The FSAs Approach to Managing the Interests of its External Scientific Advisers

1. Introduction

1.1 Context

The challenge of being an open organisation

We aspire to be a truly open organisation - transparent and open to views and perspectives from others in our work.

We recognise that when people talk to us, whether they are individual consumers, representative organisations, food businesses, scientists and others, their views are shaped by their explicit experiences and values. They might also reflect implicit biases, preconceptions and beliefs. When we receive external scientific advice to support our work, we need to recognise what might frame and shape those views.

A focus on Science Advisory Committees and scientific advice

The identification of potential conflicts of interest of scientific advisers impacts on the participation of those advisers in the framing of advice to regulatory bodies, has been a focus for scrutiny. The 2016 Triennial Review of FSA Science Advisory Committees (SACs) recommended that:

‘FSA should revise its current guidelines on interests for SACs and their Chairs to ensure they remain clear and fit-for-purpose for the current and future working environment of the committees…considering other models in use across Government nationally and internationally and their efficacy in protecting consumer interests and ensure that its SACs consistently follow the revised framework’

and the FSA Board accepted this recommendation in May 2016.[1]    

This document sets out our revised approach and guidelines on managing interests, fulfilling the recommendation. This is an active area of debate and discussion, and we will keep our approach under review. 

1.2 Criteria for success

We have identified the following success criteria for an effective approach to managing interests. These criteria have been used in developing the approach and will be used to evaluate and review how the approach is working in practice. Our approach needs to be:

• Robust - addressing the right issues in appropriate ways.
• Transparent - it is clear to FSA, its advisers, and the public what the approach is and how it is being applied. 
• Consistent - producing similar outcomes in similar situations (accepting that the approach is based on structured, informed judgement).
• Easy to implement - the effort needed to apply the approach should not outweigh the benefits and hence it is more likely to be applied consistently in practice. It is proportionate and adaptable.
• Verifiable - the FSA should be able to confirm to itself and demonstrate to others that the approach is being followed properly in practice and any problems resolved effectively.

1.3 Scope

The Good Practice Guidance applies to all our SACs and external scientific advisers. This includes the Chairs, members and co-opted members of SACs for which the FSA is sole or lead sponsor (whether they are Non-Departmental Public Bodies or Departmental Expert Committees) and any of their subgroups. This also includes lay and consumer members, and experts invited to present their research to a SAC. If you are unclear if you should complete a Declaration of interest, please contact the SAC Secretariat for advice.

External scientific advisers are people who provide scientific advice to the FSA in the capacity of an independent expert but are not members of FSA staff. Advisers include:

• Experts providing scientific and technical advice and/or evidence on an ad hoc basis that informs the evidence base for FSA’s decisions, whether provided via the SACs or other routes 
• peer-reviewers of FSA funded research
• appraisers of tenders for new FSA funded scientific research
• those involved in the oversight of FSA funded scientific research programmes (such as programme adviser or advisors on steering groups)
• and members of the Register of Specialists (which also includes the above roles).

Throughout this document, all these people are referred to as ‘advisers’.

The guidance developed here does not apply to our Chief Scientific Adviser and FSA employees. This is because FSA employees are bound by the Civil Service Code and other rules of employment to ensure their integrity.[2],[3]

1.4 Principles

Conflicts of interest can lead to bias; risk of bias must be managed effectively

We value external scientific advice as it can help our work to be more evidence-based, by providing a wider consideration of relevant issues. But we can never eliminate interests or bias entirely, as everyone has interests and biases, be they conscious or unconscious. Biases can come from previous work, personal beliefs, connections to people or organisations, or other unconscious biases.

Conflicts of interests are one potential cause of bias, so we want to be open and effective in our approach to managing advisers’ interests. We do not believe bias caused by conflicts of interest has been, or currently is, a significant issue in the scientific advice the FSA receives. 

An interest is not the same as a conflict of interest

In future, those from whom we may seek independent, scientific advice will have an increasing number of interests. This results for example from many strong incentives for scientists to engage with industry, charities and with society more generally. 

We do not believe that all interests necessarily represent a conflict of interest. Conflicts occur when:

• the interest specifically relates to the context or subject of the advice; and
• could result in advice that does not objectively reflect the evidence.

