Publication - Publication

An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland

Published: 26 Oct 2018
Part of:
Health and social care
ISBN:
9781787813342

An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland, with particular reference to the Independent Review of Transvaginal Mesh.

137 page PDF

1.0 MB

137 page PDF

1.0 MB

Contents
An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland
Chapter 3: Independence and conflicts of interest/declarations of interest

137 page PDF

1.0 MB

Chapter 3: Independence and conflicts of interest/declarations of interest

72. We have defined the term ‘independent’ as the spine which should run through any investigation. An investigation which is not perceived as independent can lead to public lack of confidence in the process and its outcomes.

73. We used ‘conflict of interest’ as the situation or experience or interest that may give rise to questions of independence.

74. Finally, we used the term ‘declaration of interest’ as the mechanism or process which facilitates exploration, examination and declaration of a possible conflict.

What is independence?

75. Independence is an amorphous concept. It can be defined in different ways depending on what it is believed to represent. For some, independence means to be free from influence or interference such as from political, or media influences. For others it can be seen as the cornerstone of credibility or legitimacy. It may also be equated with concepts of fairness or impartiality.

76. The independent element of any review commissioned requires that the members’ opinions, findings, conclusions, judgements, and recommendations have been reached after setting personal views aside. If this has not occurred, the value of the findings of the review may be compromised or undermined.[51]

77. Organisations that have produced guidance on the principles of independence tend to distinguish two themes (a) independence of mind and (b) independence in appearance; sometimes referred to as “perceived” independence.[52] Appointed members not only have to be objective in their actions but must be seen to be acting objectively.

78. Demonstrating independence in an ad hoc review, as opposed to an inquiry established under statutory provisions, has the added hurdle that its meetings and discussions are held in private. The review model may therefore appear to be less transparent than its statutory counterpart. However, being held in private does not equate to being held in secret[53] and a robust and transparent process will provide reassurance and confidence in its findings.

79. Some basic questions should be considered when setting up a review, particularly one commissioned by a government Minister.

  • How can independence be ensured when the investigation is usually commissioned by a member of the government?
  • How can an investigation maintain its independence if the administrative support is provided by civil servants?
  • What is the investigation “independent” from?

The Mesh Review

80. When we asked members what ‘independence’ meant to them, there were a variety of responses. These would most appropriately be grouped in two ways. Firstly, some members understood independence in terms of the individual review member to assess the data and to follow it to whatever conclusions it led them to. For example:

“I think an independent review is independent where there is a clear remit of what it is that has to be assessed, having set aside your own personal views, your own personal prejudices, your own personal sense of ‘I know what’s been going on here’.”

“Research doesn’t necessarily mean you are pro or against, you are fact finding.’

81. Alternatively, other Review members emphasised the independence of the process.

“Independent means unaltered by external forces”

“In this Independent Review and in other independent pieces of work I’ve been involved in, what it is designed to do is to have an externality about it. So it’s not us marking our own homework.”

82. The former perspective envisions members as independent if they do not have pre-conceived views on the topic, or a predisposition towards a certain outcome. The latter perspective views a process as independent if it is not unduly influenced by the government. The two are not mutually exclusive characteristics, but are subtly different, e.g. a group could be objective but not separate from government, or wholly autonomous but filled with vested interests.

83. Independence of the chair is a central and necessary feature of any investigation.[54] He or she has to be able to secure the confidence of those with an interest in the process and its outcomes, whether they are victims, their families or the wider public.[55] Lack of faith in the independence of chairs has led to some inquiries being converted from a non-statutory review to a statutory inquiry. For example, the Independent Inquiry into Child Sexual Abuse was announced in July 2014 and converted into a statutory inquiry in March 2015.[56]

84. The members we spoke to agreed that the independence of the group as a whole would derive from the independence of the chair. In the context of the Mesh Review, this was seen as the chair being “independent of Scottish Government”:

“A review draws its independence from how people use their skills, their expertise, their experiences, their analytical capacity to be able to answer a question that has been set for them to look at and that that can then be provided back in a way which is independent of whatever expectation from the originator. So the independence of person is then balanced by the independence of voice that comes back from the review chairman of the review group.”

85. The different interpretations of independence also influenced whether members believed that the review process was or was not independent. Those who focused on the bias, or vested interests, of participating members tended to view the Group as not independent; whereas those who viewed independence as a separation from Scottish Government officials generally saw the process as independent. Although when they were specifically challenged about this, for example, through the questions posed above, they were able to recognise the problems with the perception of independence.

