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Published on: February 19, 2021
Patient-reported outcomes instruments: bridging the gap between international copyright laws and common practice for
1MAPI Research Trust, 69003 Lyon, France. canfray@mapigroup.com
Summary
Copyright law protects authors
Area of Science:
- Health Services Research
- Intellectual Property Law
- Medical Informatics
Background:
- Patient-reported outcome (PRO) instruments are crucial in clinical research.
- Disputes over copyright for PRO instruments can hinder their use and development.
- The Asthma Quality of Life Questionnaire controversy highlights these challenges.
Purpose of the Study:
- To explain international copyright basics relevant to PRO instruments.
- To detail the specific dispute regarding the Asthma Quality of Life Questionnaire.
- To analyze the case and offer recommendations for developers and users.
Main Methods:
- Review of international copyright law, focusing on the Berne Convention.
- Analysis of a specific copyright dispute involving a PRO instrument.
- Examination of experiences as a PRO instrument distribution center.
Main Results:
- International copyright laws, like the Berne Convention, apply to PRO instruments.
- The Asthma Quality of Life Questionnaire dispute exemplifies common copyright challenges.
- Misunderstandings often stem from poor communication between PRO instrument developers and users.
Conclusions:
- Clear communication protocols are essential to prevent copyright complications with PRO instruments.
- Adherence to copyright principles ensures fair use and protects intellectual property.
- Proactive engagement between developers and users can resolve potential disputes.
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