3. Ethics Committee (EC)/ Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

Below is a summary of the application documents to be submitted. For full details, see Annex 3 of the Clinical Trials Ordinance (ClinO). 

Application documents for Category A [i.e. where the product is licensed for use in Switzerland and the proposed clinical trial is within its licensed indication] clinical trials of medicinal products, products under Article 2a paragraph 2 [Therapeutic Products Act] and transplant products: 

1. Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorization
2. Protocol
3. Case report form (CRF)
4. Information sheet and informed consent form, and recruitment documents, in particular, the wording of announcements or advertisements
5. Other documents issued to participants
6. Information on the type and amount of remuneration for participants
7. The prescribing information (for clinical trials of medicinal products)
8.  The information provided in the report on conformity and the intended use and instructions (for clinical trials of products under Article 2a paragraph 2 TPA that have been reported pursuant to Article 6 paragraph 3 MedDO63 in its version of 1 January 2002 in application of Article 108 paragraph 1 letter b MedDO)
9. For clinical trials not using proprietary products: proof of compliance with Good Manufacturing Practice and correct labeling of the medicinal products, products under Article 2a paragraph 2 Therapeutic Products Act
10. The investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge
11. Information on the suitability and availability of infrastructure at the trial site
12. Information on the secure handling of personal data
13. Agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator, and publication
14. Certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor’s behalf, and the investigator; any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.

Application documents for Category B [i.e. products licensed for use in Switzerland, but where the proposed clinical trial is for a use outside of the scope of its licensed indication, including dosage] and Category C [i.e. where the product is not licensed for use in Switzerland] clinical trials of medicinal products, products under Article 2a paragraph 2 TPA (see above) or transplant products:

1. Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorization
2. Protocol
3. Case report form (CRF)
4. Information sheet and informed consent form, and recruitment documents, in particular, the wording of announcements or advertisements
5. Other documents issued to participants
6. Information on the type and amount of remuneration for participants
7. For Category B clinical trials of medicinal products [i.e. products licensed for use in Switzerland, but where the proposed clinical trial is for a use outside of the scope of its licensed indication, including dosage]: the prescribing information and the Investigator’s Brochure (IB), giving details of how the use of the product differs from the dosage/indication specified in the prescribing in- formation
8. For Category C clinical trials of medicinal products [i.e. where the product is not licensed for use in Switzerland]: the Investigator’s Brochure (IB)
9. For Category C clinical trials of products under Article 2a paragraph 2 TPA (see above) that have been reported pursuant to Article 6 paragraph 3 MedDO in its version of 1 January 2002 (see above) in application of Article 108 paragraph 1 letter b MedDO (see above) and which are not used in accordance with the intended purpose or the instructions: the documents specified in Annex 4 number 3.5 letters a–d
10. The investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating their responsibilities and relevant professional knowledge
11. Information on the suitability and availability of infrastructure at the trial site
12. Information on the secure handling of personal data
13. Agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the clinical trial, remuneration of the investigator, and publication
14. Certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party acting on the sponsor’s behalf, and the investigator
15. For clinical trials of gene therapy: the information specified in Annex 4 number 4
16. Any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

Art. 26 of the Clinical Trials Ordinance (ClinO) provides for the following procedures and deadlines: 

“1. The ethics committee shall acknowledge receipt of the application within 7 days and notify the investigator of any formal deficiencies in the application documents;”

“2. It shall reach a decision within 30 days of acknowledgment of receipt of the formally correct application documents;”

“3. If the ethics committee requests additional information in accordance with Article 24 paragraph 2, the clock shall be stopped until this information has been received;”

“4. It shall inform [Swissmedic] of its decision in the case of Category B [ie products licensed for use in Switzerland, but where proposed clinical trial is for a use outside of the scope of its licensed indication, including dosage] and C [ie where the product is not licensed for use in Switzerland] clinical trials”.

Changes – Art. 29 of the Clinical Trials Ordinance (ClinO): the ethics committee shall reach a decision on significant changes within 30 days.

For some matters, the concept of “Silent Consent/ tacit consent” also exists, as indicated by the Ethics Committee Northwestern and Central Switzerland: 

• Non-essential changes (N.B. non-significant changes for HFV studies do not have to be reported)
• Annual safety report
• Investigator's Brochure (IB)
• Completion of the clinical trial (N.B. The "silent consent" does not apply to the termination or interruption of the clinical trial or research project)
• Final report

In each case, if the ethics committee has comments or questions then it will contact the applicant. Without a rejection (“counter-report”) within 30 days, the documents are deemed to have been taken note of and the applicant can assume that the ethics committee has no objections.