86. There were some comments on the group being influenced by external forces such as the political interests, or media attention, and that this, in turn, influenced the independence of the Group. One observed: “Outside attention [was] affecting what evidence was viewed as relevant, why and how to interpret it.” Doubts were raised whether it is possible to create “a transparent system with lay people that isn’t susceptible to politicisation through media or politics.”

We recommend that the chair identifies areas that may have the potential to compromise the independence of the investigation. This is part of his or her overall duty to ensure an effective inquiry process and public confidence in the outcomes and recommendations.

Conflict of interest

87. Conflict of interest, bias or undue influence may give rise to questions of whether independence is being compromised.

88. A conflict of interest may be defined as having judgement impaired or influenced by a secondary interest.[57] Whether or not the individual benefits or not, is irrelevant. Potential conflicts of interest are not an uncommon feature, particularly if the subject area is specialised, but a process should be in place to identify and measure them and to ensure that a proportionate response can be made. This is usually achieved through a declaration of interests.

The Mesh Review

89. This area gave rise to some of the most concerning findings of our Review. Within the membership of the Mesh Review were a number of potential conflicts of interest that should have been declared. Some clinician members had received payment to undertake clinical research. A patient representative had received payment for being part of a research project and was mentioned as an author on one of the key pieces of research considered as evidence in the Mesh Review.[58] Some members were the subject of litigation and others were suing. One of the clinician members was another Review member’s surgeon.

90. All of these matters gave rise to potential conflicts of interest and should have been declared; but weren’t.

91. Perhaps of greater concern was that, when specifically asked about these matters, some members did not immediately recognise how these issues could give rise to potential conflicts- it became clear that it has never been specifically discussed during the Mesh Review and that members individually had never been asked to consider such issues.

92. It is recognised that it would not be unusual for leading clinicians to be involved in research and their research sponsored by manufacturers in the area within which their specialism lay. Some members did raise this, making reference to the need for pragmatism in such a niche specialist area. Others highlighted the difficulty of getting expert insight without involving those with a vested interest in the topic. Instead they believed the focus should be on ensuring that interests in such a process are declared adequately, so that other members are aware of the positions and experiences an individual is bringing to the Group. However, this did not happen.

93. Depending on the nature of the subject matter under review, the fields of specialism may be particularly small, and it may not be unusual for a prospective reviewer who has extensive experience in their field to have professional or personal biases. These must, however, be disclosed. It should then be determined whether these biases would disqualify them as a prospective reviewer.

94. The test of “impartiality” may be usefully adopted.[59] This would address the problem of drawing and recruiting from a small pool of expertise and allow the recruitment of persons who have had prior involvement in the specialism and the subject matter of the review as long as this has been declared and a decision taken on the suitability of the prospective person in question. Impartiality was defined by some, as “being objective” and “keeping an open mind.”

95. Different cultures and organisations will approach this in different ways. Some will apply a rigid rules-based approach and others will adopt more flexible guidelines.[60]

We recommend applying a test of ‘impartiality’. This would allow someone with prior knowledge or involvement in the subject matter to be a potential member on the basis that their involvement was disclosed and evaluated.

96. It was not just expertise in the subject matter that was not declared. As stated, the fact that some members were involved in litigation was not discussed. We asked the first chair if she knew that one of the clinician members had been another member’s consultant and surgeon. The chair’s response was “I don’t know, we never talked about that. It’s not my business to know that. Those were personal things.”

97. A few members referenced on-going litigation involving members being avoided as a topic of discussion, with one member claiming they were explicitly not allowed to discuss the topic. However, they did not go into detail as to how this arose or who advocated such a position. A number of those we spoke to believed that it was the role of the chair to have identified those involved in litigation within the group.

98. Involvement in litigation, or a doctor patient relationship, has the potential to compromise the independence of any review. We believe that it was a major failing that these were not declared and discussed. The credibility or accessibility of outcome tends to determine public perception of independence. It is the role of the chair to address any issues which have the potential to compromise the independence of the investigation.[61]

99. One member stated that, in retrospect, they did not view the Group with the same degree of independence as they had done previously.

“It struck me that it is quite impossible to get a review group that can ever make any meaningful recommendations that is actually independent of all relevant interests. I suppose it doesn’t need to be independent, those interests just need to be declared. They never were, apart from the Final Report and they are limited.”

Declaration of interest

100. Independence of process can be scrutinized through a check list approach. The check list will contain a list of proscribed activities or circumstances under which independence may be perceived to be compromised.[62]

101. Conflict of interests or bias is much more concerned with reasons and motivations behind certain decisions or behaviour. It is concerned with internal thought processes rather than lists of prohibitions.[63] A system that recognizes both is required. A declaration of interest form may provide a checklist to address the former and as long as it is fit for purpose, it will do this adequately. However, something more, in terms of process, is required to address the latter; the individual’s objectivity.

