Ley 20.120 (Chile): Research on Human Beings, the Genome, and Accredited Ethics Committee Requirements

Chile regulates biomedical research on human beings through a single short statute — Ley N° 20.120, Sobre la investigación científica en el ser humano, su genoma, y prohíbe la clonación humana — plus the Ministry of Health regulation that gives it operational teeth, Decreto Supremo N° 114 de 2010. Between them they decide who may review your protocol, what your consent paperwork has to look like, how long each reviewer has to answer, what you may not do to a human genome, and what happens to your professional licence if you start without the paperwork.

This page is about the statute. It is not the product-approval pathway: the separate authorisation to import and use an investigational medicine is granted by the Instituto de Salud Pública through ANAMED, and is covered in Chile’s ISP/ANAMED clinical trial approval pathway. Ley 20.120 applies to biomedical research on human beings whether or not a medicine is involved; the ISP route applies only when one is. Getting the two confused is the most common sequencing error a foreign sponsor makes in Chile, and the sequencing is spelled out below.

Has Ley 20.120 been amended? A point worth checking yourself

It is widely assumed that Ley 20.120 has been amended since 2006. On the evidence of LeyChile’s own versioning service, the statute’s own articles have not been: asked for the version in force on 26 August 2026, the service returns the text dated 22 September 2006, and offers no later version of the norm. The same service correctly returns three distinct versions for Decreto 114 (19 November 2011, 5 June 2012 and 14 January 2013), which confirms it does track amendments rather than always returning the original.

What genuinely changed is the regulation, not the law. Decreto Supremo N° 30 de 2012 amended Decreto 114 to wire in Ley N° 20.584 on patient rights — which is why the reglamento’s Article 1 states that it develops both Ley 20.120 and the relevant provisions of Ley 20.584, and why Articles 10 bis and 18 bis exist at all. If a secondary summary tells you “Ley 20.120 as amended”, check whether it means the statute or the reglamento; almost always it means the reglamento.

The three authorisations, and the order they come in

No biomedical study on human beings starts in Chile on one approval. Depending on whether a pharmaceutical product is involved, you need two or three, in a fixed order.

The sequencing detail most sponsors get wrong: the director’s 20-business-day clock in Article 10 bis runs from the CEC’s favourable evaluation and from the ISP’s, where Article 7 inciso segundo applies. The institutional sign-off is therefore last, not first, and a refusal must be reasoned. Article 10 bis also makes the director’s authorisation effective only once the terms of the study have been agreed between the sponsor (and its intermediary, where there is one) and the responsible or principal investigators — so an unsigned site agreement can stall a study that has already cleared ethics.

A second detail worth putting in your project plan: the two clocks are written in different units. Article 18 N° 2 gives the committee “45 días” and a 20-day extension with no qualifier; Article 10 bis gives the director “20 días hábiles”. Do not model both as business days.

What counts as covered research

Reglamento art. 8(a) defines investigación científica biomédica en seres humanos as any research involving physical or psychic intervention or interaction with human beings, aimed at improving prevention, diagnosis, treatment, management or rehabilitation, or at increasing biological knowledge of the human being — and states explicitly that it includes the use of identifiable human material or information.

Two practical consequences:

• A purely observational study using identifiable records or stored samples is inside the scope, and needs CEC review and a director’s authorisation, even though no ISP filing is required.
• A study that uses no pharmaceutical product needs steps 1 and 3 only. There is nothing to file with the ISP.

The same article defines the other roles the reglamento then hangs obligations on: patrocinador (sponsor — which must have domicile and a legal representative in Chile), Organización de Investigación por Contrato (the CRO), investigador responsable (the site-level principal investigator), investigador principal (in a multicentre study, the one chosen to represent the responsible investigators before the committee), and director del establecimiento.

Note the domicile requirement: under art. 8(b) the sponsor must be an individual or entity with domicile and legal representation in Chile that takes the initiative to run and fund the study and assumes the resulting legal responsibilities. A foreign sponsor without a Chilean legal presence works through a local entity.

The Comité Ético Científico: accreditation, composition, powers

A CEC is Chile’s equivalent of an independent ethics committee or IRB. Reglamento art. 16 defines it as a collegiate body constituted within a public or private institution whose essential responsibility is to protect the rights, safety and wellbeing of research participants — and states flatly that committees must be accredited by the Autoridad Sanitaria. Article 10 adds that the committee must also be independent of the research team.

