Research ethics: RCN guidance for nursing staffstaff.unak.is/.../Ethics/RCNresearchethics.pdf · Research ethics RCN guidance for nurses. 2 ... RESEARCH ETHICS Ethical issues

R O Y A L C O L L E G E O F N U R S I N G

RCN guidance for nurses

Research ethics

Published by the Royal College of Nursing, 20 Cavendish Square, London, W1G 0RN

© 2004 Royal College of Nursing. All rights reserved. No part of this publication may be reproduced,stored in a retrieval system, or transmitted in any form or by any means electronic, mechanical,photocopying, recording or otherwise, without prior permission of the Publishers or a licencepermitting restricted copying issued by the Copyright Licensing Agency, 90 Tottenham Court Road,London W1T 4LP. This publication may not be lent, resold, hired out or otherwise disposed of by waysof trade in any form of binding or cover other than that in which it is published, without the priorconsent of the Publishers.

This guidance was compiled by the Royal College of Nursing ResearchSociety. It was first published as a longer article in Nurse Researcher (vol 11,issue 1, pp 7-21).

The RCN Research Society Ethics Guidance Group

Chair – Martin Johnson, Professor in Nursing, University of Salford andEditor, Nurse Education Today

Ian Buchanan, Bury and Rochdale Local Research Ethics Committee

Tony Long, Associate Head of Department for Nursing Research,University of Salford

Lyndsey Peacock, Senior Lecturer in Nursing Law and Ethics,University of Central Lancashire

Tracey Williamson, Nurse Consultant, Pennine Acute Services NHS Trust

Acknowledgements

The authors would like to thank all the critical readers who contributed tothis document and Wendy Moran for administration support and CarolHaigh who helped with the initial website development.

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Contents

Introduction 2

Your responsibilities 3

Ethical issues 4

✦ Respect for every individual 4

✦ Autonomy 4

Vulnerable people 5

✦ Children 5

✦ Vulnerable adults 6

✦ Is research with vulnerable groups possible? 7

Addressing the issues 8

✦ Consent 8

✦ Confidentiality 8

✦ Balancing risks and potential benefits 9

Conclusion 12

Useful Internet resources 13

Research ethicsRCN guidance for nurses

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R E S E A R C H E T H I C S

Introduction

This guidance considers the ethicalissues of carrying out research withhuman subjects, and the areas whichyou as a nurse researcher, manager,student, member of a research ethicscommittee or any other relevant rolemust consider when setting up oradvising on research studies. It is aguide to basic principles, and with itsextensive list of Internet resources, agateway to further information.

Nursing research has changed a greatdeal since the Royal College of Nursing(RCN) first published its influentialguidance on research ethics for nursesin 1977. Many more nurses are nowparticipating in research for degreeprogrammes; nurses based in highereducation are expected to be active inresearch; and there are more nursingroles with a research and developmentelement, such as nurse consultant.Many nursing activities involve thecollection and interpretation ofinformation from and about patientsand staff, from small-scale practicedevelopment projects to large, multi-centre clinical trials. People are alsomuch more aware of their right toinformation and consultation aboutcare, treatment and any associated

research. There is, as well, a trendtowards greater accountability inhealth care, and research is a vital partof developing the nursing evidencebase.

What do we mean by ‘research’? Themany ways of collecting and analysinginformation are described in varyingterms – research, evaluation, clinicalaudit, quality assurance or studentprojects – and will vary in depth andscale. The ethical issues are usually thesame. While the specifics of approvalfor studies by research ethicscommittees will differ for eachorganisation and according to the typeof investigation, this documentprovides general guidance for all theseforms of investigation. Key sources ofinformation are given in the textunder Further information, with fullcontact details given under Referencesand Useful Internet resources.

