HRA Organisation Ordinance (OrgO-HRA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 1 Composition
1 The research ethics committee (ethics committee) shall be composed at least of: a. persons possessing expertise in the following disciplines: 1. medicine, 2. psychology, 3. nursing, 4. pharmaceutics or pharmaceutical medicine, 5. biology, 6. biostatistics, 7. ethics, 8. law, including data protection, 9. information technology in the health sector; and b. one or more persons representing patients. 2 It shall be of balanced composition as regards gender and professional groups. 3 The ethics committee must be able to draw on knowledge of local conditions in the various areas of responsibility. 4 If the ethics committee lacks the expertise required for the assessment of a research project, it must call in external specialists.
Para. 1 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324).
Art. 2 Requirements for members
1 Members of the ethics committee must, on commencing their service, attend a course on the duties of the ethics committee and the fundamentals of the assessment of research projects, and must regularly undergo further training in this area. 2 The members specified in Article 1 paragraph 1 letter a numbers 1–3 must have experience in the conduct of research projects.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324).
Art. 3 Scientific secretariat
1 Persons working for the scientific secretariat must have: a. a higher education degree; b. adequate training in Good Clinical Practice; c. a knowledge of scientific methods for human research projects; and d. a knowledge of the legal requirements governing human research. 2 The scientific secretariat shall be staffed at a level that is sufficient: a. to ensure its availability for the committee and for applicants; and b. to guarantee that procedural deadlines are met.
Para. 1 let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324).
Art. 4 Recusal
1 Members of the ethics committee shall recuse themselves from cases in which: a. they are personally involved, or otherwise have a personal interest, in the research project; b. persons reporting to them, to whom they report, or with whom they have close personal ties, are involved in the research project; or c. they are an interested party for other reasons. 2 Members who are interested parties must not participate in deliberations or in decision-making on the matter in question.
Art. 5 Regular procedure
1 The ethics committee shall make decisions under the regular procedure with the participation of at least seven members. The composition of this group shall be such as to guarantee an expert and interdisciplinary assessment of the application. 2 Decisions shall be taken after oral deliberations. In justified exceptional cases, it is permissible for proceedings to be conducted in writing; a member may at any time request oral deliberations. 3 Decisions of the ethics committee shall be made by majority vote. In the event of a tie, the chair or vice-chair shall have a casting vote. 4 The provisions of Articles 6 and 7 are reserved.
Art. 6 Simplified procedure
1 The ethics committee shall make decisions with the participation of three members on: a. Category A clinical trials, as specified in Article 19 paragraph 1, Article 20 paragraph 1, Article 49 paragraph 1 and Article 61 paragraph 1 of the Ordinance of 20 September 2013 on Clinical Trials (ClinO), provided that the trial does not raise any particular ethical, scientific or legal issues; abis. clinical trials in Subcategory A1 as referred to in Article 6 paragraph 2 letter a and Article 6a paragraph 1 letter a of the Ordinance of 1 July 2020 on Clinical Trials of Medical Devices, provided the trial does not raise any particular specific ethical, scientific or legal issues; b. Category A research projects involving persons, as specified in Article 7 paragraph 1 of the Human Research Ordinance of 20 September 2013; bbis. research projects involving existing biological material and existing health-related personal data in accordance with Articles 32 and 33 HRA, if they raise particular eth
Para. 1 let. a — Amended by Annex No 3 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 1 let. a — SR 810.305 Para. 1 let. abis — Inserted by Annex 2 No 3 of the O of 1 July 2020 on Clinical Trials on Medical Devices (AS 2020 3033). Amended by Annex 2 No 3 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 let. abis — SR 812.213.3 Para. 1 let. b — SR 810.301 Para. 1 let. bbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS
Art. 7 Decisions to be made by the chair
1 The chair or vice-chair of the ethics committee shall make decisions on: a. research projects involving existing biological material and existing health-related personal data in accordance with Articles 32 and 33 HRA if they do not raise any particular ethical, scientific or legal issues; b. substantial modifications to an approved research project if they do not raise any particular ethical, scientific or legal issues; c. whether the requirements concerning local conditions in multicentre research projects are met; d. refusal to consider incomplete applications; e. the cancellation of applications which are no longer relevant or have been withdrawn; f. the fulfilment of conditions imposed; g. the ordering of official measures as specified in Article 48 HRA. 2 He or she may at any time order the adoption of the simplified or regular procedure.
Para. 1 let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324). Para. 1 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324).
Art. 8 Obligation to retain documents and right of inspection
1 Application documents submitted to the ethics committee, minutes of meetings and correspondence must be retained for ten years after the completion or premature termination of a research project. 2 The cantonal supervisory authority may inspect these documents.
Art. 9 Notification requirements
The cantonal supervisory authority shall notify the coordination office as specified in Article 10 of the responsible ethics committee.