Informed Consent

Informed consent in health and social care researchRCN guidance for nurses

Second edition

Royal College of Nursing Research Society 2011 Date for review: January 2015

An introductory note on indemnity and insurance cover

It is important that all nurses (and other healthprofessionals) have either indemnity orinsurance cover for their practice, which willinclude their research activities.

If you are a health professional working undera contract of employment, then youremploying organisation is liable for youractions as an employee and will haveappropriate indemnity or insurancearrangements in place. In the NHS, forexample, all staff will be covered by the NHSIndemnity arrangement.

RCN indemnity cover is also available for RCNmembers involved in the consent process forresearch purposes.

Members should be aware of their indemnityor insurance arrangements and, if they haveany queries, should speak to their employer orcontact RCN Direct on 0345 772 6100.

Acknowledgements

The RCN Research Society would like to thankall those who contributed to the preparation ofthe first and second editions of this guidancedocument.

Project Lead for RCN Research Society

Dr Leslie Gelling

Contributors

Professor Veronica Bishop

Professor Mary Fitzgerald

Professor Martin Johnson

Professor Joyce Kenkre

Professor Trish Greenhalgh

Professor Carol Haigh

Professor Susan Read

Professor Roger Watson

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

© 2011 Royal College of Nursing. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any formor by any means electronic, mechanical, photocopying, recording or otherwise, without prior permission of the Publishers or a licence permitting restrictedcopying issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London W1T 4LP. This publication may not be lent, resold, hired out orotherwise disposed of by ways of trade in any form of binding or cover other than that in which it is published, without the prior consent of the Publishers.

RCN Legal Disclaimer

This publication contains information, advice and guidance to help members of the RCN. It is intended for use within the UK but readers are advised thatpractices may vary in each country and outside the UK.

The information in this booklet has been compiled from professional sources, but its accuracy is not guaranteed. Whilst every effort has been made toensure the RCN provides accurate and expert information and guidance, it is impossible to predict all the circumstances in which it may be used.Accordingly, the RCN shall not be liable to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly bywhat is contained in or left out of this guidance.

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

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Informed consent in health and social care research

RCN guidance for nurses

Contents

1. Introduction 2

2. What is informed consent? 3

3. The ethical and legal framework 4

4. Informed consent in special circumstances 6

5. Individual responsibilities 7

6. The process of gaining informed consent 8

7. The participant’s perspective 9

8. Vulnerable participants 10

9. Conclusion 13

10. References 13

11. Additional information and legislation 14

Nurses are taking an increasingly active role in research,developing new knowledge and creating a strongerevidence base to inform their practice. This can involveworking, leading and collaborating in all stages of theresearch process.

When engaged in research involving humanparticipants, nurses have a responsibility to ensure thatthe interests of participants, whether patients or healthyvolunteers, are protected. This applies to all research –including studies not specifically related to nursing,such as clinical trials of investigational medicinalproducts (CTIMPs) or other clinical trials.

Gaining informed consent from research participants,whenever possible, is central to the research process. Itis therefore important that nurses understand theprinciples associated with informed consent and theprocess of obtaining informed consent before theyembark on, or become involved in, any research activity.

The Royal College of Nursing (RCN) Research Societyhas developed this guidance for nurses involved inresearch, regardless of what form that may take orwhere that research takes place. This document providesan overview of:

� the concept of informed consent for research

� the ethical and legal framework

� informed consent in special circumstances

� the responsibilities of those involved in undertakingresearch

� the process of gaining informed consent

� the participant’s perspective

� obtaining informed consent from vulnerablegroups.

I N F O R M E D C O N S E N T I N H E A L T H A N D S O C I A L C A R E R E S E A R C H

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Introduction

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A bibliography of useful reading on the subject ofinformed consent, together with a list of the sourcesconsulted in the development of this guidance and otheruseful sources of relevant information, can be found atthe end of this document.

