Research with Human Participants

The following research projects with persons, health-related personal data or biological material are subject to the external page Human Research Act and must be approved by a Cantonal Ethics Committee before they start:

• Research concerning diseases: Research on the causes, prevention, diagnosis, treatment, and epidemiology of impairments of physical and mental health in human beings

• Research concerning the structure and function of the human body: Basic research, in particular on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and impacts on the human body

• Trials with medical devices: Investigation involving one or more persons undertaken to assess the safety or performance of a device and performance studies with in vitro diagnostic devices

These research projects fall into one of the following external page categories:

• Clinical trial: The effect of a health-related intervention is tested. It can be preventive, diagnostic, therapeutic, palliative, or rehabilitative in nature (see external page Art. 2 KlinV).

• Non-clinical research with persons: The research participants themselves are studied, rather than the effect of an intervention. Data are collected or material is sampled.

• Non-clinical research without subjects: Further use of data or samples, research involving deceased persons, foetuses, etc.

• Trial with medical devices: Investigation involving one or more persons undertaken to systematically assess the safety or performance (validity) of a device (cf. external page Art. 3 of the Medical Devices Ordinance, medical devices are, i.e., "instruments, apparatus, appliances, softwares, implants, [...] or other articles" which are used, i.e., for the "diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease [...], injuries or disabilities" or the examination of the human body.

Technical assistance systems such as prostheses or orthoses are also considered medical devices. According to the guideline external page Leitfaden Technische Assistenzsysteme ¨C Medizinprodukte in der Humanforschung (German), certain projects in the early development phase of technical assistance systems involving healthy subjects or patients are exempt from the review by a Cantonal Ethics Committee. However, other projects must be approved if they meet one of the following criteria in accordance with this guideline:

- Validation: The systematic assessment of the performance and safety or acceptability of a system has priority
- Collecting health-related data for the purpose of this validation
- Measuring the rehabilitative effect of a system
- Aiming for certification of the product

• Also subject to approval are trials with in vitro diagnostics, register studies, and research with embryonic stem cells.

Procedure

If you are sure that your research project must be approved by a external page BASEC (top left) (cf. guidance (German)).

If a Cantonal Ethics Committee does not claim responsibility for your research project and it involves participants (i.e. not just the further use of data or material) the project should be submitted to the ETH Zurich Ethics Commission for approval. Please enclose the declaration of non-responsibility of the Cantonal Ethics Committee with your application.

Clinical trials abroad must be approved by the locally responsible ethics committee and the ETH Zurich Ethics Commission. Parallel submission is possible.

Useful Links

- external page Kantonale Ethikkommission Z¨¹rich (German)

Human Research Act and Ordinances

- external page Ordinance on In Vitro Diagnostic Medical Devices (IvDO)
 

Research with humans or their data that does not fall under the responsibility of a Cantonal Ethics Committee must be approved by the ETH Zurich Ethics Commission before it starts. This includes in particular research from the humanities and social sciences such as:

• Surveys, interviews, focus groups
  
• Behavioural studies (observational, experimental)
• Research in social networks (see guidelines)
  
• Research with students and their data (see guidelines)
• Research with personal data

Medical research with participants for which a Cantonal Ethics Committee does not claim responsibility (e.g., certain physiological measurements) must be approved by the ETH Zurich Ethics Commission. Please attach any declaration of non-responsibility to your application.

Collaborations with other research institutions

If a project is conducted by members of different institutions, the institution of the PI is normally responsible for the ethical review. The other institutions may accept the approval of the leading house or request their own review. Please contact the of the ethics commission at an early stage.

Research abroad

Medical research with participants abroad must be reviewed by the locally responsible ethics committee and the ETH Zurich Ethics Commission. Field or lab research abroad should also be reviewed by a local ethics committee to ensure compliance with local ethical norms and laws (see Research Abroad). For online experiments with participants from abroad, the review by the ETH Zurich Ethics Commission is sufficient.

Bachelor's, Master's and doctoral theses

Human research projects of students of ETH Zurich for which they or other members of ETH Zurich are responsible (PI at ETH) are subject to approval and must be submitted to either a Cantonal or the ETH Zurich Ethics Commission.

