copyright and intellectual property rights
This article is part 4 of 4 in the series Mastering Copyright Permissions for Rating Scales

Rating Scales: Mastering Copyright Permissions for Clinical Trials

3 Things That Impact Your Efficiency

By Monika Vance

 

Part 3: Copyright Licensors – Authors, Publishers and Collectives

There are several types of licensors of rating scales, all with their unique processes, niched target markets and business models.

Securing copyright licenses for rating scales that have become ‘gold-standard’ measures in clinical trials studies is much easier than for their less popular counterparts. Unless, the popular counterparts are owned or managed by the same licensor. We know where to go to get the permission and hope it won’t take too long.

Rating scales that are less frequently used and owned by individual authors, small publishers, pharma companies, service provider companies or professional associations often lack an efficient process to respond to your request and act on it in a timely manner.

Sometimes they also don’t have a value-based license fee structure in place for your volume of uses, or a process for tracking modifications and translations of the rating scale, how to issue a license agreement specifically for your needs, and to amend it in a timely manner when it becomes necessary.

Is it worth to pursue it?  If it’s the only measure that will capture the data you’re looking for, then yes, definitely!

You should never expect a copyright license for a rating scale to be in place before the beginning of your trial, especially if your protocol and/or the geographical line up of sites is still evolving.  Some licenses may take longer to secure than your trial start up.

Licensors can be slow, but they are also reasonable, and they will not penalize you for starting a study while your license agreement is in progress.  If your Internal Review Boards, or other review committees, demand license agreements to be part of your review submissions, plan ahead and/or request to provide interim progress reports instead.

The following are licensors that you encounter most frequently from within clinical development, with an overview of how they manage copyright. Understanding these licensors’ perspectives and how they work independently and cohesively, will help you with your approach, what to look out for, and how to get your permissions faster.

Individual Authors

This is a total mess.  You probably already know this.

In the most wonderful scenario, the author has his/her own website with all the information you need laid out for you like a picnic blanket.  Whenever you encounter this, praise their efforts and thank them profusely!

Here is why copyright owners, especially individual authors, can be really difficult to track down…

 

Decentralized Ad-Hoc Development

Many rating scales used in clinical research were developed by clinicians in busy private clinical practices, academic health centres, and hospitals.  A clinician, or a group of clinicians, develop new rating scales or modify existing measures for a specific localized clinical or academic purpose.  This is done either independently by securing private or government funding for such a project, or as part of an organizational initiative on their employers’ time, or a combination of both.

 

Variable Copyright Ownership Structures

Depending on the unique nature of the developmental arrangement, copyright to the rating scale can belong to people other than the group working on the new or existing measure, to the people working on the new or existing measure, or to organizations that supported the development, or it can be intentionally placed in the public domain.  Single individual authors, or groups of authors, can also form their own corporations specifically for commercializing the rating scale in an organized manner, along with ancillary research and/or consulting services.  It’s rarely disclosed in the public forum what the organizational structure is.  You have to ask the question.

Authors who are protective of the integrity of their work, tend to include their contact information in copyright notices placed in the footer of their scoring forms and user manuals.  However, I’ve come across cases when organizations adopted the use of a particular rating scale for their internal assessment strategies, created their own format of the scoring forms, and included their own copyright statement on the forms without referencing copyright ownership of the actual rating scale.  Overstatement of rights happens.  Sometimes intentionally and sometimes as an oversight.

Always verify copyright ownership when it’s your first time using a particular rating scale.

 

Optional Copyright Registration

It’s relatively rare for authors of rating scales to formally register copyright for their work.  The safest strategy on your part is to assume that any content in existence is protected by copyright, until you can demonstrate that it is not.  Check the registry records anyway.

Copyright registration is advisable, but optional.  After March 1, 1989, copyright became a fixed tangible asset regardless of copyright registration or the presence of a copyright notice.  Copyright registration is inexpensive, but perceived to be too time-consuming and hence authors don’t bother with it.

 

Optional Copyright Notices

Including copyright notices in individual works is also optional.  Published works generally include the copyright notice of the publisher, but are not necessarily specific enough to the copyright ownership of the pieces of content within the publication.  More on this in the Publisher section.

