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.
Research ethics committee
At CAIMED we have two Research Ethics Committees, formed within the framework of national and international standards (Resolution 8430 of 1993, Resolution 2378 of 2008, Law 23 of 1981, ICH-GCP, Nuremberg Code, Declaration of Helsinki (Association Médica Mundial, 1964) and subsequent revisions, Belmont Report, Universal Declaration on Bioethics and Human Rights (UNESCO, 2005), among others of national and international order described in their statutes on biomedical research.
In September 2015, the Metricsmed-CEI technological platform was incorporated into its operation, which allowed it to provide a more timely, organized, practical and efficient service for each of the users who interact with the Committee through it.
We currently have 19 research centers at a national and international level, and we have 25 independent researchers affiliated to our Committee.
Members
Dr. Miguel Antonio Tolosa
Jenny Rocío Barrera Molano
Ana Milena Gómez Camacho
Clemencia Plata Rozo
Giovanny Hernán Rincón Oyuela
Lilia Wilches Mora
Luisa Fernanda Gómez Hernández
Dra. Maria Margarita Manrique
Nelson Francisco Castañeda Alarcón
Associated centres
Colombia
República Dominicana
Members
Lilia Wilches Mora
Jenny Rocío Barrera Molano
Lina Marcela Perdomo Duran
Claudia Fernanda Álvarez Luna
Julián Daniel Guzmán Rodríguez
Associated centers
CEIC Centers
Independent Researchers - CEIC
- Angela María Giraldo Montoya.
- José Fernando Molina Restrepo
- Andrés Muricio Jacome
- Bartolome Bacci Miranda.
- Carlos Andrés Tejada.
- Carlos Daniel Bermudez.
- Donaldo Adolfo Briceño Ramírez.
- Guillermo Alfonso Barrera.
- Hector Benitez Meza.
- Iván Alfredo Perdomo.
- José Alexander Mendoza.
- José Fernando Botero Arango.
- José Luis Florez
- Julio Cesar Daza.
- Mario Danilo Parra Vera.
- Mario Rey Ferro.
- Rafael Arturo Orduz López.
- William Gutierrez.
- Alexandra Isabel Otero.
- Claudia Lenis.
- Claudia Patricia Lossa Chamorro.
- María Teresa Cacua.
- Omaira Espitaleta.
- Jesús Hernando Gonzales.
- José William Pulido.
CEIV Center
- Caimed Chía.
- Previcare Ltda.
- USOS.
What does the CAIMED
Research Ethics Committee do?
Submissions
The time required by the members of the Ethics Committee for the review and evaluation of the documents that require approval in quorum as submissions for new studies, requires a minimum review and analysis work:
- 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 different to submissions for new studies
The time required by the members of the Ethics Committee for the review and evaluation of documents that require quorum approval, such as amendments or modifications to study documents, requires a minimum review and analysis work:
- 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 study) delivered in a timely manner to the center.
- Percentage of submissions (new studies) filed with incomplete documents by the center.
- Percentage of requests (amendments to the protocol, updates to the investigator’s manual and informed consent) filed with incomplete documents by the center.
- Percentage of filings (submissions and general requests) canceled to the center because they do not meet the requirements.
- We are certified by INVIMA in Colombia for 19 research centers
- The Committee is registered with the United States Office of Human Research Protection (OHRP-IRBS).
- ISO 9001:2015 Certification
Our technology
Platform for the management of research ethics committees:
Characteristics:
- Online filings with immediate filing
- Electronic signature
- Consultation of information in real time
- Real-time audit
- Evaluation and response of the ethics committee.
- Management and analysis of SAE, deviations or Cioms submitted to the ethics committee
- Zero paper policy: 80% reduction in paper used in Ethics Committee procedures.