International Primary Care Respiratory Group

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Endorsement Policy
Introduction

The IPCRG’s charitable mission is to provide “a forum for its constituent national groups so that it may represent international primary care perspectives in respiratory medicine and raise standards of care in individual countries and globally, through collaborative research, innovation and dissemination of best practice and education.” As part of its operation, the IPCRG is asked increasingly to endorse a range of goods, services, events and guidelines or “Products”. The IPCRG’s preference is to identify needs for such initiatives itself, with its members, and either to commission its own members or contractors, or to work with partners to deliver the project prospectively, rather than to react to requests from other organisations to endorse their initiatives. However, it is also mindful that there are many useful initiatives by other reputable organisations that might increase in value if we supported them, and might also add value to our reputation/increase our ability to achieve our goal of offering international primary care cross-national educational products.

There is a separate IPCRG sponsorship policy that should be read in conjunction with this endorsement policy.


What is endorsement?

Endorsement of a Product means the IPCRG recommends it.
Endorsement entitles the use of the “Endorsed by IPCRG” logo in association with the Product, whether or not accompanied by the words “Endorsed by the International Primary Care Respiratory Group”.

IPCRG Process of Endorsement

Stage 1: within or without scope

In deciding whether to proceed to review, the IPCRG firstly decides whether the Product is within scope:
• Educational or research goods and services including questionnaires
• One-off events or a series of linked events
• Guidelines
• Conferences Eg. national groups conferences


It excludes:
• Clinical services including web-based clinical services
• Clinical products including pharmacological treatments and novel therapies
• Individuals or organizations
• Clinical informatics systems

Stage 2: self-assessment against IPCRG standards
The IPCRG asks the applicant to complete a self-assessment of whether the application meets its standards:
Essential
• The content is related to the IPCRG’s mission and to primary care and/or “real life”
• The development was sufficiently rigorous and appropriate references are available to back up any claims
• It is clear what endorsement is requested: for what, for how long, the likely frequency of updates, if there will be translations and what is the goal of the Product
• Any ethical approvals that will be required to operate in the originating country have been obtained in advance of the application
• Content accords with international guidelines or where it does not, it clearly justifies why not
• It is clear whether the Product is:
• Free/open source
• For sale to primary care professionals
• For sale to others wholly or in part eg to patients, the public, the pharmaceutical industry, an education or conference promoter, a publisher
• And what is the benefit to the IPCRG in endorsing it

Preferred
• That IPCRG collectively, or individuals associated with IPCRG, were involved in its development, and if not, that you have contacted someone within the IPCRG to ask their opinion before submission

Products that are for sale
If the Product is to be sold to end users or a third party, eg a pharmaceutical company or to an educational company or agency, this would be reflected in the application/endorsement fee requested by the IPCRG.


Stage 3: application
We accept only completed application forms. Each application must be accompanied by the appropriate application fee or gift in kind (see chart) and relevant supporting documentation demonstrating how it satisfies each of the evaluation criteria, including full details and specifications of the Product and its intended market or audience, scientific references, together with:
i. in the case of guidelines: appropriate evidence of their credibility
ii. a description of how and which general practitioners have been involved in development of the guidelines;
iii. an outline of the strategy for dissemination and implementation of the guidelines in general practice;
iv. the extent (if any) to which the guidelines will have international relevance; and

(b) in the case of an event, documentation demonstrating it adds value (defined as outcome divided by cost).

Stage 4: endorsement evaluation
Upon receipt of a correctly completed application, the IPCRG Secretariat will notify the applicant within 72 hours of receipt, and evaluate the Product by:

(a) the IPCRG Board submitting it for peer review by the relevant sub-committee, task force or individual experts (who may not necessarily be general practitioners) and collating responses;
(b) assessing compliance with the relevant (evaluation) criteria
(c) formulating a response and communicating that response to the applicant
(d) consulting with the applicant regarding any queries, and/or considering any further submissions or Product variations made by the applicant;
(e) formulating a considered final response for the IPCRG Board including a summary of reasons for the conclusion whether or not to recommend the Product for endorsement

Stage 5 Board decision
The IPCRG Board will review the evaluation and decide whether or not it agrees with the recommendation and whether to endorse the Product and accept the proposed terms eg period of time or whether to ask the evaluators for further consideration or whether to reject. It will be mindful of any potential risk to the IPCRG’s reputation or finances from the endorsement. The Board reserves the right to ask the reviewers to reconsider certain issues and then to review the proposal again.


Stage 6: notification and award of the “Endorsed by IPCRG” logo and wording
The IPCRG Board will write to the applicant outlining the terms of endorsement including the permitted period of endorsement, how updates will be reviewed, any further fee and any requirements regarding translation and validation in languages other than the original one included in the application and the required Endorsement Fee. The IPCRG might assign an element of that fee to a specific national project.

