Good practice guidelines for the conduct of psychological ... · PDF fileWe acknowledge Dr Angela Carter for contributing to the report from the ... as well as for the conduct

Good Practice Guidelines for the Conduct ofPsychological Research within the NHS

This Report is published under the auspices of the British Psychological Society and the ProfessionalPractice Board, Division of Clinical Psychology, Research Ethics Practice Working Party of the TrainingStrategy Group, The British Psychological Society, St Andrews House, 48 Princess Road East, LeicesterLE1 7DR.

This report was written by:Myra CooperOxford Doctoral Course in Clinical Psychology, University of Oxford.Graham TurpinClinical Psychology Unit, University of Sheffield.Romola BucksSchool of Psychology, University of Southampton.Gerry KentClinical Psychology Unit, University of Sheffield.

Address for correspondence:Dr Myra CooperIsis Education Centre,University of Oxford,Warneford Hospital,Oxford OX3 7JX.Tel: +44 (0)1865 226431Fax: +44 (0)1865 226364E-mail: [email protected]

The report will be submitted for publication to Clinical Psychology and made available separately as aDCP/PPB publication. The Executive Summary will be submitted to The Psychologist for publication. It is also proposed that it should be referred to within the revised ethics guidelines (BPS, 2004) andendorsed by the Society. We acknowledge Dr Angela Carter for contributing to the report from theperspective of occupational psychology.

The new systems of NHS research and ethicsgovernance pose particular issues forpostgraduate education in applied psychology,which is frequently (and necessarily) conductedthroughout the NHS, as well as for the conductof psychological research per se. This may haveserious consequences for the continueddevelopment of the knowledge baseunderpinning both psychological healthcare andpatient care within the UK.

To begin to resolve some of these issues, aseries of meetings has taken place within theBritish Psychological Society and also withProfessor Terry Stacey, Chair of COREC. ThisGood Practice Guide, written for NHS managers,LREC members (including lay and service userrepresentatives) and psychological researchers, isthe result of these meetings.

The guide summarises for non-psychologiststhe nature of psychological research, types ofresearch conducted by psychologists, and theircontribution to the health care knowledge base.It also summarises the BPS guidance that exists toinform ethical practice and research inpsychology. For psychologists, there is a summaryof NHS Research Governance and LREC/MRECprocedures, and advice on how best to engagewith NHS services.

The guide deals with distinctions betweenresearch and audit activity. It also highlights theimportance of service evaluation or improvementprojects. The role and contribution thatpsychologists make in devising and conductingresearch and research-related activities isemphasised, together with the importanceattached to these activities as evidenced bynumerous DoH and NHS documents, policiesand procedures. The role of service users withinthe conduct of psychological research is alsoaddressed.

Research Ethics Committees and ResearchGovernance procedures are reviewed from theperspective of psychological researchers andadvice offered on the important distinctionbetween research and clinical audit activities.

The various responsibilities of psychologicalresearchers are discussed and include topics suchas honorary contracts, indemnity, the timeinvolved in setting up ethics and researchgovernance approval, whether or not theresearch is student research, timely and fullcommunication with RECs, the importance ofpreventing or undoing harm or distress,completion of paperwork, the importance of dataprotection and data storage, and riskmanagement.

The following recommendations are made:

Good Practice Guidelines 1

Summary and Recommendations

Recommendations for RECs and NHS Trust R&D (and clinical audit) Departments.1. Many of the difficulties here would be resolved by a clear and transparent definition of audit and

research that is agreed upon by RECs, and by Trust R&D and Clinical Audit departments. Ideally,it should be nationally disseminated and available to researchers, whose responsibility it would thenbe to make a decision about whether or not REC approval was required.

2. The role and status of service improvement projects must be addressed as a matter of urgency.3. The length, method and storage of data and whether or not it should be destroyed needs to be

agreed.4. The role of clinical audit departments and staff in the planning and implementing of audit (small

scale) studies conducted by students needs to be addressed and agreed. This presents additionaland different challenges, and may require addressing in a separate document.

5. There should be agreement that a university’s peer review procedures, if appropriate, may be usedin place of R&D peer review, for R&D governance procedures.

6. Consideration should be given to how contracts issued by individual NHS Trusts to trainees mightcover them both for clinical and research work undertaken in their employing Trust, and mightalso apply to other Trusts, thus removing the need for multiple honorary contracts.

7. Consideration should be given to clarifying the use of a single MREC approval for large-scaleresearch projects that involve many NHS Trusts, and that does not require further local scrutinyand changes to be made.

Recommendations for psychologists (and students) conducting NHS research1. Psychologists must be prepared to become members of R&D and REC Committees. This would

facilitate communication, and understanding, of all the relevant issues that bodies involved inresearch governance developments are experiencing. However, until applied psychologists becomemembers of the Health Professions Council and are subject to statutory regulation (Turpin &Stacey, 2004), recent REC regulations prohibit psychologists from being expert members of thecommittee although committees do maintain the option to recruit psychologists as lay members.

2. Training courses in applied psychology should ensure that students are exposed to teaching on allaspects of ethical practice including research, audit and clinical activities.

3. Research supervisors must do their utmost to ensure students have considered and are aware of allrelevant recent developments in research governance and RECs.

4. Psychologists should ensure that all research and audit activities (including service evaluations,single case evaluations and service improvement projects) are subject to ethical consideration and,where appropriate, scrutinised by the appropriate body (e.g. LRECs, SPECs or local departmentalethics committees).

5. Psychologists should ensure that due attention is paid to issues of informed consent and capacity,and any changes in practice brought about by the proposed Mental Capacity Bill (pers. comm.. K.Ehlert, August, 2004).

6. Supervisors and students must ensure that their practice conforms to local NHS Trust and ethicalapproval procedures, as well as the Society’s own ethical guidelines,

2 Good Practice Guidelines


1. IntroductionWithin the last few years major policy andprocedural developments have been introducedinto the NHS with regard to ‘researchgovernance’. Many influences are at work hereincluding a greater focus on peer-reviewed, highquality NHS research, greater accountability ofclinical researchers following the Alder HeyEnquiry (HMSO, 2001), and the Clinical TrialsDirective outlining ethical procedures forconducting therapeutic trails. Indeed, theGovernment laid The Medicines for Human Use(Clinical Trails) Regulations 2004 before bothHouses of Parliament on 1 April 2004 and thisBill implements the European Clinical TrialsDirective (Directive 2001/20/EC) in UK law. TheRegulations came into force on 1 May 2004. Thishas implications for the conduct of all research,not just clinical trials involving new medicines, asthe Government has decided to have one set ofregulatory standards for all NHS research.

The current policy changes originate fromthe Department of Health’s Research GovernanceFramework for Health and Social Care (2001) andthe Governance Arrangements for NHS EthicsCommittees (GAFREC, 2001). This workingenvironment for NHS research potentially posespsychological researchers with new challenges.These include greater accountability, moreintensive ethical scrutiny, open peer reviewingand NHS approval of research, greater clarityover the use of NHS resources, and theinvolvement of users within the research process,to name but a few.

Although many of these developments are tobe welcomed and will protect NHS clients andresources from potential abuse, theimplementations of some of these policies has thepotential to make some important (andnecessary) forms of psychological researchdifficult to carry out (Peck & Jones, 2004). Thismight include research that has even been given ahigh priority within DoH policy and publications,and which can be seen online in the Research andDevelopment section of the DoH’s website(http://www.dh.gov.uk/PolicyandGuidance/ResearchandDevelopment/fs/en) or that whichhas been commissioned and funded by the DoH.Psychologists are not alone in being critical of theintroduction of these new procedures, andarticles, letters and guidance have recently been

published with regard to medicine (Norman,2004; Greenhalgh, 2004), pharmacy (Jesson &Wilson, 2004) and nursing (RCN, 2004).Moreover, many of these new arrangements havebeen introduced only very recently and theorganisational structures to support the newgovernance arrangements are still in the processof being established (COREC, 2004) resulting,sometimes, in long delays or uncertain timescales for the completion of many NHS researchprojects. Indeed, further new proposalsconcerning the ethical scrutiny of studentresearch projects in the NHS have only just beenreleased for consultation (Doyal, 2004).

