Editorial

R E S E A R C H G O V E R N A N C E :

F O R W H O S E B E N E F I T ?

The research governance frameworkrecently promoted by the UK govern-ment (Department of Health 2001) andcurrently undergoing consultation bythe Department of Health, is a knee-jerk reaction to a series of scandals thathave arisen within the UK NationalHealth Service (NHS). Foremostamongst these was the Alder Hey scan-dal in which body parts were removedfrom dead children, purportedly forresearch purposes, and without theconsent of parents. The research gov-ernance framework will set standardsfor research, define mechanisms to de-liver, and monitor and assess standardswith the aim of improving researchquality and safeguards for the public.

Clearly, when things go wrong –spectacularly wrong as in the case ofAlder Hey – something requires to bedone. However, what is done must bemeasured and aimed at minimizing thelikelihood that mistakes will be madeagain. Any research governance frame-work is still risky. Those wishing toundertake research without appropriatepermission may still do so by simplyignoring procedures and recruiting sub-jects to research and we must notbecome complacent that all will be well.Moreover, broadening the scrutiny ofresearch ethics structures may set intrain other risks as the workload ofalready heavily pressed bodies will beincreased. Paradoxically, this may re-duce the overall level of scrutiny ofindividual pieces of research, which maywell pose a risk to patients. An exclusivefocus on the permission to carry outresearch runs the risk of leaving itspractice and processes relatively un-scathed. Currently, in the UK there isno framework for standards in researchand in the UK National Health Service anumber of recent documents have poin-ted to the need for greater scrutiny(Department of Health 2000a; 2000b)

and the research governance frameworkis the result. Some research fundingbodies such as the Medical ResearchCouncil publish guidelines (MedicalResearch Council 1998) but these arenot �policed� in the way that the researchgovernance framework will be.

Extreme cases such as that of AlderHey do not make good laws, especiallyif there has not been sufficient interro-gation of the operation of current reg-ulatory systems. In the case of NHSresearch there already exist researchethics committees to scrutinize researchactivity in their locations and at nationallevel. Research governance adds anextra tier to the procedures for estab-lishing a research project and brings intofurther scrutiny research that does notinvolve patients. Clearly, staff should beprotected from poorly designed or dan-gerous research but this has never beensomething that required the overview ofresearch ethics committees in the past.Patients are vulnerable due to theirillness and possible powerlessness andbecause they are in the NHS in order toreceive treatment and care. While someprojects involving staff do come underthe scrutiny of local research ethicscommittees, staff are not vulnerable inthe same way and, while nobody wouldadvocate their inappropriate involve-ment in research, surely individualsand NHS management can decide onthe appropriateness of a research projectthat seeks the involvement of staff? Suchprojects are unlikely to involve thetesting of treatments – being more likelyto request information about workingpractices, knowledge of procedures orattitudes to policies – therefore, whatadditional information can a researchethics committee provide?

There is an additional problem.Research projects involving staff havebeen the mainstay of undergraduate andmany postgraduate nursing projects(and similar activities in otherprofessional training) and this has beena deliberate strategy to avoid the

involvement of patients – to obviatethe �research fatigue� and possible riskswhich can be inflicted upon patients(and their families) in research activeenvironments. Staff can also suffer fromresearch fatigue but they are generallyfavourably disposed towards the educa-tion of nurses and other professionals,and towards research while possessingthe right to refuse to be involved in anyparticular project. In some areas of theNHS, student projects are required to besubmitted to local research ethics com-mittees but research governance willnow require all student projects to besubmitted to a research ethics committeein addition to the full procedures ofresearch governance. In itself this scru-tiny is a positive move to academicexcellence, but time is usually not suffi-cient for such projects to be formulatedand refined, or to take into considera-tion any comments or changes made bya research ethics committee, or by theresearch governance procedures. It is thenature of such committees to makechanges, not always with justification,but with the best of intentions. Theusual custom and practice of making thescrutiny of the academic supervisor andthe relevant NHS committee sufficient,may make it impossible for futureresearch projects – usually innocuousin nature – to gain approval in time forthe students to complete their tasks.Already additional aspects of researchgovernance, such as the insistence onhonorary contracts for project researchstaff, even on very short projects requi-ring minimal or no actual presence onNHS premises, have added to the diffi-culties of conducting research in theNHS.