Constitution and minimum composition

Under art. 17, a CEC is constituted by a resolution or formal act of the institution’s Director Técnico or legal representative, and a copy of that act must be sent to the Secretaría Ejecutiva of the Comisión Nacional de Bioética. It must have at least five members, and must include at least these three estamentos:

1. A person who is not a health professional, has an interest in scientific research or bioethics, and is not connected to the entities that carry out this kind of research — the lay member representing the interests of the public.
2. An expert in biomedical research ethics with formal training in that discipline. Interest is not enough; the reglamento asks for formación.
3. A person holding the academic degree of Licenciado en Derecho.

All members must have sufficient qualification and experience to review the protocols concerned, without prejudice to the committee’s power to consult experts and request technical or scientific reports on specific matters. The committee operates under an internally approved estatuto that must cover its procedures, meeting types and schedules, quorum, kinds of resolution, minute-taking and recusal mechanisms. Art. 16 also puts a resourcing duty on the host institution’s senior authority: access to scientific and technical information for members, and the infrastructure, confidentiality safeguards and administrative support the committee needs to function.

What an accredited committee may do (art. 18)

• Evaluate protocols submitted to it.
• Report within 45 days of submission, extendable once, on reasoned grounds, by 20 days. The report must carry a reasoned favourable or unfavourable determination — unless the committee instead requires prior modifications as a condition of future approval.
• A favourable report is portable. Article 18 N° 2 says its merit is sufficient for the study to be carried out in any establishment, provided that establishment’s director authorises it — and that director may refuse to have it run on their premises. One accredited committee, many sites.
• An unfavourable report blocks the study unless it is reformulated to answer the objections raised.
• Observe protocols in progress and recommend modifications needed to protect participants.

Multicentre studies

Article 10 inciso 2 sets the model explicitly: in a multicentre study the scientific and ethical review is carried out by a single accredited committee, complemented by a local evaluation covering the investigators and institutions at that level, to verify the study’s feasibility in their communities — infrastructure, level of training, and locally significant ethical considerations. The local evaluation is a feasibility check, not a second ethics review, and it does not entitle a site to reopen the approved science.

Conflicts of interest (art. 18 bis)

The committee must require a declaration of interests from each member that could affect their participation. A member who declares a conflict on a protocol under evaluation must withdraw from reviewing it. Separately, an investigator or research group submitting a protocol must disclose potential or apparent conflicts of interest to the committee at the point of submission. Build both into your submission cover documents; they are express regulatory requirements, not good practice.

Accreditation: what the reglamento does not say

Decreto 114 states the requirement that committees be accredited by the Autoridad Sanitaria, but it does not set out the accreditation criteria, the application form, the fee, or the term of accreditation. Ley 20.584 art. 22 is the mandate for that detail: it directs MINSAL to issue regulation covering the constitution, functioning and financing of ethics-scientific committees, the approval of protocols, and the accreditation of committees by the Autoridad Sanitaria. In practice the Autoridad Sanitaria is exercised regionally: Reglamento art. 7 inciso 1 assigns oversight of Ley 20.120 to MINSAL and the Secretarías Regionales Ministeriales de Salud within their respective competences, and Ley 20.584 art. 28 expressly requires authorisation from the SEREMI de Salud in the case discussed below.

Because the operative accreditation procedure lives in ministerial instruments rather than in the reglamento itself, this page does not state a current fee, form number or accreditation term. Confirm the current list of accredited committees and the accreditation procedure directly with the SEREMI de Salud for your region, or with MINSAL, before you assume a committee’s accreditation is live. An expired accreditation invalidates the report your study rests on.

Consent: the acta is the compliance artefact

Ley 20.120 art. 11 and Reglamento arts. 11–15 build a consent regime that is stricter on form than most researchers expect. Informed consent here is not just a signed information sheet; it is a formal acta.

