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Health Data Ethics & Regulatory Frameworks in Rare Disease Research

Discover the role of health data in rare disease research, exploring the ethics and regulatory frameworks governing data use.

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Health Data Ethics & Regulatory Frameworks in Rare Disease Research

401 enrolled on this course

  • 4 weeks

  • 3 hours per week

  • Digital certificate when eligible

  • Open level

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  • Duration

    4 weeks
  • Weekly study

    3 hours
  • 100% online

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Empower ethical health data practices in rare disease research

Research can illuminate our understanding, treatment, and support for those affected by rare diseases. But how can we ensure rare disease research is conducted with integrity?

On this online course from the Foundations for Rare Disease Research, you’ll gain essential insights to confidently manoeuvre through the complex realm of rare disease research and feel confident to ethically and effectively apply these theoretical concepts in practice.

Discover more about the rare disease landscape by understanding data and data management tools

In the first week of this course, you’ll lay the foundations, defining rare diseases and data types and their respective challenges. 

You’ll learn about data sources and how to utilise patient registries for data collection. By the end of week two, you’ll be able to confidently explain FAIR principles and the data life cycle.

Understand the importance of data protection and ethical data handling

Recognize the diverse actors and frameworks involved in data processing activities, ensuring adherence to ethical and regulatory standards. 

Apply what you’ve learned from researcher and patient perspectives and effectively implement ethical data handling practices in real-world scenarios.

Feel supported by experts from data scientists to clinicians

Developed under the European Joint Programme on Rare Diseases, this expert-guided course will allow you to meet clinicians, researchers, patient advocacy groups, as well as individuals working on European infrastructure and regulation.

Interested in learning more? Expand your skillset further by taking Foundations for Rare Disease Research’s From Lab to Clinic: Translational Research for Rare Diseases.

Syllabus

  • Week 1

    Introduction

    • Welcome & introduction

      In week1, you will explore the different types of research data and sources, understand the relevance of health data in rare disease research, and tackle the related challenges and the strategies for overcoming them.

    • Setting the scene

      In this subactivity, you will be introduced to the definition and context of rare disease. You will also learn about the different types of data and their sources, as well as their different applications.

    • Data sources and patients' registries

      In this section, we will explore the various data resources and how data is encoded to improve its management and operability. We will focus specifically on patients' registries and their role in rare disease research.

    • Opportunities and challenges to use data in rare disease research

      What makes data crucial in the realm of rare diseases? What are the primary obstacles and advantages that arise from the sharing of data, especially in this particular field?

    • Test your knowledge

      What have you learnt and understood this week? Test your knowledge with a multiple choice quiz and reflect on the week's content.

  • Week 2

    Handling health data for rare disease research purposes

    • Introduction to week 2

      In this week we will discuss data collection and processing in rare disease research. You will also get introduced to the FAIR principles, the data life cycle, the Orphanet nomenclature and to several key data resources.

    • How to collect and manage health data

      What is meant by processing data? Why is this a critical process? What concrete actions should be taken during data processing? What are its specific challenges in the context of rare disease?

    • FAIR principles and data life cycle

      The FAIR principles, standing for Findability, Accessibility, Interoperability, and Reusability, provide guidelines for enhancing the management and sharing of digital data.

    • Platforms and tools to collect and manage health data

      Explore Orphanet nomenclature, Orphacodes, and their role in data interoperability and management. Discover key data resources for research like the EJPRD Virtual Platform.

    • Check your knowledge

      What have you learnt and understood this week? Test your knowledge with a multiple choice quiz and reflect on the week's content.

  • Week 3

    Ethics and regulatory considerations

    • Introduction to week 3

      The focus of this week will revolve around three key subjects: the laws governing data protection, the ethical considerations, and the regulatory factors involved in handling health data for research purposes.

    • Data protection framework

      What is the EU GDPR? What rights EU GDPR assigns to data subjects? How does it govern data ownership, access, and sharing?

    • Ethics considerations

      Here we explore the concepts of consent procedures and ethics approval. You will get introduced to the challenges related to (genetic) data sharing in rare diseases and the rights granted when the data subjects are children.

    • Regulatory considerations

      Here we discuss how real world data is used for regulatory purposes, with a special focus on RD research. The challenges related and possible solutions are illustrated. Research tools and EMA-qualified methods are also presented.

    • Check your knowledge

      What have you learnt and understood this week? Test your knowledge with a multiple choice quiz and reflect on the week's content.

  • Week 4

    How it works in practice

    • Introduction to week 4

      In this week, we will explore the aspects that different parties involved should consider when handling, collecting, or sharing data: researchers, clinicians, patients, regulatory authorities and industry.

