch in our country. This medical device is called Vitacor, already authorized by Cofepris (National Commission for the Promotion of ...

Changes in CIENI (the lymph node protocol) of the INER

The changes taking place at the National Rehabilitation Institute (INER), specifically at the Center for Research in Infectious Diseases (CIENI), are noteworthy. It is remembered for the lymph node protocol, which was criticized for malpractice in young HIV-infected patients and for the misappropriation of funds obtained from foreign universities. It turns out that yesterday, May 27, Santiago Ávila Ríos, the director of CIENI who had been responsible for the lymph node protocol and had held the position for years despite not being a doctor, was asked to resign immediately. It is assumed that his protector, Dr. Gustavo Reyes-Terán, currently the medical director of ISSSTE, no longer holds the power he held when he was coordinator of CCINSHAE.