240516_overview-data-registries_biobanks_v2.0.pdf

Overview of the different types of Data-registries/Biobanks1 Registry/biobank Consent Protocol of the Does the data- Submit the data- Cave Example Research project research project registry/biobank registry/biobank fall within the to the Ethics scope of HRA Committee? Routine data/samples2 General None. No Optional. The data/samples Swiss feed into a Consent may not yet be Stroke registry/biobank. There is no research The ethics used for Registry. question. committee can give research3. There is no research an advice as per question. Article 51 lit 2 HRA. Routine data feed into a No consent None. No No The data may not Evaluating registry at the required be used for triage of hospital/clinic for quality There is no research research. patients in assurance and quality question. an control studies4. emergency department. Data are not used for research, and won’t be used for research in the future.

1 For simplicity, it is here assumed that data or samples flow into a registry or biobank in coded form. The storage of data/samples in an uncoded form would be an

exception that would have to be clearly justified in the registry/biobank regulation. In principle, a consent from the participants/donors is always required: If there is any doubt about the need to obtain the consent from the participants/donors for a particular registry or biobank, it is strongly recommended that the ethics committee be contacted before establishing the registry or the biobank. An exception to this is if the registry is requested by the FOPH and the data won’t be used for research purposes. Additional information is available on swissethics.ch / Topics / Biobanks and data registries (link). Please see in particular the guidance document “Guiding principles for registries in human research” available in German and French. 2 Samples = biological material. 3 If research question is planned in the future, the Data registry/Biobank must fulfil the requirements set by HRO for further use research projects. 4 Refer to the swissethics guidance document « Quality assurance, or research subject to approval? When is approval by the cantonal ethics committee required,

and when not? » to distinguish between quality assurance/quality control studies, and research projects requiring ethics committee approval. The guidance is available in German, French, Italian and English.

Registry/biobank Consent Protocol of the Does the data- Submit the data- Cave Example Research project research project registry/biobank registry/biobank fall within the to the Ethics scope of HRA Committee? Routine data feed into a No consent None. No No The data may not company registry ordered required be used for by the FOPH under the There is no research research. market authorization. question.

Data are not used for research, and won’t be used for research in the future. Routine data feed into a General None. No Optional. The data may not company registry ordered Consent yet be used for by the FOPH under the There is no research The ethics research3. market authorization. question. committee can give an advice as per No samples are There is a possibility that Article 51 lit 2 HRA. collected. the data will be used for research in the future, but there is no research question yet. Routine data feed into a General HRO Yes Yes No samples are company registry ordered Consent Chapter 3 Further use HRO Art. 33 collected. by the FOPH under the of biological material market authorization. and health-related personal data for Additionally, the data is research. also used for a research question. It must be guaranteed that only routine data/samples are used.

Registry/biobank Consent Protocol of the Does the data- Submit the data- Cave Example Research project research project registry/biobank registry/biobank fall within the to the Ethics scope of HRA Committee? Routine data/samples feed General HRO Yes Yes No additional, Research into a registry/biobank for Consent Chapter 3 Further use HRO Art. 33 study-related project with a research project5. of biological material data/samples data from and health-related may be collected. the Swiss personal data for Time windows for Stroke research. visits must not be Registry. defined in the It must be guaranteed protocol. that only routine data/samples are used. Routine data/samples feed Research HRO Yes Yes The consent must Constitution into a registry/biobank. project Chapter 2 Research HRO Art. 6b clearly state the of the Additional data/samples specific involving measures procedure and Rheumatolo are collected for research informed for sampling of risks. It is gy purposes. consent biological material or described that the registry/biob form. collection of health- additional ank with a There is no research related personal data data/samples will blood question6. from persons. be collected for sample future research collection. projects.

5 In addition, it is possible that historical data or samples from other patients are included in the research project. This would be a further use of data/samples with

or without consent, which must be described in the study protocol (coding, time span, which patient collective, which consent was obtained – see protocol template for the submission of a project “further use with or without consent” published on swissethics.ch). 6 If routine clinical data or samples from the patient are also included in the data registry/biobank, this will be stated in the study-specific consent and in the study

protocol.

Registry/Biobank Consent Protocol of the Does the data- Submit the data- Cave Example Research project research project registry/biobank registry/biobank fall within the to the Ethics scope of HRA Committee? Routine data/samples feed Research HRO Yes Yes The consent must Swiss into a registry/biobank. project Chapter 2 Research HRO Art. 6a clearly state the Transplant specific involving measures procedure and Cohort Additional data/samples informed for sampling of risks. The aim of Study: are collected for research consent biological material or the research Registry purposes; there is a form. collection of health- project is with a blood research question7. related personal data explained, sample from persons. optionally with an collection. additional consent (or general consent) for future research projects.

7 In addition, it is possible that historical data or samples from other patients are included in the research project. This would be a further use of data/samples with

or without consent, which must be described in the study protocol (coding, time span, which patient collective, which consent was obtained – see protocol template for the submission of a project “further use with or without consent” published on swissethics.ch).