Research ethics

RCN guidance for nurses

This publication is a revised edition of Research ethics.RCN guidance for nurses first published in 2004.

Acknowledgements

Rosie Kneafsey, Lecturer, School of Nursing, University ofSalford, Salford Centre for Nursing, Midwifery andCollaborative Research (Chair)

Revisions team (in alphabetical order):

Dr Carol Haigh, Senior Lecturer in Research, SalfordCentre for Nursing, Midwifery and Collaborative Research

Michelle Howarth, Lecturer, School of Nursing, Universityof Salford, Salford Centre for Nursing, Midwifery andCollaborative Research

Dr Tracey Williamson, Research Fellow, University ofSalford, Salford Centre for Nursing, Midwifery andCollaborative Research

With consultation and comments from, inalphabetical order:

✦ Dr Mary Cooke, Lecturer, School of Nursing andMidwifery, University of Sheffield

✦ Fiona Duncan, Acute Back Pain Specialist, BlackpoolVictoria Hospital

✦ Professor Martin Johnson, Director of the University ofSalford Centre for Nursing, Midwifery andCollaborative Research

✦ Professor Tony Long, Professor in Child and FamilyHealth, the University of Salford Centre for Nursing,Midwifery and Collaborative Research

✦ Lillian Neville, Senior Lecturer, School of Nursing,University of Salford

✦ Rob Newell, Professor of Nursing Research andDirector of Postgraduate Research, School of HealthStudies, University of Bradford

✦ Sarah Sutton BSc (hons), nursing practice student,RCN student steward, the University of Manchester

✦ Julie Taylor, Professor of Family Health, University of Dundee

✦ Dr Alison Twycross, Principal Lecturer in Children’sNursing, Faculty of Health and Social Care Sciences,Kingston University, St. George’s University of London

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This publication contains information, advice andguidance to help members of the RCN. It is intended foruse within the UK but readers are advised that practicesmay vary in each country and outside the UK.

The information in this booklet has been compiledfrom professional sources, but its accuracy is notguaranteed. Whilst every effort has been made toensure the RCN provides accurate and expertinformation and guidance, it is impossible to predict allthe circumstances in which it may be used. Accordingly,the RCN shall not be liable to any person or entity withrespect to any loss or damage caused or alleged to becaused directly or indirectly by what is contained in orleft out of this website information and guidance.

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

© 2007 Royal College of Nursing. All rights reserved. Nopart of this publication may be reproduced, stored in aretrieval system, or transmitted in any form or by anymeans electronic, mechanical, photocopying, recordingor otherwise, without prior permission of thePublishers or a licence permitting restricted copyingissued by the Copyright Licensing Agency, 90Tottenham Court Road, London W1T 4LP. Thispublication may not be lent, resold, hired out orotherwise disposed of by ways of trade in any form ofbinding or cover other than that in which it ispublished, without the prior consent of the Publishers.

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Research ethicsRCN guidance for nurses

Contents

Introduction 2

The role of the nurse in research 2

Student research 3

Safe and ethical research 3

Informed consent 4

Confidentiality and data protection 4

Research involving vulnerable people 5

Public involvement in research 6

Robust, quality research designs 6

Gaining research governance approval for your study 7

Gaining ethical approval for your study 8

Research governance in the global arena 8

Human Tissue Act 9

Internet ethics 9

Conclusion 10

References 10

Other web-based resources 11

UK guidance 11

Law and conventions 11

Introduction

There has been growing recognition in recent decades ofthe need for health service provision to be based on thebest available evidence, rather than on custom andtradition (Stevens et. al., 2001). It has also beenacknowledged that achieving this requires the sustainedefforts of researchers, practitioners, educationalists,managers, politicians and the public to generate thisevidence through the commissioning and conduct ofhigh quality research.

