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).
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