Ethical Clearance for Swiss TPH Projects

Principle: Any project involving humans requires an ethical clearance.

General info The Swiss TPH Human Subject Research Desk (HSR Desk) (hsr-desk@swisstph.ch) has the mandate to support Swiss TPH researchers with applications to Ethics Committees and Authorities and in the related processes, and with this to ensure a consistent quality of Swiss TPH documents submitted worldwide. The service is free for Swiss TPH staff and students. The HSR Desk has to be mandatorily contacted during the preparation of any study involving humans including the collection of human health data and samples. HSR Desk provides information on documents needed depending on the study type, and the format and content of such documents.

All documents necessary for submission have to be reviewed by the HSR Desk prior to submission (see Swiss TPH intranet (https://intranet.swisstph.ch/en/information-resources/human-subject-researchdesk/). Please note: the earlier HSR Desk is contacted during the project preparation the more efficiently the service may be provided. Turnover time by HSR Desk for requests and reviews is normally five working days per cycle.

Ethical clearance The general policy of Swiss TPH is to follow the best practice rule for ethical clearance and in accordance with this all research we conduct in the Low and Middle Income Countries and in which we have a major role (Sponsor, PI, MSc / PhD supervisor or similar) has to get double clearance from Switzerland (i.e. EKNZ by law for Swiss TPH) plus the country where the research is being performed (including potentially a local institutional review board).

As an exception, no submission to a Swiss ethics committee is required if there is another official Northern Ethics Committee which has given a written positive opinion for the comprehensive project, e.g. WHO, MSF, US IRB). Local clearance by the responsible Ethics Committee is mandatory in all cases and independent of an existing Northern approval.

Drug authority authorization In addition to ethical approval which has to be obtained for each project involving humans including the collection of human health data and samples, clinical trials also need the approval of the respective National Authority (Drug Regulatory Authority, Ministry depending on the country). The necessary process needs to be clarified in advance with the local partner.

Research Clearance Certain countries require a research clearance for expatriate and/or visiting scientists. If such clearance is required in a country, researchers have the obligation to assure such approval is obtained in a timely manner from the respective national authorities.

Study Insurance Depending on the type of research and the local regulations, a special study insurance covering any harm to the participant may be necessary; HSR Desk can provide support.

Please note • For existing biospecimens, e.g. those stored at Swiss TPH, that may be re-evaluated or used in a new study, current international guidelines and literature require acquisition of a new ethical clearance and consent from the participant (certain exceptions may exist).

• Current international guidelines and literature require the destruction of samples after the completion of a study. The time point of destruction should be defined in the study protocol and be mentioned in the patient information – from a pragmatic point of view we suggest publication of the final study report or the major publication of the respective project as an optimal time point for sample destruction. We further suggest to consider in each project to integrate a separate general research consent allowing the future use of collected samples.

• In Switzerland, Ethics Committees are organized by region; the responsible Ethics Committee is defined by the domicile of the investigator. In case of a multicenter-study, the Lead Ethics

Committee (where the Principle Investigator is domiciled) informs the other Ethics Committees where the study will be conducted, so only one submission is necessary.

• When preparing your documents, please consider “good documentation practice” for the proposal and all ancillary documents. The following details should appear on each page (e.g.) in the header: o Short running study title (Study Acronym) o Version-nr and date of protocol (e.g. Protocol v1.0_15.04.2019 -

=> use 0.x for drafts; use Ver 1.0 for the first submission to ethics committee

The following details should appear on each page (e.g. in the footer): o Clear page numbering e.g. X of Y or X/Y o For study-related documents which have their own version-nr and date, the version-nr. and date of the protocol have to be added; example: for the “Patient Information and Consent (PIC)” – document:

PIC,v1.0/1.04.2019referringto protocolv1.0/15.04.2019

• For studies involving humans, add the copy of your signed PhD / Master Proposal Cover Page at the beginning of your proposal (Principal investigator and/or supervisor, student, statistician, if applicable other key persons to the project. Only collect the signatures on the final document version (i.e. after FK clearance for PhD students)

• Before submitting your dossier via the BASEC platform (Swiss ethics electronic submission platform) to the corresponding Swiss Ethics Committee (in general EKNZ) your cover letter attached to your submission dossier must be signed by: • Your supervisor • and co-signed by Prof. Daniel Paris, Medical Director at Swiss TPH (clinical trials) OR Prof. Christian Burri, Head HSR Desk at Swiss TPH (studies other than clinical trials) • Please use the correct Swiss TPH letter template (from intranet) with the contact details of your supervisor (but not your private address) • Indicate the Swiss TPH invoice address and recipient in the letter

• Please list your project in the Swiss TPH project database accessible through Swiss TPH intranet (responsibility of the Project Leader / Supervisor)

• International registration is mandatory for clinical trials: Swiss TPH has an account with clinicaltrials.gov for registration of clinical trials. Prof. Christian Burri is the Swiss TPH administrator; please contact him to obtain access for study registration (prior recruitment of 1st participant). Other official registries may be chosen if needed.

• The Swiss TPH has a US OHRP registration number, which is available at the HSR Desk if required (e.g. NIH grants, Bill & Melinda Gates Grants, US FDA registrations).

Swiss TPH Human Subject Research –Desk (HSR-Desk) & Ethical Submission Procedure in Switzerland

Action Responsible

First contact with Swiss TPH HSR-

Desk (hsr-desk@swisstph.ch) Project Leader or Student

~ 5 working days

Feedback on “risk category” of project and instructions on the documents to be prepared (according to BASEC Document Matrix)

HSR-Desk Team Details

Describe your request/study idea and attach your project proposal or synopsis if already available

•Is an ethical clearance necessary or an “ethical exemption” sufficient? •Definition of risk category •Which documents have to be prepared?

Preparation of documents, sending them to HSR-Desk for review

Project Leader or Student

Check of documents

HSR-Desk Team (+ Medical Director for clinical trials)

Documents ok Documents not yet ok

Revision of documents according to feedback of HSR-Desk

Forward Ethics Committee(s) approval to Project Leader

Project Leader or Student

Ready for submission

Create an account on BASEC platform https://submissions.swissethics.ch/en/ user/login

Upload HSR Desk approved documents •Create an account in BASEC and upload your documents •You will receive an automatic confirmation of your uploaded dossier by email

EC Approval or request for changes and invoice will be sent to HSR-Desk that will forward documents to Project Leader

Project Leader or Student

(e.g. Feedback from EKNZ ~ 4 weeks after submission date)

Ethics Committee(s) Approval

HSR-Desk Team

Please note: The HSR-Desk is provided by Swiss TPH / Department of Medicine Contact info: T: 061 284 89 60 (Monique Vogel) / Email: hsr-desk@swisstph.ch Feedback to Project Leader or Student, ≤ 5 working days

If documents ok for submission: •Get cover letter signed by Prof.

Daniel Paris (Medical Director) for clinical trials / Prof. Christian Burri (Head HSR-Desk) for all other studies •PL signs cover letter (not student) •HSR-Desk sends detailed instructions uploading of documents on BASEC platform

V09/23.07.2019