3.3 Does EC/IRB have any fast-track or expedited review process?

No, not that we have been able to determine.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

No, the EC/IRB does not have to be accredited by the RA/CA.

Swissethics is the umbrella organization of the cantonal Ethics Committees. Swissethics is mandated by the Coordination Office for Research Involving Humans and the Conference of Cantonal Ministers of Public Health (GDK) for (a) the coordination and standardization of working processes, and (b) the education and training of the members of the ethics committees.

There are seven ECs in Switzerland, two in the French-speaking part, one in the Italian-speaking part, and four in the German-speaking part of Switzerland. The ECs are responsible for a) clinical trials, b) other research projects with/on human subjects, and c) the further use of health-related data and biological material for research purposes with and in the absence of informed consent. The ECs must consider whether the research project complies with the ethical, legal, and scientific requirements of the Human Research Act (HRA). In particular, they must ensure that the dignity, privacy, and the health of the persons involved in research is protected. They can also advise researchers on ethical issues and give opinions on research projects for which they are not responsible (e.g. projects that are carried out abroad). Additionally, shortly before the COVID-19 pandemic, the ECs also provided an advisory opinion for temporary authorization on the use of therapeutic products when certain criteria set by the law are met.

In addition to the seven Cantonal ethics committees, Switzerland has a Central Ethics Committee (ZEK), - mainly focused on the development of medical-ethical guidelines as an assistance for medical practice or biomedical research. The seven ECs are listed in Section 3.5 below.

3.5 How frequently do EC/IRB meet?

In broad terms, between one and four times/month. For specific details in relation to each of the seven ECs, see below:

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

Depending on the type of study (e.g. studies with radiation sources), additional approvals will be required. See Art. 28 of the Clinical Trial Ordinance (ClinO) which indicates the following:

¹ In the case of investigations involving radiation sources, the investigator shall additionally submit to the responsible ethics committee the documents specified in Annex 3 number 5. Subject to the provisions of the following paragraphs, the authorization procedure is governed by Articles 24–27 and 29.

² The investigator shall additionally submit to the FOPH the application documents specified in Annex 3 number 6, informing the ethics committee at the same time, if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:

1. a radiopharmaceutical is used which is not authorized in Switzerland;
2. a radiopharmaceutical is used which is authorized in Switzerland, and the intervention in question is not a routine nuclear medicine examination; 
3. or some other radioactive source is used.

³ The FOPH shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.

⁴ The ethics committee shall grant authorization if:

1. the requirements covered by Article 25 are met; and
2. the FOPH has raised no objections to the clinical trial.

⁵ It shall reach a decision within 45 days of acknowledgment of receipt of the formally correct application documents. It shall inform the FOPH of its decision.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

According to Art. 24 of the Clinical Trials Ordinance (ClinO), the procedure for the Responsible Ethics Committee is as follows, assuming that the investigator/sponsor has submitted the relevant application documents referred to in Section 3.1 above (the application documents must be co-signed by the investigator) and complied with any requests for additional information made by the EC. The responsible ethics committee shall review:

• the completeness of the application;
• the categorization requested;
• the information intended for registration;
• the protocol with regard to:
  • the scientific relevance of the topic Art. 5 Human Research Act, 
  • the suitability of the chosen scientific methodology, and
  • compliance with Good Clinical Practice;
• the ratio between the likely risks and burdens and the expected benefits;
• the measures taken to minimize risks and burdens, and for the protection and follow-up of participants, including precautionary measures in the handling of personal data;
• the need to involve persons, and in particular persons who are particularly vulnerable;
• the criteria for the selection of participants,
• the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection, the appropriateness of the remuneration for participants;
• compliance with scientific integrity requirements;
• the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible involvement of particularly vulnerable persons;
• the guaranteeing of the right to compensation in the event of damage;
• the adequacy of the knowledge and experience of the investigator and of the other persons conducting the clinical trial, in relation to the discipline concerned and the conduct of a clinical trial;
• the suitability of the infrastructure at the trial site;
• the financing of the clinical trial and the agreements between the sponsor, third parties, and the investigator concerning the allocation of tasks, remuneration, and publication.