The potential for nurses to be involved in research hasgrown exponentially since the Royal College of Nursing(RCN) published its first guidance on research ethics fornurses in 1977. As a result, nurses may be involved incarrying out their own projects, collecting data for otherlead investigators, reviewing research protocols,commissioning research or acting as participants inresearch. In all of these roles, it is important that thenurse possesses an understanding of the importantissues in research ethics that should underpin researchpractices.

This guidance seeks to build on the 2004 edition, byproviding the reader with an overview of recentdevelopments in research ethics, while indicating wherefurther information can be gained. For example, a‘principals’ approach to biomedical research ethics willnot be provided here, but is explored elsewhere(Beauchamp & Childress, 2001). The booklet is dividedinto short sections, accompanied by relevant referencesand internet sources, which readers are encouraged toaccess.

Although there are many different types of research –such as service evaluations, clinical trials or actionresearch studies – the ethical principles that shouldguide those involved remain constant. It is hoped thatthis text will provide an introduction to these,signposting the reader to further resources as needed.Readers should be aware that guidance relating to themanagement of research and the structure and functionof organisations – such as ethics committees – and theimplementation of research governance requirements, isfluid and may well change in response to the needs ofthe NHS.

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The role of thenurse in research

The contribution of research to nursing knowledge andcompetence continues to influence patient carestandards. Undoubtedly, there is a continuing need forgood research evidence to fuel and supportcontemporary nursing practice. Accordingly, andsimilar to other professional groups in the healthservices, many nurses are now responsible for initiatingnew and innovative therapies through research in avariety of ways.

Whatever research role is adopted, there is a need tomake sure that research is of good quality. All nurseshave a duty of care to their patients, each of whom isentitled to safe, competent care (Nursing and MidwiferyCouncil 2004, 1.4). This also extends to theirinvolvement in research and, in common with otherprofessionals, nurses are obliged to ensure that researchis safe, robust and ethical. The NMC offers someguidance for practitioners interested in research andaudit. The A-Z fact sheet contains criteria for safe andethical conduct of research and is a useful guide fornovice researchers. The RCN also provides guidance oninformed consent in health and social care research.

Useful resources

For further information see from the NMC refer to:www.nmc-uk.org/aFrameDisplay.aspx?DocumentID=1590

For further details from the RCN about informedconsent visit:www.rcn.org.uk/publications/pdf/informed_consent_in_health_and_social_care_research.pdf

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Student research

Many nurses and other health care professionalsundertake small research projects as part of their post-qualifying education. If student research involves NHSpatients, service users, relatives or carers, staff or NHSpremises, it must be reviewed according to therequirements of governance arrangements for researchethics committees. It will also require review by a localresearch ethics committee (LREC) and the appropriateuniversity ethics committee. Guidelines for thecompletion of LREC forms for student projects havebeen produced by the Association of Research EthicsCommittees (AREC, 2002).

When completing the LREC form, many students getconfused by jargon that surrounds the concepts of‘sponsorship’. In this instance, sponsorship does notrefer to the financing of the project. Rather, the sponsoris a representative of the researcher’s employingorganisation, or the university at which the student isstudying. The sponsor’s role is to guarantee the qualityof the research environment and the competence of theresearch team. For students employed by the NHS, it isoften better to identify their employing trust as thesponsor, since this can be negotiated as part of thegovernance application. Responsibility for the safe,robust conduct of the research in question lies with theprincipal investigator. However the investigator’semploying institution is also responsible for ensuringthat the appropriate quality monitoring mechanisms arein place.

Key information

www.corec.org.uk/applicants/help/faqs.htm

Safe and ethicalresearch

It has been argued that all research can be potentiallyharmful to participants and researchers (Long &Johnson, 2007). For example, controlled trials that testnew drugs through invasive procedures couldunintentionally cause harm. Likewise, naturalisticenquiries that seek evidence about sensitive topicscould cause inadvertent emotional stress and potentialdamage to individuals.