If the principal investigator (PI) of the research project is not affiliated with ETH Zurich, it is their responsibility to obtain ethics approval. In consultation with the supervising person at ETH Zurich, a review by the ETH Zurich Ethics Commission may be considered (e.g., if the Cantonal Ethics Committee declares non-responsibility). Please contact the of the ETH Zurich Ethics Commission if you have any questions.

Bachelor's and Master's theses are assessed more quickly by the ETH Zurich Ethics Commission (cf. How long it takes).

Clarification of responsibility

If you are unsure whether your project needs to be reviewed by the ETH Zurich Ethics Commission, the secretariat can advise you. Please describe your project in this .

Exempt from review are data collections for quality assurance where no scientific use of the data is intended (e.g., teaching evaluation).

Running a project without ethics approval may have negative consequences depending on who is responsible for evaluation:

• Cantonal Ethics Committee: monetary penalty or custodial sentence (external page HFG Art. 62 und 63)
• ETH Zurich Ethics Commission: The PI is personally liable in the event of damage. Moreover, the Vice President for Research may take measures related to the PI's employment.
  

In many cases you will also be asked for an ethics approval by funding agencies or publication platforms.  

Make sure to submit your ethics proposal in time in order to avoid any obstructions.

To apply for ethical approval of a new project, follow these steps:

• Make sure the ETH Ethics Commission is responsible for your project.
  
• Read up on the required documents.

Start a new proposal on the platform eResearch  (called ¡°Ethics Grant¡±):

1. Download and fill out the current application form.
2. Register and log-in to eResearch.
3. Open a new application under ¡°My Applications¡±, got to ¡°New Application¡±, click on ¡°Apply¡± under ¡°ETH Zurich Ethics Commission¡±.
   Fill out the required fields, upload all required documents and submit your application.

For detailed information on how to submit an ethics application over eResearch you can follow Download this guide. (PDF, 116 KB)  

For technical support, please contact .
For questions on the process reach out to .

When creating your proposal in eResearch, please have the following documents ready:

• Application form (English) including information sheet(s) and consent forms (as will be shown to participants e.g., screenshots in PDF form).
• All surveys, questionnaires, interview questions, stimuli, etc. in their final version
• Recruitment material as shown to participants (if applicable)
• Contracts and approval / waiver by local authorities / IRB (if applicable)
• Contracts with panellist (if applicable)
• Publication list of the PI (this is not required for other project members)
• CVs of the primarily responsible researchers
• Please do not submit grant proposals or reports addressed to funding agencies

The ETH Zurich Ethics Commission evaluates research projects with regard to ethicality and the wellbeing of human subjects. Some core criteria are as follows:  

• Subjects must participate in the study of their own accord, and consent forms must be stored to document this.
  
• Subjects must be informed about the goals of the study and the procedures they are to undergo.
  
• The physical and mental health of subjects is to be protected.
  
• Personal data must be protected, be it by refraining from collecting sensitive data or by providing an anonymization plan.
• Collaborations with companies and institutions proceed based on clear rules.  

The Ethics Commission may weigh up these criteria and include the expected knowledge gain and societal benefit of the study in their considerations.

As soon as the commission have made their decision, you will receive a formal notification. Further steps depend on the commission's decision:

Approval without reservation

You may immediately start your project.

Approval with reservation

You may start those parts of the project that are not subject to reservations by the Ethics Commission. You will need to meet these reservations in order to obtain the full approval of your project.

Revise

There are serious reservations concerning your project that make it impossible to start it yet. You may be required to implement comprehensive revisions ("revise and reply") or to resubmit the complete proposal ("revise and resubmit").

Rejection

The project cannot be approved for ethical or procedural reasons.

Not evaluated

The commission has not evaluated your proposal, e.g., because an evaluation is not necessary based on the commission's statutes or because the project lies in the competence of the Cantonal Ethics Committee.

You will receive an email from the Office of the Ethics Commission with a decision letter. In case your proposal is approved with reservations, or rejected, you must reply to the comments of the Ethics Commission.
The most basic reply consists of two documents:

• A reply letter which fully answers the Commission's reservations directly point by point (numbered as in the decision letter).
• The revised proposal form with changes marked in yellow.