This second edition of RCN guidance on informedconsent incorporates a number of amendments andadditions that reflect significant changes in both UK lawand ethical review processes. Another RCN document –Research ethics: RCN guidance for nurses (RCN, 2009) –considers the ethical principles underpinning researchin general, and should be read alongside this document.

Research is:

“The attempt to produce generalisable newknowledge by addressing clearly definedquestions with rigorous and systematicmethods.”

(Gerrish and Lacey, 2010)


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What is informedconsent?

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Informed consent is:

“The process of agreeing to take part in astudy based on access to all relevant andeasily digestible information about whatparticipation means, in particular, in terms ofharms and benefits.”

(Parahoo, 2006)

In this section we discuss the concept of informedconsent, and the information potential participantsneed to receive and understand in order to giveinformed consent.

Freely given informed consent is central to researchinvolving human participants. It is essential that thosewho participate in research understand exactly what theresearch involves for them, and freely agree toparticipate in it; this applies equally whether they arepatients or healthy volunteers.

Obtaining informed consent helps to ensure that peopleare not deceived or coerced into participating inresearch. When potential participants may lack thecapacity to understand information or make a decision,great care should be taken in obtaining meaningfulinformed consent.

To give truly informed consent, potential participantsneed to understand the following:

� the purpose of the research

� how long their participation will last

� who is involved in the research

� the practicalities and procedures involved inparticipating

� the possible benefits and risks of participation and,when appropriate, the alternative therapies

� how data about them will be managed and used

� how long and where the data will be stored

� the purpose of the consent form

� what is expected of them if they agree to participatein the research

� how information will be provided to themthroughout the research

� that their participation is voluntary

� that they can withdraw from the study at any time,without giving any reason and withoutcompromising their future treatment

� the insurance indemnity arrangements for theconduct of the research where appropriate

� that the research has been approved by a researchethics committee.

Participants should also be given the followinginformation:

� contact details, should they have further questionsor want to withdraw

� details of the research sponsor and funding body.

In addition, a participant information sheet should beprepared which:

� invites the reader to participate in the research

� uses language appropriate to the potentialparticipant group, avoiding the use of technicallanguage

� includes diagrams, pictures, tables and flowcharts ifthese contribute to explaining the research.

It is also important to remember that writteninformation is only one way to share information withpotential participants. There may be circumstanceswhen video, podcasts, recordings or other means ofsharing information might be more appropriate.

Ongoing consent as a process

Informed consent is an ongoing process andconsequently researchers must ensure that participants:

� continue to understand what the research is aboutand what their participation involves

� are provided with any new information which mightinfluence their decision to continue theirparticipation in the research

� continue to consent to participate throughout theresearch.

Revisiting informed consent is often done informally,but on occasion it might be appropriate to formallyreconsent research participants. For example, duringlongitudinal research projects it might be wise to ask

Informed consent is bound by ethical and legalframeworks, and the processes for obtaining it must beindependently scrutinised and approved. In this sectionwe take a look at the ethical and legal requirementsregarding informed consent, and the bodies responsiblefor ensuring the processes for gaining consent areadequate and appropriate.

The ethical framework

Freely given informed consent is at the heart of ethicalresearch, and the national and international governanceframeworks – including the World Health Organisation’sDeclaration of Helsinki – state that researchers mustmake appropriate arrangements to obtain informedconsent from research participants.

The key ethical principle relating to informed consent inresearch is the belief that everyone should be treatedwith respect (RCN, 2009). Researchers must respectdiversity when gaining informed consent and must takeinto account factors such as:

� ethnicity

� gender

� disability

� religious beliefs

� culture

� language

� level of understanding.

informally if participants are happy to continue theirparticipation before commencing research activities.

Reconsenting is also appropriate if there is a significantchange to a research project, or if there is newinformation which might alter an individual’s willing toparticipate in a research project. In these scenarios itwould usually be expected that a new information sheetis provided and informed consent is revisited in a moreformal manner.