For example, an adviser may have an interest if they have previously reviewed the evidence base for a different organisation, but there is no conflict. Conflicts may be stronger or weaker depending on things like how personal, significant, current or sensitive the interest is. The aim of our approach is to have full transparency about advisers’ interests, and to be effective in managing any potential conflicts, ensuring we properly reflect perceived conflicts and well as real conflicts.  

Conflicts of interest don’t always lead to biased advice, providing they are managed effectively

We think that where conflicts arise, there is a range of ways to manage the conflicts to reduce their effects on the independence and objectivity of the advice. This could be excluding the conflicted adviser from the process, but there are also other options. For example, it is sometimes the case that SAC members have worked on the research that the committee is to assess. In such cases, the adviser might be asked to make a factual statement about the research, but otherwise not take part in the discussion.  Furthermore, advice can be, and normally is, generated by multiple advisers, so that each viewpoint is balanced and challenged by a range of others, resulting in more objective advice.

Perception of interests and of conflicts of interest can be damaging, even if they do not lead to bias

The public and other stakeholders must be able to trust our approach including the sources and use of scientific advice that informs our work. People have different views about the extent to which interests are relevant and the extent to which they represent conflicts, and whether and how interests should affect participation in decision-making. So, we need to make sure that we can robustly explain, assure and defend the way we manage advisers’ interests to the public and our stakeholders, even though unanimous agreement on the right approach is probably impossible.

There must be a balance between managing conflicts, maintaining access to diverse, good quality, and relevant scientific advice, and being practical to implement.

The approaches previously developed with the SACs are generally considered to be effective at balancing the competing needs for:

• preventing advisers from providing advice that is not in the public interest;
• accessing a diverse range of useful scientific expertise; and
• being practical, flexible and proportionate. 

This balance needs to be maintained. For example, if we were to adopt a rule of never taking advice of any kind from individuals with specific types of interests (e.g. those who receive funding from industry or lobby groups, or those who undertook the relevant research) this could remove access to an important source of scientific expertise, resulting in advice that is less soundly based and hence leading to worse outcomes for the public. Our approach needs to be effective, robust, transparent and consistent, but also needs to avoid putting a disproportionate burden on our advisers and FSA staff, or preventing us being able to access robust scientific advice.    

2. Definitions, Roles and Responsibilities

2.1 Roles and Responsibilities

Advisers are responsible for ensuring that all their relevant interests are declared and kept up to date in the Declaration of Interests form (Bottom of this page). Any interests that could reasonably be perceived as posing a potential conflict need to be declared, even if not mentioned explicitly in the Good Practice guidance. However, advisers and FSA staff are not under any obligation to search out links of which the adviser might reasonably not be aware.  

Chairs (of Science Advisory Committees) will work with Secretariats to ensure interests are declared and conflicts managed in line with guidance (e.g. asking if there are any changes to the register of interests that need to be made, asking for declarations at the beginning of the meeting and at relevant points in the agenda, if deemed necessary). For SACs, it will be their responsibility to decide whether interests pose a conflict, and how to manage any conflicts. In the event of dis-agreement about how best to manage a conflict, issues can be raised with the FSA or in extreme cases the FSA Chair.

FSA staff supporting the adviser (e.g. Secretariat, in the case of SACs) are responsible for making sure this guidance is followed and supporting its application. This will involve: 

• supporting advisers in following the guidance, including in induction and formal training if needed;
• keeping up-to-date records of adviser’s interests and how any conflicts are assessed and managed;
• checking Declarations of Interest in advance to identify any interests which might present a conflict for forthcoming work in which an adviser may be involved, regarding the topic, matter, company or substance under consideration, and managing any conflicts in line with the guidance. This will be particularly important in preparing for provision of advice to inform assessment of applications for authorisation of regulated products;
• including a summary of conflicts and how they were managed on relevant outputs [4].
• For advisers working outside of the SAC structure, FSA staff are responsible for deciding whether an interest poses a conflict, and how any conflicts should be managed. In assessing this, they will need to take proportionate approach, reflecting the scale and nature of the task and the outcome which the advice will inform.[5]

The FSA Director of Information and Science is accountable within the Executive for the oversight and review of SAC declaration of interest processes. This role includes verifying the completeness and accuracy of declared interests and the way conflicts are assessed and managed through: 

• Oversight of SAC secretariat delivery of declaration of interest processes as outlined in this guidance.   