There are also many rating scales that were never formally published.  They were developed for use within a hospital or a group of treatment centers.  They became established by way of regular internal use, and via migration of employees to other treatment centres.  These may or may not have had copyright notices written on them, but they were usually labeled with the hospital logo and contact information, and written about in books, white papers, journal papers, presentations and/or compendia.

 

Publishing

Many authors prefer to publish the development methodology of their rating scales, and its validation results, in respected academic and scientific journals, or with commercial test publishers.  The reasons are of course linked to career development and generating new income streams.

Publishing with journals or test publishers results in at least partial transfer of rights to the work that is the content of the publication.  The author then continues to focus on his/her research and clinical practice, while the publisher (depending on arrangement) may or may not manage the copyright and moral rights to the rating scale.

 

Releasing Works to the Public Domain

There are multiple domestic and international rules to what works belong in the public domain. In the U.S., the rules have changed several times over the last century.  It’s best that you consult with your counsel on which rules apply in your country.

It is your responsibility to do your own due diligence on copyright.  If you don’t know where the rating scale came from, and you’re unable to locate the copyright owner, you cannot assume that it’s in the public domain, or that you can use it without permission.  Due diligence is a set of defined steps that you must take first to verify copyright ownership before you use any intellectual property.

Here is some guidance to help you with determining if the rating scale is in the public domain:

 

Works created by government officers, employees and contractors

In the U.S., any work that is created by an officer or an employee of U.S. government as part of their official duties is by law automatically in the public domain.  There are some exceptions, but for development of rating scales this would fully apply.  Any work that is created by this same set of people that is not part of their official duties is subject to copyright.

Works created by contractors to the U.S. government can be copyrighted, and made available to the public domain only if the contractors choose to do so.  So, even if a rating scale was developed in government-funded projects, in collaboration with the FDA for example, it does not necessarily belong in the public domain.  How will you know?  You won’t, until you ask the question and check the copyright registries.

 

U.S. Copyright and Berne Convention (in Uber Shorthand)

In the U.S., copyright notices became a requirement for claiming copyright in 1964.  Since 1989, it has become optional again.  Between 1964 and 1989, works that did not bear a copyright notice, or had one in an unacceptable format, or didn’t have copyright registered, were considered to be in the public domain.  Authors, co-authors and occasionally publishers also, quote this to me as an explanation why permission is not needed.  Be very careful with this, and always verify the advice, because…

A copyright notice was never a requirement for unpublished works and yet unpublished works are protected by copyright – for the life of the author plus 70 years. Many rating scales were developed in the 1960s, 1970s and 1980s, and were not always assigned to a publisher, and hence fall into this misunderstood category of works.

If the rating scale was released via open access at any time, it does not mean that it’s in the public domain.  It just means that the authors made it easily available for reference by the public.  You may still need permission to reproduce and use the content.

If the rating scale was released without a copyright notice (e.g., in a compendium, within a healthcare network, a description in a book chapter, etc.) sometime between January 1, 1978 and February 28, 1989, and copyright registration did not occur within 5 years of first release/use or a mention of development date or timeline, then the rating scale is in the public domain.

Piece of cake, right?

 

Age

Imagine, after all the time you’ve spent tracking down an author, just to somehow discover that he/she is retired or has died.  I do check for obituaries now.  If you incorporate age into your investigative equation, you can easily estimate whether or not the author is likely to be still professionally active.

You can assume that by the time the first author developed a rating scale and published it with some solid data behind it, the author and co-authors probably spent a better part of a decade working on it.  Authors could be in their 30s or 40s at the time of the first publication.  Maybe older.  How long has it been since then?  What’s the likelihood of old age and retirement?

If the author is retired, or deceased, begin to work your way through the list of the remaining authors on the source publication, and of course, the publisher.

Publishers – Journal Publishers and Test Publishers

This category of licensors is a lot more organized.

