Valid informed consent

in research: an introduction
Jayne Hardicre

T
he process of informed consent is Box 1. Twenty elements of valid informed consent
at the very heart of ethical research Based on International Conference on Harmonisation for Good Clinical Practice E6 (R1) 1996
practice and underpins the design and (Section 4.8.10)
management of research and clinical
■■ That the trial involves research (i.e. we don’t know the answer)
trials. Informed consent is essential to protect
■■ The purpose of the trial
the rights and safety of patients in research
■■ The trial treatment(s) and possible randomisation to treatment options (if applicable)
and is the major consideration when ethical
■■ The trial procedures
and institutional approvals are granted prior
■■ Participant responsibilities
to studies being undertaken. There are many
■■ Which aspects of the trial are experimental
definitions of informed consent as applied to
■■ The reasonably foreseeable risks of participation
research and many have their routes in the
■■ The reasonably expected benefits. If there are none you must make them aware of this
guidelines of the International Conference
■■ The alternative procedure(s) or course(s) of treatment and their potential benefits and risks
on Harmonisation (ICH) for Good Clinical
■■ Compensation and/or treatment available to the participant in the event of trial-related injury
Practice (ICH, 1996):
■■ Pro-rata payments, if any, to the participant for taking part in the trial
‘A process by which a subject ■■ Anticipated expense payments, if any, to the participant for taking part in the trial
voluntarily confirms his or her ■■ Participation is voluntary and that he/she may refuse to participate or withdraw from the trial at
willingness to participate in a any time
particular trial, after having been ■■ Must agree that regulatory authority(ies), study monitors or auditors may access the original
informed of all aspects of the trial medical records for verification of clinical trial procedures
that are relevant to the subject’s ■■ That records identifying the participant will be kept confidential and the publication will not reveal
decision to participate. Informed their identity
consent is documented by means ■■ That the participant or legally acceptable representative will be informed of new information
of a written, signed and dated relevant to participation in the trial
informed consent form’ ■■ Contact details of a person or team to contact for further information and advice
(ICH, GCP E6 1.28) ■■ The circumstances and/or reasons why participation in the trial may be terminated
■■ The expected duration of participation
Parahoo (2006) offers a similar definition as:
■■ The approximate number of people being recruited into the trial.
‘The process of agreeing to
study he/she must give explicit consent and Research is now regarded as core NHS
take part in a study based on
this consent can only be obtained following business (Department of Health (DH), 2006).
access to all relevant and easily
a full and comprehensive discussion about the A report released by the National Institute for
digestible information about what
study including the risks and benefits of taking Health Research (NIHR) in 2013 indicated
participation means, in particular, in
part.This is called valid informed consent.This that 99% of NHS Trusts in England now
terms of harms and benefits.’
article will discuss some of the complexities of actively engage in clinical research with
(Parahoo, 2006)
valid informed consent in research involving 630 000 NHS patients taking part in research
Nurses are accountable for their professional adults and how researchers achieve this in in 2012 (NIHR, 2013). Clinical research
practice and should always act in the best practice. The term ‘research participant’ will be would not be possible at all if it were not for
interests of patients, clients and research used throughout this paper to embrace other the hundreds of thousands of patients who
participants. The key principle in obtaining descriptors such as research patient or subject. volunteer their time, bodies and minds to it.
informed consent to research is to put the Research nurses and allied health professionals
potential participant’s needs first (Royal Research in the NHS (AHPs) put huge efforts put into maximising
College of Nursing, 2011). In order for a Research is essential to the provision and research participants’ experience while also
patient or subject to take part in a research development of effective, efficient and safe protecting their safety and rights throughout
health and social care. New treatments, the whole of the research journey.
medicines, regimens, practices and services
© 2014 MA Healthcare Ltd

Jayne Hardicre is Lecturer in Nursing, Adult

are developed through research. Put simply, Valid informed consent
Specialty, University of Salford
research underpins where we are today Respect for the patients’ right to choose and
Accepted for publication: May 2014 and will inform what we do tomorrow make an informed choice is at the core of ethical
(Hardicre, 2013). research and clinical practice. Whether consent

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 RESEARCH

Discussion with Assess Agreement Consent to

Invitation to Time to continue prior
patient understanding of to participate,
participate consider to and at every
(and family) what is involved consent given contact