• Reviewing the results of the SAC declaration of interest audit and determining where action is needed to support SACs to comply with this guidance.  

The FSA Director of Information and Science will be supported in this role by staff in the Science Evidence and Research Division with delegated responsibility for the implementation and monitoring of this guidance. 

2.2 Defining interests and conflicts

Interests are the advantages and obligations an individual owes (or feels they owe) to another person or organisation or is owed to the individual from that person or organisation. Advantages may include direct financial reward (e.g., because of a major shareholding in a company affected by their advice) or personal advancement (e.g., future job prospects, reputation). Obligations may include loyalty to an employer or other organisation. 

Interests only need to be declared if they relate to a relevant organisation or individual (see below for the definition of relevant organisations). 

Both current and past interests that could reasonably be considered relevant should be declared, depending on the nature of the interest and its relevance to the current advisory role. 

For past interests, it is difficult to set a rigid ‘expiration date’ for past interests, as there could be interests from any point in an individual’s life which might be relevant or perceived to be so. At the same time, it is not reasonable to expect advisers to provide an exhaustive listing with no cut-off.  Advisers should declare all relevant interests within the 5 past years as a default, but consider whether there are any other interests dating to before this which could be relevant, and declare these, with reference to the guidance below under ‘Do I need to declare this interest?’

Conflicts of interest occur when the adviser has or could reasonably be perceived to have interests which are likely to cause them to act in a manner that could undermine the independence or objectivity of their advice. Conflicts of interest most often arise when the interests of an adviser overlap with the matter, product or substance under discussion but could relate to an interest relevant to the wider role of the Committee or of the FSA. For example, a conflict of interest would occur if an adviser was asked to provide a risk assessment on a product owned by their employer or interpret research that they were involved in producing.

Sometimes an interest can appear to pose a conflict even when no conflict exists. This is a reputational risk, so it is important for advisers and FSA staff to consider how an interest might be reasonably perceived by others.

2.3 Relevant organisations and individuals

Relevant organisations and individuals are those who could be affected in some way by the decisions that the advice is intended to inform. 

Industry – relevant organisations are any of the following:

• Companies, partnerships or individuals who are directly concerned with research development or marketing of the product or service (or a competitor) which is being considered by the adviser/s in question.
• Companies, partnerships or individuals who are involved with the production, manufacture, sale or supply of products or services subject to relevant legislation. The legislation may include, but is not limited to:
  • The Food Safety and Hygiene (England) Regulations 2013 (and equivalent measures in Northern Ireland and Wales)
  • The Food Safety Act 1990 (and regulations made under it)
  • The Medicines Acts 1968
  • The Food and Environment Protection Act 1985
  • The Consumer Protection Act 1987
  • Cosmetic Products Enforcement Regulations 2013
  • Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

• Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 (and equivalent measures in Northern Ireland and Wales)
• Food Supplements (England) Regulations 2003 (and equivalent measures in Northern Ireland and Wales)

• Trade associations representing companies involved with such products.

Organisations with interests in industry - organisations which have publicly stated obligations to; campaigns related to or receive funding from the above defined industries. These might be research institutes, professional societies, charities or nongovernmental organisations

Organisations with interests in the FSA’s scientific advice and the outcomes the advice is intended to inform- organisations which have publicly stated or have apparent interests or campaigns related to the outcomes of the FSA’s work that the advice is intended to inform. These might be campaign or lobby groups, representative bodies, charities, clubs, academic non-governmental organisations, other advisory panels, or other government organisations.

2.4 Types of interest and examples

Personal Interests

A personal interest involves the benefits or obligations directly affecting the adviser, or their close family. This usually includes personal partners, parents, children (minor and adult), brothers, sisters and the personal partners of any of these. 

