9. Subject considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

So far as we have been able to determine, digital advertisements are allowed. Although we have found no explicit legislative basis for such advertisements, Swissethics has published a checklist for the recruitment of study participants by means of advertising, which specifically refers to advertising on social media, among other channels. Advertisements are tightly controlled, with the use of brand names and claims to efficacy not permitted.

The checklist includes the following statements limiting the scope of the advertisements’ content and requiring EC review:

“Review of advertising by ethics committees

2. The ethics committee (EC) must review and approve the advertising materials as part of the documentation submitted for the initial review. If advertising measures are only used after the study has started, the advertising materials should be submitted to the EC after the rest of the documentation.
3. The whole recruitment concept, including the associated texts and recordings for radio or television recruitment in the form in which they will be publicly used, must be submitted to the EC (Art. 24 para. 1 Clinical Trials Ordinance (ClinO), Art. 14 para. 1 Human Research Act (HRA)). 
4. The sponsor must give contract agencies that specialize in recruiting trial subjects precise instructions and documents on how study participants should be recruited. These should also be submitted to the EC.
5. The review of the advertising materials by the EC should ensure that they do not exert any form of pressure or promise a positive result or other benefit beyond what is set out in the protocol and Patient Information.
6. Advertising may not explicitly or implicitly claim that the medicinal product, medical device, or intervention is safe or effective in the application under investigation, or that it is known to be equivalent or superior to any other medicinal product, medical device, or intervention.
7. Neither brand names of products nor the name of the sponsor or manufacturer may be mentioned."

9.2 Vulnerable Subjects

See Art. 25 of the Clinical Trials Ordinance (ClinO), Art 25.d.4, which provides that the responsible ethics committee shall review the protocol with regard to the need to involve persons, and in particular persons who are particularly vulnerable. Art. 11 of the Human Research Act (HRA) provides that “[a] research project with particularly vulnerable persons may only be carried out if equivalent knowledge cannot be obtained otherwise.”

Art. 7 ClinO deals with Information, Consent, and Revocation, which provides for consent in a non-written form, “if the person concerned, for physical or cognitive reasons, cannot read or cannot write, the investigator furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent.” 

And: “[i]n individual cases, the requirement to provide information in written form may be waived if this could only be implemented with disproportionate effort, given the language skills of the person concerned; and an independent qualified translator is called in to provide oral information and gives written confirmation thereof.” 

Art. 24 HRA deals with adults who lack capacity. It provides that:

“1. A research project with an expected direct benefit may only be carried out in adults who lack capacity if:

1. this is permitted by the consent of the person concerned, granted while in a state of capacity and duly documented;
2. informed consent has been given in writing by the legal representative, a designated trusted person, or the next of kin if no documented consent is available; and
3. the person concerned does not visibly express opposition to the research intervention either verbally or by his or her behavior.

2. A research project with no expected direct benefit may only be carried out in adults who lack capacity if, in addition to the requirements specified in paragraph 1:

1. it entails no more than minimal risks and burdens; and
2. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.”

Emergency Situations

Art. 15 ClinO deals with clinical trials in emergency situations and post hoc consent. It provides that the sponsor and the investigator must, when planning or conducting a clinical trial in an emergency situation, take any measures necessary to ensure that the consent of the person concerned can be obtained post hoc as soon as possible. Where the clinical trial involves children or adolescents, the consent of the legal representative can be obtained as soon as possible, if this is required in accordance with Articles 22 and 23 of the HRA. In the case of a clinical trial involving adults permanently lacking capacity, the consent of the person authorized to act as a representative can be obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available. The procedure for obtaining post hoc consent must be defined in the protocol. 

Art. 16 ClinO deals with the death of a subject: if a person who was included in a clinical trial in an emergency situation dies, before it has been possible to obtain consent or refusal in accordance with Article 15, then the biological material and the health-related personal data collected may only be used if the person has consented, in an advance directive or otherwise, to the use of such material and health-related data for research purposes. In the absence of a statement of wishes, use is permissible if consent is given by the next of kin or a designated trusted person. Consent is governed by Article 8 of the Transplantation Act. 

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

So far as we have been able to determine, the child must give informed consent and their legal representative has to have given informed consent in writing. “Legal representative” is stated in the singular, which suggests that the signature of only one parent is required.

See Arts. 21, 22 & 23 of the Health Research Act (HRA). These articles provide that “[c]hildren, adolescents and adults lacking capacity must be involved as far as possible in the consent procedure”.

Art. 22 (children - <14 years of age): 

“1. A research project with an expected direct benefit may only be carried out in children who are capable of judgment if:

1. the child has given informed consent; and
2. the legal representative has given informed consent in writing.

