FAQs


Can we build a web-based version or a mobile app (eCOA or ePRO) version of one of your assessment tools and make it readily available to anybody to use?

As a general rule – No. We have a duty of care to the copyright we manage, which means that many of these types of requests are not feasible. To elaborate, there are two key reasons why we don’t allow such open-access / web-based reproductions of our copyright. We do however have exceptions to this rule when suitable licensees can provide evidence they can meet our requirements when developing such web-based versions of our measurement tools. Under such circumstances we support the development of electronic (eCOA or ePRO) versions of our measures

These two requirements are:-

  1. Protecting integrity. The health measurement / Clinical Outcome Assessment (COA) tools available from us include psychometrically validated instruments. In order that everyone can continue to benefit from the measurement qualities of our tools, we require that a careful process of migration from the original paper-based measure to electronic format is carefully adhered to. A document laying out the process for such migration is available from us on request. If you feel you can strictly adhere to this process, and furthermore demonstrate measurement equivalence of your web-based COA, then we may consider granting you permissions to build an ePRO, subject to point 2 below.

  2. Regulation of use of ©. We have a duty to return royalties from the use of our COA’s where appropriate. Where fees are due, we then return the majority of those collected fees to the University of Oxford (where the © originated from the University) which is a registered charity. These collected fees go towards directly funding further research activities in clinical outcome assessment tools at the University of Oxford. Alternatively, we may have an agreement with a non-Oxford entity to manage their copyright on their behalf, which may include taking reasonable actions to manage / protect that copyright on their behalf, including the collection of fees. So by allowing free and open (unregulated) access to our COA’s through a public website, we would be undermining opportunities to collect royalties from the use of our managed copyright. However, if a licensee can prove they are carefully controlling use, by way of registration for example, then we may consider granting rights to licensees to deploy our measures in this way. What we won’t agree to is unregulated open-access of our measures through a website.

So, for organisations that can accommodate the above, and also have an appreciation of ensuring the electronic version they create is able to deliver equivalent results to the original paper version, then we welcome your approach.

Why do I have to take a copyright licence from Oxford University Innovation and not from the author(s)?

Our clinical outcomes team is active within the Technology Transfer group within Oxford University Innovation (the Licensor), the Technology Transfer Company for the University of Oxford. We work with our academic authors and others to licence the copyrighted material they produced. With the academic authors’ support, Oxford University Innovation formally acquires rights in the outcome measures from the University of Oxford and elsewhere. Therefore, as Oxford University Innovation is the copyright owner or licensor of the outcome measure, the licence you enter into is with Oxford University Innovation. It is not sufficient to get the permissions (written or otherwise) of the authors before using one of our measures.

My organisation may wish to amend the terms and conditions of the copyright licence from Oxford University Innovation – is that OK?

We strive to provide licences to our portfolio of outcome measures in an efficient manner, so we can minimise the costs of providing licences to our users, keep prices down, and ensure that we return as much of the revenue as possible to the University of Oxford. Some of the money returned to the University goes directly into supporting further health outcomes research and development at Oxford. For these reasons we use a Standard Licensing program which we can only operate if there is consistency between licences, so we will not accept changes to our Standard Licence.

My organisation is working with a partner / associate that will assist in delivery and administration of the outcome measure. Do our partners / associates also need to obtain a licence from you to participate in the study / research?

We recognise that complex studies often involve a multitude of organisations each bearing responsibility for delivering different aspects of the study. Our standard terms and conditions of use (licence) accommodates this by permitting the licensee to sub-licence to their affiliates, principal investigators and their teams, study trial centres, CROs and CRAs in each case who are directly associated with the performance of the study.

My organisation has previously used one of the health outcomes assessments from Oxford University Innovation under licence. Can we use the same outcome measure in a different study?

No. The licenses we provide are study-specific or for a defined purpose. This means that any organisation wishing to use one of our measures must apply for a separate licence for each study or purpose. For clarity, you do not need to apply for a separate licence for each trial site that is part of the same study; the usage across all sites will be aggregated in the one licence agreement. If you have an existing licence and want to be sure that your current or planned use is covered by your existing licence, then please contact us.

Do I have to pay a licence fee?

The payment (or not) of a licence fee depends on the proposed use. The fee (if any) will depend on factors such as:

  • whether the use is a commercial study or an academic study;

  • how many times the outcome measure will be used in the study / for the proposed purpose;

  • language requirements, namely access to our outcome measures translation library;

  • your choice to purchase one of our comprehensive user manuals (where available) or other support materials.