A benefit or obligation could come from financial or non-financial support, including use of equipment or facilities, research assistants, paid travel to meetings/conferences, honoraria, hospitality/expenses over £25 per occasion, or £100 over one year. Where a particular interest relates to many organisations or activities, such as trusteeship of a charity, the Secretariat/relevant FSA staff) can agree with the adviser a general declaration to cover this interest rather than draw up a detailed portfolio. Some examples of relevant personal interests that would need to be declared are:

• Any fee paid work - employment, consultancies, directorship, pension, position or work which attracts regular or occasional payments in cash or kind, from relevant organisations (as defined above).
• Shareholdings: any shareholding in or other beneficial interest in shares of industry. This does not include shareholdings where the adviser has no influence on financial management.
• Membership or Affiliation: any membership role or affiliation that the adviser or a close family member has to relevant organisations (as defined below).
• Decision making positions in organisations such as professional bodies, advocacy groups or charities, e.g. director, board member, trustee, chair.
• Political activity at a high level, e.g. holding a paid or high-profile voluntary office, political speeches on matters regarding their work, making a recordable donation, or candidature for election to local or national government.
• Substantial contribution to the work or advice being considered (e.g. named author on paper, named author on a paper within a review).
• Publication of a clear opinion which could reasonably be interpreted as prejudicial to an objective interpretation of the evidence e.g. member of a group that has published an opinion on the subject, publication of a review in that area.
• Involvement with separate work which could be seen as competing for recognition or funding with the work being considered
• Trusteeships
• Patents, royalties, copyrights
• Positions that present a conflict with the need to separate scientific advice from decision making based on that advice - for example, roles that would result in an adviser taking part in decisions on risk management informed by scientific advice they have contributed to as an adviser [6]

Please note that the above is not an exhaustive list.

If an adviser is aware that a substance, product or matter under consideration is or may become a competitor of a substance, product or matter manufactured, sold or supplied by a company in which the adviser has a current personal interest, they should declare their interest in the company marketing the rival product, substance or matter.

Non-Personal Interests

Non-personal interests include benefits or obligations not received by the adviser personally but to the organisation where the adviser works or involving people less close to the adviser.  Significant non-personal interests benefitting a close family member should also be declared. 

Some examples of relevant non-personal interests that would need to be declared are:

• Fellowships: the holding of a fellowship endowed by industry or charity.
• Financial or in-kind support by relevant organisations (as defined below). 
• Any payment, other support or sponsorship which does not convey any financial or material benefit to an adviser personally, but which does benefit their position or organisation. For example:
  • a grant for the running of a unit or department for which the adviser is responsible;
  • a grant or fellowship or other payment to sponsor a post or a member of staff or a post graduate research programme for which the adviser is responsible. This does not include financial assistance paid directly to or on behalf of students;
  • the commissioning of research or other work by, or advice from, staff who work in a unit for which the adviser is responsible.
• Current positions or research interests in any institution or as part of the wider research or professional community that could benefit from information gained through working with FSA.
• Current or applied for research funding commissioned by the FSA for which the adviser is principal or co-investigator.
• Adviser is a colleague of someone who contributed substantially to the work or advice being considered (e.g. the adviser’s colleague is a named author on paper, named author on a paper within a review). But as noted earlier, advisers are under no obligation to seek out knowledge of work done by individuals in the organisations in which they work if they would not normally expect to be informed.

Again, please note that the above is not an exhaustive list.

Specific Interests

For some committees or advisory roles, e.g., where discussion tends to focus on a certain substance, technology or process, it may be helpful to distinguish between specific and non-specific interests. It is for the relevant FSA staff to determine whether specificity is a relevant distinction for their adviser.

If it is a relevant consideration, an adviser must declare a personal specific interest if they have at any time worked on a matter, product or substance under consideration and have personally received payment for that work, in any form.

An adviser must declare a non-personal specific interest if they are aware that the organisation in which they work has at any time worked on the matter, product or substance under consideration, but they have not personally received payment for that work, in any form.

Non-Specific Interests 

An adviser must declare a personal non-specific interest if they have a current personal interest in a company concerned with the matter, product or substance under consideration (where their interest does not relate to the subject of advice).

An adviser must declare a non-personal non-specific interest if they are aware that the organisation in which they work is currently receiving payment from the company concerned which does not relate specifically to the matter, product or substance under discussion.       

3. Good Practice Guidance

3.1 Process for managing interests

The following sections describe the approach for managing interests and its application in detail.

At appointment/selection to provide scientific advice

All candidates must complete a Declaration of Interests form (provided by the Secretariat) alongside the rest of the application or it will not be considered.

For ad hoc advice this should be done when their advice is requested (or when they apply to be part of a register of experts). 

