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 refered 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 take part every three weeks and can be booked individually.


Recommended reading

Preparation for the semianr 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

27 March 2024, 12.00-13.00,online
Ethics approval: Insights from the ethics committees
This session will provide you with insights on how to get the mandatory ethics approval for your observational study. You will learn about retrospective and prospective projects, participant information and consent, and will get practical examples on how to submit your application.

For dial-in information and to recieve a certificate of attendance after the session, please register here: Registration

 

17 April 2024, 12.00-13.00, online
Data governance and protection: How to navigate the regulatory jungle
In this session you will learn about the essentials of data procurement, governance and protection. We will talk about the most important aspects regarding the new data protection law, and will give practical insights into how data are handled at different university hospitals.

For dial-in information and to recieve a certificate of attendance after the session, please register here: Registration

 

8 May 2024, 12.00-13.00, online
Registries and biobanks: Background, obstacles and practical views
This session gives insights about common pitfalls when working with large sets of clinical patient data and biological samples. We will look at practical tips for planning projects and research questions, up to regulatory requirements and real-life examples.

For dial-in information and to recieve a certificate of attendance after the session, please register here: Registration

 

29 May 2024, 12.00-13.00, online
Project quality: Law, praxis and common hurdles
In this session you will learn about “quality in a nutshell”. We will start with the respective law and then give practical tips and examples on how to keep the quality of your project high.

For dial-in information and to recieve a certificate of attendance after the session, please register here: Registration


Location

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


Target audience/prerequisites for attending

Researchers and project leaders with planned, ongoing, or completed HRO projects. Especially those who have questions about ethics approval, data governance, project quality or registries and biobanks. This includes project leaders and students with Master or Doctoral theses whose projects are observational studies.


Learning objectives:

Upon participation in this seminar series, participants will

  • know how and where to submit an ethics approval and why this is essential,
  • be aware of the regulatory aspects of data procurement, governance, and protection,
  • know about the common pitfalls when working with big data registries and biobanks in cohort studies,
  • be able to keep the quality of their observational study high.


Assessment format

n/a


Study direction

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

The seminar series has been 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

Please see "Registration" links for each session above.