The payment of fees also depends on the specific measure being licensed / purchased. However, the general rule is that for strictly non-commercial academic use or for publicly funded healthcare use, licences are provided free of charge. Further examples of the fee structure can be found in preamble to the online Licence Request web page. In order to discover if a fee applies to your planned use, please proceed to complete the licensing request process. Information on fees to be applied are provided in advance of any licensing commitment, so you can withdraw from taking a licence and incurring fees should you decide to, without commitment.

Fees for the commissioning of new translations and for testing the proper migration of electronic versions of our measures are not covered here. These activities should be discussed separately with the clinical outcomes team.
Please complete an online Licence Request Form or contact one of our team members who would be pleased to discuss your study requirements and provide a quote.
Please note all users pay fees for accessing the available translations in our library and for support materials such as comprehensive user manuals. Short user guides (where available) are provided free of charge.

Do I need to get a licence if I want to use one of your assessments only for academic research or non-profit purposes?

Yes, you must acquire rights (a copyright licence) or permissions for any use of our outcome measures, whether it is for commercial or academic research purposes. Our COA measures are protected by copyright and are available for licensing from Oxford University Innovation Ltd. If your use involves reproducing the outcome assessment in a research paper then you should still seek written permissions from us.

What do I do if I want to use a PRO measure or other Clinical Outcomes Assessment (COA) available from you?

In order for us to grant permissions (a copyright licence) for the use of one of our outcome tools, we require certain information from you and/or your organisation. We therefore ask that you complete the online licence request so we can then make an informed decision about granting (or not) your organisation a licence.
The information you provide will be relied on and used by us for any licence agreement that may subsequently be issued to you. Please therefore ensure that it is complete and accurate. The information will be received and held in confidence and used by us solely for the purposes of the prospective licence agreement and interactions with you. Oxford University Innovation’s privacy notice can be accessed through the footer of the Oxford University Innovation website.
On submitting your licence request you will receive an automated response confirming that your request has been received. A member of our clinical outcomes team will endeavour to respond to your application within 1 working day. If a request is urgent then please do let us know and we will endeavour to respond as soon as we receive the completed licence request submission.

What is a COA or Clinical Outcome Assessment?

The term Clinical Outcome Assessment or COA covers a number of health outcomes assessment instruments (questionnaires), including Patient Reported Outcome (PRO) measures (or PROMs, as used in the UK); Clinician Reported Outcome (ClinRO’s) measures and Observer-Reported Outcome (ObsRO) measures. Most of the health outcome measurement instruments that we manage and support are PRO measures.

The vast majority of medical interventions intend to maintain or improve patient functioning and well-being. Consequently the intervention should have a positive impact upon the quality of life of the individual. Despite the obvious patient-centric perspective to the assessment of well-being, the medical profession has not traditionally undertaken systematic evaluation of patient based reports. Medical professionals have tended to rely on questions such as, how does the patient feel or asking them to describe symptoms. However, clinicians and medical researchers are increasingly measuring quality of life alongside lab data. For this reason Patient Reported Outcome (PRO) measures are used to quantify the quality of life or other outcome from the patient’s perspective as part of the medical evaluation.

Are there a minimum number of times each patient must be assessed using an outcome measure to get valid results for my study?

For the outcome measures available from us, patients should be assessed at least twice using the measure – once before surgery/treatment/intervention, and at least once following surgery/treatment/intervention. The reason for this is that the absolute score is not necessarily the relevant information; it is the change in the patient’s score from the pre-therapy to the post-therapy evaluation which is the critical factor in patient assessment. Our measures have been designed, tested, and shown to be responsive to change in health status. There is no limit to the number of post-operative/intervention assessments that can be made; the number of times patients should be assessed will largely depend on the nature and purpose of the study.
The developers of the outcome measures available from us are happy to consult with organisations that require support on study design, including the optimal timing of pre-intervention or post-intervention patient assessment. Please contact one of our team if you would like to discuss consultancy support.

Are all your measures validated?

All our measures have undergone rigorous testing so we have confidence that the instrument can be used in particular specified contexts. It is the responsibility of the user to ensure the measure adopted for their study is suitable and appropriate, but we can assist potential users with such assessments.
We provide information and results of the testing that has been undertaken on our outcome measures. We also guide potential users to journal publications (and our own user manuals) that provide further details on the testing that has been applied to our outcome measures.
If you would like to get further advice on this question of validity and suitability of a measure to meet your specific study requirements, then please do enquire. This review service is available for our own instruments and for third party outcome measures.

Can I modify the outcome measure to suit my purposes?

In general the outcome measures may not be modified. All of our outcome measures are protected by copyright. Any change made without the prior written consent of us is a breach of copyright.
Also, modifying an outcome measure (for example by changing, deleting, or adding items) can damage the validity of the instrument so any results obtained using the modified measure may not be reliable or statistically relevant.

