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# Resolution 8430 of 1993: health research in Colombia and its risk categories

- Law

The Colombian rule for research with people: an ethics committee, written consent and three risk categories.

Updated Nov 5, 2026

## Key points

- Art. 11: three risk categories: no risk, minimal risk and greater than minimal risk.
- Art. 2: every institution doing research on humans must have a Research Ethics Committee.
- Arts. 14–16: written informed consent, with minimum content, signed by the participant and two witnesses.
- Art. 16, para. 1: in minimal-risk studies the committee may allow unwritten consent; in no-risk studies it may waive it.
- Chapter III (arts. 23–28): minors and people with disabilities; chapter IV (arts. 29–44): pregnant women, labour, breastfeeding and newborns.
- Arts. 45–46: subordinate groups (students, health workers, military personnel, prisoners).

## What it is

Resolution 8430 of 4 October 1993, issued by what was then the Ministry of Health, sets the scientific, technical and administrative rules for health research in Colombia. It requires every institution doing research on humans to have a Research Ethics Committee, sorts studies into three risk categories, defines written informed consent and what it must contain, and sets special rules for minors, people with disabilities, pregnant women, newborns, subordinate groups, new medicines, microorganisms, radiation and laboratory animals.

## Key articles

- Art. 2: institutions doing research on humans must have a Research Ethics Committee.
- Art. 5: in all research, respect for the person's dignity, rights and welfare must prevail.
- Art. 6: criteria: scientific and ethical justification, prior animal or laboratory experiments, qualified professionals, written consent and committee approval.
- Art. 8: privacy is protected; the person is identified only if the results require it and they authorize it.
- Art. 11: no risk (review of medical records, surveys that do not touch sensitive matters); minimal risk (routine procedures, such as a physical exam or venepuncture in healthy adults); greater than minimal risk (surgery, radiology, randomized or placebo-controlled trials, new devices).
- Art. 12: the investigator stops the study at once on noticing risk or harm, or if the person asks.
- Art. 13: the research institution or sponsor provides medical care for harm related to the study, without prejudice to compensation.
- Art. 15: consent covers justification, procedures, risks, benefits, alternatives, the right to withdraw without prejudice, confidentiality and treatment and compensation for harm.
- Art. 16: the consent form is reviewed by the committee and signed by the participant (or their representative) and two witnesses; the participant keeps a copy.
- Arts. 25–26: for minors and people with disabilities, consent from whoever holds parental authority or legal representation is required, plus the participant's assent when their capacity allows.
- Art. 30: for pregnant women, consent of the woman and of her spouse or partner is required, with exceptions (incapacity or impossibility, abandonment or imminent risk).
- Arts. 45–46: in subordinate groups, the committee includes a representative of the group, and refusing or withdrawing cannot affect their school, work, military or legal situation.

## What it covers

- Title I: general provisions and the duty to have an ethics committee.
- Title II: ethical aspects of research on human beings (risk, consent, communities, minors, women, subordinate groups, organs and cadavers).
- Title III: research on new preventive, diagnostic, therapeutic and rehabilitation resources, including drug research.
- Title IV: biosafety (microorganisms, recombinant nucleic acids, ionizing radiation).
- Title V: research with animals.

## Risk categories of article 11

| Category | Examples the rule gives | Consent |
| --- | --- | --- |
| No risk | Review of medical records, interviews and questionnaires that neither identify nor touch sensitive matters | The committee may waive it |
| Minimal risk | Physical exam, electrocardiogram, venepuncture in healthy adults, moderate exercise, common medicines in their indication | Written; the committee may allow it unwritten |
| Greater than minimal risk | Radiology, surgery, invasive techniques, new devices, randomized or placebo-controlled trials | Always written, with two witnesses |

## In clinical practice

- A retrospective review of medical records is usually classed as no risk; the committee may waive consent (art. 16, para. 1).
- A randomized or placebo-controlled clinical trial is always greater than minimal risk (art. 11, lit. c).
- If a medical student is invited by their teacher, consent must be obtained by someone else on the team, independent of that relationship (art. 16, para. 2).
- Research with medicines must also comply with the Good Clinical Practice of Resolution 2378 of 2008.

## Status and official text

- Official text verified on 2026-11-05 at minsalud.gov.co (Resolution 8430 of 4 October 1993, Ministry of Health).
- It was issued under Law 10 of 1990 and Decree 2164 of 1992.
- Resolution 2378 of 2008 (Ministry of Social Protection) complements it: it makes Good Clinical Practice mandatory for research with medicines and requires an institutional ethics committee; it does not replace it.
- The text uses terms of its time, such as «discapacitados» (the disabled); today one speaks of people with disabilities.

## Test yourself

Think of the answer, then tap the question to see it.

## What are the three risk categories of Resolution 8430 of 1993?

Research with no risk, with minimal risk and with greater than minimal risk (art. 11).

## In which category of Resolution 8430 does a placebo-controlled clinical trial fall?

Greater than minimal risk: art. 11, literal c, includes studies with random assignment and placebo-controlled studies.

## Who signs the informed consent according to art. 16 of Resolution 8430?

The participant or their legal representative and two witnesses; if the person cannot sign, they leave a fingerprint and someone they choose signs on their behalf.

## What is required in Colombia to do research with a minor, besides the parents' consent?

The minor's assent when their capacity allows (art. 26), and that the risk is justified under arts. 27 and 28; the committee oversees compliance.

## Which Colombian rule adopted Good Clinical Practice for studies with medicines?

Resolution 2378 of 2008 of the Ministry of Social Protection, which complements Resolution 8430 of 1993.

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## Connections

## Related 4

- [Research ethics committees](https://durgical.com/en/medical-ethics/research-ethics-committees/)
- [Informed consent in research](https://durgical.com/en/medical-ethics/informed-consent-in-research/)
- [Vulnerable groups in research](https://durgical.com/en/medical-ethics/vulnerable-groups-in-research/)
- [The Declaration of Helsinki](https://durgical.com/en/medical-ethics/the-declaration-of-helsinki/)

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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](https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/DE/DIJ/RESOLUCION-8430-DE-1993.PDF) (Ministerio de Salud (now Ministerio de Salud y Protección Social), 1993).

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