• It must be previous, express, free, informed, personal and in writing (Reglamento art. 11).
• Three signatures. The acta is signed by the person consenting, by the responsible or principal investigator, and by the director of the centre or establishment, who additionally acts as ministro de fe. The reglamento permits the director to delegate both the signing and the ministro-de-fe role — the statute alone does not say so, which is one of the practical reasons the reglamento matters.
• The information given to the participant must be pre-approved by the committee. Art. 13 requires it to be adequate, sufficient and comprehensible, and visada by the corresponding CEC as an official document included within the research protocol. A site cannot quietly localise the participant-facing text.
• The right to refuse or revoke at any moment and by any means, without liability, sanction or loss of any benefit, must be stated expressly — and recorded both in the participant’s ficha clínica and in the corresponding protocol document.
• Re-consent must be sought whenever the terms or conditions of the study change in a way that affects participants — unless the committee that approved the project considers the change minor (art. 14). That judgement belongs to the committee, not the sponsor, so route every protocol amendment through it and get the “minor” call in writing.
• Minors. Art. 11 requires that a minor’s participation not infringe their essential rights or pose a risk to their health and physical and psychic integrity, and that a minor’s refusal to participate or to continue must be respected.

The GES clause almost nobody plans for (art. 15)

This provision has no equivalent in most jurisdictions and it catches sponsors out. If the study involves a treatment or procedure incompatible with a GES-guaranteed procedure or treatment the participant is entitled to under Chile’s explicit health guarantees regime, and participation would therefore require giving those up, that must be disclosed in the terms above and the temporary waiver must be expressly formalised in the consent acta. Article 15 then protects the participant’s return: under the regime established by Ley N° 19.966, they may rejoin GES at the end of the study, or on express withdrawal from it.

If your protocol touches a GES-covered condition, the waiver-and-reinstatement language belongs in the consent acta from the first submission, not in a later amendment.

Adults who cannot consent (Ley 20.584 art. 28)

This is the highest bar in the Chilean system, and it lives outside Ley 20.120. Research on adults not physically or mentally capable of expressing consent, or whose preference cannot be known, is prohibited unless that condition is a necessary characteristic of the group being studied. A person whose condition is treatable such that capacity could be recovered may not be enrolled without consent. Where the exception applies, in addition to full compliance with Ley 20.120 and the Sanitary Code, all of the following are required:

• the protocol must state the specific reasons for including individuals unable to consent;
• it must be shown that the research involves a potential direct benefit to the person and minimal risk;
• a favourable report from an accredited CEC and, in addition, authorisation from the SEREMI de Salud;
• committee members must not be linked, directly or indirectly, to the centre or institution running the study, nor to the principal investigator or the sponsor — a stricter independence test than the general art. 10 rule;
• consent or expression of preference must be obtained as soon as the person recovers capacity.

Reglamento art. 12 inciso 2 points to the same place for participants with psychic or intellectual disability. See also vulnerable populations in research.

The genome provisions

Half of Ley 20.120 is about genetic material, and these are the articles international sponsors most often miss because they sit in a statute they think of as an “ethics committee law”.

Reglamento art. 23 restates the reserve and the encryption duty, and widens the cross-reference: it applies Ley 19.628 and professional-secrecy rules to the genome and to all other information related to sensitive personal data arising from the research.

One flag on art. 13. Ley 20.120 names Ley N° 19.628 as the applicable data-protection statute. Chile has since enacted a replacement personal-data framework, Ley N° 21.719, reported as published on 13 December 2024 with entry into force on 1 December 2026 — that date is drawn from secondary legal commentary and was not confirmed against the consolidated text for this page. If your study handles identifiable genomic data across that window, verify which data-protection statute governs on your actual start date directly against bcn.cl before relying on the art. 13 cross-reference.

What the statute forbids outright

These are substantive limits on the science itself, not procedural gates, and no committee can approve around them.

• Human cloning is prohibited whatever the purpose and whatever the technique (art. 5). Reglamento art. 4 defines it as the asexual generation of an organism or set of cells genetically identical to its ancestor.
• Eugenic practices are prohibited, with genetic counselling the sole exception (art. 3). Reglamento art. 3 defines the prohibited practice as applying the biological laws of heredity to the improvement of the human species, and preserves counselling given by a health professional to individuals at increased risk of offspring with a specific genetic disorder, including probability information.
• Tissue and organ culture is permitted only for diagnostic, therapeutic or scientific-research purposes — and in no case may human embryos be destroyed to obtain the stem cells giving rise to those tissues and organs (art. 6). Reglamento art. 6 adds that this must be done by clinical or public-health laboratories authorised under art. 129 and Title III of Book One of the Sanitary Code, and imposes security, confidentiality and purpose-limitation duties on anyone holding biological samples for research, diagnosis or treatment.
• Gene therapy in somatic cells is authorised only for treating diseases or preventing their appearance (art. 7). Reglamento art. 5 defines it as inserting genetic material into a somatic cell so it produces a normal protein. The authorisation is expressly limited to somatic cells; germline modification is not within what art. 7 permits.

