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| Semester | spring semester 2021 |
| Course frequency | Every spring sem. |
| Lecturers | Christian Burri (christian.burri@unibas.ch, Assessor) |
| 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 a first block, all basic topics will be taught. Students will then have time to prepare / refine their MSc proposals (including study protocols and related documents). In the second block the major points will be repeated in a practical approach, FAQs asked to StudySec presented and questions asked by the students discussed. Each student with research involving human subjects (HSR) will individually bring their documents to the attention of the StudySec and get personalized advice. Students working on topics which do not involve HSR will write a mock documentation. Content: Research ethics and history, Good Clinical Practice, Existing guidance and regulations for the various types of research involving humans, 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, Swiss TPH policy of ethics clearance (best practice approach – double clearance), Swiss TPH Study Secretariat, Swiss legal system on human research, Risk based documentation in Switzerland; documents required and formats, Additional documents required in other settings, Submission to EKNZ, Submission to other ethics committees, Reporting obligations Additional Lecturer: Aita Signorell, aita.signorell@swisstph.ch |
| 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 - pre-reading |
| Comments | Hybrid - if possible Methods: Frontal teaching with short exercises (day 1), individual feedback and consulting on homework submitted (day 2) Dates: 7 May 2021 (all day) & 28 May 2021 (morning); homework assignment online participation possible |
| 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 07.05.2021 | 09.00-17.00 | - Online Präsenz -, -- |
| Friday 28.05.2021 | 09.00-12.30 | - Online Präsenz -, -- |
| 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 | Preparation of a selected documents / parts of documents needed for Ethics committee submission, based on a mock study |
| 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 |