Recent research controversies (for example, White, 2004;Steinbrook, 2002; Smith, 2000) that have resulted inharm to participants, both in the UK and abroad, haveled to intense public concern regarding the safety ofparticipants in research studies. This has brought intosharp relief the need for researchers to uphold specificethical principles within research studies andprogrammes. Further, it is increasingly recognised thatwhile audit studies do not have to be formally reviewedby a research ethics committee, many still need externalethical consideration to ensure that potential moralissues are addressed fully. This is particularly importantas it is conceded that making the distinction betweenaudit and research is often difficult (Wade, 2005).

The ways in which researchers reduce risk arenumerous. Initially, it’s important that health and safetyrequirements have been met and that researchparticipants are fully aware and informed of anypotential harms associated with inclusion in theresearch. It might also involve the researcher, LREC andthe research’s sponsor making decisions about the useof medical devices, hazardous substances, or use ofpotentially emotive and provocative questions insurveys or interviews. Areas that must be addressedbefore research is initiated include:

✦ informed consent

✦ confidentiality

✦ data protection

✦ right to withdraw

✦ potential benefits

✦ and the potential harms.

Informed consent

Usually, informed consent should be obtained beforeentering or recruiting any subject or participant into aresearch project. Those who enter research should befully informed of the research aims and potentialbenefits and harms, giving their consent voluntarily. Atno time should the patient feel coerced to participate ina study, or be unduly persuaded by the promise of areward. Research participants need to be aware of anyrisks that may occur as a result of their involvement inthe research.

Informed consent requires that this information istransparent and in a language which the participant canunderstand. Information should be verbal and written,and time should be provided for the participant toconsider their involvement in the study and to askquestions. Ideally, a consent form should be signed andwitnessed. However, in some instances this is not alwayspractical or a requirement. For example, a researcherundertaking a non-intervention study, relying on non-participant observation of the provision of services orcare, would be unable to obtain the consent of everyindividual who passed in view.

Formally recruited research participants have the rightto withdraw from a research study, without prejudiceand without impact on their care. This should be madeexplicit to the participant at the start of the research –usually when informed consent is obtained. Where thereis doubt over an individual’s ability to provide aninformed consent, due to lack of understanding,methods of addressing this should be detailed in thestudy protocol. Nurses working as part of a clinical teamshould not have to take responsibility for recruiting andseeking the consent of study participants, unless theyare sufficiently informed about the study and feel able todo so.

Key information

For further details and a standard format consent form,visit the Central Office for Research Ethics Committees(COREC) at: www.corec.org.uk

For information from the Department of Health aboutconsent visit:www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Consent/fs/en

Confidentiality anddata protectionUsually, it is wise for the confidentiality and anonymityof research participants to be preserved by coding dataor assigning individual participants with pseudonyms.For example, the identity of research participantsshould not be recognisable in research reports detailingstudy findings. There may be exceptions to this in sometypes of research – such as action research – whereparticipants may view themselves as co-researchers andmay wish their contributions to be recognised. However,the Data Protection Act (DH, 1998) emphasises thatresearchers are responsible for ensuring compliancewith the Act, in relation to data storage and the way inwhich access to data is managed.

All confidential data should be stored in a lockedcabinet, with authorised access. Although there are goodscientific arguments for much longer storage of rawdata – such as the prevention of academic fraud (Long& Johnson, 2007) – in health and social care contexts,data are usually stored for up to five years. Someindividual organisations may have their ownrequirements and it is wise to check. For example, someethics committees recommend up to 30 years,depending on the nature of the data. Researchparticipants need to be fully aware of these details andreassured that any data pertaining to them is safe.

To use patient identifiable material, an application to thePatient Information Advisory Group (PIAG) is likely berequired – see www.advisorybodies.doh.gov.uk/piag/Index.htm. In addition, the introduction of‘Caldicott guardians’ into UK NHS organisationsprovides added assurance about the protection ofpatient data. Caldicott guardians are usually senior staffwho work in the NHS and social services who areappointed to protect patient information. Ideally,Caldicott guardians should work with ethical andresearch governance structures to ensure that the DataProtection Act is followed.

