Abstract
Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.
’Welcome to Hogwarts’, said Professor McGonagall. ‘The start-of-term banquet will begin shortly, but before you take your seats in the Great Hall, you will be sorted in to your houses’. (Rowling, 1997)
Recent research exploring how the expert and lay member roles are perceived by members of independent research ethics committees revealed the surprising fact that many members did not know either their own official role or that of colleagues. 1 All of those committees have now been disbanded, and their functions taken over by National Research Ethics Service (NRES) research ethics committees (RECs), and thus it may be supposed that the issue or problem no longer exists. This supposition is probably not quite justified, however, as, on the basis of an examination of the evidence of their annual reports, a number of NRES RECs would appear to have members who are in incorrect categories. In particular, a number of ‘expert’ members would, judging from the description of their occupations, appear to be more correctly allocated to one of the ‘lay’ categories. Such a situation is likely to have arisen accidentally. However, unless the allocation process is made tighter, it is conceivable that persons who are ineligible for membership could be enlisted onto RECs.
To many readers familiar with the NHS REC system a suggestion that there are types of person who are ineligible for REC membership at all may seem surprising, even shocking, but evidence that this is indeed so will be presented here with reference to the key legislation and associated definitions. Two illustrative groups are identified as ‘outlaws’ in this way: hospital managers and self-employed alternative therapists.
Before progressing to the ‘meat’ of my arguments I should state that I only deal here with UK legislation. Space does not permit a comparison of how other European Union member states have chosen to legislate in their national systems the directive (EU Directive, 2001) that governs clinical trial RECs in Europe. Such comparisons exist (EFGCP, 2007) but lack the detail needed for an analysis such as I am interested in. It is also the case that no explanation is offered in the legislation about the moral significance of having different categories of membership. The usual explanation would, however, suggest that the different groups are required to offer different perspectives, and so help ensure that a broad debate can be held (Evans and Evans, 1996). Whether this is achieved is, however, very much doubted. 1
The expert and lay categories
She left the chamber. Harry swallowed. ‘How exactly do they sort us into houses?’, he asked Ron. (Rowling, 1997)
The essential definitions for determining a REC member’s role category are to be found in the Clinical Trials Regulations (2004). There, the ‘expert’ member is stated (Sch. 2, para. 1) to be someone who is: (a) a health care professional; (b) professionally qualified or experienced in the conduct of, or use of statistics in clinical research (unless those professional qualifications or experience relate only to the ethics of clinical research or medical treatment); or (c) not a health care professional, but a person who has been a registered medical practitioner or a person registered in the dentists register under the Dentists Act 1984. It is noteworthy therefore that a professor of statistics would not be eligible as an expert member of a REC unless his or her qualifications or experience were in the use of statistics in clinical research. Although it is unclear what statistical qualifications might be pertinent to clinical research rather than, say, zoological research, it is undeniable that the legislation has gone out of its way to exclude statisticians who are neither qualified nor experienced in clinical research. One can note that under sub-para. (c) a struck-off doctor or dentist would still be very welcome to join a REC.
The definition of a ‘health care professional’ is relatively uncontroversial. Such persons are defined (Part 1, para. 2) as a (a) doctor, (b) dentist, (c) nurse, (d) pharmacist, (e) registered ophthalmic optician, (f) person registered in a register established and maintained under article 5 of the Health Professions Order 2001, (g) registered osteopath, or (h) registered chiropractor. ‘Nurse’ means ‘a registered nurse or registered midwife’. What could be considered controversial, however, is perhaps the inclusion (under sub-para. (f)) of, for example, a hearing-aid dispenser as a potential expert member. This indicates that an expert need have no relevant expertise. One can note too that the legislation does not − and contrary to all practice − require that there be any medical members on a REC. It is true that article 4(h) of the clinical trials directive (EU Directive, 2001) does require that where children are the subject of research, the REC, if it has no paediatric expertise of its own, must seek advice from someone with relevant expertise. However, there is still no requirement for this paediatric expertise to be from a medically qualified individual, and could come, for example, from a suitably qualified psychologist or nurse.
Everyone else is a ‘lay member’. This type of member is simply – although I shall of necessity make it rather more complicated in a short while − defined as ‘a member of an ethics committee, other than an expert member’ (Sch. 2, para. 1).
Lay ineligible − I
’When I call your name, you will put on the hat and sit on the stool to be sorted’, she said. (Rowling, 1997)
Controversy, however, really increases significantly in Schedule 2, para. 3(4). The issues here can best be illustrated by employing a fictional example case – I use a family doctor’s practice manager (PM): 3(4) A person shall not be eligible for appointment as a lay member of an ethics committee if, in the course of his employment or business, he – provides medical, dental or nursing care; or conducts clinical research.