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Your responsibilitiesNurses act in a range of roles inresearch – including carer, student,manager, investigator, researchsupervisor, sponsor, ethics orgovernance committee member.Whatever your role, you have clearresponsibilities to patients and theirfamilies, and to colleagues, to makesure that research you are involved in,or know about, is of the higheststandard.As the United KingdomNursing and Midwifery Council states,nurses must “act to identify andminimise the risk to patients andclients.”

In most respects nurses are in the sameposition as other health professionalswhen it comes to the ethics of research– their common law obligations andaccountability do not differ in principlefrom those of any other healthprofession. In ethical terms, too, nurseshave no more right than any otherhealth professional to hide behindnotions of subordination, complianceand obedience to justify avoidingpersonal responsibility for what they doas part of a research study.

You may, however, face situations inwhich your professional position andstatus as a nurse, and the nature of your

role, can present particular challenges.If you are responsible for patient orclient groups involved in research, orare simply a third party who witnessesresearch activity, you must review howyour actions, or those of others, impacton vulnerable subjects or participants.As with everything in nursing, youmust put the patient first.

Further information: If you aresetting up and seeking approval for aresearch study, the UK Central Officefor Research Ethics Committees(COREC) co-ordinates policy andprocedures for National Health Service(NHS) ethics committees in Englandand offers useful guidance on approvalprocedures.You must get approvalfrom your local research ethicscommittee (LREC), which can providegeneral advice on when to apply forapproval. Addresses for LRECsthroughout the UK can be obtainedfrom: COREC, Room 75-77, B Block,40 Eastbourne Terrace, London,W2 3QR.

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Ethical issues

Respect for every individual

Every individual is important, anddeserves to be treated with respect.This value, which is upheld in law andsupported by most philosophies, mustunderpin your work in research. It isimportant that research is done withrespondents, rather than on them. Youmay have responsibility for manyindividuals rather than just one, andyou should ensure that the rights ofeach individual are considered (forexample, sampling should be asinclusive as possible).

In law, every human being, from themoment of birth to the point of death,is held to have interests and rightsenforceable by law. The law evenprotects fetal welfare in some respects,even though a fetus is not recognisedas a legal entity.

Where research with humans isconcerned the scope of those worthy ofrespect and, therefore, protection iswide: everyone should be protectedfrom undue harm, and their rightsrespected.When it comes to obtainingapproval for research from your localresearch ethics committee (LREC),those whose rights must be consideredwill include past as well as present NHS

patients, and their records (even if theindividuals themselves are notinvolved), and those who have recentlydied in NHS premises.Approval willalso cover the use of NHS premises,access to NHS staff, and the use of fetalmaterial.

Autonomy

Autonomy is the ability of an individualto make reasoned decisions aboutissues that affect them. If we respectpeople, then we must also respect theirautonomy, and seek to incorporate theirwishes into decisions about their healthcare – and about their participation inhealth care research.

A number of factors may restrict thedegree of an individual’s autonomy, ortheir ability to exercise it. To be able toact in a truly autonomous manner apatient must:

✦ be able to understand the issuesinvolved in their care, and able toweigh them up

✦ have adequate information onwhich to base their choices

✦ have no untoward pressure orcoercion applied to them whenmaking their choices.

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Vulnerable peopleEvery recipient of health care is insome way vulnerable, but those withmore limited ability to actautonomously can also be morevulnerable to the impact of researchactivity. For example, people whosefirst language is not English – such asdeaf people who use sign language,some members of minority ethniccommunities, or overseas visitors –can find it difficult to make reasoneddecisions about their participation ifthey can’t understand the issues ormake their preferences known.Children and some specific groups ofadults need special consideration.

Children

Autonomous ability develops withmaturity, and children becomegradually more autonomous as theygrow older. Research shows that evenvery young children, of primaryschool age, can be capable of holdingreasoned, well-informed views onissues that affect them.

There has been much work, in bothlegal and health care contexts, on therole of parents or guardians inassisting with, or being whollyresponsible for, decisions about achild. In the Children Act 1989

(England) and the Children Act 1985(Scotland), parental rights are linkedclosely to their responsibilities, andthe laws make explicit the requirementfor parents to act in their child’s bestinterest. When children are unable todetermine those best interests forthemselves, then parents are normallythe best alternative decision-makers.