Following on from the introduction of thesenew procedures, many psychology researchersand students, university lecturers and researchsupervisors, as well as NHS clinicians andmanagers, have begun to familiarise themselveswith and assimilate these important but complexnew arrangements. We believe that the newsystems of research and ethics governance poseparticular issues for postgraduate education inapplied psychology, which is frequentlyconducted within the NHS. By students, we refermainly to postgraduate students either for aresearch degree (e.g. PhD, DClinPsy) or for apostgraduate professional qualification within abranch of applied psychology (e.g. MSc or DPsysin clinical, occupational, counselling, forensic orhealth psychology). MSc research projectstudents typically have only a three- to four-month period in which to complete and write upthe research. In some circumstances, the issuemight have arisen in association with psychologyundergraduates but the conduct of such projectswithin the NHS is relatively infrequent. Moreover,it is likely that the majority of undergraduate andpossibly masters level research projects will in thefuture be subject to Student Project EthicalCommittees established within higher educationinstitutions but with close involvement of LRECs(see Doyal, 2004).

Many of the issues highlighted in theseguidelines, however, have presented themselvesover the past few years in the context of clinicalpsychology training. Indeed, it was the TrainingStrategy Group of the Division of ClinicalPsychology of the British Psychological Societywhich first established a working party specificallyto examine these concerns from both practising

Ethics, research governance, and psychological researchwithin the NHS: A good practice guide

NHS clinical psychologists and members of thetraining community. However, researchers in otherareas of applied psychology, particularly thoseassociated with occupational psychology, havevoiced similar concerns, particularly in relation toresearch which is increasingly being commissionedby the DoH and NHS Trusts in order to makehealth services more effective. Not only is thereconcern about the impact of these procedures onthe conduct of psychological research per se, butthere was also a more general anxiety that ifresearch were disrupted or delayed during thecourse of training applied psychologists, this wouldresult in fewer staff with research qualifications,and fewer clinical psychologists in general, takingup posts in the NHS. This would have seriousconsequences for patient care since clinicalpsychology is already considered a shortageprofession (DH/HO/BPS, 2005).

Before discussing the specific problemsraised, it might be useful to provide somebackground to clinical and other appliedpsychology training. Clinical psychologists obtaintheir pre-registration qualification by completinga three-year doctoral training course, consistingof academic study within a university andsupervised clinical practice whilst on placementwithin the NHS. There are around 6000 qualifiedclinical psychologists working within the NHS,and currently there are around 1500 traineeclinical psychologists employed by the NHS atanyone time (annual intakes of approx 550within the UK) and studying at around 30university courses. All entrants to clinicalpsychology training will have obtained a three-year undergraduate degree in psychology (fouryears in Scotland) and, as such, have alreadyreceived extensive training in researchmethodology. Unlike the majority of studentswithin the NHS who are bursaried, clinicalpsychology trainees are all NHS employees and.as such, are also subject to enhanced CriminalRecords Bureau clearance and relevant healthchecks. Given the doctoral level of qualification,it is an essential requirement for all clinicalpsychology trainees to conduct a research thesisthat is original and that contributes to thediscipline’s knowledge base (Quality AssuranceAgency, 2004). Usually this consists of thecompletion of a major clinical research projectwithin the three years, together with the conductof one or more small-scale research projectscarried out during their clinical placementswithin an NHS Trust. During the course of theirtraining they receive additional training inresearch methods and ethics.

Occupational psychology training is currentlyundertaken in two parts following a degree inpsychology, the first being a one-year Mastersdegree (or a two-year part-time degreeprogramme) followed by a minimum of threeyears’ supervised practice that is externallyassessed. An increasing number of occupationalpsychologists are being employed within the NHSeither undertaking clinical work in areas such asrehabilitation or supporting service developmentin education, personnel services or organisationaldevelopment. Many occupational psychologistsprovide research and intervention programmesfor healthcare organisations. In addition, severaluniversities support doctoral programmes wherethe NHS is the principal research area. All ofthese programmes contain rigorous training andassessment in research methodology, statistics andethical practice. The situation for counselling,forensic and health psychology is similar to theabove consisting of either three year doctoratesor a masters degree at Stage 1 followed by asecond stage of supervised practice and furtherstudy within the workplace.

Within clinical psychology training, the mostfrequently reported difficulties with LRECs andresearch governance have arisen with respect tothe small-scale research projects. These projectsare often (but not always) audit or small-scaleservice evaluations, of existing practice, ratherthan original research and, in the past, mostLRECs have not wished to consider these.Sometimes these projects are also referred to asservice improvement projects. These also includesingle case or experimental studies of routineclinical or novel treatments (Turpin, 2001, 2002).Increasingly, however, it appears that manyLRECs are either asking to see these projects, orTrusts (either research and development (R&D)departments, or clinical audit departments) areinsisting that they are seen by LRECs. Theconsequence is that these are frequently judgedusing research standards rather than audit orservice evaluation criteria, and are often refusedapproval since they are not judged to be‘research’ (i.e. because they lack originality or arestatistically under powered) or because of thedifficulties of obtaining consent for data thathave been collected as part of routine practice.These sorts of problems are making it verydifficult for clinical psychology trainees to meettheir course requirements. Indeed, they have thepotential seriously to compromise the completionrates of pre-registration clinical psychologists – it is now not uncommon for trainee clinicalpsychologists to have to extend their training



(with consequent financial and employmentproblems for the NHS) because of delays causedby these sorts of issues. Moreover, the NHS is indanger of losing many high quality audit andservice evaluation projects that are oftenextremely well valued by clinical placementproviders/supervisors and clinical services. Theseprojects often play an important role in thedevelopment, review and planning of localservices across all areas of the NHS from mentalhealth to physical health and medicine.

Occupational psychologists are alsocommissioned to undertake large-scale researchprojects on behalf of the DoH. Many of theseprojects involve, for example, in excess of 30 NHSTrusts in different regions. This necessitates bothMREC, and associated LREC submissions beingmade in each domain1 to each LREC within adomain. The workload is an immense burden onthe research team and invariably detracts from theresources available for the research. Theseproblems could easily be avoided if the local areasaccepted the MREC approval (i.e. received andacknowledged it) but did not subject the proposalto further scrutiny, or request multiple copies ofapplications for additional LREC review, i.e. if nofurther alterations could be requested by LRECsafter MREC approval has been granted. We areaware that the relationship between LRECs andMRECs has been subject to recent review byCOREC (COREC, 2004).

In clinical psychology, and some occupationalpsychology training, other problems haveoccurred with regard to the major research thesiswhich is usually (almost always in clinicaltraining) subject to scrutiny by an appropriateLREC or MREC. Frequently, there may well bedelays because of the high number of commentsand suggestions made by LREC members. Whilesome of these may be invaluable in refining theproject and ensuring that it is ethicallyacceptable, not infrequently the comments seemto reflect confusion and ignorance about thenature and value of psychological research to theNHS. Again, delays here are a frequent cause ofextensions to training and research projects,which may delay qualification for up to 12months. Delays may also be caused by the need toobtain approval from a range of different bodies,each with their own timetable. The ‘peer review’procedures now required by R&D departmentsmay add to these delays, even though mostprojects have been scrutinised carefully by

internal university research committees,sometimes including external examiners. Thecumulative effect of these problems has not onlydelayed qualification but, importantly andworryingly, resulted in significant reduction intrainees’ interest in and motivation forcontinuing to conduct research in the NHS, post-qualification. This is not a good outcome, giventhat psychologists, unlike many otherprofessionals working in the NHS are trained notonly to consume and understand research, butalso to conduct high quality research of theirown. This skill is particularly important in view ofDoH recommendations (NHS Priorities andNeeds Research and Development Funding,2002), also highlighted in a recent publication onNHS priorities (DoH, 2003).