The Mesh Review

102. In the Mesh Review, the request to complete a declaration of interests form came, via email, from various Scottish Government officials. The Chair assumed no oversight of this process. There were conflicting accounts as to whether individuals completed these forms or were able to see and/or discuss the declaration of interest.

103. For instance, one member stated that declarations were accessible and that people were asked at every meeting if they had “anything new to declare”. Another said that they could see others’ declarations but could not discuss them. One member said that they raised the issue of not being able to view others declarations several times and were only finally able to see other members’ declarations when they were posted online.

104. The fact that there had been no proper discussion of possible conflicts of interests which should have been declared became clear when interviewing the Review members. It was only when individuals were challenged on how their own professional background or interests could give rise to a potential conflict that this was recognized. A number of those interviewed indicated at the beginning of our interviews that they were entirely independent but then conceded that there may have been conflicts of interest which they had not considered, and which would, to an outside observer, give rise to criticisms of bias or conflict.

105. For those who did complete a declaration of interest form, the majority said that they had done so at least twice and sometimes three times; however this may not have been accompanied by an explanation of why this request was being made. One member believed that some of the initial declarations were carried over from their time on the Short Life Working Group. “I lost track of what I was signing the form for.” Another said: “I really didn’t feel that the process that was in existence was at all satisfactory.”

106. Many members had serious reservations as to the appropriateness and format of the declaration of interest form used and because of this they volunteered more information than they were asked to on the standard declaration of interest form.

107. There were a number of concerns expressed. First, the form only asked for activity for a retrospective period of 12 months. The form that members were given was not fit for purpose, providing no prompt or opportunity to make a full and meaningful declaration of interests.

108. This was a major omission. Research interests, payments for clinical trials, co- authorships and involvement in litigation should all have been declared. A 12 month “snapshot” of relevant interests was insufficient.

109. A second concern was the lack of breadth in terms of the different vested interests a person might have. For example the form only asked for information on what it referred to as “commercial interests.”

“It was only about industry, so it didn’t ask about other conflicts of interest or other competing interests or other vested interests that are not money related.”

“The other thing about declarations is there’s a lot of conflict about what industry gives you but I think that the intellectual conflict is sometimes more important.”

110. Some suggestions were made to us that the declaration of interest form should have provided space to write a short commentary which may assist with putting declared information into perspective. We believe this would have been useful as it would have provided an opportunity to exercise judgment and declare what members thought would be relevant to protect the independence and integrity of the review.

111. Third, the form only covered the individual in question, and it did not enquire about the interests of family members or partners.

“I have to say I was very concerned about the form that I was given which is totally unfit for purpose. I was asked to fill it out before I attended the first meeting and because I was so unhappy about its content I made a fairly lengthy statement of previous interests at the first meeting I attended.”

112. The completed forms were added onto the Scottish Government website. However, this appears to have been done in a piecemeal fashion with some additions and amendments continuing to be made up to as recently as April 2018.

113. Concerns were expressed by members that the declaration of interest forms were removed from the website for those members who resigned. This prompted one member who had resigned to contact the Scottish Government requesting their declaration of Interest form be put back on to the website.

114. Independence of process and membership of the Mesh Review have been among the most contested areas during our investigation, both during the Review and following the publication of the Final Report. The process for declaring relevant interests was inconsistent, leaving members unsure what they were declaring and why. The actual form did not assist with this process with some members providing additional objective information and others submitted no forms at all on any occasion.

115. The fact that the chair expressed the view that it was not her – or the members’ – business to inquire about matters of research interests, litigation and potential conflicts where a doctor and their patient were both members of the Review may explain why the process was so poorly managed. Finally, the process for putting declaration of Interest forms on the Review website seems haphazard and confused, particularly where it involved the resignation of a Review member.

116. It would have been useful that there should be clarity about the process for requesting the completion of declaration of interest forms. For example, members should be advised about the form, whether there is accompanying guidance and how often such a request should be made. It should be explained how and where they are to be stored and whether they are publicly available.

117. A declaration form should have accompanying guidance or prompts to address questions of potential conflict of interest. This places the responsibility of declaration on the member and introduces a flexibility and opportunity to apply ethical judgement. Both the checklist element and ethical elements would then be satisfied.

We recommend that a process should be in place to identify and measure potential conflicts of interest to ensure that a proportionate response can be made.

We recommend that the chair has responsibility to lead the members of the review in discussion to consider possible conflicts of interest.

We recommend that the importance of transparency and accountability in the completion of Declaration of Interest should be explained as part of a general induction process.


Contact

Email: David Bishop