Licensing and eCOAs: lessons learned and pending issues

Caroline Anfray - Director, Author Collaboration unit, Mapi Research Trust
Marie Dulac Trimoreau - Client services, Author Collaboration Unit, Mapi Research Trust

No one has a legal right to do anything with any original production unless he or she is authorized to do so by its originator or an authorized deputy. Clinical Outcomes Assessments (COAs), which fall under the domain of intellectual property, are covered by this copyright statement. This includes simple copying, translating, and modifying it but also implementing it electronic devices, or manipulation of any kind.
It is worth mentioning at the outset that, in 2007, of 3,000 occasions on which developers, publishers, or users of PRO instruments submitted requested for information or asked for help from the Mapi Research Trust’s PRO Information Support Team,1 38% were questions about copyright or conditions of use. The most frequently asked questions were: “Who should be contacted to get permission to use a questionnaire, an existing translation or to develop a new translation of a PRO questionnaire?” or “Who is the copyright holder?” Thirty-four percent were about practical information about the instruments with questions such as: “Is this the last version of the instrument?”, “Does the translation reflect the original questionnaire?” or “Is the translation validated?”

In 2014, the PRO Information Support Team continues to receive the same questions, except that a new parameter has appeared, i.e., the mode of data collection through an electronic device, e.g., “Is an electronic version of this instrument available?” or “Have the instrument translations been validated on an electronic device yet?” echoing the recommendations in the field.2
In 2007, the questions about electronic Clinical Outcome Assessments (e-COAs) represented just 7% of the whole requests made to our library. Today, they represent over 27% of the requests coming from the pharmaceutical industry and 18% of the requests from academia.
The Mapi team3 -as well as Revicki and Schwartz4 – has detailed, 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 FDA guidance5, the latter is of special relevance. Copyright has proven to be one of the most efficient means for developers of COAs to maintain the integrity of their instruments by controlling their access and use. The exponential use of e-COAs in international studies as well as upcoming technologies like BYOD (Bring-Your-Own-Device) have led to questions about their accessibility and licensing conditions and have made it even more necessary to establish greater protection that is specific to this new evolving environment.

A brief reminder: copyright of original COAs
We all understand copyright – or do we? According to the Oxford English Dictionary, a 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.”
Legally, a copyright is regulated by national copyright laws and the Berne Convention, covering international copyright. The Berne Convention was implemented in 1886 to protect the rights of authors in their literary, scientific, and artistic works at an international level6 in a manner as effective and uniform as possible. The Berne Convention stipulates that copyright is automatic (it belongs to the “creator” of the work; no registration or copyright notice is needed) and gives the copyright holder exclusive rights that are divided into two main categories: authorization rights and moral rights. Authorization rights include the following: translation, reproduction, adaptation, and public recitation. Moral rights are the right to claim authorship of the work (paternity right) and the right to object to any mutilation, deformation, or other modification of, or other derogatory action in relation to the work (integrity right) that would be prejudicial to the author’s honor or reputation.
For a work to be able to be copyrighted, it must be original. However, the standard for originality is very low. “Original” in this sense simply means that the work has its origin in the author. The work needs only a minimum level of creativity and owes its origin to the author claiming copyright. In other words, the use of a COA is linked to the identification of its author who shall then be the copyright owner and who is the only person entitled to grant permission. However, in some cases, the identification of the COA copyright owner can be a hurdle since an original ownership can be shared, transferred, assigned – either intentionally or not (see Table 1).
Table 1. Issues in the identification of copyright owner of an original COA

At Mapi, based on our 20-year experience in providing information, protecting, and distributing COAs, and because of the difficulty in easily identifying the copyright holder during the questionnaire life cycle, we usually recommend that the ownership of the original COA should be determined prior to the development of the work between the parties involved and stated in writing. We also recommend registering the work and including a copyright notice. Although copyright is automatic and given “de facto,” registering the work and providing a copyright notice may be of benefit for the author, specifically in the USA, where in order to sue for infringement of copyright, the work must be registered with the copyright office. The US Copyright Office’s web site is at: http://www.copyright.gov/.
In France, it must also be noted that although these protective measures would greatly benefit the author and facilitate the procedure of proof of authorship, they are not mandatory for the work to be protected by copyright. In any case, the Code de la Propriété Intellectuelle (Intellectual property Code) states in Article L.113-1 that the person whose name appears on the work in question is to be considered as the author unless there is proof to the contrary. In other words, in the event that a person contested the fact that you were the author of a work, you would not have to prove that you are, it would be for the person to prove that you are not. In legal terms, one can say that the burden of proof is on the plaintiff (the accuser) and not on the defendant.
We also recommend that the developer(s) should be the copyright holder of any derivatives of the COA. The objective is to keep control on how the COA is going to be used, translated, modified, etc. This is particular true for translations of COA.