In order to begin to resolve some of theseissues, a series of meetings has taken place withinthe British Psychological Society and also withProfessor Terry Stacey who is the Chair ofCOREC. As a result, it was decided to produce aGood Practice Guide for NHS managers, LRECadministrators and members (including lay andservice user representatives), and psychologicalresearchers. The Guide summarises for non-psychologists the nature of psychologicalresearch, types of research conducted bypsychologists and their contribution to the healthcare knowledge base (theoretically andempirically). It also contains a summary of theBPS guidance that already exists to inform ethicalpractice and research in Psychology. Forpsychologists, there is a summary of NHSResearch Governance and LREC/MRECprocedures and advice on how best to engagewith NHS services. The guide also deals withdistinctions between research and serviceevaluation and/or audit activity. The role ofservice users within the conduct of psychologicalresearch is also specifically addressed. Finally,there is some discussion of the key currentdifficulties which have already been identified,and some recommendations for their resolutionare proposed. We have also included threeappendices: the first helps to clarify definitionsregarding research and audit activities, thesecond presents a flow chart to assist makingdecisions about distinguishing between researchand clinical audit/ service evaluation projects,and whether LREC approval is required, and thethird lists helpful references and websitesassociated with clinical research.

1 A domain is an area covered by a Strategic Health Authority (England), a Health Board (Scotland), a regional office of the NHS Wales Department or the whole of Northern Ireland.

2. Psychological researchA popular definition of psychology is ‘thesystematic study of mind and behaviour’ (BPS,2003). Psychological research, therefore, is broadin nature and has contributions to make toeducation, health, the economy, work and socialjustice (BPS, 2003). The British PsychologicalSociety (BPS) is the representative body forpsychologists and psychology in the UK. Foundedin 1901 (granted a Royal Charter in 1965), it hasnational responsibility for the development,promotion and application of psychology for thepublic good. It acts as a learned society but alsomaintains a voluntary register of CharteredPsychologists. From 2005, it is very likely thatApplied Psychologists will be legally regulatedthrough the Health Professions Council(Psychologist, 2004). Under these newarrangements it will be important to ensure thatacademic applied psychologists who are notregistered under the HPC, since they do not offerdirect psychological services to the public, retaintheir essential access to NHS research samples.

Many of the members of the BPS are appliedpsychologists; they apply psychological knowledgein specialist fields including education, health,work and the judicial system. Those who work inthe NHS include (among others) clinical,counselling, health, occupational andneuropsychologists. Indeed, details of the appliedpsychology workforce in England, Wales andScotland are available in a number of separatepublications, although often subsumed within thebroad Scientific, Therapeutic and Technical staffcategory (HMSO, 2003a, 2003b, 2004). Thelargest group within the NHS is clinicalpsychology (approximately 6,000 people). Manyacademic psychologists based within Universitydepartments of psychology are also active appliedresearchers within the NHS.

Psychologists conduct quantitative andqualitative research. Indeed, many clinicalpsychology doctorates have successfully adoptedqualitative methods to study psychological clinicalphenomena (Turpin et al., 1997). Researchmethods can involve interviews, self reportquestionnaires, observations and experiments.Issues that are typically addressed inpsychological research include tests of theory,development of reliable and valid measures, andevaluation of the process and outcome oftreatment, examination of working practices,change and staff well-being, along withorganisational intervention studies. Studies maybe large, conducted across multiple sites, withmany hundreds of participants, and many NHS

Trusts, but more typically they involve a relativelysmall number of participants. Some studies focusspecifically on small samples or even single casestudies using either quantitative or qualitativemethods to examine in detail processesunderlying therapeutic change within anindividual. In this they differ from some NHSresearch, for example, epidemiological studiesthat may have very large numbers of participants.It is important to recognise that there is also adistinction between psychological research andresearch conducted by psychologists.Psychologists may also be closely involved inresearch whose primary focus is non-psychological, e.g. drug studies, epidemiologicalstudies; to which they can bring valuable researchdesign skills.

The importance of psychological research tothe NHS is recognised, for example in theNational Service Frameworks, where research anddevelopment are seen as key components indeveloping the knowledge base needed toimplement these frameworks (e.g. NSF forMental Health, DoH, 1999; NHS Priorities andNeeds R&D Funding, DoH, 2002). Much of theknowledge gained about treatment evaluationshighlighted in these publications is essentiallypsychological in nature. Indeed, psychologicalresearch has provided much of the evidence-baseunderlying recent clinical guidelines published bythe National Institute for Clinical Effectiveness ofschizophrenia, eating disorders, depression andthe forthcoming guidance on post-traumaticstress disorder, to name just a few relevantconditions.

The majority of the occupational psychologyresearch conducted in the NHS is by experiencedresearchers often working as part of a multi-disciplinary research team. These projects areoften large-scale (e.g. gathering data from all theA&E departments in England and Wales) andinvolve complex methodologies using quantitativeand qualitative research methods. Experiencedoccupational psychologists may also supportpostgraduate research in NHS Trusts which, likemuch trainee clinical psychology work, providesinput that is desperately needed to improveservice delivery at very low cost to the NHS.

Within the NHS, much of the psychologicalresearch submitted to LRECs will be both fromqualified clinicians and researchers based withinuniversities and NHS, and also studentsundertaking postgraduate study in clinical,counselling and health psychology, as well asoccupational psychology. It is important toemphasise that unlike most student research


conducted in the NHS which is consideredunoriginal and should not qualify as originalresearch (Doyal, 2004), the majority of thesepostgraduate student projects have to beexamined to a publishable standard. Suchresearch projects, therefore, make importantcontributions to the literature and are valued byboth trainee and research supervisor. Studentresearch of this type is often excellent value formoney. All training courses should scrutinise theethical (and scientific) aspects of trainee researchprojects before they are submitted to LRECs orMRECs. These procedures for scrutiny arerigorous and involve independent assessment byexperienced researchers, and may even involveexternal examiners. Finally, it is worthemphasising that the scrutiny of the conduct ofethical psychological research is a majorresponsibility of the BPS. It produces extensiveguidelines for psychological researchers,including advice on ethical issues (Code ofConduct, Ethical Principals and Guidelines, 2000;Professional Practice Guidelines, 1995), andmaintains a strict complaints and disciplinaryprocedure for investigating and managingbreaches of those guidelines. This guidance hascurrently been reviewed and a revised set ofGuidance on Ethical research has been published(BPS, 2004).

3. Research GovernanceThe NHS also has extensive guidance for bothresearch governance and ethical scrutiny. Thelatter are also published in the documentsResearch Governance Framework for Health andSocial Care (2001) and Governance for NHSEthics Committees (2001). More up to dateadvice is available on both the DoH(http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment) and COREC websites(http://www.corec.gov.uk).

The Research Governance Framework forHealth and Social Care (2001) is a set ofguidelines for maintaining the scientific andethical integrity of the studies conducted withinNHS and Social Care settings. The Framework isdesigned to ensure that all types of research arecarried out in a manner that the public can trustand support, and that the quality of suchresearch allows it to contribute to improvementsin health and provision of services. TheFramework also sets out standards and describesthe monitoring and assessment arrangements forensuring that these are adhered to. Research andDevelopment activity, including student projects,should not proceed without notification of the

staff member who is responsible for research anddevelopment within the organisation. All R&Dactivities must also have the approval of anappropriate ethics committee.

For the purposes of the Framework, R&Dactivity is defined as an attempt to discovergeneralisable and new knowledge by addressingclearly defined questions with systematic andrigorous methods, and/or involving experimentalintroduction into practice (for example, studiesthat examine two or more alternative methods ofcare and/or procedures). All studies and projectsthat meet this definition (see also Appendix 1)are subject to research governance. This includesmost clinical psychology trainee large-scaleresearch, but not the small-scale projects, whichwill typically fall under the remit of audit and/orservice evaluation.

