USE OF PRO INSTRUMENTS- COPYRIGHT ISSUES

Author(s)

Marie-Pierre Emery, MSc, Information Resources Centre Director, Caroline Anfray, MA, Project manager Mapi Research Trust, Lyon, France

OBJECTIVES: To meet the continuing demand for PRO instruments in clinical research and practice more and more PRO instruments are being developed. Although the prerequisite for international pooling and comparison of data is an identifiable original instrument and an official translation in a given language, this is not always the case. The need to modify instruments and the emergence of item banks make it difficult to identify an original instrument and the access to it is complicated as international copyright law is not sufficiently clear on this point. The objective of this abstract is to review the issues encountered by our distribution centre when disseminating instruments and their translations in collaboration with their developers and to provide recommendations for those who wish to develop an instrument, access it, use and/or modify it. METHODS: To establish recommendations we proceeded as follows: (1) review of all requests to access, use and/ or modify an instrument or its translations, (2) classification of requests and (3) recommendations. RESULTS: Out of the 2679 requests concerning PRO instruments in 2006, 6 types of questions emerge :what are the conditions to (1) access; (2) translate ; (3) reproduce; (4) use in e-application ; (5) modify ; (6) use selected items of a given instrument. In response to this international copyright law needs to be interpreted and solutions for conflicting laws across countries must be found. Concrete examples will be provided in the presentation. CONCLUSION: Despite its importance for clinical research the identification of and access to an original instrument and its translations is not easy. This is complicated by the emerging need to modify instruments and the absence of clear indications by international copyright law. Our findings indicate the importance of questionnaire distribution centres as a step in the direction of solving copyright issues.

Conference/Value in Health Info

2007-05, ISPOR 2007, Arlington, VA, USA

Value in Health, Vol. 10, No.3 (May/June 2007)

Code

PMC18

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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