Questions of Copyright

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LETTER TO THE EDITOR

Open Access

Questions of Copyright Caroline Anfray1*, Marie-Pierre Emery2, Katrin Conway2 and Catherine Acquadro2

Abstract The Berne Convention and the national laws on intellectual property fully apply to PRO instruments. The identification of and access to an original PRO instrument is often associated with copyright ownership. This is the copyright holder of the instrument who will control its access (distribution and reproduction), its adaptation or modification, and its translation. Copyright is a means to protect the integrity of an instrument. The ownership of an instrument should be defined in the beginning between all parties involved, and each step of the instrument’s life, including distribution, should be anticipated for purpose of copyright. Keywords: Patient-Reported Outcomes, Patient-Reported Outcome Measures, Copyright, Intellectual Property

Correspondence Recently, the editors of this journal kindly suggested that a brief editorial on the subject of Copyright might be more useful than the comprehensive article on the subject that we had previously submitted. This is our response to their proposal. We all understand copyright - or do we? According to the Oxford English Dictionary, copyright is: “The exclusive legal right, given to an originator or an assignee to print, publish, perform, film, or record literary, artistic, or musical material, and to authorize others to do the same.” No one has a legal right to do anything with any original production unless authorized to do so by its originator or an authorized deputy. This includes simple copying, quotation, or manipulation of any kind. It is worth mentioning at the outset that of a total of some 2,300 requests for information on PatientReported Outcomes (PRO) measures received by MAPI Research Trust in 2009, a not-for-profit company, 90% of the questions concerned copyright. The requests were submitted by developers and users of PRO measures as well as publishers. At various occasion, the Trust has presented a review of the major international instrument on the topic (the * Correspondence: [email protected] 1 MAPI Institute, 27 rue de la Villette, 69003 Lyon, France Full list of author information is available at the end of the article

Berne Convention for the Protection of Literary and Artistic Works) to help in the exercise of copyright [1-3]. In 2009, Anfray published a discussion about the controversy between Juniper and Grammatopoulou on the 18-item version of the AQLQ(S) [4]. It was at this occasion that Revicki and Schwartz [5] made a clarification of a subject that is more complicated than it first appears. In their editorial, they detail important reasons for developers to exercise their rights. In particular, “the maintenance of the scientific integrity of the copyrighted instrument which will ensure researchers and readers of scientific journals that the study used the correct version and that there is evidence supporting the psychometric qualities of the instrument.” In the light of the recent FDA guidance