Replies are to be submitted on eResearch:

1. Log on to eResearch, go to ¡°My Applications¡± and select the application for which you wish to submit a reply. The application status will be ¡°returned¡±.
2. Click ¡°Edit¡±, which will bring you to the ¡°revision¡± page. Upload your response letter and revised proposal with changes marked in yellow and add any additional information if required.
3. Click ¡°Save And Close¡± to exit the edit mode.
4. Click ¡°Submit¡± to finalise your revisions.

For more detailed information, see Download this guide (PDF, 116 KB).

The applied start date of the project (incl. first contact with participants) should not be earlier than two months after the submission of the application. Please schedule the following times:

• 3-8 weeks until the first decision;
• 2-3 more weeks if your application is rejected and you have to respond to the Commission's reservations before you can start your project.

Human subject research for Bachelor's or Master's theses can be reviewed quicker, if you refer to this circumstance in the application and confirm that the supervisor has reviewed the proposal with regards to content and completeness. The student character of the project will be indicated in the approval letter.

You may not start a study before it has been approved. Some funding institutions such as the external page ERC require an ethics approval as an attachment to grant proposals or contracts. Best start planning early and reserve enough time for the ethics evaluation.

If you wish to modify or extend an already fully approved project, you must submit a change request (amendment) for review. The following documents are required:

• a summary of the changes including an explanation why they have become necessary
• the revised research protocol (changes marked yellow)
• if applicable: changed documents such as questionnaires or additional CVs

Change requests are to be submitted over eResearch:

• Log in and go to "My Grant¡± where you select the application you wish to amend. Only projects with the status ¡°Approved¡±, ¡°Active¡± or ¡°Complete¡± can be changed. Click ¡°Requests¡±, then select ¡°ETHICS Change Request¡± from the drop-down menu and click on ¡°Create Request¡± to initiate the process. If you wish to see more detailed information, see page 3 of Download this guide (PDF, 116 KB).

The submitted changes must not change the approved study design and the resulting risks in fundamental ways. The following changes are typically unproblematic:

• small-scale changes in the size of the sample
• additional project employees or collaborators
  
• changes in project duration

If you are planning greater changes, please consult the of the Ethics Commission to discuss possible solutions.

Before participants enrol in a study, they must be informed in writing and sometimes additionally orally about the research project (objective, method, procedure), the expected risks and their rights during their participation. Following this information, the participants must provide written or otherwise documented consent to participate. Advice on this process can be found in our application form, the EU guidelines Research involving children and adolescents, Research abroad, and the use of Deception and partial disclosure for methodological reasons.

Principally, researchers should provide a prospective participant with full disclosure of all information necessary for making an informed decision to participate in a research project (see Informed consent of participants). Withholding or omitting information from participants (e.g., about the methods or objective) or the use of deception for methodological reasons entail risks for participants and the researchers¡¯ reputation. However, if certain socially relevant research questions cannot be answered without the use of these means, they may be approved by the Ethics Commission.

Example of incomplete disclosure

• Participants are informed about the purpose of the study in vague, general terms. While these are true, participants are not informed about the specific focus and therefore the actual objective of the study.
• Participants are asked to complete a quiz without being told that the research question is how background noise affects their ability to concentrate.
• Participants are asked to read a list of words or look at a series of pictures without being told that their memory is being tested.

Examples of deception

• Participants complete a quiz and are falsely told that they did very poorly, regardless of their actual performance.
• There is an "ally" of the researcher among the participants who pretends to be a participant themself, although their behaviour is part of the experimental intervention.

Requirements

If deception or incomplete disclosure are necessary means of a study, the following requirements apply:

(i) Deception and partial disclosure in research should only be used when alternate study designs would be inadequate to answer the research question. The application to the Ethics Commission should thus explain why the study objective cannot be achieved without these means.

(ii) The use of deception or partial disclosure must be justified by an anticipated major scientific or societal benefit of the research project.

(iii) Whenever possible, participants should be informed of the withheld or false information once participation is finished. The application to the Ethics Commission should include the intended text for such a debriefing, which (a) informs participants that incomplete information was provided, or that they were deceived; (b) indicates what information was withheld or falsified; (c) explains why it was necessary to disclose only partially, or to deceive; (d) gives participants the opportunity to ask questions; and (e) allows them to have their data deleted.