So if you are undertaking researchinvolving children, or working withthem, you should support children’sautonomy as much as possible, takingtheir views and preferences intoaccount, while ensuring they areadequately protected if they cannotmake their own decisions. We are allaware of the particular vulnerability ofchildren in local authority care, and inthese cases you will need to considercarefully the complexity of parentalresponsibility in each individual case.

Further information: Specificguidance on ethical conduct forincluding children in research isavailable from the Royal College ofPaediatrics and Child Health. TheHuman Fertilisation and EmbryologyAuthority addresses issues relating toresearch with embryos.

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Vulnerable adults

Adults may also be vulnerable asresearch subjects or participants.Patients who are unconscious, haveserious or enduring mental healthproblems, some older people andsome individuals with learningdisabilities may lack competence,either temporarily or permanently. Butit is unwise and improper to dismisstoo readily their intellectual ability. Forexample, most people who are termed‘older’ retain full autonomous ability,and even those who demonstrateconfusion are rarely confused abouteverything.

If you were researching mental healthproblems, you would need to considerthe wishes of people who are unable tovoice their own concerns. Somepatients or clients may temporarilylack the ability to act autonomously,and may even be receiving treatmentagainst their expressed wishes. Thelegal right and requirement to providesuch treatment does not include theright to engage in research on thesame individuals. The absence in lawof any surrogate decision-maker forthe individual in such cases makesacting without their expressedautonomous views problematic.

In all cases, you need to do your bestto protect individuals’ interests andautonomy. The law, too, recognises thatautonomy is a complex issue whichrequires careful consideration of avariety of factors before you can arriveat a conclusion about the weight to beattached to an adult individual’sdecisions about health care. Manypotential research subjects may betemporarily vulnerable: perhaps theyhave just received bad news about apoor prognosis, or they may be in theprocess of receiving importantinformation about their health or care.In such situations, you will need to becareful not to cause informationoverload. Current developmentsencourage the involvement of users ofservices at as many levels of researchas possible to reduce vulnerabilitywhere possible.

Further information: Usefulinformation is available fromINVOLVE (formerly NHS Consumersin Research). Guidance on involvingpeople who are mentally incapacitatedis available from the Medical ResearchCouncil. The American organisationNational Alliance for the Mentally Illoffers guidance specifically onresearch with people with mentalillness (its messages are relevant for

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the UK). All research in Scotlandinvolving adult subjects who areunable to consent for themselves issubject to the provision of the Adultswith Incapacity (Scotland) Act 2000and must be submitted for approval bythe Multi-centre Research EthicsCommittee (MREC) for Scotland(whether or not the study is multi-centred) – details on the CORECwebsite.

Is research with vulnerablegroups possible?

There is no doubt that undertakingresearch ethically with vulnerablepopulations is more difficult – butsometimes there is no viablealternative to including these groups.For example, drugs intended for usewith children must be tested onchildren eventually – tests on adultsalone cannot establish drug safety.Therapies to help people withdebilitating mental illnesses canusefully only be tested on thoseaffected by these illnesses (and,therefore, at least temporarily lessautonomous than normal). To bansuch research would furtherdisadvantage many individuals whomay be subject to institutionaliseddiscrimination. Indeed, vulnerableand minority groups are often

inappropriately ‘invisible’ in research.This places extra demands onresearchers to involve, but also toprotect those involved in studies.

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Addressing the issuesThere are three main areas you mustcover to ensure research with humansubjects is carried out ethically:

✦ ensuring consent

✦ protecting confidentiality

✦ balancing the risk of harm withpotential benefit.