Full details about the DoH ResearchGovernance Framework can be obtained from:http://www.dh.gov.uk/assetRoot/04/01/47/57/04014757.pdf.

4. Audit vs ResearchThe distinction between audit and research is thesource of considerable difficulty for clinicalpsychology training courses. Typically, but notalways, audit unlike research, is considered by therelevant local Audit or Clinical EffectivenessCommittee (under the direction of a ClinicalGovernance Committee) and does not need to bescrutinised by an MREC or LREC. Meeting localAudit Committee demands poses a different setof challenges, which can also cause difficulties forapplied psychology projects, but these will not beconsidered here. The importance of a third typeof project common in the NHS and in clinicalpsychology training has been highlighted morerecently (Paxton, Whitty, Zaatar, Fairbairn &Lothian, unpublished). This has been termed‘service improvement or evaluation projects’.These do not fit, strictly speaking, mostdefinitions of audit since they do not relyexclusively on service standards but neither arethey ‘research’ as defined by the DoH. Hence,they do not fit neatly into any existing NHScategory. A review of recent descriptions ofclinical governance documents published by theDoH which detail the activities falling under theremit of Clinical Governance departments,suggests that they most clearly fall under theirjurisdiction. However, their relationship to AuditCommittees, designed specifically to scrutiniseaudit projects is unclear. Indeed, how they are tobe assessed and ‘approved’ by the NHS does notappear to have been considered. This is a grey


area of considerable difficulty for clinicalpsychology training and often results in projectsbeing passed back and forth betweendepartments and committees, and considerabledebate about who is responsible for them. This isunhelpful to everyone concerned. A similarproblem arises around single case studies ofroutine clinical procedures in order to assesstheir effectiveness within a specific client. Wejudge that such studies ought to be the subject ofclinical governance and not research governance.Clearly, however, where single case studiesexamine novel or innovative treatments, theyshould be subject to full LREC approval. A consensus, therefore, on the respectivedefinitions and scope of audit and research, andhow service improvement and single case projectsfit within the current system of scrutiny andapproval, is urgently needed. We discuss belowtheir relative similarities and differences.

Audit determines whether existing clinicalknowledge, skills and resources are being properlyused. In contrast, research is concerned withgenerating new knowledge that will have generalapplication, as for example in determiningwhether a new treatment is superior to an existingone or evaluating whether a particular theoryprovides an adequate explanation for a clinicalphenomenon. The difference is between eitheradding to the body of knowledge (research) orensuring that knowledge is being effectively used(audit) according to some predetermined criteriaor standard of good practice or agreed protocolof care. Both collect data, but for audit findingsare often relevant only to local circumstances.Audit is usually intended to influence the activitiesof an individual clinician, small team but also(sometimes) an entire service; while clinicalresearch generally seeks to influence clinicalpractice as a whole. Thus, the primary aim ofaudit is to improve the local delivery of healthcare. Effecting change should be the intention ofaudit from an early stage (i.e. collection of data isnot enough). Methods of dissemination will alsodiffer between audit and research. Research isprimarily disseminated through peer-reviewedjournals, together with national initiatives toinfluence training and practice. Audit relies moreon service evaluation reports and summarieswritten for local consumers, which may includestaff and service users. However, it may also bepublished. Service improvement is similar to auditin many respects (e.g. it usually seeks localknowledge, and aims primarily to improve localservices) but unlike audit it does not involvecomparison against set standards. Paxton and

colleagues (Paxton et al., submitted) provide thefollowing useful definition: ‘service improvementrefers to projects that do not involve set standards,but which aim to identify issues and gatherknowledge about local services in order toimprove these services rather than to acquiregeneralisable knowledge’ (p.7). They argue (inour view, correctly), that such projects should, likeaudit, be encompassed with the clinicalgovernance framework, and reviewed andapproved, in a way similar to that used for auditprojects.

It would be very helpful if a decision treewere made available designed to help researchersand students determine if an NHS LREC (orMREC) application is required. Such a decisionmight then be usefully used as a marker ofwhether a project needs to go through researchgovernance procedures or, as is currently true ofaudit, through the clinical governanceprocedures (i.e, both audit and serviceimprovement projects). Nevertheless, it is stressedthat both research and audit activities irrespectiveof which route is adopted should be subject toappropriate ethical scrutiny: ultimately theresearcher is responsible to see that ethicalstandards of practice are upheld (Wade, 2005).

This decision tree should also addressresearch conducted outwith NHS settings such asin social services and schools. Indeed, a recentconsultation on ethical review in social care hasbeen published (Pahl, 2004). Nevertheless, evenwhen research is conducted outside of the NHSremit, if the researchers are located in the NHS,although they appear not to need LRECapproval, in practice it is usually advisable toobtain NHS ethics approval for all researchconducted by NHS employees, regardless ofwhere it is done. Indeed Trusts are unlikely to bewilling to provide indemnity for a project that hasnot had this approval and which they may nothave been informed about. The impact of SPECs(Doyal, 2004) will also need to be factored intothis decision tree once they have been approved.A suggested distinction between audit andresearch is outlined in Appendix 1. A possibledecision tree for distinguishing between auditand research can be seen in Appendix 2.

All NHS research conducted by students orstaff from University Departments of Psychology,is also likely to require ethics approval from anInstitutional Ethics Committee, preferably beforeany NHS REC application is made (BPS, 2004).Again, this may be rolled into a single process forstudent projects undergoing SPEC as opposed toLREC approvals.


5. Service user groupsUsers have long been involved in research studiesas research participants. In recent years there hasbeen an increasing emphasis on involving usersin the design and development of research. Twoimportant websites relating to service userinvolvement are: CERES (Consumers for Ethicsin Research), and INVOLVE: the NHS site whichpromotes public involvement in NHS research,public health and social care research.

INVOLVE lists important reasons for involvingconsumers in research, and suggests groups fromwhich suitable people might be recruited. Theyalso produce a number of very helpfulpublications and a checklist to help researchersidentify the issues concerned with involvingconsumers (see http://www.invo.org.uk).

CERES is concerned that research beconducted ethically, and also publishes a numberof documents, including a range for ethnicminority groups in different languages (seehttp://www.ceres.org.uk).

Psychologists should be encouraged to involveusers at every stage of the research process fromestablishing research priorities through to thedissemination of relevant findings and clinicalimplications. Further discussion of these issues iscovered by Telford and colleagues(http://www.sheff.ac.uk/scharr/sections/ph/research/public-involvement/completed-projects/successful-consumer.html). A moregeneral discussion of user involvement inpsychology and mental health services hasrecently been undertaken by Diamond andcolleagues (Diamond et al., 2003).

As researchers, psychologists must be sensitiveto the impact of their research on participants(BPS, 2004). Strict confidentiality must bemaintained at all stages of the research. Thebenefits and possible harm to those who take partmust be carefully assessed. Researchers shouldhave a procedure or policy in place in case anyparticipant becomes upset or distressed.Generally, the risk of harm and distress is low instudies conducted by postgraduate psychologystudents. Indeed, many participants, includingthose who are severely affected by their problems,find the experience of a sympathetic researcherwith whom they can discuss issues that areimportant to them, a helpful experience, evenwhen ostensibly there is no clear benefit to themin taking part. Further discussion aboutminimising any risk to participants inpsychological research is to be found in the newBPS (2004) guidance.

6. Researcher responsibilitiesWhether trainee or experienced researcher, theresearcher is always responsible for his or herown actions. We have outlined below some of themajor responsibilities and duties that theresearcher should undertake. Further guidancearound some of these topics is also to be found inAppendix 2. The list is by no means exhaustivebut emphasises some key considerations forpsychological researchers working into the NHS.