The applicability of these requirements is limited in the case of observational studies without any researcher-participant interaction and collection of personal data (e.g., in public spaces or social networks).
 

Research with students during class time contributes to the development and validation of new methods of teaching and learning and provides students with insight into research practice. Still, educational research entails specific risks due to demands on the curriculum and the dependency of students on lecturers. To protect students in the best way possible, it is therefore required to consider the following points when planning and conducting educational research:

a. If the activities to be tested are performed by some or all students during class time, these activities must be related to the content of the course and contribute to the achievement of its learning objectives.

b. Students must be informed about planned experimental studies or other data collection for research purposes and agree to the use of their data by signing a consent form (or otherwise recorded). The information must be provided in writing and sufficiently early so that students can decide on the use of their data without pressure. The information sheet must clearly state that student consent is required for the use and anonymous publication of data and that this can be refused without incurring any disadvantages. Further information on the consent form can be found in the application form (cf. practical links).

c. Students should not sustain any disadvantages by participating or not participating in research. It should thus be prevented that data collected or refusing to let data be analysed has any impact on the evaluation by the lecturers. For research in education settings, it is recommended to gather data anonymously so that re-identification of individual students is not possible. If this is not feasible for technical reasons or through study design, data should be anonymised by educational researchers as soon as possible or, if necessary, be coded/pseudonymised. When data is collected in an anonymous form, students should be given the option within the data gathering tool (online survey, questionnaire) to specify whether they would like their data to be used for scientific purposes or not.

d. Where educational researchers collaborate with lecturers, lecturers may only have insight to consent forms and identifying raw data once course grading has been completed, and only if this is necessary for the use of data before anonymisation.

e. Generally, principal investigators should not conduct research with their own students. If this should nevertheless be the case, special care must be taken to ensuring voluntary participation and to prevent influencing grading by the data collected or refusals to participate. Consent forms and identifying raw data may only be viewed after courses have been graded and the dual relationship as teacher and researcher to students has ended. In the application to the ETH Zurich Ethics Commission, this dual role towards students should be justified and precautionary measures taken should be made explicit in the proposal and information sheet provided to students.

f. If (some) participants in an experimental study achieve a greater learning success than the other students, this comparative advantage needs to be redressed afterwards. This can be achieved, for example, by a debriefing or by offering all students the opportunity to go through the experimental activity.

g. If studies take place during courses, participation should not be compensated as it contributes to the achievement of learning objectives (cf. point a). Participation in studies that take place in student¡¯s free time can be compensated, but not with ECTS credits.

Requirements and Focal Points

Research projects with students must be approved by the ETH Zurich Ethics Commission before they start. This also applies to the planned collection and use of data from ongoing teaching without intervention for research purposes (e.g. log files from course management systems or exam results). In both cases, informed consent of the students is required. In justified cases, the ETH Zurich Ethics Commission may waive the requirement to obtain informed consent.

Studies to improve your own teaching (reflective teaching / instructor development) and anonymous surveys for quality assurance purposes do not require approval but cannot be used for publications. The Department of Educational Development and Technology (LET) offers advice and support. The contractually regulated use of such student data not available to lecturers (e.g., enrolment data, academic origin data, data from academic applications) can be requested from the Head of Academic Services.

These guidelines have been approved by the ETH Zurich Ethics Commission in November 2021.
 

The ethical and legal requirements increase when research with participants is conducted abroad ¨C particularly in low-income regions. On the one hand, your research must comply with the ethical and legal requirements of the host country as well as those of Switzerland. On the other hand, research in low-income settings should take place in partnership with local researchers and aim to be of local relevance. Please consider the following items when planning your field research abroad.

Local ethics approval
In addition to a review by the ETH Zurich Ethics Commission, you should have your research project approved by an ethics committee of the host country. Attach the approval letter to your application to the ETH Zurich Ethics Commission or submit it upon receipt. Make sure that the applied methodology is compatible with the local legislation and context.

