What is a Clinical Research Ethics Committee?

The Clinical Research Ethics Committee is a pluralistic, interdisciplinary, deliberative, autonomous, secular and independent group that carries out its work of evaluating and monitoring clinical research protocols, free from political, religious, institutional, professional or commercial influence. Its main objective is to safeguard and protect the dignity, rights, safety and well-being of the participants in the clinical trials evaluated by it.

The Clinical Research Ethics Committee has a multidisciplinary group of 11 members, eight of whom are from the medical-scientific area, a lawyer and two members representing the community, supported by an administrative team, who are responsible for ensuring adequate protection of the rights, safety and well-being of the subjects involved in the clinical trials.

CAIMED Clinical Research Ethics Committee

We have a Clinical Research Ethics Committee that is responsible for the review, approval and constant monitoring of research projects and amendments to the documentation along with the informed consent of the clinical trial subjects, always focusing on the integrity of the participant.

  • CAIMED’s Research Ethics Committee was created in 2009.
  • The Committee has a multidisciplinary group of professionals who are in charge of ensuring the adequate protection of the rights, safety and welfare of the subjects involved in the clinical trials.
  • We currently provide our services in Colombia for 16 research centers and 20 independent researchers and internationally in one research center.
  • We are conformed under the framework of national and international regulations.
  • For the last three years the operation of the Clinical Research Ethics Committee has been electronically systematized with the medical informatics software MetricsMed®, which allows us to provide a timely, organized, practical and efficient service for each of the users.

Members

Dr. Miguel Antonio Tolosa

Cargo: President
Experiencia: Medical Surgeon Specialist in Clinical Toxicology.

Dra. Maria Margarita Manrique

Cargo: Member
Experiencia: Medical Genetic Surgeon, Ontogenetic.

Lilia Wilches

Cargo: Member
Experiencia: Nurse

Clemencia Plata Rozo

Cargo: Community Member
Experiencia: Computer and Systems Engineer.

Ana Milena Gómez

Cargo: Miembro
Experiencia: Médico cirujano, Esp. Genética Medica, Oncogenética.

Luisa Fernanda Gómez

Cargo: Member
Experiencia: Lawyer, alternate member of the Community Representative MSc and Specialist in Administrative Law and Social Security Law.

Dr. Manuel Luna

Cargo: Miembro
Experiencia: Médico cirujano, especialista en Neurología pediátrica, Magister en Bioética.

Associated centres

Colombia

  • Caimed Acacías, Meta

  • Caimed Aguazul, Casanare

  • Bogotá, D.C:

    • Caimed Bogotá
    • CEPAIN
    • EndocareNeumoinvestigaciones
    • SENASolano Terront
    • (14) Investigadores Independientes
  •  Barranquilla, Atlántico

    • (14) Investigadores Independientes
  •  Bucaramanga, Santander

    • (14) Investigadores Independientes
  •  Cali, Valle del Cauca

    • (14) Investigadores Independientes
    • Hematooncólogos
  •  Cartagena, Bolivar

    • (14) Investigadores Independientes
  •  Cúcuta, Norte de Santander

    • (14) Investigadores Independientes
  •  Medellín, Antioquia

    • CICLAM
  •  Pereira, Risaralda

    • Cardiomet Pereira
  •  Valledupar, Cesar

    • Sociedad de Hematología y Oncología del Cesar
  •  Caimed Yopal, Casanare

  •  Zipaquirá, Cundinamarca

    • Healthy Medical Center

República Dominicana

  • Caimed República Dominicana

Miembros

Gabriel Martinez Arciniegas

Cargo: Presidente
Experiencia: Médico cirujano, Esp. en Medicina Interna.

Ligia Patricia Laverde Jimenez

Cargo: Secretaria
Experiencia: Médico cirujano, Esp. en Medicina Interna.

Lina Marcela Perdomo Duran

Cargo: Representante de la comunidad
Experiencia: Abogado

Claudia Fernanda Álvarez Luna

Cargo: Abogada
Experiencia: Abogado, Esp. en Derecho Comercial y Financiero.

