Engaging patients: Informed consent forms - ECCRT

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Engaging patients in the development of informed consent forms

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About this course

Reasons to attend

ECCRT and EUPATI have collaborated to create this course on the importance of patient engagement in the development and use of informed consent forms in clinical trials and other clinical research.

Informed consent forms is a critical component of clinical research. It's essential that patients understand the potential benefits and risks of participating in a study before they agree to take part. However, informed consent forms can be lengthy and complex, making it difficult for patients to fully understand what they're signing up for. That's why it's crucial to engage patients in the development of informed consent forms.  

This course will teach you how to involve patients in the informed consent process, so they can provide valuable feedback on the language, format, and content of consent forms. You'll learn how to create consent forms that are clear, concise, and easy to understand for patients of all backgrounds. 

What's included?

  • Documents and materials related to this course are included
  • Globally recognised certificates awarded after test completion

Course schedule

We provide this course in two distinct formats: Classroom OR Online

Classroom:

1-Day face-to-face: 09:00 - 17:00

Online:

2 webinar sessions of 3hours


Course Description

One of the critical ethical considerations in clinical research is obtaining informed consent from participants, which involves providing them with all the necessary information about the study, its risks and benefits, and their rights and responsibilities. 

Developing clear and concise informed consent forms (ICFs) that effectively communicate the study information to participants is a challenging task. In many cases, ICFs are lengthy, complex, and difficult to understand, which can lead to participant confusion and lower recruitment and retention rates. Therefore, involving patients in the development of ICFs can improve their clarity, readability, and relevance to participant needs and preferences. 

This course is designed to equip clinical researchers, research coordinators, and patient advocates with the knowledge and skills to engage patients in the development of ICFs. The course will cover the following topics: 
  1. Legal aspects of the informed consent form 
  2. The importance of patient involvement in ICF development 
  3. The principles of patient-centeredness and health literacy in ICF development 
  4. Methods for engaging patients in ICF development 
  5. Techniques for incorporating patient feedback into ICF revisions 
  6. The differences between Paper vs. Digital ICF  
  7. Cases from daily practice 

The course will be delivered through a combination of interactive lectures, case studies, group discussions, and hands-on exercises. Participants will have the opportunity to practice patient engagement techniques and receive feedback from instructors and peers.

By the end of the course, participants will have gained the knowledge and skills to effectively engage patients in the development of ICFs, improve participant comprehension and satisfaction, and enhance the ethical conduct of clinical research. 

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