Course description

Human research includes more than clinical trials: It also covers observational studies. Those are regulated under the Human Research Ordinance (HRO), an implementing ordinance of the Swiss Human Research Act (HRA). They are therefore referred to as HRO projects. HRO projects are based on the collection or further use of biological material and/or health-related personal data and account for almost 80% of authorisation applications submitted to Swiss ethics committees. As the range of possible projects is large, it is often challenging to keep track of qualitative, regulatory and legal requirements.

This lunch seminar series offers compact overviews with room for questions on important topics related to HRO projects. As researcher, you can shape the focus of the individual sessions by submitting your specific questions in advance. This ensures that the seminars are tailored to your needs.

Do you have questions about your HRO project? Register for one or more of the dates below to receive brief and concise information on each topic - "HRO in a nutshell", so to speak.

Course structure

Online seminar series with four 1-hour sessions over lunchtime, covering one main topic each. Sessions can be booked individually.

Recommended reading

Preparation for the semianar series is not necessary.

If you wish to learn about the specifications of HRO you might consider completing the online course "Human Research Beyond Clinical Trials: Conducting HRO Projects".

Course dates

The first series of the HRO lunch was received very well, and the list of important topics is still long – we are thus currently preparing the second series of the HRO lunch.

The next four sessions will take place between September and December 2024 and will cover the topics BASEC, consent, data sharing and biobanking. More information will be available soon.

Location

Online via zoom. You will receive the respective login information after registration.

Target audience/prerequisites for attending

Main focus groups are researchers, project leaders and study personell with planned, ongoing, or completed HRO projects. Especially those who have questions about BASEC, consent, data sharing or biobanking. This includes project leaders and students with Master or Doctoral theses whose projects are observational studies. In general, the sessions are open to everybody who is interested in learning about HRO projects.

Learning objectives:

Upon participation in this seminar series, participants will

• know in detail how to submit an HRO project in BASEC and which documents are needed,
• be aware of the specificities of general consent and other aspects of informed consent for HRO projects,
• know about best practices and necessary contracts when it comes to data sharing,
• have insights into the essentials of biobanking for HRO projects.

Assessment format

n/a

Study direction

Verena Golz, PhD
Training and Education, Department of Clinical Research

The seminar series is developed by the SCTO Education Platform.

Speakers

Experts from the respective areas. For details, please see the individual dates and sessions.

Contact

Verena Golz, PhD
Training and Education, Department of Clinical Research

Costs

Free-of-charge

Miscellaneous

Seminar language is English.

A certificate of attendance will be issued after participation if you have registered for the session.

Registration

will follow shortly

Ethics approval (27 March 2024)
Further information and presentation slides can be found here.

Data governance and protection (17 April 2024)
Further information, session recording, presentation slides and Q&A can be found here.

Registries and biobanks (08 May 2024)
Further information, session recording, presentation slides and Q&A can be found here.

Project quality (29 May 2024)
Further information, session recording, presentation slides and Q&A can be found here.