Research ethics committees
- Topic
An independent group reviews and approves each study with people before it starts, and monitors it while it runs.
What it is
A research ethics committee is an independent, multidisciplinary group that reviews research protocols involving human beings to protect participants' rights, safety and welfare. It approves, asks for changes to or rejects a study before it starts, reviews the informed consent, monitors the ongoing study and can suspend it. It is not the same as the hospital or clinical ethics committee, which advises on clinical cases. The Declaration of Helsinki, the CIOMS guidelines and, in Colombia, Resolutions 8430 of 1993 and 2378 of 2008 require its prior approval.
Key facts
- Helsinki, para. 23: the committee is transparent, independent of the researcher and sponsor, competent, with at least one member of the public; it has the right to monitor studies.
- CIOMS, guideline 23: the committee is formally established, multidisciplinary and has mechanisms that ensure its independence.
- In studies sponsored from another country, ethical review takes place in both the host country and the sponsor's country.
- The investigator reports adverse events to the committee, and the committee can suspend or cancel the study (Resolution 8430, art. 52).
Minimum committee membership under Resolution 2378 of 2008
| Requirement | What it is for |
|---|---|
| At least five members | Plural deliberation |
| At least one non-scientific member | Brings the view of the public and the participant |
| At least one physician | Assesses clinical risks |
| At least one member independent of the institution | Reduces conflicts of interest |
In clinical practice
- The committee reviews scientific value, the risk-benefit balance, selection of participants, consent, confidentiality and conflicts of interest.
- Any major change to the protocol goes back to the committee before it is applied.
- A study with people without committee approval is usually rejected by journals and may lead to sanctions.
- The hospital ethics committee advises on hard clinical decisions; the research committee approves protocols: they must not be confused.
Legal framework in Colombia
- Resolution 8430 of 1993, art. 2: every institution doing research on humans has a Research Ethics Committee.
- Resolution 8430, art. 6, lit. g, and art. 16, lit. b: the committee approves the project and reviews the consent form.
- Resolution 8430, art. 46: for subordinate groups, the committee includes one or more members of the population studied.
- Resolution 2378 of 2008, art. 7: an institutional ethics committee that meets the technical annex; an institution without one may use that of another institution certified in Good Clinical Practice.
- Technical annex of 2378: at least five members, balance of sex and age, at least one non-scientific member, one physician and one member independent of the institution.
Test yourself
Think of the answer, then tap the question to see it.
Which Colombian rule requires every institution doing research on humans to have an ethics committee?
Resolution 8430 of 1993, article 2.
What is the minimum number of ethics committee members required by the technical annex of Resolution 2378 of 2008?
Five, with balance of sex and age, at least one non-scientific member, one physician and one member independent of the institution.
What can an ethics committee do when a serious adverse event occurs in a study?
Suspend or cancel the research if the adverse effect makes continuing ethically or technically unacceptable (Resolution 8430, art. 52).
What is the difference between a research ethics committee and a hospital ethics committee?
The research committee approves and monitors study protocols; the hospital or clinical one advises on decisions about specific clinical cases.
Connections
Educational content on ethics and health law; not legal advice. Laws and case law change: each page links the official text and says when it was last checked. For a real case, read the text in force and ask a lawyer or the medical ethics tribunal.
Sources: Resolución 8430 de 1993: normas científicas, técnicas y administrativas para la investigación en salud (Ministerio de Salud (now Ministerio de Salud y Protección Social), 1993); Resolución 2378 de 2008: Buenas Prácticas Clínicas para las instituciones que conducen investigación con medicamentos en seres humanos (Ministerio de la Protección Social (normograma of the Superintendencia Nacional de Salud), 2008); WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (World Medical Association, 2024); International Ethical Guidelines for Health-related Research Involving Humans (Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization, 2016).
Spotted a mistake?We are always improving for the community. Tell us what is wrong and our team will review it.Report a mistake
Representative model, for educational purposes only.