Ethical and legal
Local research ethics committees and nursing: a critical look
c
Geoffrey Hunt, Thames Valley University, London
The Department of Health guidelines on local research ethics committees are now in operation. But, are they enforceable and what relevance do they have to nursing?
onfusion has always reigned in the UK over the remit, functions, structure and powers of ethical research committees (Gil bert et al, 1989). As a result, patients and healthy volunteers have been vulnerable and exposed. Nurses who are disturbed about research being conducted on patients in their care have often felt powerless and without a voice. The new Department of Health (DoH) guidelines on ethical re search committees entitled Local Research Ethics Committees (LRECs), which became effective in February this year, are a big step in the right direction but may not go far enough (DoH, 1991). Structure
Dr Hunt is the Director of the National Centre for Nursing and Midwifery Ethics at Queen Charlotte’s College, Thames Valley University, Hammersmith Hospital, London
The DoH now requires every district health authority (DHA) to establish a LREC com prising 8-12 members, women as well as men and from a wide age range. The pur pose of a LREC ‘is to consider the ethics of proposed research projects which will in volve human subjects, and which will take place broadly within the NHS’. A LREC must be consulted about research involv ing: NHS patients, including those treated under contracts with the private sector; fe tal material and in-vitro fertilization involv ing NHS patients; and the recently dead in NHS premises. It will consider access to records of past or present NHS patients, and the use of, or potential access to, NHS premises or facilities. Of great concern to the public is the in dependence of such committees. The DoH hopes that, although the DHAs will estab lish and provide for the administrative sup port of the LRECs, they ‘are not in any sense management arms of the DHA’. The LREC will give independent advice but the decision on whether to proceed with the research ultimately is made by the NHS body concerned with the research. Nurses, who are expected under the terms of their professional Code to act as advocates for their patients (UKCC, 1989),
British Journal of Nursing, 1992, Voi 1. No 7
may also wonder how effective LRECs will be. The guidelines only state: ‘If it comes to the attention of a commit tee that research is being carried out which it has not been asked to consider or which it has considered but its recom mendations have been ignored, then the LREC should bring this matter to the attention of its appointing authority, the relevant NHS body and to the ap propriate professional body.’ Some people might regard this as rather weak, and wonder whether there should not instead be a statutory national research ethics authority with powers to investigate all research (NHS and private), monitor compliance and apply sanctions. Nurses might also feel more encouraged to make requests and complaints to such a body without fear of reprisal. Such a body could also deal more easily with non-NHS re search, in which nurses are often involved. The new guidelines only say that a body with no NHS connection conducting re search should ‘be encouraged to submit its proposals to the LREC for advice’. One wonders how it could do this and what difference ‘encouragement’ would make. Legal accountability
It has recently been pointed out (Mont gomery, 1992) that there are easier ways to give legal force to LRECs. The Secretary of State could, under the 1977 National Health Service Act, give directives to health authorities to set up LRECs, and failure to do so would attract sanctions. NHS trusts could be required to operate LRECs as part of their service contracts. It would be a great advance for nursing if its representa tive bodies were to petition for these kinds of protection for patients and volunteers. At present some ethics committees are enormous and medically dominated but with no nurse member. The DoH now rec ommends that membership should include hospital medical staff, nursing staff, general
349
Downloaded from magonlinelibrary.com by 129.215.017.188 on January 20, 2019.