The EC shall also consider significant changes to the clinical trial, which include the following:

• changes affecting the participants’ safety and health, or their rights and obligations;
• changes to the protocol, and in particular changes based on new scientific knowledge that concern the trial design, the method of investigation, the endpoints, or the form of statistical analysis;
• a change of trial site, conducting the clinical trial at an additional site; or
• a change of sponsor, coordinating investigator, or investigator responsible at a trial site.

The ethics committee shall reach a decision on significant changes within 30 days.

Other changes must be notified to the ethics committee in the annual safety report specified in Art. 43 of the Clinical Trials Ordinance (ClinO).

The ECs are subordinate to the cantons. Members (at least seven) are elected by the canton and serve for a fixed term. They work according to the militia system (community service) and their decisions are independent. Depending on the particular EC, meetings are held from one to four times a month. Depending on the nature and the risk of the research project, there are three different procedures: a) full procedure with at least seven members, for research projects that involve greater than minimal risks and stresses or involve non-authorized drugs and medical devices, b) simplified procedure with three members, for research projects with minimal risks/stresses or with authorized drugs and medical devices and c) presidential procedure for research with health-related data or biological material with an existing informed consent of the research subject.

The scientific secretariats of the ECs with scientific, legal, medical, or pharmaceutical backgrounds are responsible for assessing research projects for their form and content (i.e. whether they are formally complete and can therefore be submitted to the EC for assessment, and whether their content complies with the legal requirements of the HRA). The ECs are funded partly by fees and partly by the cantons. The fees are determined by a corresponding regulation that applies uniformly throughout Switzerland.

For studies that are carried out at several trial sites in Switzerland, there is a multicentre approach with a lead EC and participating ECs; the latter committees only assess the local conditions with a presidential procedure, and inform the lead EC of their views. The lead EC then makes a legally binding decision for all trial sites (decrees). The location of the lead EC corresponds with that of the coordinating investigator (researcher). The applicant (investigator or sponsor) has the right to appeal against decisions. The competent body for appeals is usually the canton.

The ECs are coordinated by the Federal Office of Public Health and by Swiss Ethics, the umbrella organization of the 7 cantonal ECs. The purpose is to harmonize all research proposals with uniform templates for applications and an electronic portal (BASEC) for submissions. The BASEC portal also provides a tool (for internal use by the EC) that simplifies the administrative work of the EC secretariats and generates consistent annual statistics.

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

See Swissethics notification on fees.

The fees of the ethics committees are regulated on the following basis:

1. The Research Ethics Committees shall charge procedural fees for administrative acts carried out within the scope of their executive competence in the area of the [Human Research Act (HRA)] of 30 September 2011;

2. The amount of the fees is intended to contribute to covering the operating costs of each Ethics Committee that is requested to do so and of its secretariat;

3. Anyone who requests an administrative act from an Ethics Commission is required to pay a procedural fee;

4. The fees are calculated according to fixed tariffs harmonized for all the RECs according to a common scale, with however a range of fees applicable by the RECs, depending on the type of procedure;

5. The Ethics Commission will send its invoice to the billing address indicated; and

6. In the case of a multi-center study, each of the RECs involved will send its invoice to the billing address indicated.

3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

This information was not publicly available, but it is expected that details would be provided to the applicant after invoicing the fees (see Section 3.8 above).

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

Yes - see the Federal Office of Public Health’s (FOPH) Website. 

Applications must be made to the local ethics committee, using Swissethics’ Business Administration System for Ethics Committees (BASEC). BASEC is the portal for submissions to ethics committees in Switzerland for clinical trials, research projects, modifications, notifications of safety events, clarification of responsibilities, application of temporary authorization, general questions, etc. 

BASEC portal- FAQ page- contains detailed guidance on different topics.

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

There is no specific mention of such materials in anything that we have reviewed, but a submission to the EC is expected to include “other documents issued to participants” (see Section 3.1 above). Thus, our expectation is that these should be provided, in the local national language.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

Yes – in the national languages of French, German, and Italian.