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The ethical andlegal framework

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“The aim [of the Mental Capacity Act 2005] isto balance the importance of properlyconducted research into the treatment or careof people who lack capacity with the need toprotect their interests and respect their currentand previously expressed wishes andfeelings.”

(Piffaretti, 2007)

Since researchers cannot know how any or all of thesefactors might affect a potential participant, they must besensitive when going through the process of gaininginformed consent.

Once an individual has made a decision relating toparticipation in a research project, the researcher mustrespect that autonomous decision – even if they disagreewith it. This respect for autonomous and informeddecision-making also requires that potential participantsare never coerced into participating in research. It isimportant to remember that all research participants arepotentially vulnerable to such coercion, by virtue of thevery nature of their relationship with the researcher.

The legal framework

Gaining informed consent for research which involvesinvasive procedures is considered to be a legalrequirement. If a research activity proceeds without anindividual’s informed consent, then legal action couldbe taken against the chief investigator or researcher.

UK case law on consent has established threerequirements that need to be satisfied before a potentialresearch participant can give informed consent:

� consent should be given by someone with themental ability to do so

� sufficient information should be given to theparticipant

� consent must be freely given.

If any of these requirements is lacking then the consentis invalidated.

In recent years it has become increasingly important forresearchers to consider the law when planning theirresearch and the manner in which they will seek toobtain informed consent. Researchers should considerthe following when considering issues related toinformed consent:

� Mental Capacity Act (2005)

� Adults with Incapacity (Scotland) Act (2000)

� EU Clinical Trials Directive 2004/20/EC

� Medicines for Human Use (Clinical Trials)Regulations (2004)

� Data Protection Act (1998)

� Human Tissue Act (2004).


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You can find detailed information on these items andtheir application to research ethics and informedconsent on the National Research Ethics Service (NRES)website at www.nres.nhs.uk

Independent scrutiny

All research should be subject to independent scrutinyto ensure it is ethically acceptable; this includesconsideration of the proposed processes for gaininginformed consent.

Researchers must gain approval from the relevantresearch ethics committee before beginning theirresearch. Depending on the nature of the research, thisethical approval should be sought and obtained fromone of the following sources:

� NHS/NRES research ethics committee

� university or faculty research ethics committee

� other independent research ethics committee (forexample, a local authority social care research ethicscommittee).

The research ethics committee (REC) will want to bereassured that all participants freely give informedconsent, and will therefore scrutinise carefully theparticipant information sheet and the proposed processrelating to obtaining informed consent.


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Informed consentin specialcircumstances

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“Failure to include any patient group inresearch could be described as discriminationbecause its members will not benefit from thepotential advances in knowledge andunderstanding of their condition.”

(Gelling, 2004)

The principles and processes for obtaining informedconsent are the same for all potential researchparticipants, except in a small number of specialcircumstances. Sometimes it is not possible to obtain aparticipant’s informed consent before research activitybegins. This should not prevent important researchfrom being undertaken, but researchers must take greatcare to protect the interests of participants and toconsult other appropriate people about the individual’sparticipation. This section briefly discusses informedconsent in special circumstances where usual practicesmay be difficult to apply.

Delayed consent

Delayed consent usually occurs in emergency situations,when obtaining informed consent might make the studyimpossible. For example, it may be needed for researchundertaken:

� at the roadside in the event of an accident

� at a cardiac arrest

� during the early stages of a patient’s emergencyadmission to an accident and emergencydepartment.

The Mental Capacity Act (2005) states that urgent oremergency research can be undertaken if ‘it is notreasonably practical’ to meet the requirements forinformed consent from a potential participant wholacks the capacity to consent for themselves. Theresearch team will be expected to demonstrate to an

NHS REC that this research is necessary, and could nothave been undertaken in a population able to provideinformed consent in advance of any research activities.In each instance, the research team should seekinformed consent as soon as possible from theparticipant or seek the opinion of a consultee.