Honorary ContractsRecommendations in the Follett Report, set up toexamine University/NHS responsibilitiesfollowing the Alder Hey tragedy, assume thathonorary contracts are in place for university staffworking in the NHS. The Follett implementationgroup has since recommended that NHS staffwho teach or do research in universities shouldalso have honorary contracts with the university.There is mutual advantage in this arrangementfor university staff. The NHS body then acceptsthat researchers with honorary contracts (and thusuniversity and other non-NHS employees) arecovered, like NHS staff, by NHS indemnity, i.e.the NHS organisation must discharge its ‘duty ofcare’. At the same time, by issuing university andother non-NHS staff with honorary contracts, theNHS organisation ensures that all researchersworking on its premises with its staff, patients,and their data are contractually bound to takeproper account of the NHS duty of care. Thus,honorary contracts afford protection to both parties.

Some university researchers work in manyNHS organisations. This is particularly the casefor those working in primary care. Only individualNHS Trusts can issue contracts – there is no suchthing as an ‘NHS wide honorary contract’. Thisalso creates problems for clinical trainees who areusually employed by one NHS trust but who willhave clinical placements in several Trusts and mayconduct research across several trusts. Drawing upan honorary contract is often a lengthy process,and many Trusts insist on new criminal recordsclearance each time, increasing the time taken toset up arrangements to work in Trusts that are notthe employing Trust. Fortunately, at least one‘host’ Trust has successfully managed to modifytrainee contracts to allow for cross-NHS Trustworking without the need for further honorarycontracts. With the new employmentarrangements being introduced within the NHSas a consequence of Agenda for Change (DoH,2004), discussions are taking place about anationally agreed trainee contract which mightseek to clarify indemnity arrangements for both


clinical and research activity of trainees employedby one NHS trust but working either onplacement or doing research within another trust.

IndemnityAn Honorary Contract with an NHS trust meansthat, like NHS staff, researchers are covered byNHS indemnity. The situation with regard tostudent research, however, is less clear than it firstappears. The supervisor (who usually applies as aco-investigator) takes responsibility under ResearchGovernance for the student’s study. The supervisoris not always an NHS employee, honorary orotherwise. In these circumstances, it may beadvisable for the supervisor to arrange an honoraryNHS contract. In the case of research conductedacross many sites and Trusts this may be a lengthyprocess. The situation will also be dependent uponthe student’s status and whether they themselvesare NHS employees, as is the case for clinicalpsychology trainees. Additionally, most universitieswill also have their own research governanceprocedures in place and will have arrangements forindemnifying their students and staff. Researchersand students should ensure that they havediscussed these issues with their local R&DDepartment and that there is agreement as to whothe Principal Investigator should be and whichorganisation should act as the research sponsor.Our experience, in practise, is that thesearrangements vary across NHS Trust to NHS Trust.

TimeAlthough, under the new legislation, LRECs willbe required to turn around applications in 60days, the overall process of obtaining RECapproval in practice usually takes a minimum oftwo months and can take as long as six months, ifmultiple localities or honorary contracts areinvolved. The 60-day clock will also stop if arequest for further information or clarification isrequired from the application, and start onlywhen a response is received. The researcher isadvised to begin this process as early as possible,and to make use of all available sources ofsupport, especially LREC administrators (forcontact details in England see:http://www.corec.org.uk/applicants/contacts/contacts.htm) and R&D co-ordinators (contactthe NHS Trust which will be the main or onlysource of participants for your study).

Research governance approvalIn addition to REC approval, investigators mustalso seek permission to conduct their study fromthe R&D Directorate of the Trusts where they

wish to recruit and also from the relevant DataProtection/Caldicott Guardians. These bodies areresponsible for ensuring that the standards setout in the Research Governance Framework aremet. All NHS Trusts now require R&D approvalbefore they will accept a submission to an REC.Many trusts are implementing a ‘passport’ system.This requires the researcher to obtain signaturesor codes on a checklist, which allows the NHStrust to be certain that all safeguards are in placebefore research commences. Your RECAdministrator and/or R&D Co-ordinator shouldbe able to advise you on local procedures.

R&D approval may take an additional twomonths to arrange; although most R&DDepartments are developing more streamlinedapproaches alongside the REC process, whichshould increase their efficiency.

Student researchThe student research agenda is of particularinterest to RECs, who have discussed it atmeetings of the Association for Research EthicsCommittees (AREC). The AREC website givesdetails of past and future meetings and can befound at http://www.arec.org.uk. A system ofStudent Project Ethics Committees (SPECs) iscurrently in development, to which studentprojects will be sent for ethical scrutiny. TheSociety generally welcomes their establishment,and has suggested that these may be a suitableplace to review undergraduate projects, someMSc dissertations, and clinical psychology small-scale projects, but that large scale doctoralprojects, because of their potential contributionto knowledge, should continue to be treated asoriginal research and to be scrutinised by RECs.

CommunicationTimely and full communication with RECs is oneof the researcher’s key responsibilities. Most RECsand R&D Directorates now have forms forprotocol amendments, annual reports and finalreports. In the absence of specific forms, RECsshould be written to on the headed paper of theinstitution regarding any amendments to theprotocol, annual and final reports of the studyand with copies of any publications arising fromthe study. It is generally advisable to obtain advicein writing; and e-mail is usually sufficient.Postgraduate students are recommended to keepcopies of all documentation and anycorrespondence with the RECs and Trust R&D orAudit offices. This documentation should be keptin a file and copies made available to thesupervisor. Some NHS Trusts stipulate that such


‘site files’ need to be stored confidentially for upto 15 years. Many clinical psychology coursesrequire a copy of the REC approval letter to bebound into the thesis in an appendix.

Preventing or undoing harm and distressIt is important to specify what steps have beentaken to prevent or alleviate the potential forharm caused by a study. It is useful to divide thisinto actions to take before, during and after thestudy. Before the study, researchers may wish toconsider carefully the nature of the tasks they areasking participants to complete. During the studyit is important to consider what the researcherwill do in the event that an individual becomesdistressed. Taking a break, if possible trying adifferent task, or stopping altogether are theusual options. If appropriate, a short debriefingsession is advisable afterwards, to explain anyresults, answer questions, etc.Unfortunately, many RECs take the view that it isalways unethical to ask participants questions thatmight upset them regarding this as anunacceptable level of distress. We would arguethat with sensitive handling and full debriefing,the risk that a participant may feel anger orsadness, for example, should not necessarily bean impediment to psychological research. Firstly,many participants find such research experiencesare a safe and anonymous opportunity to explorethoughts and feelings that they do not feel thatthey can share with family or friends. Secondly, totake such an approach prevents importantresearch into areas such as bereavement, terminalcare or following a disaster (e.g. Collogan et al.,2004), to name just a few. Thirdly, appliedpsychologists (by virtue of their training) are veryappropriate researchers to conduct such sensitive,but essential work.

PaperworkIt is important to complete all forms accurately,on time and as fully as possible. No questionshould be omitted. If questions are clearlyirrelevant then a note explaining the reasonshould be made, rather than leaving the space fora response blank. Guidelines on word length andstyle should be followed. It is very important thatsupplementary information such as consentforms and information sheets are compiled asdirected by the guidance notes and as faithfully aspossible. These can be found on the CORECwebsite (http://www.corec.org.uk), together withthe standard electronic application form.

Data ProtectionThe Data Protection Act (1998)(http://www.dataprotection.gov.uk/) providessecurity to individuals about the uses to whichtheir personal data can be put. Personal detailsinclude all information from which an individualmay be identified. For example, the age, genderand street name of an individual’s address wouldbe considered personal information as it may besufficient to identify them. Perhaps the biggestData Protection issue is about access to clients’records. The Act considers reading records aform of processing. This can be particularlyconfusing for trainee clinical psychologists andtheir supervisors due to the mixture of University-based and NHS-based training. If a trainee isworking on a clinical placement with theirsupervisor and he, or she, would normally haveaccess to the patient’s records then there is nobreach of the Act to look at them. If a trainee iscarrying out research only, and needs to processthe records to select participants, then most RECsinsist that the local clinician first identifies andcontacts potential participants, if the researcherhas no clinical role there.

