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20/39 TAR Retender - Conflicts of Interest Policy

 

Contents

NIHR Policy on Conflicts of Interest for NICE and HTA TAR Reports

Introduction

This document sets out guidelines for declaring and managing potential conflicts of interest for TAR Centre members and expert advisors, and complements NICE’s policy.

This policy is intended to ensure that the NICE Appraisal Committees and Diagnostics Advisory Committee have access to independent academic advice and that the reports published in the NIHR Journals Library, including HTA TARs, are not biased by financial and non-financial interests.

The overriding principle is that TAR Centre members and expert advisors must declare any matters that would reasonably be perceived as affecting their impartiality. This will ensure transparency. A declared potential conflict of interest is much easier for the Committee or readers to take account of than an unknown one that, if it became known, might discredit the process and become an embarrassment to the authors, the TAR Centre, NICE or the NIHR.

All Centres are expected to be able to meet the terms of their TAR contract regarding volume and quality of work expected. No allowance will be made for any failure to meet the terms of the contract because of conflicts of interest.

The following table summarises the policy for easy reference. More details are given in the following sections.

Conflicts of InterestAction in the case of TAR CentreAction in the case of Expert advisor

Work done on the company submission with or without payment
The whole TAR Centre to be excluded from working on an evaluation regardless of time elapsed Expert advisor not to take part in the evaluation regardless of time elapsed
Financial interest*
Payment received in the previous 12 months from a company associated with the evaluation

Payment received for the work done on the same health technology(ies) indication or same comparator(s) indication pairs Declare conflict
If payment is made to a TAR Centre member, TAR Centre is permitted to work on the evaluation as long as the conflicted member is excluded from the project. If payment is made directly to the TAR Centre the whole team is excluded
Declare conflict
If a choice of experts, TAR Centres should make every effort to choose the least conflicted. If not possible, because of reduced number of experts or input believed to be invaluable, then TAR Centre should declare the conflict and seek for at least two other non-conflicted experts
Payment received for work done on the same health technolgy(ies)/comparator(s) - different indication pairs Declare conflict 
If payment is made to a TAR Centre member, TAR Centre and conflicted member are permitted to work on the evaluation. If payment is received directly by the TAR Centre the whole team is excluded
Declare conflict 
Expert advisor permitted to take part in the evaluation

Payment received for any other type of work not related to the health technology(ies)/comparator(s) under evaluation  Declare conflict
If payment is made to a TAR Centre member, TAR Centre and conflicted member are permitted to work on the evaluation. If payment is received directly by the TAR Centre the whole team is excluded
Declare conflict
Expert advisor permitted to take part in the evaluation
Non-Financial Interest*
Any activity taken place in the previous 12 months that can affect objective judgement.
Individual has made public statements, including publications, about particular company or health technology(ies)/comparator(s)
Individual could be potentially affected by the outcome of the evaluation
Individual closely connected with a charity or pressure group that would have an interest in the outcome of the evaluation
Declare conflict 
TAR Centre permitted to work on the evaluation as long as the conflicted TAR Centre member is excluded from the project
If a choice of experts, TAR Centres should make every effort to choose the least conflicted. If not possible, because of reduced number of experts or input believed to be invaluable, then TAR Centre should declare the conflict and seek for at least two other non-conflicted experts
Participation in NICE Scientific Advice Programme (SAO)
Individuals providing advice to NICE on a specific health technology
Same company-health technology(ies)/comparator(s) indication trio TAR Centre permitted to work on the evaluation but TAR Centre member is precluded from participating in any evaluation for which advice was provided for a period of 12 months previous N/A

 * Generic drugs (i.e. out of patent) manufactured by three or more companies are not considered sources of conflicts, and therefore are excluded here.  

 

Conflicts of Interest

In the case of TAR Centre members

TAR Centre members here are considered as those participating in the evaluation, and those that form part of the main TAR team. The latter excludes members that only participate in NICE evaluations on an add-hoc basis.

Generic drugs (i.e. out of patent) manufactured by three or more companies are not considered sources of conflicts because of the low impact of any decision on the companies involved, and therefore are excluded in what follows.

