Basic↦Ethics and Laws↦Human Research Ordinance↦Projects with Data and Biological Material
What is it? Why is it important?
In these research projects, the Human Research Ordinance (HRO) regulates the prospective collection of Biological Material (BM) and Health-Related personal Data (HRpD) from participants in order to:
- Answer a scientific question
- Make the data/samples available for reuse at some later date in order to answer a research questions
The regulatory requirements of these projects are defined under chapter 2 of the HRO.
Research projects are categorised based on risk-category into:
- Category A, which:
- Entails only minimal risks and burdens; or
- Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria
- Category B, which:
- Entails more than minimal risks and burdens; and
- Is not recognised as standard as specified under category A
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In particular, minimal risks and burdens may be associated with:
- Surveys and observations
- Peripheral venous or capillary blood sampling and skin punch biopsies of limited extent
- Non-invasive interventions removing or collecting bodily substances, in particular, saliva, urine and stool samples
- Taking swabs
- Magnetic resonance imaging scans without a contrast medium
- Ultra-sound examinations or electrograms
- Accompanying examinations involving ionising radiation, provided the effective dose is below 5 mSv per research project and person concerned, without using a contrast medium and:
- The radiopharmaceutical is used in accordance with authorisation or are exempt from authorisation, or
- Using an authorised MP in accordance with instructions for use
What do I need to do?
As a project leader:
- Categorise the project based on expected risks and burdens
- Provide insurance coverage for category B projects
- Submit the project to the Ethics Committee (EC) / FOPH for approval
- Set-up a database which guarantees data protection, quality, traceability, and data confidentiality (e.g. data coding, access, data protection act)
- Define IC procedures (e.g. participant information and recruitment). Ensure project participant are informed about their rights (e.g. information regarding their health, revocation of consent, genetic testing)
- Plan safety procedures during study conduct (e.g. risk-control measures, notification of serious events)
- Comply with notification requirements (e.g. protocol amendments, project completion or discontinuation)
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Ensure to adhere to notification procedures, such as:
- Serious events including safety and protective measures
- Project completion or discontinuation
Multi-centre projects:
- Ensure appropriate agreements are in place between project leader and participating site(s), such as data / sample transfer agreements – DTA / MTA).
In case of research projects involving ionising radiation, additional documents must be submitted to EC. If products are not used according to instruction, not authorized, or have no conformity marking, additional documents must be submitted to the FOPH.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Templates and checklists
- Study protocols / Research projects with persons
References
HumRes: Coordination portal for human research in Switzerland
Swiss Law
HRO – see in particular articles and chapters / sections
- Art. 5 Storage of HrPD and BM
- Art. 6 Research project purpose
- Art. 8 Participant right to information
- Art. 7 Categorisation and definition of minimal risks and burdens
- Chapter 2, section 2. Authorisation procedures
- Chapter 2, section 3. Notification and reporting