Penalties — including the two that fall on individuals

Two observations a compliance officer should carry away. First, art. 19 inciso 3 makes an incomplete consent acta a fineable offence in itself — not merely a finding at monitoring. Second, art. 20 falls on the person running the study, not on the sponsoring entity, and it is what a “we started while the report was pending” decision buys. Reglamento art. 27 then places an affirmative duty on the Autoridad Sanitaria and on CEC members themselves to report conduct constituting these offences that they learn of in the course of biomedical research.

Obligations that continue after approval

• Serious adverse events. Reglamento art. 10 bis inciso 3: every serious adverse event arising in the course of the research must be reported promptly by the responsible investigator to the director of the establishment where the research is being carried out and to the committee, as applicable. Two recipients, not one.
• Sponsor duties (art. 25). The sponsor, itself or through its intermediary, must select suitable investigators whose experience and professional qualification match the complexity of the study, and adopt the safeguards set out in the protocol. The protocol must expressly record the insurance and guarantees covering adverse events that are foreseeable, or that cause harm without being foreseeable.
• Responsible investigator duties (art. 26). Guaranteeing participants’ safety and wellbeing throughout, and the scientific and ethical justification of the project, the integrity of the data collected, its analysis and its conclusions. A principal investigator on a multicentre study additionally coordinates and monitors activity across the participating establishments.
• Director duties (art. 24). The establishment director is responsible for complying with the agreements they sign with the investigator and the sponsor or its intermediary.
• Committee oversight (art. 18 N° 3). The committee observes protocols in progress and may recommend modifications needed to protect participants.

The Comisión Nacional de Bioética

Articles 15 and 16 of the statute create a Comisión Nacional de Bioética of nine bioethics experts appointed by the President of the Republic with the agreement of the Senate, adopted by two-thirds of its members in exercise in a session specially convened for the purpose. Members serve four-year renewable terms; the President proposes which member will chair. Its function is advisory: counselling the branches of the State on ethical questions arising from scientific and technological advances in biomedicine and on matters relating to biomedical research on human beings, and recommending that norms be issued, amended or repealed. Resolutions pass by simple majority, but dissent and minority positions must be recorded. Reglamento arts. 19–21 restate this and place its Secretaría Ejecutiva within the Ministry of Health.

For a researcher, the Commission is not a body you file with. The one contact point that matters is procedural: under Reglamento art. 17, the act constituting a CEC must be copied to the Commission’s Secretaría Ejecutiva.

Ley 20.120 versus the ISP/ANAMED pathway

Note the direction of dependency written into Reglamento art. 7 inciso 2: the ISP authorises the research use of medicines previo informe favorable del Comité Ético Científico responsable. The ethics report is a precondition of the product authorisation, not a parallel track you can run to save calendar time.

Pre-submission checklist

1. Confirm the committee you intend to use is currently accredited by the Autoridad Sanitaria and is independent of your research team (arts. 10, 16). For a study under Ley 20.584 art. 28, confirm members are also unconnected to the site, the PI and the sponsor.
2. Confirm the sponsor entity has domicile and legal representation in Chile (art. 8(b)).
3. Prepare the participant information document as a protocol annex for the committee to visar — not as site-level material (art. 13).
4. Draft the consent acta with all three signature blocks, including the director as ministro de fe (or the delegation instrument) (art. 11).
5. If the study touches a GES-covered condition, include the express temporary-waiver and reinstatement language (art. 15).
6. Include the investigator conflict-of-interest disclosure in the submission (art. 18 bis).
7. Record insurance and guarantees for foreseeable and unforeseeable harm expressly in the protocol (art. 25).
8. For multicentre studies, identify the investigador principal who represents the responsible investigators before the committee, and plan the local feasibility evaluation at each site (arts. 8(d), 10).
9. Plan for 45 days plus a possible 20-day extension at the committee, then ISP where applicable, then 20 business days for each director.
10. Stand up an SAE reporting route to both the director and the committee before first participant in (art. 10 bis).
11. If genomic data is collected, implement encryption at rest and in transit for identifiable genome data (art. 13), and obtain a separate consent basis for genetic-identity work (art. 9).