  • Work done on the company submission with or without payment. A TAR Centre member should always declare any financial and non-financial interest that might potentially affect their objective judgement (see Section 1.4). Potential conflicts have a time limit of 12 months except in the case of participation in the company submission. If a TAR Centre member has participated in the company submission in any way, with or without payment, the whole TAR Centre will be precluded from working on the evaluation regardless of time elapsed. Any other type of conflicts will be treated as follows.
  • Financial interest. A TAR Centre member should always declare a conflict of interest on an evaluation if they have had any financial relationships or interests (see Section 1.4 below) in a company associated (as the manufacturer of either the health technology being evaluated or one or more of the comparators) with that evaluation within the previous 12 months, or any such payments are likely from such association. In this situation the actions to take are as follows:
    • If a TAR Centre or a TAR Centre member has received payment from the company for work done on either the same health technology-indication pair under evaluation or the same comparator(s)-indication pair, the TAR Centre will be precluded from working on the evaluation
    • If a TAR Centre member has received payment from the company for work done on either the same health technology or comparator(s) under evaluation but different indication, the TAR Centre will be permitted to work on the evaluation provided the conflicted member is excluded from the work and the conflict is clearly disclosed
    • If a TAR Centre member has received payment from a company associated to the evaluation for work not related to the health technology or comparator(s) under evaluation the TAR Centre and conflicted member will be permitted to work on the evaluation but the conflict must be clearly disclosed
    • If the TAR Centre itself is the one receiving payment from any of the companies associated to the evaluation regardless of the type work, the whole TAR Centre should be excluded from participating in the evaluation
  • Non-Financial interest. A TAR Centre member should always declare any non-financial interest that might potentially affect their objective judgement (see Section 1.4). Generally, the TAR Centre will be permitted to work on the evaluation provided the conflicted member is excluded from the work. Although the need for the latter will depend on the degree of conflict and should be considered on a case-by-case basis
  • Participation in NICE Scientific Advice Programme (SAP)
    • Individuals providing advice to NICE on a specific product as part of the NICE Scientific Advice Programme (SAP) are precluded from participating as a member of a TAR Centre for a period of 1 year in any evaluation involving the same company and health technology-indication or comparator(s) –indication pair for which the advice was provided. Preclusion is taken from the date of the last point of contact for the above
    • The above is based on the understanding that participation in a SAP entails assisting NICE in commenting on the development plans proposed by the company. In addition, assisting in answering the specific questions that have been agreed between NICE and the company. At no time would the expert be required to make detailed proposals on the way forward e.g. presenting the company with a model or analysis. Projects of this nature would be considered outside the remit of Scientific Advice and subject to separate ruling on potential for a conflict of interest. NICE will be responsible for deciding which members of TAR Centres will be approached to invite their participation in each piece of advice (i.e. companies are not entitled to express a preference for particular teams)

In the case of expert advisors

It is recognised that many of the experts that TAR Centres will rely upon to provide advice will have connections with the pharmaceutical and other commercial and non-commercial organisations whose business may be relevant to the evaluation. Therefore, it would be important to ask all advisers to declare any matters that would reasonably be perceived as affecting their impartiality, such as any payments that they had received or any activity that might affect their objective judgement (see section 1.4 below) in the previous 12 months, or at any time if they participated in the company submission, and for this to be declared in the evaluation. This information should be declared in the protocol if it is available at the time.

The rule of thumb is that if there is a choice of experts TAR Centres should make every effort to choose the least conflicted. There are situations when the benefits of using a conflicted expert outbalances the risk e.g. a very knowledgeable expert can provide an invaluable input. In this case the TAR Centre should seek at least two additional non-conflicted experts to ensure the committee have a balanced view.

It is generally more challenging to find non-conflicted experts that are knowledgeable enough to provide a useful input in rare conditions. In this case, the TAR Centre should also make every effort to find a non-conflicted expert. If none are available, a combination of conflicted and non-conflicted with limited knowledge is acceptable.

Generic drugs (i.e. out of patent) manufactured by three or more companies are not considered sources of conflicts because of the low impact of any decision on the companies involved, and therefore are excluded in what follows.