No local ethics approval is required for online experiments and surveys with foreign participants (e.g., on MTurk or Prolific). However, if such a data collection is conducted with a local partner institute, their requirements should be observed. The secretariat of the ETH Zurich Ethics Commission can advise you in such cases, for example regarding a possible acknowledgement of the ethics approval of the partner institution.

Cooperation
Human research abroad should be planned and conducted in partnership with a local research institution. Such collaborations are to be pursued under the conditions for fair, respectful and responsible scientific cooperation among researchers (no "upward accountability"). In this regard, please observe the Download Code of Conduct for Scientific Cooperation of ETH Zurich.

Relevance
The involvement of volunteers for your research should be justified by its anticipated social and scientific value. This is particularly true for human subject research in low-income regions. Ensure with local partners that your research is of local relevance and meets the needs of the host country.

Fairness and respect
Tailor the process of informing and obtaining consent to participate to the local requirements. In certain regions it may be necessary to obtain the consent of the participants' living community in addition to individual consent. Provide interested participants the opportunity to be informed about the results of the project in an adequate form (keep contact details separate and secure). Further important points to consider can be found in the external page Global Code of Conduct for Research in Resource-Poor Settings.

Safety
The physical and psychological wellbeing of participants and researchers always comes first. Involving local people and experts familiar with the local context and how to deal with specific risks can considerably minimise these risks. Please refer to the country report of the Download Safety & Security Recommendations for Research Enterprises Abroad (PDF, 124 KB). 
For research taking place in areas with ¡°High¡± or ¡°Extreme¡± risk (according to ) must be contacted early on, so that a safety concept and precautions can be established if necessary. The SSHE will then issue a confirmation document, please attach this to your application to the ETH Zurich Ethics Commission.

Export of personal data
If personal data (i.e. information relating to a specific or identifiable person) must be exported from the host country to Switzerland for research purposes, this cross-border disclosure must comply with the legislation of the host country. Find out about the applicable regulations at an early stage and refer to the intended export in the information consent letter for the participants.

What is social media research?
Research may take place on social media platforms, chat rooms, discussion forums, comment fields, blogging sites and other. Online platforms may be used to recruit participants, exploring digital lives or collecting data. The blurred boundaries of public and private spheres on social media, the difficulty to receive informed consent, and particular exposure of participants and researchers, makes research using social media distinct to other methods of social research. Data gathered on social platforms online can broadly be distinguished as passive data gathering, or active social media research where researchers interact with participants.
Any kind of social media research is generally subject to approval by the ETH Zurich Ethics Commission. Researchers should take these guidelines into account when planning social media research.

Informed consent
Even though data, images, and content are widely available to the general public on social media, valid consent may still be required when using such data for research. When evaluating in how far the data is public or informed consent necessary, the reasonable expectation of being observed by strangers and expectation of privacy a user may have on a specific site and context is central. The research context and applied methods need to be considered to decide what form of consent is appropriate.

For studies where researchers interact with participants or ask them to perform certain actions, such as to comply with a particular intervention, prior informed consent should be collected. See our guidelines on informed consent and deception and partial disclosure.

If additional information is combined with data gathered from the social media accounts of participants, prior informed consent is necessary. An example: in a first step, a study collects survey data from a sample of Twitter users. The researchers obtain informed consent on the starting page of the survey, but for the survey only, as revealing the research goals would compromise the study. In a second step, the researchers collect information on how participants behave on Twitter. Researchers may not link this data without the consent of participants.

Prior consent may be omitted when the expected value of the research outweighs the need for consent and if at least one of the following conditions holds true:

• Prior informed consent is technically not feasible. Such may be the case when collecting large aggregate data.
• When notifying participants would change their behaviour, lead to bias in the study results and make the research question unanswerable (see guidelines on deception and partial disclosure).
• When notifying subjects of a study may endanger researchers or participants and cause greater harm than the violation of consent of participants. This risk may be of escalating behaviour, doxing or attacks (e.g., research with internet trolls, hate speech and extremist groups).
  

When publishing direct quotes or other content that may easily re-identify individual participants, researchers must obtain informed consent before the dissemination stage.