Useful resourcesFor guidance on the Data Protection Act, see:www.dh.gov.uk

Details of Data Protection Act 1998 are available at:www.dca.gov.uk/foi/datprot.htm

Also see the COREC website at: www.corec.org.uk

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Research involvingpeople who arevulnerable

The phrase ‘people who are vulnerable ’ may encompassa multitude of different populations – for example,children, people with mental illness or learningdisability, people with communication difficulties,prisoners or young offenders. In varying degrees, othergroups could also be considered to be vulnerable, suchas people who are deaf or sight-impaired, or thoseindividuals for whom English is not readily understood.In theory, any person who is receiving health care couldbe considered to be vulnerable. However, vulnerabilityshould not be considered a label, applied as a blanketterm to specific groups.

In relation to research, the term implies that theindividual may not be able to understand what theirparticipation in a research study will involve, or whofinds it difficult to make their wishes and preferencesknown. The result is that the individual may be less ableto make an informed or reasoned decision about theirparticipation. To this end, there is potential for theindividual to be either manipulated or misled, or tomake a decision that they may regret.

It is important that all potential research participantshave sufficient time to consider whether they wish totake part in a research study. This may be particularlyimportant when including people with learningdisabilities in research (Cameron & Murphy, 2006).Ensuring this happens requires planning on the part ofthe researcher.

When involving individuals who may be considered tobe vulnerable, extra care must be taken in the provisionof information about the research, and promoting theindividual’s autonomy when seeking consent. A range ofguidance exists – for example, see Lewis & Porter, 2004.Some organisations have developed ‘vulnerable adultpolicies’, while research ethics committees may requestthat researchers apply a test of competency to potentialresearch participants. Where the adult individual cannotprovide informed consent, it is common to request theconsent of the next of kin.

All research in Scotland involving adult subjects who areunable to consent for themselves is subject to the

provision of the Adults with Incapacity (Scotland) Act2000. Research projects must be submitted to the Multi-Centre Research Ethics Committee (MREC) forScotland, even if the study is not multi-centred. Inmental health, although at times some patients may bereceiving treatment against their wishes, this does notmean that the individual must also participate inresearch against their wishes.

Research involving children should seek the child’sand/or the parent’s consent, where appropriate – see theChildren Act 1989 for England and 1985 for Scotland. Ingeneral, a more demanding rule is set for consent wheninvolving children in research, compared to consentrelating to medical treatment. In research studies whenan adult makes decisions for a child who is too young todecide for themselves, as well as ensuring the consent ofthe parent or guardian, the researcher should, at least,also make sure that the child does not object toparticipation.

If participating in non-therapeutic research, the MedicalResearch Council (2004) allows for only a negligible riskof harm to children. In therapeutic research withchildren, it demands that possible risks must beoutweighed by likely benefits. In clinical trials, parentalconsent is always required (EU Directive 2001/20/ED).There is a need to limit guarantees of confidentiality tochildren taking part in a research study. Researchershave a clear responsibility to divulge information ifthere is the potential that a child may be harmed.However, before doing so they must discuss this withthe child.

Although involving vulnerable populations in researchcan be complex, time-consuming and ethicallychallenging, it remains an important necessity. In thelonger term, if vulnerable groups remain ‘invisible’ inresearch they will be further disadvantaged, as theirviews, experiences and needs will not be representedwithin the evidence base.

