Ethics Review and the Research Ethics Committee

Every researcher who has ever designed a study believed it was worth doing. That belief is necessary — nobody runs a trial they think is pointless or unsafe — but it is also exactly why the researcher's own judgement cannot be the final word on whether the trial should go ahead.

This module is about the one body whose job is to answer that question from the outside: the research ethics committee, and the review it performs before a single participant is approached. We cover what the committee is, which committee is yours, what you put in front of it, what it weighs, and the decision it returns. What happens to that relationship after the trial starts — amendments, safety reports, the end-of-trial notification — is Module 9; the Swiss legal categories that decide how deep the review goes are Module 6. Here, the subject is the review itself.

Learning Objectives

After this module, you can:

• Explain why ethics review must be independent, and what makes a committee competent to give it
• Determine which ethics committee is responsible for a trial — including the lead committee in a multicentre study
• Assemble the initial-submission dossier and explain what each document lets the committee check
• Anticipate what the committee weighs — including that it judges the science, not only the safeguards
• Distinguish the three decisions a committee can return, and act correctly on each before any trial activity begins

Why the Researcher Cannot Be the Judge

The history in Module 2 makes the case better than any argument can. Tuskegee, the Nuremberg-trial experiments, and the abuses that followed were almost all run by people convinced they were justified — and reviewed, where they were reviewed at all, only by colleagues inside the same institution. The reform that emerged was not better-intentioned researchers. It was review by a body that sits outside the study and has nothing to gain from its result.

That is what a research ethics committee is: an independent panel that decides whether a research project may proceed, and whose authorisation is a precondition for starting it. Module 3 introduced the committee as one of the parties in a trial; here we are concerned with the review it performs. Two features make its judgement worth more than the researcher's own — independence and composition.

Independence is structural, not assumed. Committee members must disclose their interests, each committee keeps a publicly accessible register of those interests, and any member who is an interested party in a project does not take part in assessing or deciding it. HRA The investigator and sponsor may give the committee information about the trial, but they take no part in its decision or vote. ICH E6(R3)

Composition is what lets the committee actually evaluate what it is shown. A Swiss committee must hold the professional skills and experience its work demands — including experts in medicine, ethics, and law, and at least one person representing patients. HRA ICH-GCP — the international Good Clinical Practice guideline that sets the standard for how trials are run (Module 8) — frames the same idea in numbers: a committee should have a reasonable number of members — recommended at least five, including at least one whose primary interest is non-scientific and at least one independent of the institution and the site. ICH E6(R3)

Its mandate follows from that make-up. The committee assesses whether a research project meets the ethical, legal, and scientific requirements of the law, and in particular whether the protection of the people taking part is guaranteed. HRA ICH-GCP states the purpose in one line: to safeguard the rights, safety, and well-being of all trial participants, with particular care for trials that recruit vulnerable people. ICH E6(R3)

Which Committee Is Yours: the swissethics Landscape

Switzerland does not have a single national ethics committee. Each canton designates one recognised committee for its territory — at most one per canton — and oversees its work. HRA The committee responsible for your trial is the one in the canton where the research is conducted. HRA

Sitting around the cantonal committees are two more bodies, and they are the ones people mix up. The easiest way to keep all three straight is by what each does for you: one is the website you submit through, one is a government office coordinating in the background, and only the third actually decides your trial.

• You submit through swissethics. It is the joint organisation of all the cantonal committees — it runs the online portal (BASEC) you upload your dossier to, and it sets the standard forms so every committee asks for the same things. It does not judge your trial; the submission itself goes through the cantonal information system the law provides for. HRA
• The FOPH coordinates in the background. The Federal Office of Public Health holds the statutory coordinating role — keeping the cantonal committees aligned and publishing the official list of which committee is responsible where. You never submit to it, and it never approves your trial. HRA
• The cantonal committee decides. The committee you just met — the one in the canton where the research is conducted — is what actually reads your dossier and returns the verdict: yes, no, or yes-with-changes.

When a trial runs at sites in more than one canton, one committee takes the lead and the others review only their own sites. That mechanism has enough moving parts to need its own section, and it comes last, once the rest of the review is clear.

The Submission Dossier

Review begins when the investigator submits the application documents to the responsible committee. The sponsor may submit instead of the investigator — but if it does, it takes on the investigator's notification and reporting obligations toward the committee: the ongoing duties to tell the committee about substantial amendments, serious safety events, and the end of the trial (those duties are the subject of Module 9). KlinV

Everything that follows turns on one fact: the committee can only judge what it is shown. The dossier is not administrative throat-clearing — it is the entire evidence base for the decision. A protocol that is clear in your head but vague on the page gets reviewed as vague.