The following templates are available on the Swissethics website:  

• Study information for participants in clinical trials (template for drafting information for participants in studies involving humans in accordance with the Human Research Act (HRA) and the Clinical Trials Ordinance (ClinO);
• Study information for relatives/parents/legal representatives (template for writing the study information for relatives/parents/legal representatives);
• Study information for pregnant study participants or pregnant partners of study participants (template for drafting information for pregnant study participants or pregnant partners of study participants);
• Conception and application of an electronic informed consent (eIC) (guideline on the conception and application of an electronic informed consent (eIC) in clinical trials); and
• Information on participants in foreign languages (Consensus paper of Swissethics / SCTO (Swiss Clinical Trial Organization)).

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

Yes – see Section 2.18 and Section 9.6 of this guidebook.

See also Art. 10 Clinical Trials Ordinance (ClinO) which provides for certain exemptions from liability, as follows:

• any person who proves that the damage is attributable to the administration of an authorized medicinal product used in accordance with the prescribing information; or
• the administration of an authorized medicinal product, if this is recognized as standard in guidelines prepared in accordance with internationally accepted quality criteria;
• the use of some other health-related intervention which is recognized as standard in guidelines prepared in accordance with internationally accepted quality criteria;
• where comparable damage could also have occurred if the injured party had undergone standard therapy for the disease; or
• in the case of acutely life-threatening diseases for which no standard therapy exists.

Also exempt from liability is any person who proves that the extent of the damage is no greater than would be expected in the current state of scientific knowledge.

Requirements for liability coverage include:

• Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event;
• Within the framework of the insurance coverage, the injured party or legal successor has a direct claim against the insurance company.

Swissmedics has extensive guidance on “Insurance” depending on the type of research involved.

Regarding remuneration, Art. 14 of the Human Research Acts (HRA) indicates the following:

“Non-remunerative participation 

¹ No person may receive payment or any other non-cash advantage for participation in a research project with an expected direct benefit. Participation in a research project with no expected direct benefit may be appropriately remunerated. 

² No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s participation in a research project.”

Swissmedic clarifies the “participant reimbursement” further in their position paper “Monetary contributions to patients participating in research projects_09 Mar 2016” (note: only available in French and German).

Section 3 - “The perspective of the cantonal ethics committees”, indicates the following:

“General principles

• When assessing a research project, the decisive factor is and remains whether the potential benefit of the research is considered to be higher than the risk associated with it - regardless of any financial contributions.
• Research with a direct benefit may not be associated with remuneration or a monetary benefit.
• The Human Research Act generally allows appropriate remuneration for participants in research without direct benefit, i.e. in principle also for patients, if the project as such or individual elements of the project (e.g. additional diagnostics that are not individually necessary or blood samples for pharmacokinetic studies) do not have a direct benefit or expected benefit.
• A payment to patients (or the granting of a monetary benefit) can be made, but it does not have to be (“can” provision).
• Financial donations to test subjects and patients must be disclosed to the ethics committee (and, if necessary, justified upon request) and clearly stated in the test subject/patient information.
• The ethics committees make decisions on a case-by-case basis as to whether a financial contribution or its amount is appropriate or not.
• The ethics committees do not consider it their task to counteract the current heterogeneous practice by standardizing financial donations.”

3.14 Are there any specific local safety reporting requirements for clinical studies?

Yes – please refer to Section 2.15 of this guidebook. See also Swissmedic’s Information "Safety measures in clinical trials".

Only SUSARs (suspected unexpected serious adverse reactions) in clinical trials of categories B [i.e. products licensed for use in Switzerland, but where proposed clinical trial is for a use outside of the scope of its licensed indication, including dosage] and C [i.e. where the product is not licensed for use in Switzerland] must immediately be reported to Swissmedic, in line with Art. 41 of the Clinical Trials Ordinance (ClinO).

SUSARs must fulfill all of the following three criteria:

1. serious (based on the usual definitions);
2. suspected (a connection with the IMP cannot be excluded);
3. unexpected (in terms of the type of AE or degree of severity, the event has not been described previously for the IMP, e.g. in the Investigator's Brochure).

Only SUSARs observed at Swiss trial centers must be announced immediately to Swissmedic, even when it concerns international trials. Other adverse drug reactions must be announced to Swissmedic in the Annual Safety Report (ASR). 

Additional clarification can be found under the Swissmedic “FAQ on clinical trials with medicinal products.”

3.15 Does the EC/IRB require any periodic study reporting?

Yes - the annual follow-up is sent to the person who has registered as the applicant for the file (the project owner) on the BASEC submission platform.

Please refer to Swissmedic’s Information sheet FAQ on clinical trials with medicinal products. See also Section 2.16 of this guidebook.