The Mental Capacity Act (2005) is relevant only toresearch involving adults aged 16 years or older, appliesonly in England and Wales, and is not relevant toCTIMPs; the Adults with Incapacity (Scotland) Act(2000) and the Age of Legal Capacity (Scotland) Act(1991) apply in Scotland. While there are no equivalentstatutes in Northern Ireland, similar common lawprinciples relating to capacity and consent apply.

Implied informed consent

Implied consent may arise when express written and/orverbal consent is not given; for example, when aparticipant implies their informed consent by returninga completed anonymised questionnaire. In thesecircumstances the REC will want to be reassured thatthere is no way that the researcher will be able toidentify the participant from their responses.

Consent by proxy

Before the enactment of the Mental Capacity Act (2005)and the Adults with Incapacity (Scotland) Act (2000)there was a lack of clarity around the inclusion of thoseunable to give their own informed consent to participatein research, and the term ‘proxy consent’ was used todescribe the process of seeking consent/assent from afamily member or other person to include anotherindividual in research. The law has now been clarifiedon this issue, and it would be unusual to use the term‘proxy consent’ in a research situation.


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Individualresponsibilities

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“Informed consent is at the heart of ethicalresearch.”

(Department of Health, 2005)

In this section we examine the responsibilities ofpractitioners and groups involved in the process ofobtaining informed consent.

Nurses

Even when they are not leading research studies, nursesare often involved in delivering the intervention orinvestigation concerned. The Nursing and MidwiferyCouncil’s code states that nurses should:

“...make the care of people your firstconcern, treating them as individuals andrespecting their dignity.”

(Nursing and Midwifery Council, 2008)

Every nurse is accountable for their own practice, soevery nurse must be satisfied that participants havegiven informed consent to take part in a research studybefore being involved in any research activities.

Furthermore, nurses and other health care professionalsneed to consider their professional responsibilitiesalongside their responsibilities as a researcher.

Lead researcher

While each individual member of the research team isresponsible for their own specific actions, overallresponsibility for all elements of research activity –including gaining informed consent – rests with thelead researcher who is sometimes described as the chiefor principal investigator.

The lead researcher may delegate the task of obtaininginformed consent to another appropriately qualified andtrained member of the research team, but this

delegation must be clearly documented and the persongaining informed consent must sign the consent formwhen required. While entirely irrelevant to theconsenting process itself, signing a consent form whenyou have not been personally involved is poorprofessional practice (in other words, the signaturecarries no weight in the assessment of whether thepatient did lawfully consent to the proposedintervention).

Sponsors and funding bodies

It is not unusual for the sponsor and funding body of aresearch study to be the same entity (such as apharmaceutical company). However, both have slightlydifferent roles:

� the funding body provides financial supportthrough contracts with the researchers and/or theirinstitutions

� the sponsor has primary responsibility for ensuringthat the design, conduct and reporting of the studymeet appropriate standards.

Both will have a view on how informed consent isgained. For example, some protocols specify thequalifications of the person required to obtain consent.The sponsor is responsible for ensuring that theindividual obtaining informed consent is trained to doso.

Research participants

Potential participants should understand that, if theyconsent to take part in research, there is an expectationthat they will comply with the requirements of theresearch as detailed in the participant information sheetand consent form. If the participant does not do what isexpected of them, this can have implications for thequality of the research.

If at any time they are unable or unwilling to do this, theparticipant should consider withdrawing from theresearch. It is important to emphasise that withdrawalfrom a clinical study will not compromise the quality ofcare an individual receives, although this treatment maychange. For example, if the study relates to examining anew treatment, the individual may go back to receivinga standard treatment.

In this section we review the factors to be consideredwhen going through the process of obtaining informedconsent.

