Informed consent in research

What it is

Informed consent in research is more demanding than in clinical care, because the study seeks knowledge and not necessarily the benefit of the person taking part. The person must receive complete information in plain language, understand it and decide without coercion or undue incentives. In Colombia, Resolution 8430 of 1993 requires it to be written, with minimum content, reviewed by the ethics committee and signed by the participant and two witnesses. When the person cannot consent, their legal representative decides and the person's assent is sought.

What it must include

• Justification and aims of the study.
• Procedures, identifying which are experimental.
• Expected discomforts and risks, and possible benefits.
• Alternatives that could be advantageous to the person.
• Freedom to withdraw at any time without prejudice to their care.
• Confidentiality, treatment and compensation for harm, and who covers additional costs.

How it is done

1. Check that the ethics committee approved the protocol and the current consent form.
2. Assess decision-making capacity; if in doubt, Resolution 8430 asks for assessment by a neurologist, psychiatrist or psychologist.
3. Explain in plain language the aims, procedures, what is experimental, risks, benefits and alternatives.
4. Explain confidentiality, care and compensation for harm, costs and the right to withdraw without prejudice.
5. Give time, answer every question and check understanding (for example, by asking the person to explain it in their own words).
6. Avoid coercion and undue incentives; if there is a subordinate relationship, another team member obtains consent.
7. The participant (or representative) and two witnesses sign; give the participant a copy.
8. Inform again and re-consent if new information appears that could change the decision.

In clinical practice

• The «therapeutic misconception» is believing that the study is designed for personal benefit; randomization and placebo must be explained.
• Helsinki (para. 32) and CIOMS (guidelines 11 and 12) also require consent to use samples and data, unless the committee approves an exception.
• In no-risk studies the committee may waive consent; in minimal-risk studies it may accept unwritten consent (Resolution 8430, art. 16, para. 1).
• For pregnant women, Resolution 8430 (art. 30) also requires the consent of the spouse or partner, with exceptions.

Common mistakes

• Using a form the committee did not approve, or an expired version.
• Obtaining consent in a hurry, just before the procedure, with no time for questions.
• Having the treating doctor ask their own patient, or the teacher their own student, without an independent third party.
• Forgetting the minor's assent or not re-consenting when the protocol changes.

Test yourself

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

Add to my cards (4)

Connections

← All of medical ethics

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); The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (U.S. Department of Health and Human Services, Office for Human Research Protections, 1979); WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (World Medical Association, 2024).

Spotted a mistake?We are always improving for the community. Tell us what is wrong and our team will review it.Report a mistake

Send

Representative model, for educational purposes only.