Data storageResearchers should take all reasonable steps toanonymise their data, or to pseudo-anonymise incircumstances where there will be a need torevisit the identity of the individual participants,say for longitudinal studies. Following the recentpassage of European legislation (Directive2001/20/EC) in relation to clinical trials, theMedicines for Human Use (Clinical Trials)Regulations (2004) came into force on 1 May2004. This means that standards of Good ClinicalPractice for Clinical Trials in relation to thearchiving of original data are now being appliedacross all research being conducted in the NHS.The law requires storage for up to 15 years.Clarity on the degree to which this legislation willbe applied to student research in the NHS isneeded. Further complications arise becausesome LRECs have asked students to destroyoriginal data (for example, videos of participants)as soon as the study is finished. This may bebecause they view the transcripts of these videosas data that is not so easily rendered anonymous.However, most scientific journals require originaldata (which would apply to videos as well astranscripts) to be stored for five years post-publication. Most universities, on the other hand,do not ask supervisors or students to keepstudent data for more than one year, unless thedata are published, in which case the five-year



rule usually applies. This is clearly an arearequiring clarification, in particular as it presentsapplied psychology programmes with significantlogistical and storage difficulties. In the case ofdestroyed data, it prevents checks on the dataitself, including its existence, and the validity ofits use and interpretation by the student. This is aparticular problem for work that is to beexamined.

Risk ManagementThe general sources of risk to participants havebeen addressed earlier. Risk to investigators alsoneeds careful consideration. The most significantsources of risk arise through the potential forharm to the investigator by a participant (e.g.home visits) and it is essential that riskassessments and appropriate researcher safetyprotocols are agreed with the supervisor.Consideration also needs to be given to thepotential for risk to both participant andinvestigator from equipment. A clear and full riskprocedure needs to be in place for the risks ofevery study. It is usual for both universities andNHS Trusts to have Risk Assessment protocols.Students and supervisors should be aware ofthese and implement them.

7. RecommendationsWhilst we would not wish to advocate a lesseningof ethical or scientific standards for research,more time efficient and user-friendly systems thatfacilitate rather than impede the process ofobtaining approval for student and organisationalstudies are likely to be beneficial in the long run,both to students and to the NHS. We believe theprocedures recently instituted by COREC and theproposals to institute SPECs will go a long waytowards increasing the level of ethical scrutinyand public protection within the NHS, and alsoin co-ordinating and hopefully streamlining theprocesses undertaken by researchers and thestudents for whom they act as supervisors.Nevertheless, in writing this Good Practice Guide,we believe that there are still some outstandingissues which require further attention andresolution. Our recommendations fall into twomajor categories and we have identified thesebelow:

Recommendations for RECs and NHS Trust R&D (and clinical audit) Departments 1. Many of the difficulties here would be resolved by a clear, and transparent, definition of audit and

research that is agreed upon by RECs, and by Trust R&D and Clinical Audit departments. Ideally, it should be nationally disseminated and available to researchers, whose responsibility it would thenbe to make a decision about whether or not REC approval was required.

2. The role and status of service improvement projects must be addressed as a matter of urgency.3. The length, method and storage of data and whether or not it should be destroyed needs to be

agreed.4. The role of clinical audit departments and staff in the planning and implementing of audit (small

scale) studies conducted by students needs to be addressed and agreed. This presents additionaland different challenges, and may require addressing in a separate document.

5. There should be agreement that a University’s peer review procedures, if appropriate, may be usedin place of R&D peer review, for R&D governance procedures.

6. Consideration should be given to how contracts issued by individual NHS Trusts to trainees mightcover them both for clinical and research work undertaken in their employing Trust, and mightalso apply to other Trusts, thus removing the need for multiple honorary contracts.

7. Consideration should be given to clarifying the use of a single MREC approval for large-scaleresearch projects that involve many NHS Trusts, and that does not require further local scrutinyand changes to be made.


Recommendations for psychologists (and students) conducting NHS research1. Psychologists must be prepared to become members of R&D and REC Committees. This would

facilitate mutual communication, and understanding, of all the relevant issues that bodies involvedin research governance developments are experiencing. However, until applied psychologistsbecome members of the Health Professions Council and are subject to statutory regulation (Turpin& Stacey, 2004), recent REC regulations prohibit psychologists from being expert members of thecommittee although committees do maintain the option to recruit psychologists as lay members.

2. Training courses in applied psychology should ensure that students are exposed to teaching on allaspects of ethical practice including research, audit and clinical activities.

3. Research supervisors must do their utmost to ensure students have considered and are aware of allrelevant recent developments in research governance and RECs.

4. Psychologists should ensure that all research and audit activities (including service evaluations,single case evaluations and service improvement projects) are subject to ethical consideration and,where appropriate, scrutinised by the appropriate body (e.g. LRECs, SPECs or local departmentalethics committees).

5. Psychologists should ensure that due attention is paid to issues of informed consent and capacity,and any changes in practice brought about by the proposed Mental Capacity Bill (personalcommunication. K. Ehlert, August, 2004).

6. Supervisors and students must ensure that their practice conforms to local NHS Trust and ethicalapproval procedures, as well as the Society’s own ethical guidelines.

8. ConclusionIn this Guide we have raised concerns about thevarious ways in which new developments mighthinder the research training of psychologystudents. Many of these also apply to researchconducted by qualified psychologists. Ourintention in producing this Guide was not tocriticise the new developments – all of them have

important and desirable goals – but to suggest away forward that will enable psychology educatorsand the NHS to maximise the contribution thatpsychological researchers, including psychologistsin training, can make to the NHS agenda. Wehope that it is received in the spirit ofcollaboration and desire for progress with whichit was conceived.


BPS (1995). Professional Practice Guidelines. Division ofClinical Psychology, BPS: Leicester.

BPS (2000). Code of Conduct, Ethical principles andGuidelines. BPS: Leicester.

BPS (2003). About the British Psychological Society. See: http://www.bps.org.uk/about/welcome.cfm

BPS (2004). Draft Guidelines for Minimum Standards ofEthical Approval in Psychological Research. BPS: Leicester

COREC (2004). New Operational Procedures for NHSRECs: Guidance for applicants to Research EthicsCommittees. [email protected]

Collogan, L.K., Tuma, F., Dolan-Sewell, R., Borjas, S. &Fleischman, A.R. (2004). Ethical issues pertaining toresearch in the aftermath of disaster. Journal ofTraumatic Stress, 17, 363–372.

Diamond, B., Parkin, G., Morris, K., Bettinis, J. &Bettesworth, C. (2003). User involvement: Substanceor spin. Journal of Mental Health, 12, 613–626.

DoH (1999). National Service Framework for MentalHealth. London, Department of Health.

DoH (2001). Research Governance Framework for Healthand Social Care. London, Department of Health.

DoH (2002). NHS priorities and needs research anddevelopment funding. London, Department ofHealth.

DoH (2003). Report on the NHS priorities from 2001/2.London, Department of Health.

DoH (2004). Agenda for Change Proposed Agreement:Final Draft. London, Department of Health.

DoH/HO/BPS (2005). English survey of the appliedpsychology workforce. Leicester, BPS.

Doyal, L. (2004). The ethical governance and regulationof student projects: a draft proposal. COREC.

EC20/20 Clinical Trials directive, UK implementation ofthe European Clinical Trials Directive: the Medicinesfor Human Use (Clinical Trials) Regulations 2004.

Greenhalgh, T. (2004) The new ethics. British MedicalJournal, 328 (15 March), 651.

HMSO (2001). Redfern Report: Report of the RoyalLiverpool Children’s Inquiry. London: Her Majesty’sStationery Office.

HMSO (2003a). The NHS Workforce in England 2003.London: Her Majesty’s Stationery Office.

HMSO (2003b). Staff directly employed by the NHS(Wales), 30 September, 2002. London: Her Majesty’sStationery Office.

HMSO (2004). NHS Scotland Workforce Statistics.London: Her Majesty’s Stationery Office.

Jesson, J. & Wilson, K.A. (2004). The New UK ResearchGovernance: its impact on pharmacy undergraduateresearch projects. Pharmacy Education, 14, 41–48.