  • Work done on the company submission with or without payment. An expert adviser should always declare a conflict of interest on an evaluation if they have had any financial or non-financial relationships or interests (see Section 1.4 below). If an expert advisor has participated in the company submission they should not be take part in the evaluation, regardless of time elapsed. Any other type of conflicts should be treated as follows
  • Financial interest. An expert adviser should always declare a conflict of interest on an evaluation if they have had any financial relationships or interests (see Section 1.4 below) in a company associated (as the manufacturer of either the health technology being evaluated or one or more of the comparators) with that evaluation within the previous 12 months, or any such payments are likely from such association. In this situation the actions to take other than declaring the conflict of interest are as follows:
    • If an expert advisor have received payment from the company for work done on either the same health technology-indication pair under evaluation or the same comparator(s)-indication pair, they should not be take part in the evaluation
    • If an expert advisor, has received payment from the company for work done on either the same health technology or comparator(s) under evaluation but different indication, or for work not related to the health technology or comparator(s) under evaluation, they should be allowed to take part in the work as long as the potential conflict is fully disclosed
  • Non-Financial interest. An expert advisor should always declare any non-financial interest that might potentially affect their objective judgement (see Section 1.4). Generally, TAR Centres should make every effort to choose non-conflicted experts, but in situations in which the degree of conflict and availability of expert advisors are low they could be permitted to take part in the evaluation as long as the potential conflict is fully disclosed. This will be decided on a case-by-case basis

Declarations

To demonstrate probity, all members of a TAR Centre likely to be engaged on a specific evaluation are required by NIHR to make a written declaration of any matters that would reasonably be perceived as affecting their impartiality at specific key stages in the process:

  • When expressing preferences for topics prior to allocation (in respect of all topics)
  • In protocols and assessment reports

Additionally, TAR Centres should alert NIHR if they become aware of any matters that would reasonably be perceived as affecting their impartiality because of potential conflicts of interest held by other members of the main TAR team. However, TAR Centres are under no obligation to seek out potential conflicts from associated departments or by members that only participate in NICE evaluations on an add-hoc basis.

If any TAR Centre knows that there are matters that others might reasonably perceive would affect their impartiality, but it considers that there are credible reasons why it should be allowed to undertake the evaluation, it should submit a declaration and justification. NIHR will review this information to determine the degree of ‘significance’ and the Centre will be advised. Such decisions will need to be taken on a case by case basis, taking account of the nature of the involvement and its specificity among other things.

Once allocated a topic, for the duration of the evaluation, staff in the TAR Centres should refrain from entering into any consultancies that might reasonably be perceived as affecting their impartiality.

The Director of the NIHR Evidence Synthesis Programme will act as final arbiter in any disputes about the significance of potential conflicts of interests, including the acceptability of potential co-authors, clinical experts and Advisory Group members.

Different types of interests

The following is intended as a guide to the types of interest that may affect an individual’s impartiality or could reasonably be perceived as affecting their impartiality, and must be declared if occurring in the previous 12 months, or at any time in the case of company submission participation.

Financial interests

Payments to an individual personally. The main examples are:

  • Consultancies: any consultancy, directorship, position in or work for the health industry which attracts regular or occasional payments in cash or kind
  • Fee-paid work: any work commissioned by the health care industry for which the individual is paid in cash or in kind (e.g. fees for organising education or speaking, reimbursement for attending a symposium, hospitality)
  • Share-holdings: any shareholding, or other beneficial interest, in shares of the health care industry. This does not include shareholdings through unit trusts, pension funds, or other similar arrangements where the individual has no influence on financial management

Payment which benefits the TAR Centre, but is not received by an individual personally. The main examples are:

  • Fellowships: the holding of a fellowship endowed by the health care industry
  • Support by the health care industry: any payment, or other support by the health industry, which does not convey any pecuniary or material benefit to an individual personally but which does benefit his/her position or department For example:
    • A grant from a company for the running of a unit or department
    • A grant or fellowship or other payment to sponsor a post or member of staff
    • The commissioning of research or other work by, or advice from, staff who work in a TAR Centre or associated departments

Non-financial interests

Some examples include:

  • an individual has made public statements (either favourable or unfavourable and including publications) about a particular company, treatment or product
  • an individual may be affected by a change in standard NHS practice as a result of the review
  • an individual participates in, or is connected with, a charity or pressure group that would have an interest in the outcome of the appraisal