Let us apply this role to our case, and ask the question, does our fictional PM ‘in the course of his employment … provide … medical … care’? To answer this question correctly, any definitions in the legislation will need to be considered. Unfortunately, the term ‘medical care’ is not defined in the legislation, but ‘health care’ is. ‘Health care’ means (Part 1, para. 2(1)) ‘services for or in connection with the prevention, diagnosis or treatment of illness’. So does our PM provide ‘services for …’? He might well answer this as ‘no’, perhaps because his contract of employment will typically be a ‘contract of services’ rather than a ‘contract for services’. So does he then ‘provide services … in connection with the prevention, diagnoses or treatment of illness’? If we follow the ‘prevention’ route, and note that he is under an employment contract ‘of services’, he could be said to be providing services to his employer(s). He is likely, for example, to source, order, and manage the influenza vaccine campaign every year at his surgery. The aim of the ‘flu’ vaccination service is to prevent the illness of influenza. On this interpretation he would be ineligible for lay membership as he ‘provides’ the relevant services on this reading.
However, because a ‘lay member’ is a member of a REC ‘who is not an expert member’, and because he is ineligible for lay membership can he be ‘bumped up’ to the ‘expert’ category by a backdoor mechanism? Bizarre (and illogical) as this seems, the author’s first letter of appointment to an NHS REC was as an ‘expert’ member, apparently on this very basis − the assumption being that no one could be ineligible for REC membership. This cannot be correct, however.
Furthermore, I do not think the above is a correct interpretation of ‘providing services’ in the context of the legislation either, and I believe more emphasis should be placed on the notion captured by the word ‘provide’. This term would relate to the activity of the business owners, and thus, in our fictional case, to the GPs, rather than to any of their staff (the services at the relevant facility would simply not be available without the GPs’ existence: thus it is the GPs who ‘provide’, albeit via their staff). Indeed, this interpretation would be consistent with the definition of the main category of expert member as someone with recognized clinical qualifications who provides care.
If the legislation does not quite destroy the hopes of the PM, let us now consider the position of a hospital manager, for example those in charge of a foundation or other trust, perhaps the Chief Executive Officer, and consider their eligibility in the light of paragraph 3(4). They surely can be said to be in the business of providing the services, even though they are not perhaps administering the treatments and so forth themselves, nor are they necessarily medically qualified. They are thus ineligible as ‘lay members’ – nor do they qualify as expert members. The conclusion is that they are ineligible for REC membership − not on the basis of moral failings but on their choice of career.
That this may have been the intent of the legislation is supported by Hedgecoe’s history of how lay members got on to UK RECs (Hedgecoe, 2009): this was accidental. Hospital boards acted as early RECs and on these there happened to be a few non-clinical persons such as the hospital secretary, an almoner, and perhaps a local big-wig as the chair. Other than those members, RECs were clinically oriented. The administrative team on the boards were essentially there to ensure the implementation of the clinician’s decisions, but the practice was to deem all members of the board as members of the REC. Lay members were the accidental result, subsequently accepted by legislation. However, not all medical members appreciated the lay presence, and that could account for the vengefulness of the legislation. Certainly it is an odd situation that hospital managers are excluded from membership and not one otherwise obviously explainable.
Lay ineligible − II
Sometimes, Harry noticed, the hat shouted out the house at once, but at others it took a little while to decide. (Rowling, 1997)
If we move on, Sch. 2, para. 3(5) requires that: (a) at least one third of the total membership shall be lay members; and (b) at least half of the lay members must be persons who are not, or who never have been – health care professionals; persons involved in the conduct of clinical research, other than as a subject of such research; or a chairman, member or director of: (aa) a health service body; or (bb) a body, other than a health service body, which provides health care.
Those persons caught by 3(5) (b) are what NRES terms ‘lay+’, and this designation is used for ensuring a quorum (see Sch. 2, para. 6).
To return again to our fictional example of a PM, in this context we can note that s/he is an employee of a GPs’ practice, and typically neither its chairman nor a director (the practice is likely to be a partnership). Is the PM a ‘member’ of the practice, as an employee? Let us look at the definitions. The term ‘member’ is not defined. Would a ‘commonsense’ definition of ‘member’ include an employee? Without immediately answering that question, one can note that there is a definition of a ‘health service body’ which may help our understanding. A ‘health service body’ is defined (in Part 1, para. 2) as ‘(a) a Strategic Health Authority … (b) a Special Health Authority, Primary Care Trust … (h) a National Health Service trust … (i) an NHS foundation trust’. Our PM is not employed by any of those bodies, but clearly is employed by ‘(bb) a body, other than a health service body, which provides health care’. This is beginning to look worrying for our fictional PM! However, perhaps using some Hogwartian magic, the PM can again escape ousting. By reference to Sch. 2, para. 6 (4) of the regulations (as amended by SI 2008/941) we find a ‘full meeting of an ethics committee’ defined as: 6 (4) one at which at least seven members of the committee (including any members co-opted under paragraph 8) are present, including at least − one lay member who is not and never has been a health care professional, or a chairman, member, director, officer or employee of a health service body; and an expert member.