Local research ethics committees and nursing: a critical look c. . . in relation to children, it is not the age that is decisive but the ability to understand. Children under 16 years of age may give consent to therapeutic research if the attending doctor judges that the child sufficiently understands what is proposed. 5
practitioners and two or more lay persons. These are not representatives, but are ‘ap pointed in their own right’. I do not think this is strong enough. I think that each committee should have at least two nurses who are currently practising, one of whom should be from outside the hospital envi ronment, and that there should be a rule that the committee cannot proceed if both nurses are absent. In the public interest the DHA should manage resources to ensure that this is possible. The guidelines say that members should serve for 3-5 years and normally not more than two terms of office should be served consecutively. Business by telephone, post or chairman’s action ‘should be discourag ed’. Meetings are private and minutes are confidential, but annual reports must be made to the DHA, relevant NHS bodies and the Community Health Council, and be available for public inspection. Criteria
Proposals are to be judged most import antly on these criteria: their scientific merit; effects on health of subjects; hazards and preparedness to deal with them; discomfort or distress to subjects; whether adequately supervised and whether the supervisor is qualified and experienced; whether there are any inducements to the NHS body, the researchers or the subjects; adequate con sent procedures; and the provision of a good information sheet for subjects. The remit of the LREC includes thera peutic and non-therapeutic research, and the latter may involve healthy or patient volunteers. It includes questionnaire re search. The DoH recommends written consent from subjects. The UKCC has already made it clear in its document Exercising Ac countability (UKCC, 1989) that nurses have a special responsibility with regard to consent. This applies to research as well. If the patient or subject has not fully under stood, then the nurse must recall the doctor or researcher and ‘the [nurse] practitioner might decide not to cooperate with a pro cedure if convinced that the decision to agree to it being performed was not truly informed.’ Nurses have a similar strong duty con cerning confidentiality. Researchers must confirm that personal health information will be kept confidential. Nurses may be regarded as standing vir tually in loco parentis for vulnerable groups such as children and the mentally disorder
350
ed and should be particularly vigilant. If in doubt about the propriety of a research project, the attending nurse should find out what is going on. The guidelines emphasize that research may be conducted on children only ‘where it is absolutely essential to do so and the information required cannot be obtained using adult subjects’. As is generally the case with consent in relation to children, it is not the age that is decisive but the ability to understand. Children under 16 years of age may give consent to therapeutic research if the at tending doctor judges that the child suffi ciently understands what is proposed. The guidelines state that all the same it would ‘be unacceptable not to have the consent of the parent or guardian.’ However, the parents cannot override the child’s refusal unless the child is not competent and the research is therapeutic and for the child’s benefit. Proxy consent for non-therapeutic re search on a child is probably illegal, except if the risks are ‘so insignificant as to be neg ligible’. Further guidance on this tricky area has been provided by the Medical Research Council (1991a). Specific needs
I think the guidelines are much too general on the question of research on mentally dis ordered people. There is a pressing need for specific protection for those deemed ‘in competent’ (e.g. the severely demented el derly in continuing care) who may have no guardians or relatives in contact and may fall into the hands of researchers who (dare I say it) are primarily pursuing their careers. It is here perhaps that the need for greater legal force and clearer legal protection is most evident. Again, the Medical Research Council (1991b) has provided more detailed discussion and this should be feeding into a public debate involving nurses, patients and their relatives and friends. Certainly, LREC members themselves need education in professional ethics and the law. The Manual for Research Ethics Committees recently produced by King’s College (1992) should be studied by every LREC member and every nurse involved in research. There are three issues of importance to nurses on which the guidelines appear to be silent: 1. One should consider whether there is not a need for nursing research being re viewed by a separately constituted nurs ing review committee, as it is in parts
British Journal ofNursing, 1992,onVoi l,N o720, 2019. Downloaded from magonlinelibrary.com by 129.215.017.188 January
Local research ethics committees and nursing: a critical look of North America. Developing nursing knowledge often entails different re search methods which may be under valued by those who view nursing as ‘soft science’ or even ‘unscientific’. Nursing research, even where non-therapeutic, does require ethical review be cause of its potential impact on patients’ comfort and privacy. 2. Practising nurses may feel that there is a great need for proper multidisciplinary ethical review of difficult clinical (non research) cases such as those involving withdrawal of life support, or organ do nation for transplants. Such ethical re view might help provide policy guide lines for practice (Murphy, 1989). 3. Serving on a LREC is very time-con suming. I know nurses who find this work very burdensome and have to resist the constant inclination to resign. In an earlier article (Hunt, 1990) I raised ques tions about how this could be tackled. Should LREC members be paid for their services? Should such service be included in contracts of employment? Most im portantly, should nurses in particular be given time off from ordinary duties to serve on LRECs? KEY POINTS • The Department of Health guidelines on local research ethics committees (LRECs) came into effect in February 1992. • Every district health authority must establish a LREC to oversee research in its area, including trust hospitals. • Every LREC must have a nurse among its 8-12 members. • The remit of the LREC covers therapeutic and non-therapeutic research. • Difficulties with LRECs may be the enforceability of the guidelines, the ethical education of its members, research in the private sector, and the predominance of the biomedical definition of acceptable research.
The fundamental issue?