Frequently asked questions

Has Ley 20.120 been amended since 2006?

On LeyChile’s versioning service, no: the version in force on 26 August 2026 is the text published on 22 September 2006. Its regulation has been amended — Decreto 114 has consolidated versions dated 19 November 2011, 5 June 2012 and 14 January 2013, the last following Decreto Supremo N° 30 de 2012, which aligned it with Ley 20.584.

Do I need ISP approval if my study uses no medicine?

No. Reglamento art. 7 inciso 2 attaches ISP authorisation specifically to the use of medicines with or without sanitary registration for research purposes. A study with no pharmaceutical product needs the accredited CEC’s favourable report and the establishment director’s express authorisation, and nothing from the ISP.

How long does CEC review take?

The committee must report within 45 days of submission, extendable once on reasoned grounds by a further 20 days (art. 18 N° 2). Note the reglamento does not qualify these as business days, unlike the director’s 20 días hábiles in art. 10 bis.

Can one CEC approval cover several hospitals?

Yes. Article 18 N° 2 states that a favourable report is sufficient for the study to be carried out in any establishment, provided that establishment’s director authorises it — and the director may refuse. In multicentre studies art. 10 requires a single accredited committee to do the scientific and ethical review, complemented by a local feasibility evaluation at each site.

Who accredits Comités Ético Científicos in Chile?

The Autoridad Sanitaria (Reglamento art. 16). Oversight of Ley 20.120 sits with MINSAL and the Secretarías Regionales Ministeriales de Salud within their respective competences (art. 7), and Ley 20.584 art. 28 expressly requires SEREMI authorisation in the incapacity case. The accreditation criteria and procedure are set in ministerial instruments rather than in Decreto 114 itself; confirm current status with the SEREMI for your region.

Does Ley 20.120 apply to social-science or purely questionnaire research?

Its scope is defined by Reglamento art. 8(a) — biomedical research involving physical or psychic intervention or interaction with human beings, including the use of identifiable human material or information. Non-biomedical social research falls outside that definition, though Chilean universities and funders commonly require their own ethics review regardless. Where the boundary is genuinely unclear, the safe course is to ask an accredited committee rather than to self-certify out of scope.

Are DNA sequences patentable in Chile?

No. Article 8 states that the structure of a gene and total or partial DNA sequences are not patentable, and that knowledge of the human genome is the common heritage of humanity over which no property may be claimed. Biotechnological processes derived from that knowledge, and diagnostic or therapeutic products obtained directly from them, remain patentable under general rules.

Is germline gene editing permitted?

Article 7 authorises gene therapy in somatic cells, and only for treating diseases or preventing their appearance. The authorisation does not extend to germline modification, and art. 5’s cloning prohibition applies whatever the technique or purpose.

Primary sources

• Ley N° 20.120, Sobre la investigación científica en el ser humano, su genoma, y prohíbe la clonación humana — Ministerio de Salud, promulgated 7 September 2006, published Diario Oficial N° 38.570 of 22 September 2006. Consolidated text via LeyChile, norma 253478, version in force 26 August 2026.
• Decreto Supremo N° 114 de 2010 (Ministerio de Salud), Aprueba Reglamento de la Ley N° 20.120 — promulgated 22 November 2010, published 19 November 2011, in force 1 October 2012. Consolidated text via LeyChile, norma 1032919, consolidated version of 14 January 2013.
• Ley N° 20.584, Regula los derechos y deberes que tienen las personas en relación con acciones vinculadas a su atención en salud — arts. 21, 22 and 28, consolidated version of 16 February 2026, via LeyChile.

Chilean legal texts are authoritative in Spanish; the English renderings above are the author’s and are not official translations. Where a term carries no clean English equivalent — acta, ministro de fe, visada, presidio menor — the Spanish is kept.

Related reading

• Chile’s ISP/ANAMED clinical trial approval pathway — the product-authorisation half of the picture.
• ANID Chile and Fondecyt — who funds the research this statute governs.
• FONDEF (Chile): applied-research and technology-transfer funding lines.
• Declaration of Helsinki and ICH GCP — the international standards a Chilean CEC will expect a protocol to meet alongside the statute.
• Research integrity and compliance — the cluster this guide belongs to.