What does the law say about the copyright of COA translations?
Translators are protected by copyright national laws. For instance, Article L. 112-3 of the French CPI stipulates that the authors of translations benefit from the same rights given to authors by virtue of the present code, without prejudice to the rights of the author of the original. On an international level, UNESCO has adopted a recommendation, which specifies that: “Member States should accord to translators, in respect of their translations, the protection accorded to authors under the provisions of the international copyright conventions to which they are party and/or under their national laws, but without prejudice to the rights of the authors of the original works translated.”7
Therefore, in the absence of any statement from the owner of the original questionnaire that he/she wants to own the copyright on translations of his/her questionnaire or of a written contract between the parties involved, the translator is the copyright owner of the translation.
One of the risks to developers who do not control the translations of their original questionnaires is the multiplication of “same language” translations (i.e., different Spanish versions of the same original). In this case, it is almost impossible to identify the “right” translation. In the context of international clinical trials, this situation can be very problematic for users and generate unnecessary delays and extra costs if a new translation should be developed. From a copyright perspective it could be possible to develop several translations for a same language and country, but in opposition, our domain requires that a translation for a given language shall be unique, in order to further its validation, and shall be shared across users for harmonization purposes and comparison of data.
That‘s why a centralized ownership has proven to be extremely efficient to protect the instrument and how it is used globally, because the its use and its users can be properly tracked. Also by keeping control in this manner, updated and reliable information on the instruments can be provided to new and former users.

Recommendations
The owner of the original COA is key in determining the future of the instrument and in protecting its integrity globally by controlling access and use. At Mapi, we recommend that ownership of translations should be centralized to the copyright owner of the original COA and this should be stated in writing.
As seen in Table 1, the situation about copyright may become even more complex depending on specific situations. For instance, in the case of a work made for hire, the employer or other person for whom the work was prepared is considered the author for purposes of this title, and, unless the parties have expressly agreed otherwise in a written contract signed by them, owns all of the rights comprised in the copyright. This area of copyright can be found under 17 U.S.C. 101.
That is the reason why for purpose of copyright, it is of utmost importance to state everything in writing as copyright may be situation-specific.

Specificities of e-COAs
E-COAs are often adapted from paper-based measures. E-COA data collection implies (a) the use of data-collection software, (b) a data-collection device, and (c) changes to the content and format of the paper version following the migration from paper to an electronic platform/device.2
In terms of copyright, e-COAs derived from paper versions are an adaptation of the original and can be considered as derivative works, like translations. Ideally the lessons learned from the copyright of translations should apply: (a) the owner of the original instrument is key in determining the future of the e-versions of his/her instrument, and (b) copyright is crucial for preserving the integrity of the measure and its e-versions.
However, some pitfalls that are specific to the e-domain exist:

Ownership is unclear – a mixing of of rights (questionnaire/device/software),
e-COAs are customized, and cannot be shared across users,
Equivalence, not only between paper and e-version, but also between e-versions, should be addressed,
There is a multiplication of e-versions for the same content
Certifications of paper versions do not apply to e-versions,
Where to find relevant information? Who should be contacted?

There has also been an increasing interest in Bring-Your-Own-Device (BYOD) technology. It is said that BYOD may offer a number of advantages over traditional eCOA studies,8 but there are also several significant challenges that must be overcome before it can become a feasible option. Copyright over a BYOD instrument is part of it. This is also the reason why copyright in the original content can help developers to keep control on these aspects.
Lessons learned from the copyright of translations may indeed apply partly to the copyright of e-COAs. We believe that centralized copyright ownership on the content and a centralized licensing process for e-COAs by the owner of the original paper version may be helpful to:

• Control use and users (sub-licensees),
• Protect the integrity of the instrument across e-versions by providing clear rules of electronic implementation,
• Harmonize the electronic validation procedures across e-vendors,
• Centralize reliable information on the eCOA versions.

In conclusion, whatever mode of administration used, i.e., being paper-based or electronic-based, copyright helps in maintaining the quality and integrity of the COA used. Despite its importance for clinical research, the identification of and access to an original COA and its derivatives is not easy and should always be associated with copyright ownership. Finally, copyright is situation-specific, and should ideally be assured by the existence of written agreements between developers, distributors, users, and now e-vendors.

References
1. Anfray C, Emery MP. Access and Use of Patient-Reported Outcomes (PRO) instruments in international studies: authorship and copyright issues. Presented at the 14th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Toronto, Canada, October 10, 2007
2. Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009;12:419-29. Available from: http://www.ispor.org/workpaper/patient_reported_outcomes/Coons.pdf
3. Anfray C. Patient-reported outcomes instruments: bridging the gap between international copyright laws and common practice for developers and users – a case example. Qual Life Res 2009;18(10):1281-1283.
4. Revicki DA, Schwartz CE. Intellectual property rights and good research practice. Qual Life Res 2009;18(10):1279-1280.
5. US Department of Health. Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims. Federal Register 2009;74(35):65132-133. Available at [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf] 6. Berne Convention for the Protection of Literary and Artistic Work, September 9, 1886, as revised at Paris on July 24, 1971 and amended in 1979 (1989). United Nation Treaty Series, 1161 (I-18838) 3-74. Resource document: United Nations.
7. UNESCO (1976). Recommendation on the Legal Protection of Translators and Translations and the Practical Means to Improve the Status of Translators. Resource document: UNESCO. http://portal.unesco.org/en/ev.php-URL_ID=13089&URL_DO=DO_TOPIC&URL_SECTION=201.html
8. e-COA Forum CRF HEalth / Mapi /ISIS Outcomes 24-25 June 2014 – Oxford, UK.