Norman, J. (2004). New system for ethics approval isunacceptable. British Medical Journal, 328 (24 April),1018.

Pahl, J. (2004). Ethics in Social care Research: OptionAppraisal and Guidelines. London: Department ofHealth.

Paxton, R., Whitty, P., Zaatar, A., Fairbairn, A. & Lothian,J. (unpublished). Research, audit and serviceimprovement.

Peck, D. & Jones, A. (2004). Bureaucratic barriers toresearch training in the NHS. Clinical Psychology, 36,7–10.

Quality Assurance Agency for Higher Education (2004).Subject benchmarks for clinical psychology.http://www.qaa.ac.uk

RCN (2004). Research guidance for nurses. London: The Royal College of Nursing Research Society.http://www.man.ac.uk/rcn/rs/publ/researchethic.pdf

Turpin. G. & Stacey, T. (2004). NHS ethics committees.The Psychologist, 17, 433–434.

Turpin, G., Barley, V., Beail, N., Scaife, J. Slade, P., Smith,J. & Walsh, S. (1997). Standards for research projectsand theses involving qualitative methods: Suggestedguidelines for trainees and courses. Clinical PsychologyForum, 108, 3–7.

Turpin, G. (2001). Single case methodology andpsychotherapy evaluation: from research topractice.In C. Mace, S. Moorey & B. Roberts, (Eds.), Evidencein the balance: A critical guide for practioners.(pp.91–113). London: Routledge.

Turpin, G. (2002). Single case methods and evaluationwithin psychotherapy. In M. Hersen & W. Sledge(Eds.), Encyclopaedia of Psychotherapy, Vol. 2(pp.659–668). Academic Press.

Wade, D.T. (2005). Ethics, audit and research: All shadesof grey. British Medical Journal, 330, 468–471.

Wainwright, T. (2004). Surveying the health of theprofession. The Psychologist, 17, 246–245.See also BPS website; tinyurl.com/yrg7e.

9. References


It is sometimes hard to find the dividing linebetween research and audit. The following isdesigned to make the distinction clearer.

How is audit different from research?Audit determines whether existing clinicalknowledge skills and resources are being properlyused. In contrast, research is concerned withgenerating new knowledge which will havegeneral application, as for example indetermining whether a new treatment is superiorto an existing one. The difference is betweenadding to the body of knowledge (research) andensuring that knowledge is effectively used(audit). Both collect data, but for audit thefindings are often relevant only to localcircumstances.

Audit is intended to influence the activities ofan individual or a small team; clinical researchseeks to influence clinical practice as a whole.

ResearchFeatures of research include:1. May involve experiments on human subjects,

whether patients, patients as volunteers, orhealthy volunteers.

2. Is a systematic investigation which aims toincrease the sum of knowledge

3. May involve allocating patients randomly todifferent treatment groups

4. May involve a completely new treatment5. May involve work or input for patients and

staff beyond that required for normal clinicalmanagement

6. Usually involves an attempt to test anhypothesis

7. May involve the application of strict selectioncriteria to patients with the same problembefore they are entered into the researchstudy

8. Usually will be sufficiently statisticallypowered.

AuditClinical audit or service evaluation is a systemicapproach to the peer review of clinical care inorder to identify opportunities for improvementand to provide a mechanism for bringing themabout.

‘Clinical audit involves systematically lookingat the procedures used for diagnosis, care andtreatment, examining how associated resourcesare used and investigating the effect care has onthe outcome and quality of life for the patient’(DoH, 1993).

‘The systematic critical analysis of the qualityof medical care, including the procedures usedfor diagnosis and treatment, the use of resourcesand the resulting outcome and quality of life forthe patient’ (DoH, 1989).

‘Audit is the process of reviewing the deliveryof health care to identify deficiencies so that theymay be remedied’ (Crombie et al., 1993)

The primary aim of audit is to improve thedelivery of health care. Effecting change shouldbe the intention of audit from an early stage (i.e. collection of data is not enough). Auditshould also compare current practice withstandards of care.

Features of Audit/service evaluation include thefollowing:1. Never involves experiments, whether on

healthy volunteers, or patients as volunteers.2. Never involves allocating patients randomly to

different treatment groups3. Never involves a completely new treatment4. Places demands on patients and staff that do

not significantly exceed those required fornormal clinical management

5. May involve patients with the same problembeing given different treatments, but onlyafter full discussion of the known advantagesand disadvantages of each treatment. Thepatients are allowed to choose freely whichtreatment they get.

Appendix 1GUIDELINES ON THE DISTINCTION BETWEEN RESEARCHAND AUDIT

Crombie, I.K., Davies, H.T.O., Abraham, S.C.S. & duFlorey, C. (1993). The Audit Handbook: ImprovingHeathcare through Clinical Audit. John Wiley & Sons:Chichester, UK.

DoH (1993). Clinical Audit: meeting and improvingstandards in healthcare. London: Department of Health.

DoH (1994). The Evolution of Clinical Audit. London:Department of Health.

DoH (1989). Working for Patients. London: Departmentof Health.

References


Appendix 2DECISION TREE TO DECIDE WHETHER OR NOT A PROJECT ISAUDIT OR RESEARCH (and requires REC approval or not)

Ethics decision tree Answer Outcome1. Does the study require access to any of: No Continue to 2

a) NHS patientsb) NHS staff Yes Continue to 3c) Relatives of NHS patients

2. Does the study require access to any of: No REC application not requireda) Social services patientsb) Social services staff Yes REC application may be requiredc) Relatives of social services patients Continue to 3

3. Does the study require access to children or Yes or No REC application not requiredtheir parents sourced through schools? Continue to 4

4. Does the study involve any activity which is Yes REC application requirednot part of routine clinical care?(Such as extra visits to hospital or home visits No REC application may not be requiredby researcher, extra assessments, new or extra Continue to 5interventions or therapy not normallyoffered)

5. To determine if the study is research or audit If anyanswer the following: answer:a) Is the study a systematic investigationwhich aims to increase the sum of knowledge? Yes REC application requiredb) Does the study involve allocating patients randomly to different treatment groups? No REC application may not be requiredc) Does the study involve an attempt to test Continue to 6an hypothesis?d) Does the study involve the application ofstrict selection criteria to patients with the same problem before they are entered into the research study?

6. Does the study involve patients with the same Yes REC application may not be requiredproblem being given different treatments, but Continue to 7only after full discussion of the knownadvantages and disadvantages of each No If patients cannot choose, RECtreatment, and the patients are allowed to approval requiredchoose freely which treatment they get?(If only one treatment, this is not relevant).

7. Is the study an evaluation of routine services/ No REC application requiredclinical care? Yes REC application may not be required

Continue to 8

8. Has this routine clinical care previously been Yes REC application not requiredoffered by this NHS service? No REC application may not be required

Continue to 9

9. Although new, is this service/clinical practice Yes REC application not requiredbased on services/clinical practice for whichthere are established standards in the No REC application requiredscientific literature?

Although research guidance is designed to cover Health and Social Care, presently it is only set up forNHS settings. This means that technically LREC approval for Social Services-based research is currentlynot required but that it will be at some stage in the future. However, most RECs will be happy toconsider an application for Social Services-based research should you feel that scrutiny of the ethics ofyour study would be beneficial.