The most fundamental question about ethi cal committees has still not been addressed. Are they ethical? Can they be moral? Not only is there evidence of wide diversity in the LREC members’ recognition of what basic moral and ethical questions and issues should be addressed in appraising any re search project (Gilbert et al, 1989), but it also appears that quite a few LRECs are not really about ethics at all. They are in stead about experimental design and science, with some lip service being paid to ‘being covered’ legally. The kinds of fundamental moral issues that would concern an informed public will not be raised, whatever guidelines are pub lished and whatever laws are passed, if the biomedical paradigm and the corporate power of medical goods manufacturers continue to define the very parameters of ‘valid’ or acceptable research in healthcare (Hunt, 1992). Nursing, not as a branch of biomedicine, but as the science and art of caring may be in the best position to begin the work of redefining research in healthcare. Department of Health (1991) Local Research Ethics Committees. (HSG(91)5). Department of Health, Heywood, Lancs. (Available free from DHSS Pubs, Health Pubs Unit, No 2 Site, Manchester Road, Heywood, Lancs OLIO 2PZ Gilbert C, Fulford KWM, Parker C (1989) Diversity in the practice of district ethics committees. Br Med J 299: 1437-9 Hunt G (1990) A constitutional framework for ethical review committees. / Man Med 4: 155-9 Hunt G (1992) Taking science too far. Dorset and Sal isbury College Gazette 2: 3-4 King’s College (¡992) Manual for Research Ethics Committees. The Centre for Medical Law and Eth ics, King’s College, London Medical Research Council (1991a) The Ethical Con duct of Research on Children. MRC, London Medical Research Council (1991b) The Ethical Con duct of Research on the Mentally Incapacitated. MRC, London Montgomery J (1992) New law not needed for better RECs. Bull Med Eth 78: 34-5 Murphy P (1989) The role of the nurse on hospital ethics committees. Nurs Clin N Am 24: 551—6 UKCC (1989) Exercising Accountability. UKCC, London
BJN CLASSIFIED SECTION Just the job for B JN readers! A re y o u looking for a jo b ? O r are y o u interested in going on a co u rse? Turn to o u r n e w classified section starting on p age 3 6 4
British Journal of Nursing, 1992, Voi I, No 7
351
Downloaded from magonlinelibrary.com by 129.215.017.188 on January 20, 2019.
Local research ethics committees and nursing: a critical look
c
Geoffrey Hunt, Thames Valley University, London
The Department of Health guidelines on local research ethics committees are now in operation. But, are they enforceable and what relevance do they have to nursing?
onfusion has always reigned in the UK over the remit, functions, structure and powers of ethical research committees (Gil bert et al, 1989). As a result, patients and healthy volunteers have been vulnerable and exposed. Nurses who are disturbed about research being conducted on patients in their care have often felt powerless and without a voice. The new Department of Health (DoH) guidelines on ethical re search committees entitled Local Research Ethics Committees (LRECs), which became effective in February this year, are a big step in the right direction but may not go far enough (DoH, 1991). Structure
Dr Hunt is the Director of the National Centre for Nursing and Midwifery Ethics at Queen Charlotte’s College, Thames Valley University, Hammersmith Hospital, London
The DoH now requires every district health authority (DHA) to establish a LREC com prising 8-12 members, women as well as men and from a wide age range. The pur pose of a LREC ‘is to consider the ethics of proposed research projects which will in volve human subjects, and which will take place broadly within the NHS’. A LREC must be consulted about research involv ing: NHS patients, including those treated under contracts with the private sector; fe tal material and in-vitro fertilization involv ing NHS patients; and the recently dead in NHS premises. It will consider access to records of past or present NHS patients, and the use of, or potential access to, NHS premises or facilities. Of great concern to the public is the in dependence of such committees. The DoH hopes that, although the DHAs will estab lish and provide for the administrative sup port of the LRECs, they ‘are not in any sense management arms of the DHA’. The LREC will give independent advice but the decision on whether to proceed with the research ultimately is made by the NHS body concerned with the research. Nurses, who are expected under the terms of their professional Code to act as advocates for their patients (UKCC, 1989),
British Journal of Nursing, 1992, Voi 1. No 7
may also wonder how effective LRECs will be. The guidelines only state: ‘If it comes to the attention of a commit tee that research is being carried out which it has not been asked to consider or which it has considered but its recom mendations have been ignored, then the LREC should bring this matter to the attention of its appointing authority, the relevant NHS body and to the ap propriate professional body.’ Some people might regard this as rather weak, and wonder whether there should not instead be a statutory national research ethics authority with powers to investigate all research (NHS and private), monitor compliance and apply sanctions. Nurses might also feel more encouraged to make requests and complaints to such a body without fear of reprisal. Such a body could also deal more easily with non-NHS re search, in which nurses are often involved. The new guidelines only say that a body with no NHS connection conducting re search should ‘be encouraged to submit its proposals to the LREC for advice’. One wonders how it could do this and what difference ‘encouragement’ would make. Legal accountability
It has recently been pointed out (Mont gomery, 1992) that there are easier ways to give legal force to LRECs. The Secretary of State could, under the 1977 National Health Service Act, give directives to health authorities to set up LRECs, and failure to do so would attract sanctions. NHS trusts could be required to operate LRECs as part of their service contracts. It would be a great advance for nursing if its representa tive bodies were to petition for these kinds of protection for patients and volunteers. At present some ethics committees are enormous and medically dominated but with no nurse member. The DoH now rec ommends that membership should include hospital medical staff, nursing staff, general
349
Downloaded from magonlinelibrary.com by 129.215.017.188 on January 20, 2019.
