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# The CIOMS international ethical guidelines

- International document

Twenty-five guidelines from CIOMS and WHO that explain how to apply Helsinki in practice, especially in low- and middle-income countries.

Updated Nov 5, 2026

## Key points

- Current version: 2016, 25 guidelines, prepared in collaboration with WHO.
- Guideline 1: scientific and social value is the fundamental justification of all research.
- Guideline 5: placebo only if there is no established effective intervention, or with compelling scientific reasons and no more than a minor increase above minimal risk.
- Guidelines 15 to 19: vulnerable persons, adults without capacity, children and adolescents, women, pregnant and breastfeeding women.
- Guideline 23: every protocol goes through an ethics committee before it starts.

## What it is

The Council for International Organizations of Medical Sciences (CIOMS), a non-governmental organization linked to the World Health Organization (WHO), publishes ethical guidelines for health-related research involving humans. The current version is from 2016, prepared with WHO, and has 25 guidelines with commentaries. Its aim is to turn the principles of Helsinki into concrete rules, with special attention to low-resource settings, vulnerable groups and new topics such as biobanks, digital data and research during epidemics.

## Key points

- Guideline 1: scientific and social value, and respect for rights.
- Guideline 2: research in low-resource settings must respond to the needs of that population and has no less demanding standards.
- Guideline 4: risks are minimized and justified by individual benefits or social value.
- Guidelines 9 and 10: informed consent of those who are capable, and when it can be modified or waived.
- Guidelines 11 and 12: collection, storage and use of biological materials and of data.
- Guideline 14: treatment and compensation for research-related harms.
- Guideline 20: research in disasters and disease outbreaks.
- Guidelines 24 and 25: public accountability (registration and publication) and conflicts of interest.

## Historical context

- First version in 1982; new versions in 1993 and 2002; guidelines for epidemiological studies in 1991 and 2009.
- The 2016 version merged biomedical and epidemiological research into one text under the name «health-related research».
- They were created to apply Helsinki in countries where trials sponsored from abroad were being run.

## The CIOMS 2016 guidelines asked most often

| Guideline | Topic |
| --- | --- |
| 1 | Scientific and social value and respect for rights |
| 5 | Choice of control in clinical trials (placebo) |
| 9 | Consent of capable persons |
| 15 | Vulnerable persons and groups |
| 17 | Children and adolescents |
| 23 | Research ethics committees |

## Today

- They are the most detailed reference on placebo, minors and pregnant women; ethics committees use them alongside Helsinki.
- The idea of a «minor increase above minimal risk» allows some studies without direct benefit in children or adults without capacity, if the committee approves.
- Guideline 19: pregnant and breastfeeding women should not be excluded by default; evidence on their treatment is needed.
- In research sponsored from another country, ethical review must take place in both the host country and the sponsor's country (guideline 23).

## Revisions and official text

- Current version: International Ethical Guidelines for Health-related Research Involving Humans, CIOMS and WHO, 2016.
- Official text consulted on 2026-11-05 on the CIOMS website.

## Test yourself

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

## How many guidelines does the 2016 CIOMS version have, and with which organization was it prepared?

Twenty-five guidelines, prepared in collaboration with the World Health Organization.

## According to CIOMS guideline 1, what justifies doing research with human beings?

Its scientific and social value: the prospect of generating knowledge needed to protect and promote health.

## When does CIOMS allow placebo if an effective intervention already exists?

Only with compelling scientific reasons and if delaying or withholding the intervention adds no more than a minor increase above minimal risk, with risks minimized.

## What does CIOMS say about ethical standards in low-resource countries?

They cannot be less demanding than in high-resource countries, and research must respond to the health needs of the host population (guideline 2).

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## Connections

## Related 4

- [The Declaration of Helsinki](https://durgical.com/en/medical-ethics/the-declaration-of-helsinki/)
- [Vulnerable groups in research](https://durgical.com/en/medical-ethics/vulnerable-groups-in-research/)
- [Clinical equipoise and placebo controls](https://durgical.com/en/medical-ethics/clinical-equipoise-and-placebo-controls/)
- [Research ethics committees](https://durgical.com/en/medical-ethics/research-ethics-committees/)

[← All of medical ethics](https://durgical.com/en/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: [International Ethical Guidelines for Health-related Research Involving Humans](https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf) (Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization, 2016).

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