2. A research project with no expected direct benefit may only be carried out in children who are capable of judgment if, in addition to paragraph 1:

1. it entails no more than minimal risks and burdens; and
2. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.

3. A research project with an expected direct benefit may only be carried out in children who lack capacity if:

1. the legal representative has given informed consent in writing; and
2. the child does not visibly express opposition to the research intervention either verbally or by his or her behavior.

4. A research project with no expected direct benefit may only be carried out in children who lack capacity if the requirements specified in paragraphs 2 and 3 are met.”

Art 23 (adolescents - 14 years of age or more)

“1. A research project with or without an expected direct benefit may only be carried out in adolescents who are capable of judgment if:

1. the adolescent has given informed consent in writing; and
2. the legal representative has given informed consent in writing if the research project entails more than minimal risks and burdens.

2. A research project with an expected direct benefit may only be carried out in adolescents who lack capacity if:

1. the legal representative has given informed consent in writing; and
2. the adolescent does not visibly express opposition to the research intervention either verbally or by his or her behavior.

3. A research project with no expected direct benefit may only be carried out in adolescents who lack capacity if, in addition to the requirements specified in paragraph 2:

1. it entails no more than minimal risks and burdens; and
2. it can be expected to yield substantial findings which could in the long term be beneficial for persons with the same disease or disorder, or in the same situation.”

9.4 Financial Disclosures

Interpharma is the trade association for research-based pharma companies in Switzerland. The Interpharma “Pharma Cooperation Code (PCC)” that came into force in 2014 regulates relationships between pharmaceutical companies and healthcare professionals (particularly doctors, pharmacists, etc.), healthcare organizations (hospitals, research institutions, etc.), and patient-support organizations. The PCC was developed by the Business Association of Science Industries, which also oversees compliance with the Code.

The PCC requires companies to disclose the recipients of pecuniary benefits. These benefits include payments for consultancy or other services such as presentations, training events, or scientific studies. The term also covers financial support for research and development in the healthcare sector and contributions by pharmaceutical companies towards the cost of attendance at events by professionals, a category that includes registration fees, travel expenses, and accommodation. With few exceptions, pharmaceutical companies may no longer give gifts (neither cash nor material objects) to professionals, which is tantamount to a ban on gifts. Wherever possible, disclosure should be on an individual basis, with the aim of making it possible to identify which individual has received the benefit.

The PCC brings Switzerland into line with common practice in Europe (EFPIA Code of Practice) and the USA (Physician Payments Sunshine Act).

The EFPIA (European Federation of Pharmaceutical Industry Associations) Code of Practice provides, in Article 22, for an annual disclosure of Transfers of Value (ToVs) to HCPs and HCOs.  “Research and Development ToVs in each Reporting Period must be disclosed by each Member Company on an aggregate basis. Costs related to Events that are clearly related to activities covered in this section can be included in the aggregate amount under the “Research and Development Transfers of Value” category.”

9.5 ICF translations – Are Certificates Required? 

The national law is silent on whether or not a translation certification is required. However, under normal practice, Certificates of Translations (CoTs) are not required to be submitted, however, relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

Yes, according to the “General Insurance Conditions (GIC) Clinical Trials in Human Research (Edition 2022)”, the insurance for clinical trials must list the “Policyholder” as well as the “Sponsor”. Therefore, the study sponsor should be the “Policyholder” and the Sponsor’s representative in Switzerland to be listed under “Sponsor”. 

Art.2 of ClinO defines the “Sponsor” as:

“Person or institution headquartered or represented in Switzerland that takes responsibility in Switzerland for organizing a clinical trial, namely its initiation, management, and financing (Art. 2 lit. d ClinO).”  

The template for the insurance certificate for clinical trials can be found on the Swissethics website.

Art 13. 3. of the ClinO indicates that the “liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.”

Additionally, see Annex 2 of the ClinO which provides that: 

“For Category A clinical trials (where the product is licensed for use in Switzerland and the proposed clinical trial is within its licensed indication), where any measures for the collection of health-related personal data or the sampling of biological material entail more than only minimal risks and burdens, the policy value shall be at least:

1. per person: 250 000 Swiss francs;
2. for damage to property: 20,000 Swiss francs;
3. for the entire clinical trial: 3 million Swiss francs. 

For other clinical trials (e.g. Category B (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 (where the product is not licensed for use in Switzerland)), the policy value shall be at least:

1. per person: 1 million Swiss francs;
2. for damage to property: 50,000 Swiss francs;
3. for the entire clinical trial: 10 million Swiss francs."