The discussionIt is important to make potential participants ascomfortable as possible about discussing the research, sothat they are able to concentrate and feel confidentenough to ask questions. A location should be used wherethere are unlikely to be any interruptions, and thepotential participant should be encouraged to have arelative or close friend present if this makes them feelmore comfortable.

When giving information about the research, it isimportant to ensure potential participants are in aposition to give informed consent by:

� repeating, explaining and reinforcing information

� asking questions to check their understanding of theinformation.

It is also important to think about the timing of thediscussion. For example, patients who may have just beengiven news of a life-threatening illness are unlikely to beable to make an informed decision about participating ina research project while struggling to come to terms withtheir situation. Many of these issues will need to beconsidered when preparing the initial application forethical approval.

Acknowledging diversityIt is important to acknowledge diversity, alongside allother factors listed in section 3 of this document, whengaining informed consent. Researchers are not expected

to know how these factors might affect individuals, andshould not make assumptions based on stereotypes.Asking questions can help the researcher to understandwhat might influence potential participants, so that theycan deal with these issues sensitively.

Reinforcing the discussion

It is not enough to give potential participants a verbalexplanation of the research project and what theirinvolvement will entail. They must also be given apermanent record of information about the research –such as a written participant information sheet – to takeaway to support them in their decision-making.

It may be necessary to prepare information materials invarious formats, depending on the particular needs ofthe potential participants (see the section on vulnerablepeople).

For example, information for people with a visualimpairment should be written in large, clear print.Alternatives to written information can includerecordings and pictures as an aid for discussion on theproposed research.

The materials used should explain the main points ofthe research, acting as a prompt to remind potentialparticipants of your discussion and as a point ofreference when individuals discuss their participationwith their family and others.

The consent form

The signing of a form has become standard practice inconfirming an individual has freely given their informedconsent to participate in a research study. However, whilea signed consent form provides good evidence that adiscussion has taken place, it does not prove that consentis truly informed and therefore legally valid.

Potential participants should not be asked to sign theconsent form until they have been given adequateinformation about the study and have had time toconsider their decision. When asking for their decision,it is important to explain verbally all aspects of thestudy again and check their understanding. In certaincircumstances a protocol may require that a witness ispresent who also signs the consent form; for example,where a potential participant can neither read nor write.


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The process ofgaining informedconsent

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“A fundamental principle underlying ethicalpractice is ‘informed consent’.”

(Dobson, 2008)

Deciding whether or not to participate in a researchproject involves considering a number of issues. Thesecan often be complicated, so it is essential that theresearcher presents them as clearly as possible. In thissection we examine how consideration of the benefitsand the risks might impact on an individual’s decisionto participate, and briefly consider how a health careprofessional’s views may influence decision-making.

Benefits

Participation in research can have a number ofperceived benefits for patients including:

� access to experimental treatments that may givebetter outcomes than standard treatments

� closer monitoring

� increased access to members of themultidisciplinary team

� extra investigations

� the satisfaction of benefiting future patients.

Potential participants must be informed of the potentialbenefits of taking part. However, care should be taken toensure that these benefits do not lead to people beingpersuaded to participate in research for the wrongreasons. If the proposed research is a randomisedcontrolled trial, it should be made clear that potentialparticipants might not receive the experimentaltreatment or an intervention but may receive standardcare or a placebo.

Participants might be offered a financial incentive toparticipate in a research project. When this happens theresearch ethics committee will want to be reassured thatthe sum offered is commensurate with the burden ofparticipation, and is not so much that it will alter thepotential participant’s decision. This can be difficult tojudge, because what might seem like a small sum forone person could seem like a considerable sum tosomeone else.

Risks

Potential participants should also be informed of thepossible risks or burdens associated with participatingin the research project; for CTIMPs this might be a longlist of possible physical side-effects. Researchers shouldalso consider the possible emotional and psychologicalrisks which might arise, particularly in the context ofqualitative research, but can often be overlooked.