Diego Leon Severiche Hernandez

Cargo: Miembro
Experiencia: Médico cirujano, Esp. en Medicina Interna, Bioética, Educación Médica, Neumología, Cuidado Intensivo.

Centros Asociados

Colombia

  • Caimed Acacías, Meta

  • Caimed Aguazul, Casanare

  • Bogotá, D.C:

    • Caimed Bogotá
    • CEPAIN
    • EndocareNeumoinvestigaciones
    • SENASolano Terront
    • (14) Investigadores Independientes
  •  Barranquilla, Atlántico

    • (14) Investigadores Independientes
  •  Bucaramanga, Santander

    • (14) Investigadores Independientes
  •  Cali, Valle del Cauca

    • (14) Investigadores Independientes
    • Hematooncólogos
  •  Cartagena, Bolivar

    • (14) Investigadores Independientes
  •  Cúcuta, Norte de Santander

    • (14) Investigadores Independientes
  •  Medellín, Antioquia

    • CICLAM
  •  Pereira, Risaralda

    • Cardiomet Pereira
  •  Valledupar, Cesar

    • Sociedad de Hematología y Oncología del Cesar
  •  Caimed Yopal, Casanare

  •  Zipaquirá, Cundinamarca

    • Healthy Medical Center

República Dominicana

  • Caimed República Dominicana

What does the CAIMED
Research Ethics Committee do?

CAIMED Research Ethics Committee
Comité de ética tiempos de aprobación de documentos

Submissions

For the evaluation, review and analysis of documents that require quorum approval, such as amendments or modifications to study documents, the members of the ethics committee require time of:

  • Eight (8) business days prior to the ordinary session, for submissions for new studies, counted from the time the documents submitted are complete, in accordance with the requirements of the Committee and current applicable regulations.

Documents with approval in quorum other than submissions for new studies

For the evaluation, review and analysis of documents that require quorum approval, such as amendments or modifications to study documents, the members of the ethics committee require time of:

  • Eight (8) business days prior to the regular session for: protocol amendments, and updates, changes / amendments to the investigator’s manual, and changes or updates to the informed consent format. These days are counted from the time the documents submitted are complete, in accordance with the Committee’s requirements and current applicable regulations.
  • Four (4) business days prior to the ordinary session for: renewal of civil liability policies, counted from the time the documents submitted are complete. These days are counted from the time the documents submitted are complete, in accordance with the Committee’s requirements and current applicable regulations.

Documents with expedited approval

The time required by the members of the Ethics Committee for the review and evaluation of documents by expedited route, requires a review and analysis work of around eight (8) business days, counted from the time the documents submitted are complete. In accordance with the Committee’s requirements and current applicable regulations; however, given the nature of the request, the assigned member may extend the time.

The performance of the tasks carried out in the Committee is monitored through the following indicators:

  • Percentage of responses to submissions (new studies) delivered to the center in a timely manner.
  • Percentage of responses e to requests (protocol amendments, updates to the investigator’s manual and informed consent)
  • Percentage of submissions (new studies) filed with incomplete documents by the center.
  • Percentage of requests (amendments to protocol, updates to the investigator’s manual and informed consent) filed with incomplete documents by the center.
  • Percentage of filed documents (submissions and general requests) canceled at the center because they do not meet the requirements.
  • Percentage of responses letters (submissions and general requests) canceled because they present errors by the Ethics Committee.
Comité de ética de investigación indicadores CEIC
Comité de ética certificaciones
  • Recertification by INVIMA in GCP – COLOMBIA (16 Centers)
  • Registration with the Office of Human Research Protection in the United States (OHRP-IRBS)
  • ISO 9001:2015 Certification
Caimed comité de ética en investigación tecnología

The added value of our Research Ethics Committees (CAIMED / VITA):

  1. Online submissions to the Research Ethics Committee with immediate filing
  2. Electronic signature
  3. Real-time information query and audit
  4. Assessment and timely response
  5. Management and analysis of SAEs, deviations and CIOMS
  6. 90% reduction of paper used in procedures.