If an interview is held, the Declaration of Interests form should be discussed, and any potential conflicts should be discussed and resolved, if possible. If conflicts are likely to occur so frequently that it would seriously hinder the contribution the adviser can make, they should be dismissed or not appointed to the advisory role.

Details of interests and how any conflicts have been assessed and managed should be suitably recorded, including the rationale for this judgement with reference to this guidance.

During appointment/contract/while providing advice

Following appointment, advisers should inform the relevant FSA staff of any change in their personal interests when it occurs.[7] FSA staff will also contact each member on an annual basis to update their Declaration of Interests. 

The Declaration of Interests should be regularly reviewed by the appropriate members of FSA staff, and the interests compared to the topics of future work for the adviser. FSA staff should also enquire about any item on the form they feel may be a conflict for the current topic, matter, or substance under discussion.

Records or reports produced by advisers including SAC opinions and advice should include a statement on interests (covering interests that were declared and by whom, and how any conflicts were managed, and the rationale for this judgement).

In meetings with advisers including SAC meetings

At the start of the meeting the Chair should ask advisers to declare any interests potentially relevant to the items under discussion relating to themselves or their close family members. Advisers should be encouraged to flag any additional interests at later points if they believe there are any relevant interests that they have failed to declare at the start of the meeting. This includes interests relating to any significant items which emerge in discussion but were not foreseen in advance.[8]  The Secretariat (or other FSA staff) should remind the Chair to do this if it doesn’t happen.  

This ensures that relevant interests that have been declared previously are considered as part of the discussion. It also ensures that any interests which have only become relevant in relation to the current item, and so have not been declared before, are declared and discussed. As the Declaration of Interests is only intended as a high-level record of interests, the Declaration is not expected to cover all possible interests that could become relevant during meetings.

Based on this information, the Chair will consult with the Secretariat, FSA staff and potentially other SAC members, and decide on an approach to managing the interest. Guidance on choosing an approach is given in Section 3.3 below.  

In the case of interests declared by the Chair, the same process will apply as to when there is an absence of the chair; the relevant FSA staff are responsible for deciding whether an interest is a conflict and if so, how it should be managed. FSA staff may also request input from other committee members on appropriate action. 

The interests declared, and the chosen action should be recorded in the minutes of the meeting with the rationale for this decision.

SAC Members are welcome to inform the Secretariat in advance if they may have an interest in an agenda item for an upcoming or future meeting, especially if they consider this may be a conflict.

For SACs specifically 

At start of any formal meeting (including sub-groups) the Chair should ask if there are any changes to the register of interests. 

3.2 Publishing interests

A register of interests should be developed and published based on advisers’ Declarations of Interests, and any further discussions. To protect the privacy of advisers, personal data or items which could plausibly lead to their personal safety and security being compromised should not be published and should be kept securely within the FSA. 

SACs

For SACs, a register of members’ interests should be published on its own dedicated page of the SAC website. Changes to the register should be published in a timely manner and the whole register should be reviewed and updated at least annually. All interests that have been declared and the dates over which they applied should be included, as well as interests of those who left the committee within that reporting year.

When advice is provided outside of formal meetings (e.g. by email or over the phone) interests must also be managed in the same way.

SACs should discuss the register periodically as a group, to provide peer support and challenge on declaring interests.[9]  

Any other external scientific experts who are not SAC members but who provide material input to Committee discussions (for example as a co-opted expert to an SAC or sub-group, or through providing evidence or analysis for consideration by them) should declare relevant interests in the same way as SAC members and their interests should be recorded as for SAC members in the records of the SAC’s work.  

Expert advice provided outside of SAC structures 

When advice is provided outside of SAC structures the same principles apply. 

FSA staff requesting advice should check the declared interests of potential advisers and ask them if they have any other interests potentially relevant to the item they might be asked to advise on, relating to themselves or their close family members. This can include interests that have not been declared previously. If relevant interests lead to potential conflicts, FSA staff should decide on an approach to manage the these, including deciding whether it is appropriate to ask the expert to fulfil the advisory role in question in this case.  This will be particularly important in preparing for provision of scientific advice to inform assessment of applications for authorisation of regulated products.

All interests, conflicts and any mitigating actions and the rationale for this should be recorded in a ‘Statement of Interests’ to be included in any written outputs of the advice (e.g. the SAC advice or opinion, or the note of a peer-review panel).  