Participants should also be informed of the economicconsequences of taking part in the research. Forexample, it is important to inform potential participantsif expenses are to be reimbursed – or not. While thismay not be a factor in preventing an individual’sparticipation in research, this knowledge is important tothem making an informed decision.

When it comes to creating a meaningful and usefulparticipant information sheet, it can be helpful ifpatients and/or representatives from groups likely to berecruited to the research are involved in thedevelopment of this information.

Professionals’ views

When discussing a research study with potentialparticipants, it is important that nurses and health careprofessionals do not allow their own opinions toinfluence whether or not the individual consents to takepart in the research.

It is the responsibility of the nurse or health careprofessional to ensure the individual is given sufficientinformation, and then allowed to decide for themselves.


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The participant’sperspective

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“Many research ethics committee membersstart their review by reading the participantinformation sheet for a concise understandingof the purpose of the research and what it willentail. If the information provided does notconvey this understanding, it will cause delaysin obtaining approval, however good the restof the application may be.”

(Smajdor et al., 2009)


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Vulnerableparticipants

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“Every recipient of health care is in some wayvulnerable, but those with more limited abilityto act autonomously can also be morevulnerable to the impact of research activity”.

(RCN, 2009)

This section examines the special needs of individualsand groups who may be considered vulnerable, andreviews the factors to take into account when gaininginformed consent for their participation in research.

Assessing a potential participant’s capacity to giveinformed consent autonomously is an essential part ofthe informed consent process. This, however, can provechallenging so it is important to involve practitionersand others who know the individual in making suchdecisions.

It is important to remember that the Mental CapacityAct (2005) begins with the presumption of competence,and that capacity can fluctuate and be affected by themanner in which information is provided. Theprovision of accurate and meaningful information is atthe very heart of the process of acquiring informedconsent.

Recognising special needs

People can have a range of special needs that need to betaken into account and which are not always obvious;some people may conceal them. For example, somepeople with reading or writing difficulties may concealtheir limitations due to embarrassment -“I’ve forgottenmy glasses, I’ll read it later” – while others may havevisual or hearing impairments, illness or emotionaldifficulties. It is vital, therefore, to explore the potentialparticipant’s abilities sensitively.

Where the researcher and the potential participant donot speak the same language or their command of thesame language is not good enough to enable effectivecommunication, information should be translated into

the first language of the participant; to ensure theparticipant can freely give consent on the basis ofproper understanding, a professional interpreter shouldbe available. Research ethics committees seldom permitthe involvement of families at this stage in theconsenting process because the quality of thetranslation cannot be guaranteed.

The ability to process information can slow with age, soolder people should be given plenty of time andopportunity to ask questions and think about whetherthey wish to participate. Consideration also needs to begiven to problems that might arise as a result ofmemory problems. It is important, however, that olderpeople are involved in research and not excluded for thisreason.

Capacity to decide

People can only give consent if they are capable ofchoosing between alternative courses of action. Thismeans they must be able to understand the informationgiven by researchers.

Including participants with impaired capacity to decideis more acceptable where research is necessary topromote the health of that particular group, and cannotbe performed on legally competent people instead. Forexample, in testing drug dosages for children orinterventions for individuals diagnosed withAlzheimer’s disease. Researchers must be particularlysensitive to the needs and vulnerabilities ofparticipants.

Children and young people

Children and their parents or guardians should beinvolved in the research consent process in proportionto the child or young person’s competence to weigh therisks and benefits, and they may need extra time to doso; the child must also indicate that they do not objectto the research activity.

Children can give consent to participate in researchthemselves provided they have the capacity to do so.This means they are able to understand the nature andconsequences of their participation in the research.

Young people aged 16 years and older are generallycapable of giving their own consent, while many under


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16 years of age are also able to give informed consent orbe involved in the decision making process. It isnecessary to assess the individual child’s capacity,depending on their maturity and understanding. Onmany occasions this is best achieved with support fromparents or guardians.