Research governance in isolation is areasonable concept. It has been institu-ted for the benefit of research partici-pants. It has an important aim inpromoting confidence in health servicesresearch in a context not only of the�active patient� (Rose 2002) but alsopatients who are increasingly informed

� 2002 Blackwell Science Ltd 515

and involved in setting research agen-das, serving on research steering groupsand advising on the publication ofresearch outcomes.

However, research ethics relate tomore than the giving of permissionsand permitting entry into health caresystems. If any new framework is con-ceived as a gatekeeping function alonethen opportunities will have been missedto instil ethical principles throughoutthe research process. In many ways agatekeeping model sits comfortably withlarge-scale, quantitative methods – withrandom controlled trails (RCT) as amajor example. But the world of healthservices research also includes otherinfluential approaches such as ethno-graphy, policy studies and actionresearch. User-led research has also beena major strand in health research inproviding a critical perspective on careor exploring new areas. Such approa-ches are generally in need of supportrather than further barriers.

Nurses know that many of the mostvulnerable people live not in NHS set-tings but in what is loosely called �thecommunity�. Older people with demen-tia for, example, generally live at homeor in social care provision. Research ontheir lives, perspectives and needs isgenerally in short supply. The extensionof formal ethical processes to includesuch individuals as proposed by theResearch Governance Framework issurely uncontroversial.

Questions remain, however, about theproposals and details of the Framework,

such as the greater workload for ethicscommittees and research and develop-ment offices in NHS Trusts and localauthorities, particularly as no significantincrease in resources is promised toencourage good practice. Social servicesdepartments in local authorities havelittle experience in this area of managingexternal access for research purposes. AsLewis (2002, p. 3) has commented theethical issues raised by research (and thisis an umbrella term covering broadareas) �vary hugely�. Not all researchrequires �the same level of ethical scru-tiny� and, she observes, from a positionof authority as Director of the JosephRowntree Foundation that the mostintractable ethical research problemsdo not arise at the design stage but inthe carrying out of the research. Advice,judgement and reflection are neededduring such difficulties. Nurses have anability to see research ethics working inpractice and their perspective onresearch governance is potentially valu-able and informative. Whilst nurses areincreasingly involved in research, fre-quently in collaboration with otherprofessionals or disciplines, they areoften involved on the periphery of otherpeople’s grand ideas or projects. It isoften nurses who collect data not in anabstract or mechanical sense butthrough active engagement with thehuman subjects of research.

Lewis proposes that attention shouldshift from a focus on permissions todevelopments around what constitutesethical research practice. She calls for a

debate about what would conceivablyrepresent good practice and high stand-ards. Nurses have much to contribute tosuch consensus building, spanning astheir work often does, the blurredinterfaces of science, social science andart.

Roger WatsonUniversity of Hull, UK

and Jill ManthorpeUniversity of Hull, UK

References

Department of Health. (2000a) The NHSPlan. Department of Health, London.

Department of Health (2000b) An Organi-sation with a Memory – A Report of anExpert Group on Learning from AdverseEvents in the NHS. Department of Health,London.

Department of Health (2001) ResearchGovernance Framework for Health andSocial Care. Department of Health,London.

Lewis J. (2002) Research and development insocial care: governance and good practice.Research, Policy and Planning 17(2), 3–11.

Medical Research Council (1998) MRCGuidelines for Good Clinical Practice inClinical Trials. Medical Research Council,London.

Rose H. (2002) Building genethics frombelow. In Gender, Health and Healing:the Public/Private Divide (Bendelow G.,Carpenter M., Vautier C. & Williams S.A.,eds). Routledge, London, pp. 49–67.

Editorial

516 � 2002 Blackwell Science Ltd, Journal of Advanced Nursing, 39(6), 515–516