Local research ethics committees and nursing: a critical look c. . . in relation to children, it is not the age that is decisive but the ability to understand. Children under 16 years of age may give consent to therapeutic research if the attending doctor judges that the child sufficiently understands what is proposed. 5
practitioners and two or more lay persons. These are not representatives, but are ‘ap pointed in their own right’. I do not think this is strong enough. I think that each committee should have at least two nurses who are currently practising, one of whom should be from outside the hospital envi ronment, and that there should be a rule that the committee cannot proceed if both nurses are absent. In the public interest the DHA should manage resources to ensure that this is possible. The guidelines say that members should serve for 3-5 years and normally not more than two terms of office should be served consecutively. Business by telephone, post or chairman’s action ‘should be discourag ed’. Meetings are private and minutes are confidential, but annual reports must be made to the DHA, relevant NHS bodies and the Community Health Council, and be available for public inspection. Criteria
Proposals are to be judged most import antly on these criteria: their scientific merit; effects on health of subjects; hazards and preparedness to deal with them; discomfort or distress to subjects; whether adequately supervised and whether the supervisor is qualified and experienced; whether there are any inducements to the NHS body, the researchers or the subjects; adequate con sent procedures; and the provision of a good information sheet for subjects. The remit of the LREC includes thera peutic and non-therapeutic research, and the latter may involve healthy or patient volunteers. It includes questionnaire re search. The DoH recommends written consent from subjects. The UKCC has already made it clear in its document Exercising Ac countability (UKCC, 1989) that nurses have a special responsibility with regard to consent. This applies to research as well. If the patient or subject has not fully under stood, then the nurse must recall the doctor or researcher and ‘the [nurse] practitioner might decide not to cooperate with a pro cedure if convinced that the decision to agree to it being performed was not truly informed.’ Nurses have a similar strong duty con cerning confidentiality. Researchers must confirm that personal health information will be kept confidential. Nurses may be regarded as standing vir tually in loco parentis for vulnerable groups such as children and the mentally disorder
350
ed and should be particularly vigilant. If in doubt about the propriety of a research project, the attending nurse should find out what is going on. The guidelines emphasize that research may be conducted on children only ‘where it is absolutely essential to do so and the information required cannot be obtained using adult subjects’. As is generally the case with consent in relation to children, it is not the age that is decisive but the ability to understand. Children under 16 years of age may give consent to therapeutic research if the at tending doctor judges that the child suffi ciently understands what is proposed. The guidelines state that all the same it would ‘be unacceptable not to have the consent of the parent or guardian.’ However, the parents cannot override the child’s refusal unless the child is not competent and the research is therapeutic and for the child’s benefit. Proxy consent for non-therapeutic re search on a child is probably illegal, except if the risks are ‘so insignificant as to be neg ligible’. Further guidance on this tricky area has been provided by the Medical Research Council (1991a). Specific needs
I think the guidelines are much too general on the question of research on mentally dis ordered people. There is a pressing need for specific protection for those deemed ‘in competent’ (e.g. the severely demented el derly in continuing care) who may have no guardians or relatives in contact and may fall into the hands of researchers who (dare I say it) are primarily pursuing their careers. It is here perhaps that the need for greater legal force and clearer legal protection is most evident. Again, the Medical Research Council (1991b) has provided more detailed discussion and this should be feeding into a public debate involving nurses, patients and their relatives and friends. Certainly, LREC members themselves need education in professional ethics and the law. The Manual for Research Ethics Committees recently produced by King’s College (1992) should be studied by every LREC member and every nurse involved in research. There are three issues of importance to nurses on which the guidelines appear to be silent: 1. One should consider whether there is not a need for nursing research being re viewed by a separately constituted nurs ing review committee, as it is in parts