Gaining a child’s views and desires can require the useof creative ways of providing information andalternative means for them to express their thoughts.

Children should not receive monetary rewards forparticipation in research, although you can give non-monetary gifts, such as toys, providing their value is notexcessive. Any rewards for participating should benefitthe child, not the parents. In addition, travel costsshould be reimbursed for the child and those travellingwith them.

Long-term care residents

Older people and others in hospitals or living in long-term care facilities may find it more difficult to refuse toparticipate in a study if approached by staff involved intheir day-to-day care. If the research involves such apopulation, it is important to take particular care thatpotential participants do not feel pressured or coercedinto taking part and to ensure that every effort is madeto facilitate the consenting process in a way that meetsthe needs of the older person.

People with learningdisabilities

Individuals with learning disabilities must be given thesame respect as anyone else and be protected fromharm if they take part in the research. Some may not beable to exercise fully their right to self-determination,but they should be offered choices within theircapabilities. These potential participants can choose orrefuse to participate.

Care should be taken in evaluating each individual’scomprehension; use plain language, supported ifnecessary by other material such as pictures. If apotential participant finds it difficult to understand thenature of research it may be necessary to present theinformation in different formats or over a longer periodof time.

Every effort should be made to seek informed consentand researchers should record evidence that theindividual consented to participate after weighing uppotential risks and benefits. It may be necessary toinvolve a range of people who understand theindividual’s situation and can contribute to anassessment of their best interests.

Unresponsive patients

Unresponsive patients, as a result of injuries or sedation,can only be included in research for very specificreasons. For individuals recruited to a CTIMP theMedicines for Human Use (Clinical Trials) Regulations(2004), enacted as a result of the EU Directive2001/20/EC, allows for written informed consent to beobtained from a legal representative. The principles inthe regulations require that:

� the informed consent given by a legal representativefor an incapacitated adult in a clinical trial shouldrepresent that adult's presumed will

� the clinical trial is designed to minimise pain,discomfort, fear and any other foreseeable risk inrelation to the disease and the cognitive abilities ofthe patient

� the risk threshold and the degree of distress arespecially defined and constantly monitored

� the interests of the patient will always prevail overthose of science and society.

In Scotland the Adults with Incapacity (Scotland) Act(2000) permits another (defined) person to give consenton behalf of an incapacitated adult. It is argued that theexclusion of unresponsive patients from non-medicinalresearch is a form of discrimination as the evidencebase for their care will not develop without it (Gelling,2004).

If the patient regains consciousness and capacity,informed consent should be sought as soon as ispractical. If the individual refuses consent, alldocumentation and data relating them to the studyshould be destroyed. However in the case of a clinicaltherapeutic trial, all documentation must be retainedfor audit purposes, but it should not be used as part ofthe research.


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Prisoners

Prisoners should not be used as research participantsunless there is a valid reason; for example, if the study islooking at conditions associated with violent andcriminal behaviour. In addition to the usual approvalprocedures, approval must be sought from the head ofhealth care within the appropriate statutory bodies. Aprisoner’s participation will be subject to their informedconsent in the normal way, but particular attentionshould be paid to the need to avoid coercion.

Armed forces

Research carried out on members of the armed forces issubject to the Official Secrets Act, which hasrepercussions in relation to confidentiality, honesty andpublishing results. The armed forces rarely give consentfor studies on their personnel, unless it relates to issuesspecific to them. However, if research is undertaken onforces personnel the principles of informed consentapply, paying particular attention to the need to avoidcoercion.

Health care staff

Health care staff are sometimes invited to becomeresearch participants. Their knowledge may be nogreater than other participants, so they must receive thesame detailed information. They must also be givenencouragement to ask questions, as they may bereluctant to display gaps in their knowledge. It isimportant not to assume that because they understandthe need for research, they are any more predisposed toparticipate than other people.