Para 6(4) (a) (ii)’s ‘member … or employee’ thus indicates that an ‘employee’ is different from a ‘member’. On this basis that the PM is thus not a ‘member’ and so is excluded from para. 3(5) (iii): s/he is eligible therefore as a ‘lay+’ member.
The legislation can be seen not to, and incorrectly in my view, preclude an expert statistician from combining with an equally non-clinical lay member to adjudicate in a two-person sub-committee on a substantial amendment which may have arisen due to new medical information that has come to light.
Lay ineligible – III
At this juncture it is appropriate to issue a caution to any current lay members who are invited as a member of the public to join a local NHS trust which is seeking ‘foundation’ status. Many hospitals and other trusts are, or have been, attempting to achieve this status, as it offers certain managerial freedoms. One of the requirements for achieving that status is to have a certain percentage of the local population as signed-up members. Typically there is no fee or indeed responsibility involved – but if one was considering becoming a REC member such membership of an NHS trust is likely to exclude one from ‘lay+’ status.
Other issues to note, though, with the existing UK regulations, include that, although para. 3(5) separated the ‘lay+’ from the ‘lay’ category, it did so by reference to chairmen, members and directors of a health service body or other body that provides health care. It made no mention of the ‘officers or employees’ referenced by para 6(4) (a) (ii). So where do these persons belong? A person who is ‘lay+’ by virtue of para. 3(5) may still not be suitable for the quorum requirement (i.e. if they are an ‘officer’ or ‘employee’ of a health service body). Perhaps there is a need for a ‘lay++’ category to supplement ‘lay’ and ‘lay+’? (And what has happened to those chairmen, members and directors of other bodies (para. 3(5) (b) (iii)) that provide health care – why are they no longer referenced?)
Expert ineligibles
A second category of persons can now be identified as ineligible for REC membership. We can recall that ‘health care’ was defined as ‘services for or in connection with the … treatment of illness’. Let us now think about another fictional character − the self-employed thermal auricular therapist (‘ear candler’) who for tax and/or other reasons is also a director of their own limited company. Such an individual, being a director of a body which provides services in connection with the treatment of illness, ‘shall not be eligible for appointment as a lay member’ (para. 3(4) (a)) on that basis. They will also not be eligible for expert membership because they are not a ‘health care professional’ under its definition. It is quite a convoluted, yet rather intriguing, situation.
It is not every application that strictly (legally) requires a correctly constituted REC. The main area of concern would be if a clinical trial of an investigational medicinal product (CTIMP) was involved and someone objected to the REC’s decision. In such a case the objectors could instigate a legal challenge based on the incorrectly constituted REC and thus an ‘illegal’ decision. This has never happened. Nor did any such challenge materialize between the time of the original paragraph 6(4) of schedule 2 of the regulations (which inadvertently stipulated that ‘No business shall be transacted at a meeting of an ethics committee, or a sub-committee of an ethics committee … unless at least seven members … are present’) and 1 May 2008 when SI 2008/941 (Clinical Trials Regulations, 2004) came into force. The latter statutory instrument corrected (via reg. 5(4) (b)) the size of the sub-committee to however many ‘specified members’ the full ethics committee had nominated. But no longer is it just CTIMPs that require a legally constituted ethics committees, as other legislation now stipulates NHS ethics committee involvement (NRES, 2012). It cannot be a matter of ‘anything goes’.
Extra-legal requirements of NRES
Having discussed the broad ‘problem’ with some NRES co-ordinators and their colleagues further up the hierarchy, it transpires that the present arrangement for allocating a category label to a member is dependent upon the co-ordinator’s interpretation of the would-be member’s curriculum vitae. One regional manager has confided that she had spent about three hours with a co-ordinator trying to sort one member into a particular category. There are clearly situations which can be more complex than first supposed.
The complexity of the legislation is also compounded, though, by NRES policies. For instance, it is their policy to deem clinicians who are neither dentists nor medical doctors (such as pharmacists and nurses) as belonging in the expert category unless they gave up practice five or more years prior to their appointment. Some individuals could therefore have been out of practice for approaching a decade and still be considered an expert, whilst others who gave up the role just over five years ago would be classed as lay members. The legislation does not require this.
To try to address the problem caused by a misunderstanding of a curriculum vitae, the following algorithm is proffered to help the member get correctly sorted into his or her appropriate category. It should make the task of assigning roles more straightforward. It also helps to highlight those persons who are not eligible for REC membership at all – such as the hospital managers and the self-employed alternative therapists.
A horrible thought struck Harry, as horrible thoughts always do when you’re very nervous. What if he wasn’t chosen at all? What if he just sat there with the hat over his eyes for ages, until Professor McGonagall jerked it off his head and said there had obviously been a mistake and he’d better get back on the train? (Rowling, 1997)