Key information

Guidance relating to involving people with mentalillness is available at:www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002409

Guidance relating to involving children in research isavailable at: www.rcpch.ac.uk/publications/r.html

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Public involvementin research

Increasingly, it is seen as ethically appropriate thatactive partnership will be promoted between the publicand researchers in the research process, rather thanpeople being viewed as ‘subjects’ of research.Involvement is commonly described as research carriedout ‘with’ or ‘by’ the public, rather than ‘to’, ‘about’ or ‘for’the public. Where possible, it is advocated that serviceusers should be involved in all stages of the researchprocess. This includes the development of ideas andprioritisation; design of studies; methods of datacollection; dissemination of findings; and overall studymanagement.

How patients and the public choose to be involvedshould be discussed and agreed with them. It isdesirable to recognise and reward service users forgiving up their time and to recompense travel expenses,in addition to meeting any support and training needswhich may arise. At the beginning of a study, it is notalways possible to know what opportunities there maybe for public involvement. Opportunities may occur fordeeper engagement in a project, or withdrawal by theperson in a particular role. As a result, an individual’sinvolvement may vary over the lifetime of a study. It isperceived by some that service users have the right to beinvolved in research that concerns them. There is anemerging consensus that involvement has a positiveimpact on the quality of research.

Key information

Visit: www.invo.org.uk orwww.invo.org.uk/invoNET.asp

Robust, qualityresearch designs

Good research rests on a good research design. All thoseinvolved in research must ensure that appropriateresearch methods have been selected to answer givenresearch questions. In addition, the research protocolshould be peer-reviewed and approved by relevantethics committees. It is advised that this process is notundertaken in isolation.

To provide support for researchers, local peer reviewnetworks have been developed in many areas to helpensure that proposed research is of good quality.Researchers should locate their local peer review systemto help develop and refine the research protocol. Furthersupport is also provided by the national network ofresearch and development support units for health careresearch. In England, these units are funded by theNational Co-ordinating Centre for Research CapacityDevelopment. They aim to support high quality andmultidisciplinary health and social care research. Theyprovide a range of courses and training programmes toassist the development of capability and capacity,helping to increase research awareness through localand national meetings.

For nurses working in the clinical setting who may beasked to facilitate a research study or collect researchdata, it is important to recognise the limits of this role.For example, if a research participant requests an in-depth explanation of a study and its design, nurses withany doubts about their ability to answer the questionsshould refer the individual to the research’s leadinvestigator.

Useful resources

For A-Z advice on research and audit see:

www.nmc-uk.org/aFrameDisplay.aspx?DocumentID=1590

For an example of a peer review group see the NorthWest Peer Review system:www.cmht.nwest.nhs.uk/peer_review/

For further information about the National Co-ordinating Centre for Research Capacity Developmentcontact: www.national-rdsu.org.uk/

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Gaining researchgovernanceapproval for yourstudy

Since 2001, the UK Government health departmentshave implemented the Research Governance Frameworkto strengthen public confidence in research and improvethe management and monitoring of research. Theframework relates to set standards that outline the keyprinciples of a quality research culture in fivegovernance domains. Additional legislation, publishedin April 2001, resulted in European directives to supportthe development of robust research (91/507/EEC). Thisguidance – used in conjunction with researchgovernance – provides the public with addedassurances of safety and quality, helping to foster aquality research culture across all organisations.

The Research Governance Framework is of relevance tothose who host, carry out or participate in research. Allnurses involved in research, at whatever level, should befamiliar with the framework, and ensure that researchadheres to its key principles. The research governancestandards relate to five domains: ethics; science;information; health, safety and employment; financeand intellectual property.

The ethics domain is concerned with ensuring that thedignity, rights, safety and well-being of participants arethe primary consideration in any research study. Inaddition, data protection, ethics committees, informedconsent and confidentiality are integral concerns to theresearch process.

The science domain argues that unnecessary researchduplication is unethical and that only original highquality research should be generated. In practice, thismeans that existing sources of evidence should be usedand all research proposals should be subject to peerreview. Special guidance is given for research involvinghuman embryos, animals, genetically modifiedorganisms, and medicines.