Journal publishers can be mammoth commercial publishing companies with extensive international reach through scientific publications across a long list of specialties.  They can also be professional associations with niched publications, or academic institutions.  Test publishers are mostly commercial companies specifically centered on acquisition and/or development and commercialization of a variety of psychological tests/psychiatric measures.  Some test publishers specialize only in specific industry sectors.

Authors of rating scales are attracted to publishers, because publishers’ reach offers a marketing channel that extends way beyond authors’ personal and professional networks.  In addition, they can offer protection in liability, manage the administrative burden associated with copyright, and become a source of a new passive income stream.

Most publishers have very efficient licensing processes in place, because they generate a large volume of copyright licenses every day.  However, despite the volume, permissions for clinical trials are still painful with many of them.  Their licenses are cookie-cut for all purposes except for the highly regulated process needs of clinical trials.

The advancement of technology within pharma has left many of them standing and falling behind.  Today, growing demand to integrate patient-reported and clinician-reported outcome measures into mobile applications running on proprietary data collection platforms (eCOAs) present an enormous amount of friction to your ability to secure timely license agreements.

This is namely because publishers are still relatively ‘old school’ in their copyright management. They know their own industry and the basic needs of licensees who need permissions for other kinds of publishing – dissertations, academic research projects, books, presentations, other journal papers, etc.. They don’t understand pharma as an industry.  They don’t understand how you collect data, how you transfer it for review and approval and why, and how you integrate rating scales into mobile apps.

Some publishers’ licensing models work well enough, others’ are set up in a way that tell you that they don’t care.  There are also still those who insist on paranoid license terms that are set up in a manner that can literally act as a stop sign in the middle of your study.

Here is how publishers approach copyright licensing for clinical trials…

 

Journal Publishers

When an author publishes a scientific paper in a journal, the publisher automatically requests copyright to the entire content of the paper.  If the paper includes the rating scale itself, then the rights to the rating scale can be included.  In most cases, authors agree to complete transfer of copyright to the publisher.  This is how you end up with that “source” journal publication reference in your protocols.

In some cases, especially if the author has previously registered copyright to the rating scale, he/she will exclude the registered content from the rights assignment to the publisher.  So, the journal publisher will own copyright to the content of the paper, and the author will retain copyright to whatever work he/she intends to keep.  To take advantage of the publishers’ subscriber market reach, the author may choose to allow fair use sample of the content he/she intends to keep.  For example, including 20-25% of the total rating scale items in the paper.

My experience has been that most journal publishers are now well organized and their licensing officers have ready access to information that is specific to what they own and what they don’t own.  It does happen, however, that the publisher will make a mistake, and not disclose that they don’t own the rights to the actual scale.  Hence, again, it’s best to contact the publisher and the author to verify.  If the stories don’t add up, present the inconsistency to both sides.  One of them will concede and they will work it out for you.

License agreements from journal publishers are usually in the form of a simple form letter.  Read the terms.  Make sure that the cookie-cut template you receive has the correct study information on it, and that the terms are not in conflict with your internal workflow.  If they are, ask for a revision.  To help speed up the process, recommend the wording that you want the letter to contain.

If you need a license for integrating a rating scale into some type of a tablet/mobile app, the usual cookie-cutter letter issued by journal publishers won’t cut it.  You’ll need a formal and complete license agreement set up specifically for your digital integration purpose with clearly defined parameters.  Interpretation of vague or ambiguous terms in the standard form permission letter does not grant you greater flexibility with what you can do.    Between your company and the publisher’s, you have equal bargaining power and both have the ability to be competently represented by legal counsel.  Don’t take the easy way out on this one.

 

Test Publishers

Test publishers approach licensing similarly to journal publishers.

They are more sophisticated with licensing rating scales because it’s their core business.   They are curators of rating scales.  However, they prefer to acquire rights to measures that were not previously published elsewhere, or released through open access, or modified from public domain versions.  Managing copyright is much easier under these circumstances.  There are exceptions.

With test publishers, authors retain moral right to their work, and are offered a much more collaborative relationship in the development of rating scales and ancillary works, and marketing support.  Authors can choose to assign full copyright in exchange for liability protection, or they can assign exclusive worldwide or territorial rights for publishing, sales and distribution of the rating scale.  Test publishers are diligent about fully disclosing copyright ownership with copyright notices.