Responsiveness
IPCRG will normally notify an applicant of its decision within 8 weeks of the application, and ten weeks maximum. It reserves the right for this to be longer in extraordinary circumstances but would communicate this to the applicant.

In the case of a Product requiring multiple sub-committees to review, this may be an interim notification.

Right of Appeal

Any applicant aggrieved by the decision to reject or the conditions imposed may seek to have that decision reviewed by the IPCRG’s Appeal Panel. A determination of the endorsement fee shall not be reviewed, however, and must be regarded as final.

Evaluation Criteria
1. All Products must satisfy the following criteria in order to achieve IPCRG endorsement. They must:
(i) be promoted, marketed and offered for sale or use in the market by a reputable and solvent entity possessing an image and philosophies consistent with ours;
(ii) not conflict with any existing Products offered by the IPCRG or currently endorsed by the IPCRG
(iii) be in line with the IPCRG’s mission and strategic direction;
(iv) there must be demonstrable benefit to the patient target group by endorsing the initiative.
(v) complement existing or proposed IPCRG activities;
(vi) be relevant to general practice or otherwise add value for general practitioners and/or other primary care professionals;
(vii) be environmentally compliant, safe, clearly labelled and, if appropriate, accompanied with clear instructions as to use, restrictions or limitations;
(viii) possess an acceptable degree of consistency in performance generally considered acceptable in the market-place for Products of that nature in accordance with its intended purpose or outcome;
(ix) possess inherent quality and integrity of design and/or manufacture; and
(x) represent the best or most appropriate solution then available in the same class of Product
(xi) be time-limited with a description of the time period for which the endorsement is sought

The request for endorsement should define what is expected from the IPCRG, and what IPCRG can expect from the organisation. This will be informed by the estimated benefit to the applicant of IPCRG endorsement. (For example, if the IPCRG endorses a publication or resource, we might want to negotiate a re-selling agreement to make the product available to our members, if appropriate, or if the IPCRG endorses an educational programme then it might want to negotiate a per delegate fee or promotion of IPCRG events).

2. In the case of guidelines, the guidelines must additionally:

(i) be evidence-based using GRADE, and current;
(ii) be balanced and comprehensive (including where relevant providing additional sources of information and support);
(iii) possess clarity of presentation;
(iv) identify options, benefits and risks (including areas of uncertainty); and
(v) support shared decision-making where relevant.

Translations policy
Unless the original request is to endorse a Product in multiple languages, the IPCRG undertakes only to review the Product in the language in which it is submitted. The IPCRG will make a separate agreement with the applicant about the responsibility for verifying translations, or if our members wish to translate resources that we have endorsed.

Renewal Agreement
The IPCRG shall, so long as the applicant and the Product comply with the terms and conditions contained in the formal agreement endorse a Product for the maximum period (not exceeding 3 years and expiring on a date specified in the agreement. Guidelines should be re-endorsed each time they are changed. We reserve the right to propose changes if these do not review new practice-changing evidence and to end our endorsement if there is no such review

Intellectual property
Before any agreement is signed, there needs to be a written understanding about ownership, copyright and intellectual property.

Register of Endorsement
The IPCRG will maintain and publish on its website a register of current IPCRG-endorsed Products.

Publicity
The applicant must not make any press or other announcements or releases relating to this document and the evaluation and endorsement process without the approval of the IPCRG of the form, content and manner of the announcement or release, unless that announcement or release is required to be made by law or by a stock exchange. This does not prohibit an applicant from disclosing to any of its employees, contractors or agents the fact that is has applied for endorsement and for what, provided that they comply with this publicity confidentiality clause.

Maintaining Confidentiality
The IPCRG agrees to respect the applicant’s confidential information and must only use or disclose the confidential information needed to evaluate the Product and complete the evaluation process. It will not otherwise disclose, reproduce or use the confidential information without the prior written consent of the applicant unless the use or disclosure complies with mandatory disclosure.

Mandatory Disclosure
The IPCRG may disclose confidential information if required by:

(a) law;
(b) an order of any court or tribunal of competent jurisdiction; or
(c) any government agency, stock exchange or other regulatory or administrative body that has the legal right to require disclosure,

and where such disclosure is required, the IPCRG will do all that is reasonable to:

(d) ensure that the third party recipient of the confidential information is made aware that it is confidential;
(e) limit any such disclosure in any way that the applicant may reasonably request; and
(f) give the applicant sufficient notice to enable it to take action to protect its confidential information.

S Williams
28 March 2011

Approved by IPCRG Board
March 2011

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