The information domain highlights the need forinformation on research and subsequent findings to beaccessible to the public through publication. To ensure

that research findings are visible, NHS trusts have theresponsibility for entering ongoing and completedresearch projects into a web-based National ResearchRegister.

The health, safety and employment domainrecommends that the safety of research participantsand staff is assured by adhering to health and safetyregulations. New or existing medical devices need to beapproved by the Medical Devices Agency to ensuresafety for staff and patients.

Finally, the finance and intellectual property domainadvocates compliance with the law and rules set for theuse of public funds. Compensation is recommended foranyone harmed as a result of studies. Intellectualproperty (IP) is concerned with inventions, know-how(knowledge), copyrights and database rights, designs,trademarks and materials. For example, it should beagreed who will be credited with funds and authorshipat a study’s outset.

To find out about the research governance arrangementsin a specific NHS trust or organisation, contact theirresearch manager.

Key information

Visit the Department of Health’s website:www.dh.gov.uk.

For the National Research Register, visit:www.nrr.nhs.uk/

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Gaining ethicalapproval for yourstudy

In the UK, research ethics committees (RECs) areformed of voluntary members, of which one-third arelay – that is, non-health care related. The rest of thecommittee members provide medical, educational andscientific experience and expertise. Each committee issupported by a local administrator and by the CentralOffice of Research Ethics Committees (COREC).

Providing it is not a clinical trial of a new medicinalproduct, a study that is to be held on one site can beconsidered by the local research ethics committee(LREC). If the study is to be held on many sites that fallwithin one domain – in other words, an area that is theremit of one specific body or organisation – then theapplicant can be reviewed by any LREC in that area. If thestudy is being conducted on multiple sites spanning twodifferent domains, the applicant may submit to bothLRECs covering those geographic areas. If the projectspans more than two separate geographical areas, theapplication should be made to the Multi-Centre ResearchEthics Committee (Haigh, 2007).

Although the COREC form can look daunting, taking asystematic approach to completing the sections helps tomake it more manageable. LRECs and MRECs willusually respond within 60 days to applications.However, it is worth building several months intoresearch plans or proposals to allow enough time to gainethical and research governance approval. For example,researchers may need to complete an enhancedCriminal Records Bureau check or undergooccupational health screening. To supplement thepractical information on COREC’s website, Haigh (2007)has produced guidance on the elements of successfulethical review. This provides useful tips for both noviceand experienced applicants.

Key informationwww.corec.org

Also visit the Medical Research Council:www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/index.htm

Researchgovernance in theglobal arena

The global drive to ensure high quality research isevident in a range of countries where similar ethical andgovernance frameworks have been developed. Thesepromote robust, ethical and safe research in order toprevent research misconduct and poor performance(Howarth & Kneafsey, 2007). It has also become morecommon for research studies to take place in multiplesites spanning several countries. Often these large-scalestudies have been designed to assess the efficacy of newdrugs and therapies, or to gather epidemiological data.As such, they require large sample sizes.

For nurses directly involved in this kind of research, theneed to adhere to ethical research principles remainsparamount. Within Europe, there are also a number ofdirectives that focus on research ethics in specific areas,for example, clinical trials. Nurses involved in suchresearch should check the European Union website on aregular basis for new developments or guidance.

Key information

European Union website: http://europa.eu/

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Human Tissue Act

In the current UK research climate, it is highly unusualfor nurses to be the principal investigator leadingresearch that involves the collection and storage ofhuman tissue. Nonetheless nurses are involved in suchresearch as clinical research nurses. They may be part oflarger, often physician-led, teams and are regularlyconcerned with issues such as obtaining consent fromstudy participants. Therefore it is important that nursesin these situations are aware of the responsibilities theycarry under the Human Tissue Act (HTA) 2004.