AUDITMadden, A. (2003). Research or audit? In S. Eckstein (Ed.). Manual for Research Ethics Committees.Cambridge: Cambridge University Press. weblink: N/A

The Audit Commissionweblink: www.audit-commission.gov.uk

Clinical Research and Audit Groupweblink: www.show.scot.nhs.uk.crag

The Commission for Health Improvementweblink: www.chi.gov.uk

The National Audit Officeweblink: www.nao.gov.uk

PATIENT & PUBLIC INFORMATIONDuman, M, (2003). Producing patient information – How to research, develop and produce effective informationresources. London: Kings Fund. ISBN: 1-857-17470-4.weblink: www.kingsfund.org.uk/pdf/poppisummaryinfo.pdf

Secker, J. & Pollard, R, (1995). Writing leaflets for patients – Guidelines for producing written information.Edinburgh: Health Education Board for Scotland. ISBN: 1-873-45271-3.weblink: www.show.scot.nhs.uk/nhsfv/clineff/documents/patient%20information%20guidelines.pdf

Shepperd, S., Charnock, D. & Gann, B. (1999). Helping patients access high quality healthinformation. British Medical Journal, 319, 764–766.weblink: bmj.bmjjournals.com

RESEARCH GOVERNANCEResearch Governance Framework for Health and Social Care (2001). This document outlines theresponsibilities of students, clinicians and researchers both in the NHS and in Universities undertakingresearch on patients, their families or the staff who care for them.weblink: www.dh.gov.uk/assetRoot/04/01/47/57/04014757.pdf

Guidance notes on Research Governance and Honorary Contractsweblink:www.dh.gov.uk/PolicyandGuidance/ResearchandDevelopment/ResearchandDevelopmentA2/ResearchGovernance/fs/en#5036858

Governance Arrangements for NHS Research Ethics Committees weblink: www.dh.gov.uk/assetRoot/04/05/86/09/04058609.pdf

Association for Research Ethics Committeesweblink: www.arec.org.uk

Appendix 3REFERENCES AND WEBSITES


ETHICS AND CONSENTSocial Research Association (SRA). The SRA is an organisation open to social research practitionersand trainees from all sectors, as well as others with an interest in social research. The SRA websitecontains useful codes of practice on ethical issues in social research and safety for lone researchers.weblink: the-sra.org.uk

Central office for research ethics committees (COREC). Lists all the Local Research Ethics Committeesand gives e-mail contact details for the UK.weblink: www.corec.org.uk

COREC, Guidelines for researchers: Patient information sheet and consent form.weblink: corec.org.uk/appliants/help/docs/Guidance_on_Patient_Information_pdf

Guidelines on seeking patients consent (1998) – General Medical Council.weblink: www.gmc-uk.org/standards

Draft Protocol on Biomedical Research. The Additional Protocol to the Convention on Human Rightsand Biomedicine concerning Biomedical Research (Strasbourg 251 2005)is intended to build on theprinciples embodied in the Convention, with a view to protecting human rights and dignity in thespecific field of biomedical research. Its purpose is to define and safeguard fundamental rights inbiomedical research, in particular of those participating in research.weblink: www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/activities/biomedical_research/195%20Protocol%20recherche%20biomedicale%20e.pdf

The Ethical Conduct of Research on the Mentally Incapacitated. Working Party on Research on theMentally Incapacitated (1993).weblink: www.mrc.ac.uk/pdf-ethics-mental.pdf

ETHICS AND BEST PRACTICEThe Medical Research Council issues guidance and advice on the conduct of research in key areas.Some guidance concentrates on ethical, legal and practical aspects of ensuring the interests and safetyof people participating in research is protected. Other guides cover principles for the conduct andorganisation of high quality, reliable, and safe research.weblink: www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm

Declaration of Helsinki, World Medical Association (1964). Ethical Principles for Medical ResearchInvolving Human Subjects.weblink:www.wma.net/e/policy/b3.htm

Informed consent – BMJ.Collected resources on informed consent from the online British Medical Journal. eBMJ collections listthe most recent BMJ articles (usually with links to the full-text) in a subject area or speciality, and alsolinks to relevant books and journals from the BMJ Publishing Group.weblink: www.bmj.org/cgi/collection/informed_consent

DATA PROTECTIONData Protection Act (1998).weblink: www.hmso.gov.uk/acts/acts1998/19980029.htm

NHS Confidentiality Code of Practice. This is a guide to required practice for those who work within or under contract to NHS organisationsconcerning confidentiality and patients’ consent to use their health records. It replaces previousguidance. HSG(96) 18/LASSL (96)(5) – The Protection and Use of Patient Information, and is a keycomponent of emerging information governance arrangements for the NHS.weblink: www.dh.gov.uk/assetRoot/04/06/92/54/04068254.pdf


RISK MANAGEMENTWorking Alone in Safety: Controlling the risks of solitary work. Health and Safety Executive.weblink: www.gov.uk/pubns/indg73.pdf

A Code of Practice for the Safety of Social Researchers. This is the Social Research Association’s Code of Practice for the safety of social researchers,particularly those conducting research in the field on their own. The code focuses on safety ininterviewing or observation in private settings but is of relevance to working in unfamiliarenvironments in general.weblink: www.the-sra.org.uk/stay%20safe.htm

Guidelines on Good Research Practice. Medical Research Council.weblink: www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm

Guidelines on Personal Information in Medical Research. Medical Research Council.weblink: www.mrc.ac.uk/pdf-pimr.pdf

Research: The Role and Responsibilities of Doctors. General Medical Council.weblink: www.gmc-uk.org/standards

Code of Conduct, Ethical Principles & Guidelines. British Psychological Society.weblink: www.bps.org.uk/documents/code.pdf

Avoiding plagiarism in psychological writing. This site provides a handout on how to avoid plagiarism.It is provided by Monmouth University, New Jersey, US.weblink: bluehawk.monmouth.edu/~psych/conducting-research/plagiarism.pdf

WELLCOME TRUST’S BIOMEDICAL ETHICS PROGRAMMEWellcome Ethics Bulletin: the newsletter of the Wellcome Trust’s Biomedical Ethics Programme.weblink: www.wellcome.ac.uk/doc%5FwtX023241.html

The British Psychological SocietySt Andrews House, 48 Princess Road East, Leicester LE1 7DR, UKTel: 0116 252 9530 Fax: 0116 247 0787 E-mail: [email protected] Website: www.psychtesting.org.uk

Incorporated by Royal Charter Registered Charity No 229642

The Society has more than 42,000members and:� has branches in England, Northern

Ireland, Scotland and Wales;� accredits around 800 undergraduate

degrees;� accredits over 150 postgraduate

professional training courses;� confers Fellowships for distinguished

achievements;� confers Chartered status for

professionally qualified psychologists;� awards grants to support research and

scholarship;� publishes 10 scientific journals and also

jointly publishes Evidence Based MentalHealth with the British MedicalAssociation and the Royal College ofPsychiatrists;

� publishes books in partnership withBlackwells;

� publishes The Psychologist each month;� supports the recruitment of

psychologists through the AppointmentsMemorandum and www.appmemo.co.uk;

� provides a free ‘Research Digest’by e-mail;

� publishes newsletters for its constituentgroups;

� maintains a website (www.bps.org.uk);� has international links with

psychological societies and associationsthroughout the world;

� provides a service for the news mediaand the public;

� has an Ethics Committee and providesservice to the Professional ConductBoard;

� maintains a Register of more than12,000 Chartered Psychologists;

� prepares policy statements andresponses to government consultations;

� holds conferences, workshops,continuing professional developmentand training events;

� recognises distinguished contributionsto psychological science and practicethrough individual awards andhonours.

� maintains a Register of PsychologistsSpecialising in Psychotherapy.

The Society continues to work to enhance:� recruitment – the target is 50,000

members by 2006;� services – the Society has offices in

England, Northern Ireland, Scotlandand Wales;

� public understanding of psychology –addressed by regular media activity andoutreach events;

� influence on public policy – throughthe work of its Boards andParliamentary Officer;

� membership activities – to fully utilisethe strengths and diversity of theSociety membership.

INF76/04.05

The British Psychological Society was founded in 1901 and incorporated byRoyal Charter in 1965. Its principle object is to promote the advancement anddiffusion of a knowledge of psychology pure and applied and especially topromote the efficiency and usefulness of Members of the Society by setting up ahigh standard of professional education and knowledge.

Documents

Good practice guidelines for the conduct of psychological ... · PDF fileWe acknowledge Dr Angela Carter for contributing to the report from the ... as well as for the conduct