For an interventional drug trial, the application set runs roughly as follows. Most of these documents are subjects in their own right elsewhere in the course; this is the overview roster, and the point here is simply what each one lets the committee check. KlinV ICH E6(R3)

• The protocol — the scientific plan, the objectives and endpoints, and the risk–benefit case. This is the centre of the dossier; its full structure and content are covered in depth in Module 15.
• The case report form (CRF) — what data will actually be collected, so the committee can see what participants are being put through. CRFs are covered in depth in Module 12.
• Informed-consent and recruitment documents — including the exact wording of any advertisement — so the committee can judge how people are informed and approached. Consent is the whole subject of Module 7.
• Information on participant remuneration — to check that payment does not become an undue inducement; incentives are covered in Module 7.
• The Investigator's Brochure or prescribing information — the sponsor's safety dossier on the product, so the committee can weigh known risks. The Investigator's Brochure is covered in depth in Module 13.
• The investigator's CV and a list of the site team with their responsibilities and qualifications — so the committee can judge competence. Roles, qualifications, and delegation are covered in Module 3.
• Information on the site infrastructure — so it can judge whether the site can actually run the trial safely.
• Information on secure handling of personal data — the privacy and data-protection precautions; the operational handling is Module 12 and the underlying data-protection law is Module 6.
• The agreements between sponsor and investigator — financing, the investigator's remuneration, and publication rights — which expose financial pulls and protect the right to publish. The conflict-of-interest and financing angle is covered in Module 4.
• The certificate of insurance or other proof of cover for trial-related harm; the compensation-and-insurance legal framework is covered in Module 6.
• Any decisions or opinions of ethics committees abroad on the same trial, including conditions they imposed.

The committee may always ask for more than this where it needs it to do its job. KlinV Which exact subset of documents applies depends on the study's category under Swiss law (Module 6), and a multicentre trial adds a separate, site-specific packet for each participating site (covered below).

What the Committee Weighs

Swiss law sets out, explicitly, the areas the committee reviews — it is not left to each committee's taste. KlinV The list groups into a handful of questions:

• The science — is the question relevant, is the chosen methodology suitable to answer it, and does the design comply with Good Clinical Practice?
• Risk versus benefit — is the ratio between the likely risks and burdens and the expected benefit acceptable?
• Protection of participants — are risks minimised, is follow-up provided for, are personal-data precautions in place?
• Who is enrolled — is it necessary to involve these people (and any who are particularly vulnerable), and are the selection criteria justified?
• Consent — is the information-and-consent procedure adequate, including the time for reflection, and are the consent documents complete and comprehensible?
• Remuneration — is what participants are paid appropriate?
• Integrity and independence — are the scientific-integrity requirements met, and what do the financing and the sponsor–investigator agreements reveal?
• Compensation, competence, and the site — is the right to compensation for harm guaranteed, are the investigator and team adequately qualified, and is the site infrastructure suitable?

The detailed framework behind several of these — the four ethical principles, equipoise, the protection of vulnerable populations — is Module 6's. What matters here is that the committee applies all of it at once, before approval.

And one of those questions is the one investigators most often forget the committee is allowed to ask: the science itself. In Switzerland the committee does not merely check that a study is wrapped in the right safeguards. It reviews the scientific relevance of the topic and the suitability of the methodology. KlinV HRA

The Decision: Approval, Conditions, or Rejection

The committee works to a defined clock. It acknowledges receipt within 7 days and flags any formal deficiencies in the application. It then reaches its decision within 30 days of acknowledging a formally complete application — and if it asks for additional information, that clock stops until the information arrives. KlinV Above this sits the statutory ceiling: the decision must be available within two months of submission. HRA

The decision itself takes one of three forms, each of which the committee documents. ICH E6(R3)

• Approval (favourable opinion). The trial may proceed as reviewed.
• Modifications required before approval. You have not been approved. The committee has told you what to fix; you fix it and resubmit, and only its approval of the revised version lets you start.
• Disapproval (negative opinion). The trial, as submitted, may not proceed.

The distinction that trips sites up is the middle one. "Conditions" or "minor modifications required" is a refusal until you have met them — not a yellow light to begin while you tidy up.

Multicentre Trials: the Lead Committee

When a trial follows one standard protocol but runs at sites in more than one canton, it is a multicentre trial, and the review is shared. HRA It works through one person and two tiers of committee.

The coordinating investigator — the person responsible in Switzerland for coordinating the investigators at the individual sites (the role is defined in Module 3) — submits a single application to the lead committee: the committee of the canton where the coordinating investigator is based. KlinV HRA

From there the work divides:

• The lead committee performs the substantive review — everything in the section above, for the trial as a whole.
• The committees concerned at the other sites review only local conditions: the local investigator's CV, the site's infrastructure, the site-specific consent and recruitment documents, and the local agreements and insurance. They report their assessment to the lead committee within 15 days. KlinV
• The lead committee reaches its decision within 45 days of acknowledging a formally complete application. KlinV

The pivot is this: on those local conditions, the lead committee is bound by the opinion of the committee concerned. The lead committee cannot wave a site through over its own canton's committee's objection that the local site or investigator is unsuitable. HRA

Module Summary

The ethics committee is the one party to a trial with no stake in its result — which is the entire reason its yes is worth having. Before that yes arrives, documented and in writing, nothing happens: not screening, not recruitment, not a single procedure.

You can now:

• Explain why ethics review must be independent, and what makes a committee competent to give it
• Determine which ethics committee is responsible for a trial — including the lead committee in a multicentre study
• Assemble the initial-submission dossier and explain what each document lets the committee check
• Anticipate what the committee weighs — including that it judges the science, not only the safeguards
• Distinguish the three decisions a committee can return, and act correctly on each before any trial activity begins

The committee can only ever judge what you put in front of it — so the quality of your dossier is the quality of your review. And the moment it matters most is the simplest to state: until the written approval is in your hands, the trial does not exist.