Consent

Patients who are able to consider whatparticipation will involve have theright to decide whether or not to takepart in a research study.You will needto make effective arrangements to:

✦ provide full information which iseasy to understand

✦ ensure the individual’s informedconsent is given

✦ provide opportunities forparticipants to withdraw consent

✦ repeat consent procedures inlonger studies to ensure consent iscontinued.

With more vulnerable groups ofsubjects, you may need to make extraefforts to achieve truly informedconsent. Only in exceptionalcircumstances will the nature of a

study and its likely benefits justify notgaining consent. The Department ofHealth website offers access to full textpublications about consent, and the RCNhas produced Guidance for informedconsent (publication code 002 267).

Confidentiality

You must safeguard participants’dignity and privacy. This often meansensuring that personal informationgiven as part of the study is keptconfidential. In some cases researchparticipants may need to be asked tomaintain the confidentiality ofinformation about other people that isrevealed in meetings or focus groups.

Whatever the nature of the data, theresearcher has an obligation toguarantee its secure storage, and makearrangements for disposal of materialson completion of the study. Data mayexist in a wide variety of formats, andmay include, for example:

✦ details of participants and theirfamily

✦ extracts from medical records

✦ photographic, videotape, orelectronic material

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✦ human tissue.

Further information: As well as localguidance, you will find that the GMChas guidelines on the ethical use ofvideotape recording in research,including this vital issue ofconfidentiality. The Department ofHealth (England) offers guidance onthe use of confidential patientinformation, and information on theData Protection Act 1998 is providedby the Home Office. In the light ofgrowing concerns about the ethicaldifficulties associated with the use ofInternet-based research, theAssociation of Internet Researchershas appointed a working party for thedevelopment of ethical guidelines foronline research.

Balancing risks andpotential benefits

In an ideal world, no research wouldinvolve any risk or harm to anyoneinvolved – but in health care, this isunrealistic. We have to accept thatsome of what we do as nurses maycause immediate harm, balanced by amore important long-term benefit(such as giving a painful injection ofmedication). Similarly, people whoare research subjects may benefitdirectly from research interventions,

but for many the benefits are lessimmediate, and they need to be madeaware of the future benefits forothers.

To gain approval from research ethicscommittees, a study should bereviewed in the light of both its short-term effects as well as its long-termgoals. Committees are expected toadopt a practical approach andconsider questions in three areas.

1. The goals of the proposed study.

2. The researcher’s duties.

3. The rights of participants.

Study goalsIf you are a prospective researcher, youshould ask yourself:

1. how important is the researchquestion that is posed?

2. can the proposed research answerthe question?

Committees should allow onlyresearch that is expected to result inworthwhile findings – participantsmust not be inconvenienced orharmed to no justifiable end. It may bethat a particular study, while well-designed, will ultimately serve nouseful purpose. Alternatively, a studywhich sets out to answer an important

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question, but which is poorlydesigned, is unlikely to provideanswers in sufficiently rigorous terms.

Sometimes, small-scale research doneas part of an education programmemight not seem to meet these criteria.But in these cases, the benefit attachesto the development of research skillsin novice researchers, balanced againstthe often minor inconvenience thatsuch studies might create. Just likeaudits or research, the informationcollected in an educational case studycould be harmful if misused, and it isimportant that research studentsfollow institutional policy and areproperly guided and monitored by aresearch supervisor.

The researcher’s dutiesThe World Medical Associationwebsite has details of the internationalconvention and agreements thatidentified the duties of a researcher.You can use these as sources ofguidance. For the UK, the EuropeanConvention on Human Rights (nowbecoming part of national law) is alsocentral, as is the Convention on theRights of the Child.

The participant’s rightsIn order to ensure the protection andwelfare of research subjects:

✦ the extent and precise nature oftheir participation ought to beclear before the study begins

✦ a risk-benefit analysis should becarried out.

You will need to identify risks to thephysical or psychological health andwelfare of subjects, and balance themagainst potential benefits – benefitsthat will often only manifestthemselves in the future, and notdirectly for the participants. So askyourself:

1. what will participating in the studyinvolve? Is this made explicit?

