Ethical review of research involving animals:

A role for Institutional Ethics Committees?

 

The Boyd Group, March 1995


Summary

This discussion paper results from informal conversations over the past two years among a group of individuals concerned with the ethics of animal research. Those involved were from diverse backgrounds, spanning a wide range of views. They included antivivisectionists, members of animal welfare organisations, veterinarians, scientists using animals, members of bodies funding or directly engaged in research, philosophers and others. Their meetings were convened by Professor Colin Blakemore, Waynflete Professor of Physiology, University of Oxford, and Mr Les Ward, Director, Advocates for Animals, whose involvement in public debate led them to believe that common ground might usefully be explored in this way. The group became known as ‘the Boyd Group’ after its chairman, Dr. Kenneth Boyd (Director of Research, Institute of Medical Ethics, Edinburgh).

After extensive discussion, the group agreed that any means of improving the process of ethical review of research involving animals should satisfy three objectives:

  1. it should ensure the ethical acceptability of all research projects involving animals. In practice this means ensuring:
    1. that they are scientifically necessary and of high quality; and
    2. that, wherever possible, the use of animals is replaced, refined or reduced.
  2. it should improve public confidence in the review process.
  3. it should enable those responsible for ensuring the acceptability of work in their institutions to carry out their duties as effectively and efficiently as possible.

The group examined the possibility that institutional ethics committees might provide a means of fulfilling these objectives. It concluded that such committees could enhance the ethical review process:

  1. by widening consultation; and
  2. by providing a clearer institutional focus for the consideration of relevant ethical issues.

This paper sets out, for wider discussion, the arguments which led to this conclusion.

 

1. Introduction

In recent years, committees to review the ethics of animal research and testing have been established in some scientific organisations across the UK. Should such committees be more widely recommended as part of the ethical review process for research involving animals? This will depend on what are seen as the likely benefits, and whether these are thought to outweigh the likely difficulties and objections.

Among the benefits which might accrue from establishing institutional ethics committees are that they could:

  1. provide opportunities for discussion of best practice and other ethical issues in animal research – thus assisting in the ethical process of weighing harm and benefit required by the Animals (Scientific Procedures) Act 1986 [hereafter A(SP)A];

  2. encourage best practice within institutions – thus promoting the best possible scientific standards as well as the best possible animal welfare;

  3. widen consultation on animal research issues – thus helping to improve the soundness of, and public confidence in, decisions in this area;

  4. help to create an environment in which broader educational benefits might follow within the institution; and provide an avenue for communication with interested groups outside the institution.

On the other hand, potential difficulties and objections include the possibility that such committees might:

  1. contradict or duplicate the role of the Home Office, and lead to non-uniformity of policy on animal issues across the country;

  2. increase bureaucracy and cost in the control of animal research, using already scarce resources;

  3. by virtue of involving additional people in ethical review, delay or restrict research and/or compromise the confidentiality of scientific work in progress.

Before examining further the benefits and difficulties, a role for such committees, their relationship with legal controls and their broader educational functions should be specified.

 

2. Role of committees and relationship with legal controls

An important role for such ethics committees would be to review the ethical issues arising in applications from the institution for Project Licences to carry out animal research prior to the applications being submitted to the Home Office for a formal, legally binding decision.

One goal would be to help the applicant prepare the best possible application to send to the Home Office. Its aim would be to refine the project, with particular reference to local conditions. Its general ethical concern would be to determine if a case has been made adequately that the likely benefits of the work ‘outweigh’ the harms likely to be caused to the animals. This might involve asking questions such as:

Such committees would most appropriately be related to existing legal controls if they were set up to assist the institution’s Certificate Holder (the holder of the institution’s Certificate of Designation under the terms of the A(SP)A), in carrying out his or her statutory duties.

Certificate Holders, by virtue of the standard conditions of Certificates, bear ultimate responsibility for maintaining standards of care and welfare of the animals in their institutions. They must sign all Project Licence applications from members of the institution to confirm that suitable facilities will be made available for the proposed work. The committee’s advice on this could enable Certificate Holders to carry out their duties more effectively – in particular, helping them to feel comfortable about, and able to defend, work carried out within the institution. This relationship with existing legal controls would provide the committee with a clear and recognised role within the institution.

In considering the feasibility of constituting such a role for ethics committees, institutions would also need to consider devising procedures for appeal against the committee’s decisions or for advice and resubmission by researchers.

 

3. Broader educational functions of committees

Although one important function would be to advise the Certificate Holder about applications for Project Licences under the A(SP)A, committees constituted in this way could help to create an educationally beneficial environment in the institution. Through on- going review of the ethical issues committees could, for example:

  1. promote general awareness of ‘the 3 Rs’ – that is, the possibilities for ‘replacing’ animals with procedures not involving living animals, ‘reducing’ the number of animals used in the procedures, and/or ‘refining’ the procedures so as to cause less harm to the animals involved;

  2. facilitate collaboration between researchers to ensure that when an animal is killed, its use in research is maximised and therefore that the number of animals used is minimised;

  3. broaden the focus of ethical concern by being alert to ethical issues arising in any project within the institution, including:
    1. the use of species currently not protected under the A(SP)A, and
    2. other work which currently does not require a licence under the terms of the A(SP)A (e.g. studies in which animals are killed by Schedule 1 methods to obtain body parts for in vitro work, or studies involving no potential adverse effect);

  4. promote awareness of the terms and conditions of the A(SP)A – including an awareness of the range of jurisdiction of the Act;

  5. provide a mechanism for monitoring research projects identified as being of particular ethical concern;

  6. act as a forum for members of the institution to raise concerns about research within that institution;

  7. help to improve public confidence in decisions about the ethical acceptability of scientific work involving animals [see also 5 below];

  8. keep debate alive within the institution about what constitutes ethically acceptable use of animals.

