What is Clinical Research?

The Research Ethics Committee (REB) at Medical Center is an independent and diverse group responsible for evaluating and supervising all health research involving human subjects. This includes the handling of personal data and biological samples.

Clinical research is the process by which new treatments, drugs, medical devices, or healthcare methods are investigated to ensure they are safe and effective. It may include:

  • New drugs or combinations
  • Medical devices
  • Surgical procedures
  • Studies analyzing data from medical records
  • Research on habits or factors that affect health

It is important to note that participation is entirely voluntary, and individuals may withdraw at any time.

Why is a CEI important for the community?

The CEI is essential because it provides security, transparency, and trust. Its work ensures that:

  • People receive clear information before deciding to participate.
  • Carefully evaluate the risks and benefits.
  • Data privacy is protected.
  • Ensure that the study is conducted correctly, paying particular attention to vulnerable populations.
  • Research brings real value to health.

The CEI acts as a bridge between science and the community, ensuring that scientific progress always respects people's rights.

Mission, Vision, and Values

Mission: The IRB is committed to ensuring that all biomedical research at Medical Center respects the dignity, rights, and safety of participants, as well as the well-being of the community and the environment.

Vision: To be a benchmark as an ethics committee, recognized for its independence, rigor, and commitment to human rights in research.

Values:

  • Respect for human dignity
  • Independence and impartiality
  • Transparency
  • Distributive justice
  • Protection of vulnerable populations
  • Scientific and methodological rigor
  • Confidentiality
  • Social responsibility

Functions of the Committee

The CEI at Medical Center :

  • Evaluates and supervises all research protocols.
  • Ensures compliance with Good Clinical Practices.
  • Review informed consents and safety reports.
  • Request modifications or suspend studies if necessary.
  • Conduct periodic ethical monitoring based on the risk of the study.
  • Protect sensitive personal data.
  • Evaluate the researcher's competence and the suitability of the site.
  • Issues clear rulings within predictable timeframes.

The CEI is accredited by the GCBA: 

Committee Members

The CEI is composed of a multidisciplinary team that includes:

  • Doctors from various specialties
  • Outside counsel
  • Specialists in research methodology
  • Healthcare professionals
  • Community and patient representatives

Types of Studies Reviewed

The CEI evaluates different types of studies, including:

  • Pharmacological clinical trials
  • Studies with medical devices
  • Surgical procedures
  • Genetic research and research using biological samples
  • Epidemiological and psychological studies
  • Observational studies and protocols involving different levels of risk

A Fast and Efficient Process

The CEI meets every 15 days to ensure a swift and timely review, and convenes extraordinary meetings when necessary. It also guarantees:

  • Decisions within a maximum period of 15 days.
  • Smooth communication and ongoing support through a direct channel.
  • Evaluation of studies from other centers, ensuring quality and efficiency.

The Medical Center has a well-established Research Unit equipped to support highly complex clinical studies.

The CEI has Standard Operating Procedures approved by the Central Ethics Committee of the GCBA.