Legal aspects
Researchers should spend time getting to know the medium they intend to use, both in policies (privacy restrictions, user settings, legal restrictions) and culture. When using social media for their research, researchers also accept the contractual conditions of the specific platform. Social media platforms generally forbid the use of data crawling (locating and indexing data by systematically scanning online) or scraping (extracting specific information from a specific platform).

Protecting the privacy and safety of participants and wider communities
Researchers have a duty of care to identify who could be vulnerable in the specific research context and what kind of harm they might be exposed to. Researchers should develop further mitigating measures, should the wellbeing and safety of participants, researchers or external persons be threatened.

• The principle of data minimisation should be followed and only the data necessary to answer the research question should be collected. Data collected and stored must be proportionate to the need of the study and the expected benefits generated for society (see information on data protection at ETH Zurich). Usernames are considered personal data. IP address, location or email address should not be collected as it makes the identification of an individual easy. Researchers should ensure that this data is not inadvertently collected. What may seem to be anonymous data, could be combined and show patterns which by themselves or when combined with other data could enable re-identification of individuals and link them with information of potentially sensitive nature. In justified cases, IP addresses, locations or other sensitive data may be collected but must be stored separately from the other data and deleted as soon as their special purpose has been achieved (e.g., check for multiple completions).
• Direct recruitment of participants on social media should be omitted as it leaves traceable online records. Rather allow participants to contact researchers via an institutional address or a secure webpage/form external to the social platform.
• There should be a sound anonymisation strategy in place with defined data access protocols that include measures in case of staff mutations.
• Anonymisation of verbatim quotes is not possible, as search engines and accruing data from multiple sources may lead to re-identification of the original source. Measures for anonymisation may be paraphrasing, descriptions of content or sharing derived variables.
• Researchers should evaluate the risk their research project may have on the wider community they are investigating. In the context of research using social media, researchers should refrain from disturbing a group ecosystem, infiltrating private groups or joining publicly available groups under false pretence of being a regular member (¡°lurking¡±). E.g., Social groups that may be publicly open, but not obvious to find and therefore benefit from a degree of privacy, exposure to a broader public through research activities could cause harm to members of this group or the group as a whole. Researchers planning on doing covert observation of a public forum and collecting personal information of participants should reach out to Legal Office of ETH Zurich for advice. Any information that may re-identify an individual, including comments posted in a chatroom online, may be considered personal information.

Protecting researchers

• The duty of care also applies to members of the research team. Mitigation protocols should include measures to protect researchers from threats, data leaks, doxing and psychological harm through exposure to disturbing material. As an example, when studying extremist groups via online forums, personal information of researchers could be exposed and lead to harassment, verbal or physical violence by the group studied or people who disagree with the study goals.
• Researchers should refrain from sharing their own social media accounts with potential research participants when possible. Personal social media accounts should not be used for recruiting participants for studies taking place online or other research related activities as this may expose the researchers as well as their colleagues, friends and family. For studies taking place offline (e.g., behavioural studies, physiological measurements), recruitment through personal accounts poses less risks and is still possible.
• Researchers should create research specific social media accounts when necessary or consider using sock puppet accounts that do not reveal the identity of the researchers. When they are not essential to the research project, friend requests to these sock puppet accounts are best left unanswered.
• Being exposed to harmful content also creates emotional labour for researchers. This affects individuals differently and researchers should be mindful of their co-workers and their belonging to marginalised groups.
• All members of the research team should receive appropriate training in dealing with harmful or potentially criminal content, and referral mechanism need to be implemented. Such may be a designated person who serves as the point of contact for team members reporting concerning or threatening behaviour, or steps to take when receiving unsolicited messages such as by individuals seeking urgent help (e.g., victims of domestic violence).

When to pause or stop the project
When designing a study, researchers should define specific criteria, under which circumstances the study will be put on hold or terminated. This is particularly salient for intervention studies where researchers intervene with participants to observe behavioural changes on a social media platform. Researchers need to continuously monitor the development of participant¡¯s behaviour and stop the intervention when necessary, e.g., if:

• Study participants reveal a researcher¡¯s identity.
• Study participants publicly share the research protocol of the study. Participants being aware of the goal of the study risks distorting study outcome or may lead to online or physical attacks against members of the research team.
• Members of the research team may receive targeted and hateful replies and harassment on their sock puppet accounts from study participants or by-standers.
• While backlash does not always necessitate early termination, it should be carefully monitored.