    • I am a researcher: what should I pay attention to when processing rare diseases data?

      With the expert guidance of Prof. Schaefer and Dr. Cornet, we will delve into the difficulties that researchers meet when attempting to fully maximize the capabilities of data in rare disease research and how they can be ovecome.

    • I am a clinician: what is my role in making sure data will be fit and accessible for research?

      How can clinicians ensure data is collected for research in a usable and accessible manner? How can they address challenges related to data fragmentation? How a biobank works? How is information shared with patients?

    • I am a patient: how can I contribute and access information?

      Here we will explore how patients’ participation and engagement in research and healthcare delivery can be ensured by acknowledging and fulfilling their desires and needs.

    • Regulatory authorities: what is their role in processing data?

      Here we will explore how EMA (the European Medicine Agency) processes and utilizes health data to undertake studies that support EMA decisions, as well as the EMA ongoing activities in the data and rare disease fields.

    • Industry: what is their role in processing data?

      How is data used in the pharmaceutical industry? How industry approaches health data research, by ensuring the ethical use of patients’ data and by complying with the EU GDPR? What are the challenges faced related to RD data use?

    • Check your knowledge

      What have you learnt and understood this week? Test your knowledge with a multiple choice quiz and reflect on the week's content.

When would you like to start?

Start straight away and join a global classroom of learners. If the course hasn’t started yet you’ll see the future date listed below.

  • Available now

Learning on this course

If you'd like to take part while our educators are leading the course, they'll be joining the discussions, in the comments, between these dates:

  • 6 May 2024 - 28 Jun 2024

On every step of the course you can meet other learners, share your ideas and join in with active discussions in the comments.

What will you achieve?

By the end of the course, you‘ll be able to...

  • describe the different types of research data and identify data sources
  • explain the importance of health data for rare diseases research
  • identify the different actors involved in the data processing activities
  • identify the main challenges related to the use of health data in research and how they could be overcome
  • discuss the role of data sharing and its benefits
  • explore the ethics, regulatory and data protection framework governing health data processing
  • identify the main existing resources for the use of health data
  • present the different perspectives of the main subjects involved in the data processing activities for research purposes

Who is the course for?

This course is designed for anyone interested in health data research and rare diseases, such as undergraduates, PhD students, healthcare professionals, researchers, and enthusiasts keen on understanding ethics and regulatory frameworks in this field.

Who will you learn with?

I am a Research Policy and Initiatives Director at EURORDIS, Rare Diseases Europe. Since 2019, I have been involved in the development of several MOOCs as part of the EJP RD.

I'm a passionate biomedical researcher and regulatory scientist since my PhD and deeply invoved in rare diseases both for my professional and personal life

PharmD. II level Post graduate Master in Regulatory Science. Researcher at Gianni Benzi Foundation.

As a project manager for ERN EpiCARE I believe strongly in the power of collaboration and innovation & I'm dedicated to making a meaningful impact in the lives of those affected by epilepsy.

I'm a research project manager passionate about neuroscience. Since 2019, I am dedicated to epilepsy disorders and thus is in charge of the research activities of the ERN EpiCARE and ECET.

Scientific projet manager at Fondation Maladies Rares. I coordinate the development of this and other MOOCs within the European Joint Programme on Rare Diseases.

Who developed the course?

Foundation for Rare Diseases

The Foundation for Rare Diseases is coordinating a series of courses on rare diseases research topics within the context of the European Joint Programme on Rare Diseases. The first course will address research issues related to diagnosis in the rare diseases context.

European Joint Programme on Rare Diseases

The European Joint Programme on Rare Diseases (EJP RD) brings over 130 institutions (including all 24 ERNs) from 35 countries to create a comprehensive, sustainable ecosystem allowing a virtuous circle between research, care and medical innovation.

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Choose the best way to learn for you!

Subscribe & save

$244.99 for one whole year

Automatically renews

Develop skills to further your career

  • Access to this course
  • Access to 1,000+ courses
  • Learn at your own pace
  • Discuss your learning in comments
  • Digital certificate when you're eligible

Cancel for free anytime

Buy this course

$134/one-off payment

Fulfill your current learning need

  • Access to this course
  • Learn at your own pace
  • Discuss your learning in comments
  • Printed and digital certificate when you’re eligible

Limited access

Free

Sample the course materials

  • Access expires 24 Jun 2024

Find out more about certificates, Unlimited or buying a course (Upgrades)

Sale price available until 3 June 2024 at 23:59 (UTC). T&Cs apply.

Find out more about certificates, Unlimited or buying a course (Upgrades)

Sale price available until 3 June 2024 at 23:59 (UTC). T&Cs apply.

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