Students

Students should receive the same level of care andprotection as all other research participants. Whenrecruiting students to research being undertaken bylecturers, fellow students or others investigators shouldgive due consideration to possible power relationshipsand the risk of coercion. Like participants in all otherforms of research, student should be able to make anautonomous and informed decision about their

participation in a research project. Students shouldnever be obliged to participate in research.

Human tissue samples

Not all research involves the active participation ofvolunteer living participants. In some instances theresearch involves studying tissue samples from living ordeceased donors. In undertaking this form of research itis necessary to comply with the requirements of theHuman Tissue Act (2004). As with all other forms ofresearch samples cannot be collected, stored or analysedunless informed consent has been obtained from theindividual or their next of kin. The principles andprocesses described above also apply to research of thiskind.


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Conclusion

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Nurses are accountable for their professional practiceand should always act in the best interests of patients,clients and research participants.

The key principle in obtaining informed consent toresearch is to put the potential participant’s needs first.

To participate effectively in informed consent processes,the researcher should have the knowledge, expertise andcapability to give sufficient information and be able toanswer any questions raised by a potential researchparticipant.

The researcher should also have knowledge of therelevant law and, when necessary, be able to assess apotential participant’s capacity to give informedconsent. If the researcher is open and honest, andensures the participant understands all they need toabout the study, then truly informed consent will beobtained.

In this guidance document it has only been possible tooffer the briefest of insights into informed consent inhealth and social care research. The following sectionwill highlight some additional sources of information.

References

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Department of Health (2005) Research governanceframework for health and social care (2nd edition),London: DH. Available from www.dhgov/uk/en

Dobson C (2008) Conducting research with people nothaving the capacity to consent to their participation: apractical guide for researchers, Leicester: BritishPsychological Society. Available from www.bps.org.uk

Gelling L (2004) Research patients in the vegetativestate: difficulties of studying this patient group, NursingTimes Research, 9(1), pp.7-17.

Gerrish K and Lacey A (2010) The research process innursing (6th edition), Oxford: Wiley and Sons.

Nursing and Midwifery Council (2008) The code:standards of conduct, performance and ethics for nursesand midwives, London: NMC. Available from www.nmc-uk.org

Parahoo K (2006) Nursing research: principles, processand issues (2nd edition), Basingstoke: PalgraveMacmillan.

Piffaretti E (2007) Capacity to make decisions? Changesin the law – are you prepared? Clinical Discovery,Jun/Jul, pp.20-21.

RCN (2009) Research ethics: RCN guidance for nurses,London: RCN. Available fromwww.rcn.org.uk/publications Publication code: 003 138

Smajdor A, Sydes MR, Gelling L and Wilkinson M(2009) Applying for ethical approval for research in theUnited Kingdom, British Medical Journal, 339, pp.968-972.


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Additionalinformation andlegislation

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Further information

WMA Declaration of Helsinki – ethical principles formedical research involving human subjects. Availablefrom the World Medical Association’s websitewww.wma.net (Internet).

The Integrated Research Application System (IRAS) canbe accessed via www.myresearchproject.org.uk(Internet).

The National Institute for Health Research (NIHR)provides extensive resources on informed consent on itswebsite www.nihr.ac.uk (Internet).

Full information on the NHS National Research EthicsService (NRES) can be found at www.nres.npsa.nhs.uk(Internet).

Information on the RCN Research Society, and the RCNResearch and Development Coordinating Centre, can befound at www.rcn.org.uk (Internet).

Legislation

The following UK legislation can be viewed atwww.legislation.gov.uk (Internet):

� Adults with Incapacity (Scotland) Act (2000)

� Data Protection Act (1998)

� Human Tissue Act (2004)

� Medicines for Human Use (Clinical Trials)Regulations (2004)

� Mental Capacity Act (2005)

� The EU Clinical Trials Directive 2004/20/EC can beviewed at www.eur-lex.europa.eu (Internet).

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Informed Consent

Documents

Transcript of Informed Consent