Where advisers provide material input (advice, evidence or analysis) which informs the FSA’s assessment of applications for approval for regulated products, we would expect the relevant interests and the management of any conflicts and its rationale to be published as part of the record of that assessment.

For other types of external scientific advice, interests would be published annually on an overarching register of external advisers’ interests, for those advisers who have provided advice to the FSA in that year. This would not link individual advisers to individual pieces of work. This will preserve the anonymity of advisers providing peer review and other advice where publication of their roles would inhibit their ability to provide objective critique and challenge.

3.3 For FSA staff and SAC Chairs

Guidance on managing conflicts and bias

Managing Potential Conflicts of Interest

Once a potential conflict of interest is identified, the following factors should be considered and will determine how it is managed:

• how current or recent the interest is;
• how relevant and specific the interest is to the matter, product, or substance under discussion;
• how personal the interest is to the adviser;
• the significance of the interest to the adviser; and/or
• sensitivity – anything that would amplify the concern such as political sensitivity, public perception of conflicts, controversial issues, multiple potential conflicts.

The impacts of different options on the FSA’s ability to access appropriate scientific advice should also be considered.

Some options for managing conflicts of interest in group meetings are:

• be aware and record the conflict, and continue the group discussion;
• subject the adviser’s comments to additional scrutiny and group discussion; 
• use formal votes, not allowing the conflicted adviser/s to vote;
• co-opt additional external (or if necessary, internal) advisers to give a second opinion on the weight or quality of the evidence;
• allow the adviser to provide descriptive information, and their own conclusion, but not comment on the strength of the evidence, robustness of conclusions or what it means for the questions asked;
• allow the adviser to remain in the meeting, but only to listen to the discussion without speaking. The Chair may first allow them to make a statement on the item under discussion;
• ask the adviser to leave the room for the duration of the meeting or agenda item (even if held in public). Again, the Chair may first allow them to make a statement on the item under discussion. If the advisor is the Chair then another member of the group that remains must be selected by the Secretariat to chair in their absence;
• exclude the adviser from serving in this advisory role.

The considerations above should be discussed between the Secretariat of the committee and the Chair. The decision on how the conflict is managed should be recorded, with reasoning given. In particularly difficult cases (such as the SAC Chair having a conflict), advice may be sought from the Chief Scientific Advisor or the Chief Medical Officer.

For managing conflicts of interest without group meetings (e.g., for peer review or an appraiser), some potential options are:

• be aware and record the conflict, and allow the adviser to provide advice; 
• allow the adviser to provide advice, but co-opt additional external (or if necessary, internal) experts to give a second opinion; and/or
• exclude the adviser from completing this advisory task.

In recording interests of members and actions taken (or not taken) to manage the risk of conflict, the Secretariat or relevant FSA staff should consider how the situation could be perceived. In particular, where a lighter-touch option for managing the interest is chosen, this decision and its rationale should be explained clearly in the minutes.

3.4 Other ways of managing risk of bias

Conflicts of interest are only one potential source of bias. This is a non-exhaustive list of options that FSA staff could consider using to manage the effects of potential conscious and unconscious bias in scientific advice.

For all advisers

• Hold consultations (internal or external) on outputs of the advisers.
• Encourage a culture of challenge of all evidence presented.
• Ensure that candidates for adviser positions are committed to the principles and values of public service. FSA staff are required to explore any issues concerning probity or potential conflicts of interest with the candidate prior to appointment.
• Use in-house scientific expertise to identify any conclusions and weightings given to the evidence that seem biased and flag these to the CSA (or the Science Assurance and Coordination Team).
• Feedback to the CSA by the Chairs of SACs or project officers or programme managers on how the process is working

For committees (SACs, appraisal panels, or other advisory committees)

• Have a diverse range of people on the committee, with different work backgrounds or with some differing areas of scientific expertise (depending on context).
• Ensure transparency of operation by exposing the work and decisions to external scrutiny.
• Seek consensus, but also recognise different views on a subject. Any significant diversity of opinion among the members of the Committee that cannot be resolved should be accurately reflected in the minutes or report [10]. Committee decisions should always include an explanation of where differences of opinion have arisen during discussions, specifically where there are unresolved issues and why conclusions have been reached.
• The SACs Secretariats should act as a forum to discuss any issues of inconsistent interpretation and application of the approach.