 

4. Potential difficulties and objections

Despite these positive features, the difficulties and objections which might occur deserve serious consideration.

4.1 Committees could be seen as duplicating or contradicting the role of the Home Office.

This need not be a difficulty if the distinction between law and ethics is kept clearly in view. Laws, however well framed, cannot provide more than a framework for ethical decision- making. Nor can laws relieve those working within them of the responsibility to make their own moral judgements. An ethics committee should encourage the institution and its researchers to exercise responsible moral discrimination in the ethical ‘fine-tuning’ of their protocols. Moreover, since the effectiveness with which the provisions of the A(SP)A are implemented depends, in no small measure, on local arrangements, local committees could play an important part in ensuring that the spirit as well as the letter of the law is adhered to.

In this way the work of such committees would complement the Home Office’s role.

4.2 Committees would increase bureaucracy and use already scarce resources, of both time and money.

Such resource implications need to be considered carefully and, in particular, should be weighed against the benefits which could come from avoiding the kind of adverse publicity that can be engendered by particular cases. As suggested above, ethics committees could help to improve the effectiveness and efficiency as well as the public acceptability of work involving animals. The latter could make research workers – whose scientific judgement would be defended by an appropriate appeals procedure –less likely to have to spend time defending themselves against unwarranted criticism [see also 5 below].

4.3 Local judgements by committees would lead to non-uniformity of policy across the country.

Uniformity, of course, may not always be possible – or necessarily desirable. A degree of non-uniformity may simply reflect the need to keep debate alive on ethical issues which, of their nature, are essentially contestable. However, adequate communication between committees [see 7 below] could encourage wider agreement on relevant policies.

 

5. Educational functions outside the institution and with the public

The very existence of ethics committees, it can be argued, would engender public confidence in decisions about the ethical acceptability of scientific work involving animals. Multi- disciplinary committees including lay members [see 6 below] could be seen as a broader affirmation of the complex, contestable nature of decision-making in this area.

A further role for ethics committees could be to facilitate communication with the public when work within the institution is subject to criticism. Not all scientists have or normally need the communication skills required to explain the necessity or potential benefits of their work to a lay audience. An ethics committee, however could encourage or assist them, when submitting a protocol, to prepare a brief statement, in lay language, of its ethical justification. Such a statement, showing that these matters had been seriously considered, could be of considerable assistance to the Certificate Holder and to the scientist involved, if it became necessary to respond to public criticism.

Ethics committees could also assist in responding to requests for factual information about work carried out within the institution. Animal welfare and anti-vivisection organisations frequently scan the scientific literature for reports of research which might be of concern; but the lack of detail in many published reports of animal experiments is a barrier to accurate criticism. Individual scientists are often wary about responding to requests from such organisations for information about animal procedures, for fear of reprisals. Ethics committees, in consultation with researchers, could provide a more acceptable channel for the communication of such information. This could help to promote public understanding and avoid misinterpretation of the nature of the work carried out in the institution.

 

6. Composition of committees

Ethics committees would provide a wider forum and clearer focus than currently exists for consultation about ethical issues in animal research at the institutional level. To fulfil this role, their membership would need:

  1. to encompass as wide a range of views as is compatible with reasoned, expedient discussion and decision-making;

  2. to foster an atmosphere of public trust and confidence in the work;

  3. to command respect within the institution; and

  4. to have the support and commitment of the institution’s management.

A committee set up to assist the Certificate Holder in carrying out his or her statutory duties would largely meet the last two requirements. Suitable candidates for the committee might be:

Other members, with particular expertise in an area under debate, might be co-opted as required.

Lay membership, particularly by members of animal welfare organisations, is likely to raise at least two important concerns – namely

  1. whether research might be held back by obstructive lay members;
  2. preserving the confidentiality of research in progress and of other aspects of the institution’s use of animals.

These concerns, however, have to be set against the need for an atmosphere of greater public trust and confidence in scientific work with animals – an atmosphere unlikely to be achieved nowadays without informed lay participation. In this context, it is clear that some individuals or organisations with an interest in animals hold extreme convictions so passionately that they are unable to take part in reasoned, expedient discussion and decision-making. On the other hand, the conversations leading to the production of this discussion paper have amply demonstrated that this is far from true of all such individuals and organisations. A key proviso here is that institutions, in setting up such committees are seen to be seeking ‘to further the refinement, reduction and replacement of the use of living and sentient creatures consistently with the essential needs of scientific research and safety evaluation.’ Given the recognition of this common goal, lay members are likely to provide a constructive contribution to the committee’s work. Clearly, ground rules would have to be negotiated when lay members were invited to join the committee. (There would, for example, be a need to establish clear rules for dealing with disruptions or breaches of confidentiality.) But this can be done frankly, recognising that lay members are needed to bring perspectives which can help to raise awareness of the spectrum of opinion on matters to be discussed by the committee.

 

7. Education and communication

Many of the issues which institutional ethics committees would be likely to discuss are complex, either scientifically or ethically. Members of such committees therefore may well wish educational support in these areas. Training, including discussion of ethical issues, is now required for licence holders. While the needs of committee members may differ from those of licence holders, and indeed may vary for different members, the subject will be an important one to explore if such committees are set up more widely. The best forum for exploring this is likely to be created if the committees themselves establish a network of mutual communication. Such a network would also provide a useful way for committees to help appraise one another of current ethical issues and relevant technical matters, thus contributing to more informed decision-making.

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