2. are the risks necessary andacceptable? Are these made explicit?

Risks All patient care and treatment containsan element of risk, as does all research– but the level of risk depends on thenature of the research. For example, thephysical risks of anaesthesia, surgery orother invasive procedures, which mightform part of a new treatment trial, areclearly greater than the potential risksof observing or interviewing patientsor staff.

Even when safe for the majority ofusers, testing new procedures andtreatments may cause harm, such as

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allergic reaction, to particularindividuals. Other risks are lessobvious: for instance, interviewingpeople about sensitive subjects mightprovoke a reaction in some participantswho will need further help. Datacollected for one research project mightsensibly be used for some otherpurpose, such as planning health careor another research project – but again,if there are risks that this could causeharm, such use should be restricted.

Whatever the nature of theinvestigation, potential participantsshould be able to make an informeddecision about their participationbased on knowledge of both the risksand potential benefits to themselves orothers.

Potential benefits

The benefits of research can be many.For example:

✦ direct improvement in the healthor care of individuals involved inthe study

✦ more commonly, health carebenefits for others in the longerterm

✦ the improvement of care by nursesundertaking research as part oftheir professional development.

Some research will not prove to be ofdirect benefit, and may even proveharmful. It is not always possible topredict problems in advance, butstudies should be designed in order tominimise any harm and with clearprotocols to remedy any difficulties.This can be straightforward in clinicaltrials where the new treatment can beabandoned if it is found to be lessbeneficial, or even more harmful, thana rival treatment or no treatment atall. Decisions can be much moredifficult in less structured, qualitativeresearch approaches such asethnography and action research.

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ConclusionTechnological change, the drive forevidence-based practice and the needto evaluate health care delivery havecreated many opportunities forresearch, but also challenges to bothexperienced and new researchers.Whatever the quality and ethicalcontrol mechanisms available, as withcare itself, much depends on theintegrity and training of thoseinvolved – for those using research inpractice, as well as those actuallydoing the research. As a practitioner,you have a responsibility to useresearch evidence if it is available, butyou must use it wisely and afterappropriate evaluation of its qualityand relevance.

The NHS and other agencies haveproduced rules and frameworks toimprove the approval and regulation ofresearch. These can seem, at times, abureaucratic and limiting factor forresearchers, inclining them towardresearch designs which avoid many ofthe challenges. But with support fromexperienced researchers, you cannegotiate these hurdles. The need forethical approval should be no bar toany study that might improve theevidence base for nursing which

patients, rightly, should expect tounderlie their care.

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Useful Internetresources(Website addresses correct as of12 January 2004.)

Professional bodies

The United Kingdom Nursing andMidwifery Council offers guidance forresearch and audit and a professionalCode of Conduct not specificallyfocused on research at

www.nmc-uk.org/nmc/main/advice/researchandaudit.html

The UK Central Office for ResearchEthics Committees (COREC) givesvery comprehensive guidance toresearchers and ethics committees,with criteria, application forms andprocedures and a guide to many otheruseful sources

www.corec.org.uk

The Medical Research Council offers anumber of publications in hard copyor as Adobe Acrobat PDF files (such aspersonal information in medicalresearch, ethical management of humantissue in research, etc)

www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm

The RCN Research Society websitecarries further guidance

www.man.ac.uk/rcn/

The General Medical Council providesadvice to doctors on good practice inresearch, and this advice can be usefulto other professions, too

www.gmc-uk.org/standards/research.htm (General guide)

www.gmc-uk.org/standards/aud_vid.htm (Specific to the use of videoand audio recording in research)

A Code of conduct is provided by theBritish Psychological Society

www.bps.org.uk/index.cfm

The Market Research Society provides acode of conduct together with bestpractice guides

www.marketresearch.org.uk/

The Association of Internet Researchershas a working party to developguidelines for researchers

www.aoir.org

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UK National/Internationalguidance

EnglandThe Department of Health offers itsown guidance on the expanded topicof ‘research governance’ whichincludes financial, intellectualproperty, and other issues

www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/fs/en

All relevant current regulationsrelating to Research Ethics Committeepolicy can also be found at thisaddress.

