Facts and pitfalls of observational studies: How to plan and conduct HRO projects
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.
The first series of the HRO lunch was received very well, and the list of important topics is still long – thus the seminar series goes into a second round.
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.
Course dates
BASEC – A practical walk-through for HRO projects
When it comes to Swiss human research, there is no way around BASEC. In this session, we will show you how to submit an observational study and a further use project to the ethics committees in Switzerland. We will provide you with practical guidance on how to navigate the BASEC portal.
11.09.2024, 12.00-13.00, online via zoom
Please register here.
Mastering Consent: Key insights into general and informed consent for HRO projects
Many institutions implemented a general consent for human research, but there are still many open questions. We will provide an overview and clarify when general consent can be used for your research project. If a general consent is not in place or not suitable for your project, we will also discuss alternative methods for obtaining participant consent.
02.10.2024, 12.00-13.00, online via zoom
Please register here.
Data sharing and open research data – details for HRO projects
Data storage, data sharing, and contracts around data and samples – many researchers are not sure about what to handle how. In this session, we will talk about common practices, possibilities and must-knows, focussing on data storage and data sharing.
13.11.2024, 12.00-13.00, online via zoom
Please register here.
Sample management and biobanking – essentials for HRO projects
This session gives insights about the most important aspects of biobanking for HRO projects. We will look at common practices in different hospitals and talk about practical and organisational tips when setting up and maintaining biobanks.
04.12.2024, 12.00-13.00, online via zoom
Please register here.
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.
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".
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
Please click on the link below to register for the corresponding course.
Past Sessions
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.