British Journal ofNursing, 1992,onVoi l,N o720, 2019. Downloaded from magonlinelibrary.com by 129.215.017.188 January
Local research ethics committees and nursing: a critical look of North America. Developing nursing knowledge often entails different re search methods which may be under valued by those who view nursing as ‘soft science’ or even ‘unscientific’. Nursing research, even where non-therapeutic, does require ethical review be cause of its potential impact on patients’ comfort and privacy. 2. Practising nurses may feel that there is a great need for proper multidisciplinary ethical review of difficult clinical (non research) cases such as those involving withdrawal of life support, or organ do nation for transplants. Such ethical re view might help provide policy guide lines for practice (Murphy, 1989). 3. Serving on a LREC is very time-con suming. I know nurses who find this work very burdensome and have to resist the constant inclination to resign. In an earlier article (Hunt, 1990) I raised ques tions about how this could be tackled. Should LREC members be paid for their services? Should such service be included in contracts of employment? Most im portantly, should nurses in particular be given time off from ordinary duties to serve on LRECs? KEY POINTS • The Department of Health guidelines on local research ethics committees (LRECs) came into effect in February 1992. • Every district health authority must establish a LREC to oversee research in its area, including trust hospitals. • Every LREC must have a nurse among its 8-12 members. • The remit of the LREC covers therapeutic and non-therapeutic research. • Difficulties with LRECs may be the enforceability of the guidelines, the ethical education of its members, research in the private sector, and the predominance of the biomedical definition of acceptable research.
The fundamental issue?
The most fundamental question about ethi cal committees has still not been addressed. Are they ethical? Can they be moral? Not only is there evidence of wide diversity in the LREC members’ recognition of what basic moral and ethical questions and issues should be addressed in appraising any re search project (Gilbert et al, 1989), but it also appears that quite a few LRECs are not really about ethics at all. They are in stead about experimental design and science, with some lip service being paid to ‘being covered’ legally. The kinds of fundamental moral issues that would concern an informed public will not be raised, whatever guidelines are pub lished and whatever laws are passed, if the biomedical paradigm and the corporate power of medical goods manufacturers continue to define the very parameters of ‘valid’ or acceptable research in healthcare (Hunt, 1992). Nursing, not as a branch of biomedicine, but as the science and art of caring may be in the best position to begin the work of redefining research in healthcare. Department of Health (1991) Local Research Ethics Committees. (HSG(91)5). Department of Health, Heywood, Lancs. (Available free from DHSS Pubs, Health Pubs Unit, No 2 Site, Manchester Road, Heywood, Lancs OLIO 2PZ Gilbert C, Fulford KWM, Parker C (1989) Diversity in the practice of district ethics committees. Br Med J 299: 1437-9 Hunt G (1990) A constitutional framework for ethical review committees. / Man Med 4: 155-9 Hunt G (1992) Taking science too far. Dorset and Sal isbury College Gazette 2: 3-4 King’s College (¡992) Manual for Research Ethics Committees. The Centre for Medical Law and Eth ics, King’s College, London Medical Research Council (1991a) The Ethical Con duct of Research on Children. MRC, London Medical Research Council (1991b) The Ethical Con duct of Research on the Mentally Incapacitated. MRC, London Montgomery J (1992) New law not needed for better RECs. Bull Med Eth 78: 34-5 Murphy P (1989) The role of the nurse on hospital ethics committees. Nurs Clin N Am 24: 551—6 UKCC (1989) Exercising Accountability. UKCC, London
BJN CLASSIFIED SECTION Just the job for B JN readers! A re y o u looking for a jo b ? O r are y o u interested in going on a co u rse? Turn to o u r n e w classified section starting on p age 3 6 4
British Journal of Nursing, 1992, Voi I, No 7
351
Downloaded from magonlinelibrary.com by 129.215.017.188 on January 20, 2019.