Fundamentally, the HTA covers all ‘relevant material’ –which is defined as any material containing humancells, except gametes and fetal material outside awoman’s body. This includes hair and nails from livingpeople. The primary principle of the Act is one ofexplicit and appropriate consent. The Act itself isextremely complex, but Brazier and Forvargue (2006)have produced an excellent, brief guide exploring itsramifications in more detail.

Key information

www.opsi.gov.uk/acts/acts2004/20040030.htm

Internet ethics

The development of the internet over recent years hasseen a corresponding growth in the development anduse of internet-based research methods. There arenumerous approaches that lend themselves to internetresearch, including: web page content analysis; onlinefocus groups; online interviews; and analysis of ‘e’conversation.

Many of the concerns surrounding the ethics of onlineresearch are identical to those of ‘real world’ research.The Association of Internet Researchers (AoIR) arguesthat certain issues require greater consideration than isgenerally expected from real world human subjectresearch. It has highlighted the potential difficulties inmaintaining participants’ privacy and confidentiality;gaining informed consent; and ascertaining the identityof subjects in the world of online research. However, theAoIR Internet ethics report (2002) stopped short ofproviding a specific internet ethics framework. Instead,it places the burden of ethical decision-making inherentin internet research firmly back with the researchersthemselves.

Haigh and Jones (2005) have provided an analysis of theethical dilemmas that underpin cyberspace research.Any person planning on undertaking such researchshould be aware that extra ethical consideration mightbe required, when using cyberspace as a researchenvironment.

Key information

For the Association of Internet Researchers, please referto http://www.aoir.org/

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Conclusion

The generation of research evidence is crucial to theprovision of safe and effective health and social care. Ifresearch is based on a robust design and is conducted ina safe and ethical manner, the process and outcome ofknowledge generation can be of benefit to everyoneinvolved.

As this guidance illustrates, a range of resources can bereadily accessed to support nurses undertaking aresearch study. However, guidance published by theNMC, RCN and DH is subject to change. It is worthremembering to identify any changes before youembark on your study. As you develop your researchproject, you will come into contact with many of theorganisations listed here, through which you will be ableto keep abreast of fluctuations in ethical or governancerequirements.

Most importantly though, many of the key conceptsoutlined in this guidance – such as the safety ofparticipants – will remain constant, no matter whattype of research you undertake. You should be mindfulof these elements, remembering that at the heart of allrobust and ethical research is respect for individualsand protection of the vulnerable.

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References

AREC (2002) Interim advice for the review of studentresearch projects www.arec.org.uk/table_archive.htm(accessed 15/11/06)

Beauchamp T and Childress J (2001) Principles ofbiomedical ethics, 5th edition. Oxford: Oxford UniversityPress

Brazier M and Forvargue S (2006) A brief guide to theHuman Tissue Act 2004. Clinical Ethics; 1 26-32

Directive 2001/20/ED of the European Parliament andthe Council of 4 April 2001 on the approximation of thelaws, regulations and administrative provisions of theMember States relating to the implementation of goodclinical practice in the conduct of clinical trials onmedicinal products for human use

Cameron L and Murphy J (2006) Obtaining consent toparticipate in research: the issues involved in includingpeople with a range of learning and communicationdisabilities, British Journal of Learning Disabilities(online early articles)

Haigh C (2007) ‘Getting ethics approval’, in Long T &Johnson M (editors) Research ethics in the real world:issues and solutions for health and social care. London:Churchill Livingstone, Elsevier

Haigh C and Jones N (2005) An overview of the ethics ofcyberspace research and the implication for nurseeducators. Nurse Education Today; volume 25, issue 1,pages 3-8

Howarth M and Kneafsey R (2007) ‘Researchgovernance: an international perspective’, in Long T &Johnson M (editors) (2007) Research ethics in the realworld: issues and solutions for health and social care,page 103 – 121. London: Churchill Livingstone, Elsevier

Lewis A and Porter J (2004) Interviewing children andyoung people with learning disabilities: guidelines forresearchers and multi-professional practice. BritishJournal of Learning Disabilities; 32(4), 101 – 197

