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| Semester | spring semester 2024 |
| Course frequency | Every spring sem. |
| Lecturers |
Christian Burri (christian.burri@unibas.ch, Assessor)
Aita Signorell (aita.signorell@unibas.ch) |
| Content | Description The course will prepare the students to be able to submit their Master Thesis and future research projects to ethics committees (in general, with particular reference to EKNZ). In the first block, all basic topics will be taught. The homework assignment will consist of the preparation of selected parts of a study protocol / informed consent for Ethics committee submission, based on a mock study In the second block the submitted homework assignments will be discussed and reference made to daily practice; followed by a short repetition of major points Detailed content: • Basics of research ethics and its practical implications for the set-up and conduct of a research project involving humans • Existing guidance and regulations for the various types of research involving humans, with a special focus on the Swiss legal system on human research • Discussion of special situations of interest (research in low resource settings, vulnerable populations) • Risk assessment and risk based project management • Functioning and duties of ethics committees • Communication with ethics committees • Documentation required for ethics clearance of a project in Switzerland • Additional documents required in other settings • Submission to EKNZ • Submission to other ethics committees • Reporting obligations • Swiss TPH HSR Desk |
| Learning objectives | Know the basics of research ethics, know the basics of good clinical practice and general guidelines, know the composition, duties and functioning of an ethics committee, know the Swiss legal system for research (including ethical requirements), know the content of ethics committee proposals, know the process of proposal submission to ethics committees, the Ethikkommission Nordwest- und Zentralschweiz in particular, know the support function of the Swiss TPH Human Subject Research Desk (HSR Desk), be able to write a study plan (proposal, protocol and related documents) ready for submission to an Ethics Committee, know about reporting requirements in research involving human subjects |
| Bibliography | Helsinki Declaration, Version 2013 Fortaleza - detailed pre-reading required |
| Comments | Methods: Frontal teaching with short exercises (day 1), individual feedback and consulting to groups on homework submitted (day 2) Workload: 9 lessons, 15 – 20 hours of homework assignment |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Course auditors welcome |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| Block | See individual dates | ||
| Date | Time | Room |
|---|---|---|
| Friday 03.05.2024 | 09.00-17.00 | Swiss TPH Neubau, Seminarraum 4 |
| Friday 24.05.2024 | 09.00-12.30 | Swiss TPH Neubau, Seminarraum 4 |
| Modules |
Courses: Master Infection Biology (Master's Studies: Infection Biology) Doctorate Science Epidemiology: Recommendations (PhD subject: Epidemiology) Module: Transferable Skills and Competences (Master's Studies: Epidemiology) |
| Assessment format | continuous assessment |
| Assessment details | Participation in lectures and homework discussion Satisfactory homework assignment (rectification may be required if classified as unsatisfactory); submission of homework Fri 17 May 2024 12:00 (CEST) |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | no repeat examination |
| Scale | Pass / Fail |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Science, studiendekanat-philnat@unibas.ch |
| Offered by | Schweizerisches Tropen- und Public Health-Institut |