A key difference in test publishers’ licensing process is their request for rater qualification forms. The study’s medical director can be asked to complete a qualification form for the rating scale being licensed.  Test publishers classify rating scales into categories that make them either accessible to the general public or restricted for use only by clinically qualified individuals.  Test publishers are required by their industry regulations to document and link any purchase of a restricted rating scale to a qualified rater.  When the form is completed, be sure that the person whose information is on the document is represented as an employee of your company, and not as a clinician in private practice.  By completing this form, this person is assuming responsibility for oversight of raters across all sites that will use that rating scale in your clinical trial.

The specificity of test publisher’ license agreements is limited to their understanding of the pharma industry.  Some test publishers still issue “letters of permission” that haven’t changed for at least 20 years and are not at all relevant to what the pharma industry is doing today.   These old license agreements can come in two or even three parts that are not referred to within the individual documents.  So, again, question the terms, and discuss with the publisher how the generality of such a license agreement impacts your ability to execute your operational and regulatory workflows.

Interpretation of terms is important here too.  For example, test publishers are accustomed to charging license fees on per-use basis.  Be clear on what “per-use” really means. For some test publishers this means every time you administer the scale to a subject, and to others that have not moved on with the times yet, it means every time you reproduce the items, even for internal and regulatory reviews.  Another example, some test publishers allow distribution of an electronic version of the rating scale (i.e. PDF) to be made from paper, and to email it to your colleagues.  Others require that you have a separate agreement for conversion from paper to PDF, then to email the file, and another agreement to store it somewhere.  Yes…..I’m totally serious.  We’re not all made equal.  This is where you just have to step up and educate.

Copyright Collective Agencies

Copyright collectives are licensing agencies that manage copyright on behalf of copyright owners that are its members.  They have the authority to issue license agreements, collect and distribute royalties.

Examples are Copyright Clearance Center (CCC), or AFM/SAG-AFTRA Intellectual Property Rights Distribution Fund.  Almost every country around the world has several collectives representing various types of works covered under their Intellectual Property Laws.

Copyright collectives are straight forward.  Except for clinical trials.

They do not offer an option for a license agreement specifically for a clinical trial.  This is because copyright collectives have not been authorized to issue licenses for clinical trials.  Yet.  This can change.

So, when you find a journal paper that contains the rating scale you need, and you click on the link that will lead you to the Collective’s website and permission application, check the available options.  If you don’t see an option for clinical research or clinical trial or some euphemism that means the same thing, contact the publisher of the paper directly.

My experience with collectives has been generally positive, but there were instances when I received concerning instructions.  For example, to “just select Dissertation” as the purpose and proceed with the license.

Please, do not follow an instruction like that.  Getting a license agreement for a purpose other than for your clinical trial is completely useless to you.

Advise the person who contacted you that your license agreement must be specific to a clinical trial and if they can’t help you, then you need to get in touch directly with the copyright owner.

Request the copyright owner’s contact information or go the source publisher’s contact page and work your way to their licensing department.

ALWAYS do your due diligence.

Disclaimer:  Please note that I, the author of this article series, am not a Lawyer.  The information in this article is based solely on my own experience in licensing rating scales and may not reflect the experience(s) of another party.  The information in this article is intended for informational purposes only, and should not be construed as legal advice or legal opinion on any specific facts or circumstances.  Additionally, the information about copyright collective agencies is true at the time of writing of this article and may change at any time.  Readers should seek professional counsel specializing in Intellectual Property Law when acting on the information provided in this article series.

Introduction

Rating Scales: Mastering Copyright Licensing

Part 1

Your Copyright Licensing Purpose and Situation

Part 2

Your Copyright Licensing Experience and Skill

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I'm a specialist in clinical outcome measurement and its impact on treatment effects and patients' quality of life across cultural boundaries. I help physicians and clinical researchers improve patients' lives by teaching best practices in measuring psychiatric and neurological states and traits, with thoughtful focus on specificity.

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