Long T and Johnson M (editors) (2006) Research ethicsin the real world: issues and solutions for health andsocial care, page 103-121. London: ChurchillLivingstone, Elsevier

Medical Research Council (2004) Medical researchinvolving children. London: MRC

Stevens A, Abrams K, Brazier J, Fitzpatrick R and LilfordR (2001) The advanced handbook of methods inevidence-based healthcare. London: Sage Publications

Smith R (2000) Babies and consent: yet another NHSscandal. British Medical Journal; 320, 1285-1286

Steinbrook R (2002) Improving protection for researchsubjects. The New England Journal of Medicine;346(18), 1425-1430

Tee SR and Lathlean J (2004) The ethics of conducting aco-operative inquiry with vulnerable people. Journal ofAdvanced Nursing; 47, (5), 536-543

Wade D (2005) Ethics, audit and research – all shades ofgrey. British Medical Journal; 330 (7489), 468. Accessedon: www.bmj.com/cgi/content/full/bmj;330/7489/468

White C (2004) Destruction of data prompts calls forSwedish agency to investigate research misconduct.British Medical Journal; 329, 72

Other web-based resources

(Websites correct as of 1 February 2007)

The General Medical Council provides guidance ongood practice in research for doctors that may also bevaluable to others:

www.gmc-uk.org/guidance/a_z_guidance/guidance_list/list_r.asp

The British Psychological Society has published a codeof ethics and conduct in research:

www.bps.org.uk/the-society/ethics-rules-charter-code-of-conduct/code-of-conduct/code-of-conduct_home.cfm

Other UK national guidance

In England, the Department of Health for Englandprovides guidance about research governance and otherresearch related issues: www.dh.gov.uk/Home/fs/en

In Northern Ireland, visit the Department of Health andSocial Services for Northern Ireland at:www.dhsspsni.gov.uk/

The Research Governance Framework for NorthernIreland can be located at:www.dhsspsni.gov.uk/publications/2002/researchframework.pdf

In Wales, visit the National Assembly for Wales at: ww.wales.gov.uk/keypubconcord/content/concordats/health_e.htm

The Research Governance Framework for Wales can beaccessed at: www.word.wales.gov.uk/content/governance/governance-e.htm

In Scotland, visit the Scottish Executive HealthDepartment at:www.scotland.gov.uk/About/Departments/HD

The Research Governance Framework for Health andCommunity Care is available at:www.sehd.scot.nhs.uk/cso/Publications/ResGov/Framework/RGFEdTwo.pdf

Law and conventions

For worldwide agreements on research ethics, the WorldMedical Assembly holds details. See:www.wma.net/e/policy/b3.htm

The Human Rights Act 1998 is available at:http://www.opsi.gov.uk/ACTS/acts1998/19980042.htm

The Council of Europe Convention for the Protection ofHuman Beings and Dignity of the Human Beings isavailable at: http:conventions.coe.int/

Details and text of the convention on the Rights of theChild can be found at: www.unicef.org/crc/index.html

Law in Scotland relating to adults with incapacity canbe located at: www.opsi.gov.uk/legislation/scotland/acts2000/20000004.htm

The Race Relations Act 1976 & Race Relations(Amendment) Act 2000 can be accessed at:www.hmso.gov.uk/

Explanatory guidance from the Commission for RacialEquality can be found at: www.cre.gov.uk

Some studies will impact on health and safety at workor involve hazardous substances. Advice on theregulations can be found at the Health and SafetyExecutive: www.hse.gov.uk

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

11

May 2007

Review date May 2008

Published by the Royal College of Nursing 20 Cavendish SquareLondon W1G 0RN

020 7409 3333

The RCN represents nurses and nursing,promotes excellence in practice and shapeshealth policies

Publication code 003 138

ISBN 978-1-904114-34-2