How can I find out more information about the outcome measures from you?

You can find more information about each of the outcome measures, including references to journal articles and other literature, on the measure-specific web pages.
If you are unable to find the information you require on our website then please don’t hesitate to contact one of our team.
We can provide further information on our PROs in the form of PRO dossiers. These are available on request and can, for example, be used in support of regulatory submissions.

Do I need local ethics board (Institutional Review Board, or IRB) approval when using one of your Clinical Outcomes Assessments?

If the purpose of your study is to collect outcomes data for research purposes, then a local ethics board must review your methods, patient recruitment, consent and privacy processes. However, if you are using one of our outcome measures for clinical care, then ethics board approval is generally not required. If in any doubt, you should contact your local ethics board for advice.

What is the licensing process – when do I receive the actual questionnaire measure, any language versions I require and/or user manual?

Once you submit your completed online licence request you will receive an automated response from us acknowledging receipt of your request. This does not give you the rights to use the outcome measure yet; you require a formal confirmation of grant of licence from Oxford University Innovation Ltd. Your licence request is forwarded to Oxford University Innovation who will then respond in a timely (normally within 24 hours) manner by either:
i) Emailing you a confirmation of the licence using the details you have supplied during you online licence request, or
ii) We may request further information and will contact you directly to discuss.
It is important that the online licence request is completed as fully and accurately as possible as this makes the whole process faster. When we email you confirming the provision of licence, we will also send all the relevant files you requested during the completion of the online licence provision request, e.g. the actual questionnaire (normally as an MS Word file) any translations (with letters certifying the translation method used) and any user manuals purchased.
The information you provide will be relied on and used by Oxford University Innovation for any licence agreement that may be issued to you. Please therefore ensure that it is complete and accurate. The information will be received and held in confidence and used by Oxford University Innovation solely for the purposes of the prospective licence agreement and interactions with you. Oxford University Innovation’s privacy notice can be accessed at the footer of our website.

I represent an organisation that is interested in deploying outcome measures in a study we are planning to undertake. Can you provide advice?

Yes, we can assist in a number of ways depending on your requirements and the availability of suitable outcome measures:

  • We can, working with our academic researchers and associates (who are experts in the field of outcome measures) provide advice on suitable measures for your study and how they may be best used.

  • If a suitable condition-specific measure does not exist for your study requirements, then we can advise on the development of a new outcome measure for your study.

Do you have translations of the outcomes measures you manage? If not, what do I do if I need to use the measure in another language?

We manage an extensive translation library of our outcome measures. You can find complete lists of the translations available for each of the outcome measures on the relevant web pages.
If you require a language that is not available, then we will support you in obtaining the required translation. Oxford University Innovation’s standard licence does permit licensees to translate the PRO, subject to that translation following our own Translation and Linguistic Validation Methodology, developed in association with PharmaQuest Ltd. Any translations undertaken by licensees must follow our methodology which uses industry best-practice in line with ISPOR’s Good Outcomes Research Practices. In this way, we can continue to provide outcome measures of the highest quality.
Any translations generated in connection with the licensee’s permitted use of one of our outcome measures shall be the property of Oxford University Innovation Limited and formal assignment of rights will be required.
If you have not previously worked with translation companies and you would like to commission a translation of an outcome measure from us (or elsewhere), we can manage this process for you. We work with industry-leading providers of outcome measure translation and linguistic validation services, to ensure that the integrity of the instrument is maintained following translation of the measure.

Who owns the data that is collected from patients who participate in a study that uses one of your measures? Does you require access to this data?

Any data generated in a study using one of our measures shall belong solely to the Licensee. We shall have no legal interest in the data and does not require access to the data generated under the study, unless agreed otherwise between the parties.

For what conditions are the individual outcome measures validated? Can I use a measure to assess patients with conditions for which the score is not validated?

The conditions for which each outcome measure is validated are listed on the product-specific web pages.
If your organisation wishes to use the outcome measure to assess patients with a condition for which it is not validated, this is done entirely at your organisation’s own risk. We highly recommend that a new validation study is conducted on the measure in the target patient group prior to commencing the actual study. Please contact one of our team if you would like to use one of our instrument for any purpose for which it is not validated. Our developers may be able to assist you with the validation study.

Do I need to get a licence if I only want to use a PRO for academic research or non-profit purposes?

Yes, you must acquire rights (licence) or permissions for any use of the PROs, whether it is commercial or academic research. The PROs are protected by copyright and are available for licensing from Oxford University Innovation Ltd. If your use involves reproducing the PRO in a research paper then you should still seek permissions from Oxford University Innovation.

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