3.5 For Advisers

Guidance on declaring interests

Do I need to declare this interest?

As outlined earlier, it is your responsibility to ensure you have declared all relevant interests that have the potential to become a conflict on the Declaration of Interests form (Bottom of this page).  The examples given back in Section 2 cover some common types of interest that need to be declared, but not all possible interests are listed there.

The following questions are given to help you decide if an interest needs to be declared. If the answer to any of the following questions is ‘yes’, the interest should be declared.

• Could this interest in some way compromise your judgement or integrity, or create some form of obligation? 
• Would a reasonable member of the public believe that this interest is relevant to your advisory role and/or could be a potential conflict?
• Would you or the FSA be embarrassed if the interest became public, having not previously been declared? 
• Would it be difficult to report this internally, or explain it when it is known externally?
• Was the hospitality or other gifts in kind offered unusual or unreasonable in the circumstances? (For example, attending a meeting where lunch worth less than £25 was provided or receiving food for use in experiments would be considered normal and reasonable, whereas being offered tickets to a sporting event would not).

If you are not sure whether an interest needs to be declared, you should declare it on the Declaration of Interests form. The Secretariat/FSA staff can then discuss it with you and remove it if irrelevant. At meetings, interests you’re uncertain about should also be declared, but to avoid disruption Members could seek guidance from the Secretariat/FSA staff or the Chair in advance, which can then be recorded as part of the meeting as appropriate. 

3.6 Ensuring that the guidance is followed

Every participant in the provision of and support to external scientific advice has a role to play in ensuring that the guidance is followed, as set out under Section 2.1 Roles and Responsibilities. If they have any concerns that guidance is not being followed, they should raise these through the Science  Assurance and Coordination team and Director of Wales, Information and Science.[11]  

3.7 What happens if the guidance is not followed?

For an adviser: Failure to declare interests could represent a breach of the terms of appointment, and as such could result in termination of appointment.

For FSA staff: Any issues would be dealt with as part of the established procedures and policies for performance review and conditions of employment as FSA staff and Civil Servants.    

Declaration of Interests Form

Footnotes

[1] https://www.food.gov.uk/about-us/fsa-board-meeting-may-2016

[2] There is an exception to this where relevant FSA employees have roles as independent scientific experts. For example, if FSA employees supporting the experts have contributed as authors or peer reviewers to work under consideration, they should declare that interest in line with the guidance presented here.

[3] External advisers from other government departments who are civil servants are also be bound by the Civil Service Code when they are acting in the capacity of civil servants; where the acting as independent advisers rather than civil servants, they will be covered by this guidance.

[4] If outputs are developed for an external organisation in a specific format where inclusion of a statement of interests would be inappropriate, the summary of conflicts can be omitted. 

[5] For example, advice informing a complex, high profile issue with a high direct impact on consumers, industry or other stakeholders will need a more extensive consideration than in the case of a small, short piece of work in a less contentious or complex area. 

[6] In line with this, FSA staff may not serve as members of FSA’s SACs or as independent advisers to FSA. Civil Servants or other employees of other parts of government may be eligible to serve, depending on their role. If they hold a primarily technical or expert role in other government organisations, in which they provide scientific expertise and advice, they may be eligible. This interest should be declared, and any conflicts managed as for other interests (for example, they would not take part in assessments of work they or their teams had produced). If their role involves policy or risk management, this would be a significant conflict with the need for advice to be clearly independent of decisions on risk management which that advice informs and is likely to preclude their participation as an adviser.

[7] This should be done within one month or at the point of any subsequent input to a task to which it is relevant, whichever is sooner.  

[8] Where members wish to raise new items, for example under Any Other Business (AOB), they should if possible inform the Chair and Secretariat in advance so that any interests and conflicts can be considered in good time.

[9] The regular workshops of SAC Chairs with the FSA Chief Scientific Adviser and Director of Science, and the FSA’s internal Secretariats group provide two mechanisms to do this.

[10] If, however, member(s) feel they cannot support the Committee conclusions, they may declare a ‘minority report’ identifying which member(s) are making the report and setting out their position.

[11] In line with FSA’s wider procedures for governance, all participants also have the option to raise concerns directly with the CSA outside formal channels, or to use FSA’s ‘whistleblowing’ procedure.