Northern IrelandDepartment of Health and SocialServices Northern Ireland

www.dhsspsni.gov.uk

Research Governance Framework forNorthern Ireland

www.dhsspsni.gov.uk/publications/2002/researchframework.pdf

WalesNational Assembly for Wales

www.wales.gov.uk

Research Governance Framework forWales

www.word.wales.gov.uk/content/governance/governance-e.htm

ScotlandScottish Executive Health Department

www.scotland.gov.uk

Research Governance Framework forScotland

www.show.scot.nhs.uk/cso/

ConsentThe full text of publications relating toconsent may be found at theDepartment of Health

www.doh.gov.uk/consent/

Additional guidance is provided by theGeneral Medical Council

www.gmc-uk.org/standards/default.htm

Vulnerable GroupsGuidance specifically on ethicalconduct for including children inresearch is available from the RoyalCollege of Paediatrics and ChildHealth

www.rcpch.ac.uk

Guidance on the Ethical Conduct ofResearch on the MentallyIncapacitated is available form theMedical Research Council

www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice/publications-ethics_series.htm

The National Alliance for the MentallyIll (an American consumerorganisation) offers wide-ranging

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information about the participation ofpeople with mental health problems inresearch

www.nami.org/Content/NavigationMenu/Inform_Yourself/About_Research/About_Research.htm

Issues relating to research withembryos are addressed by the HumanFertilisation and EmbryologyAuthority

www.hfea.gov.uk/Research

INVOLVE (Formerly NHS Consumersin Research)

www.invo.org.uk/

Law and Conventions

For worldwide agreements on researchethics, the World Medical Assemblyholds details

www.wma.net

The Human Rights Act 1998www.hmso.gov.uk/acts/acts1998/19980042.htm

Council of Europe Convention for theProtection of Human Rights andDignity of the Human Being

http://conventions.coe.int/

Details and text of the convention onthe Rights of the Child can be found at

www.unicef.org/crc/crc.htm

Details of the Data Protection Act 1998www.dca.gov.uk/foi/datprot.htm

Law in Scotland relating to adults withincapacity

www.scotland-legislation.hmso.gov.uk/legislation/scotland/

Assistance in navigating through theAct is to be found at:

www.scotland.gov.uk/about/JD/CL/00016360/home.aspx

The Race Relations Act 1976 & RaceRelations (Amendment) Act 2000

www.hmso.gov.uk/

and explanatory guidance from theCommission for Racial Equality at

www.cre.gov.uk

Each of these sites offer access topublications relevant to the countriesof the UK

Some studies will impact on healthand safety at work or involvehazardous substances. Advice onregulations may be found at the Healthand Safety Executive:

www.hse.gov.uk

Additional references to printedresources are provided by the RoyalCollege of Nursing website

www.rcn.org.uk/learning/learning_library_information.html

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In addition, many RCN publicationscontain information on consent inspecific contexts, for example:

Working in independent and boardingschools. Guidance for nursing staff(2003), publication code 002 168

Digital rectal examination. Guidancefor nursing staff working with childrenand young people (2003) publicationcode 002 062

You can download copies of RCNpublications from the members’ areaof the RCN website

www.rcn.org.uk/members/publications/

March 2004

Published by the Royal Collegeof Nursing20 Cavendish SquareLondon W1G 0RN

020 7409 3333

The RCN represents nurses andnursing, promotes excellence inpractice and shapes healthpolicies

Publication code 002 013

Documents

Research ethics: RCN guidance for nursing staffstaff.unak.is/.../Ethics/RCNresearchethics.pdf · Research ethics RCN guidance for nurses. 2 ... RESEARCH ETHICS Ethical issues