These guidelines have been approved by the ETH Zurich Ethics Commission in March 2023.

Further resources

You may find further information on ethical social media research and internet mediated research in these guides:

• Association of Internet Researchers: external page Ethical Guidelines
• The British Psychological Society: external page Ethics guidelines for internet-mediated research
• National Research Ethics Committees Norway: external page Guide to internet research ethics
   

At present, all measures regarding Covid-19 have been lifted at ETH Zurich. Research with participants involving physical presence should still be conducted following basic safety precautions to protect the health and safety of research participants and staff. For further information please visit the external page website of the Canton of Zurich.

Research in a clinical context should follow guidelines applicable to healthcare clinics as well as any regulations affecting clinical partners.

When conducting research abroad requiring physical presence, ensure to follow all local regulations regarding Covid-19 as well as any national vaccination requirements. For questions regarding pretravel consultations and vaccinations please contact the external page travel health clinic.

Before the study
If your study population involves vulnerable people, a safety concept must be submitted with your ethics proposal. The unit Safety, Security, Health, Environment (SGU) can give you advice if needed. Researchers should be mindful that some participants may continue to be reluctant to take part in face-to-face research studies and it may still be appropriate to offer alternative ways of interaction (such as online or remote).

During the study
Wearing face masks is recommended in rooms where there is increased risk of transmission (e.g., enclosed or poorly ventilated areas, gathering of people).

Participants should be reminded to refrain from participating if they show symptoms of illness.
 

The digital Trial Intervention Platform (dTIP) is an ETH Zurich technology platform that offers clinical trial consulting and trial management support, ranging from study design and monitoring, ethical committee submission or data management to advice on regulatory aspects of product development by Regulatory Experts. Please visit the dTIP website for further information.

Ethics approvals always make reference to a specific project. The commission does not give approval for reusable methods independently of projects.

When you are planning to conduct a series of studies with similar designs, you may obtain approval for the full series and submit new studies in the same framework as an amendment. This is possible when the individual studies are close in time, share the same set of participants, and differences between them are minimal and do not have an impact on ethical considerations.

Project proposals that are classified as "Minimal Risk" are processed faster and according to a simplified protocol. Proposals are classified in this regard by the Office of the Ethics Commission and the commission itself. PIs cannot influence their decision.

Some typical indicators for Minimal Risk are a minimum of invasive actions or complete anonymization of the collected personal data.

In addition to verbal or written information of participants in childhood or adolescence, their legal representatives (parents, legal guardians) usually receive the complete study information and sign the consent form. Please refer to the swissethics guidelines on educational research apply.

Developing technical products (e.g. orthoses, wheelchairs, exoskeletons, e-textiles) often involves testing with external participants (healthy / target group) or on researchers themselves. These tests investigate, for example, the basic functioning or certain properties of the products.

If a medical device is to be tested with regard to its safety or performance, approval must be obtained from a Cantonal Ethics Commission (see responsibility of the Cantonal Ethics Commission and the external page Leitfaden Technische Assistenzsysteme ¨C Medizinprodukte in der Humanforschung (German)).

Tests with medical devices or other technical products that do not have to be reviewed by a Cantonal Ethics Commission must be approved by the ETH Zurich Ethics Commission prior to their start, provided that

• the participants are not researchers or students who are involved in the development of the products, and
• you intend to publish the results or data of the tests in a scientific medium.

In contrast, tests involving ETH internal or external participants do not require approval if there is no such intention to publish the results, or if the products are tested only on those researchers or students who are involved in their development. In this case, the secretariat of the ethics commission may issue a declaration of non-responsibility (¡°waiver¡±) for publication purposes (send us a Download clarification of responsibility (DOCX, 47 KB) before the start of the testing). Self-testing on researchers must not endanger their wellbeing.

For all tests and measurements that do not have to be reviewed by an ethics commission, the participants should sign a Download Participation Agreement (DOCX, 43 KB).
 

The ETH Zurich offers courses on Good Clinical Practice and CAS or MAS on topics of clinical research and regulatory thinking. Visit the overview on the dTIP website.