Figure 1. The consent process in research

is being sought for clinical or research purposes, be included in participant information sheets much time should be given to allow for
it is clear that patients need information in (the information sheets about the research) valid informed consent. This is an important
order to make an informed choice. and should also be discussed with the potential factor from the patient’s point of view but
At its most basic level there are three elements participant. Although initially developed for is also dictated by the type of research itself.
of consent (Beauchamp and Childress, 2009): the more complex clinical trials, these 20 The research protocol will outline this time
■■ Adequate information: full information elements can also underpin other research allocation and can range from hours to
about the research so that the patients know designs or methods to ensure completeness months. If, for example, the research involves
exactly what they are consenting to of information. Research ethics committees emergency situations, such as patients admitted
■■ Voluntariness: an understanding that they review all participant information sheets and to accident and emergency with trauma or
are under no obligation to agree to take part trial-related documents to ensure that the stroke, and the research involves the trial of
and if they do decide to take part they are information included accurately reflects all a drug to be administered within the first
free to withdraw at any time elements of research, making sure the potential 3 hours of admission, then this clearly dictates
■■ Competence: that the patient is capable of participants will be fully aware of: the time a patient or family has to consider
understanding what participation entails ■■ What the research is about participation (Box 2). At the other end of
and has the capacity to make a free and ■■ Why it is being done the spectrum, a study may be investigating
informed choice. ■■ What the purpose of the study is and what the experiences of childbirth using focus
It should be recognised at this point that will happen to the results groups. The research design may be such
there are differences between consenting ■■ What will be expected of them if they agree that a mother can be approached via her
for clinical care and consenting for research to participate midwife and could have up to 3  months
participation. Obtaining consent for clinical ■■ How long they will be required to participate to consider participation. The time allowed
care is to benefit an individual patient and this in the study prior to consent is also examined carefully by
care is underpinned by a body of evidence. By ■■ What the risks of participation could be and research ethics committees who ensure that
contrast, when a patient consents to participate any potential benefits the time allocated is indeed appropriate for
in research, this is undertaken to develop this ■■ That information about them will remain the research design and aims, thus allowing
body of evidence for future patients and may confidential and anonymous maximal available time for consideration. The
not be of any direct benefit to the participant ■■ That they do not have to participate and
himself/herself. It is being undertaken because that if they do agree they are free to Box 2. Consent in emergency situations
we don’t yet have the answers or because we withdraw at any time.
Emergency research poses its own set
don’t know which method or treatment is It is important that all participant information of challenges in terms of providing
best. This is sometimes referred to as ‘clinical sheets and research-related information be information about research and obtaining
equipoise’, a state of genuine uncertainty comprehensive yet written in non-technical valid informed consent.
as to the advantages or disadvantages of language to aid understanding. They should be
each treatment option in a clinical trial. The as free from jargon as possible and should never Emergency research is when:
following sections will briefly discuss each of include abbreviations. There are many patient ■■ Treatment needs to be given urgently, and
the three elements to consent in relation to and public involvement groups interested ■■ It is necessary to take urgent action for the
consent for clinical research. in the development of research. In addition purposes of the study.
to being involved in the identification of In some emergency situations:
Adequate information research priorities, it may also be possible ■■ Potential participants may lack capacity to
There are many types of research a patient may for researchers to ask the groups to consider give consent themselves
be approached to participate in.These can range the participant information sheets to check ■■ Obtaining consent from a legal
from simple non-sensitive surveys to early-stage for completeness of understanding. Also of representative/consulting others is not
drug trials.What is common between the two is use are readability tools such as the SMOG reasonably practicable.
the depth of information required for potential index (simplified measure of gobbledygook).
participants when considering whether or not The National Institute of Adult Continuing
© 2014 MA Healthcare Ltd

Further guidance on this specific research area

this is something they would wish to volunteer Education (NIACE) provides useful resources is provided by the Health Research Authority
themselves for. The ICH (1996) outlined the on this including a SMOG calculator (http:// and Medical Research Council: ■
20 elements of valid informed consent for tinyurl.com/mt36p8l). http://tinyurl.com/qhh3are
clinical trials (Box 1).These 20 elements should There is often a discussion about how

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 Table 1. Research and consent with adults lacking capacity demonstration of the underlying unequal
CTIMP* trial Non CTIMP trial distribution of power within the nurse-patient
relationship. Here the patient may agree to
Medicines for Human Use (Clinical trial) Mental Capacity Act (2005)
whatever the ‘expert’ says. This must be at the
Regulations (2004) ■ Research must be about the patient’s
■ Must have specific reasons for inclusion
forefront of all researchers’ minds, ensuring
condition or treatment
that the very nature of their relationship does
■ Direct benefit outweighs foreseeable risk ■ Research cannot be carried out if confined to
not exert unintended pressure on potential
See also Medicines for Human Use (Clinical only those with capacity
participants. Researchers frequently hear, ‘If
Trials) Amendment no. 2 Regulations (2006) ■ Possible benefits not disproportionate to
you think it’s going to be helpful then I’ll do
2006/2984 burden
it’ or ‘If it will help you with your numbers
If unable to give consent, who can be If unable to give consent, who can be then I’ll do it’. This is not acceptable as valid
involved? involved?
informed consent because the patient does not
■ Personal legal representative ■ Personal consultee demonstrate any understanding of the elements
Suitable by virtue of the relationship to the Family member, carer (unpaid) or of the study. The potential of professional
adult i.e. family member nominated third party ■ influence is also considered by research ethics
■ Professional legal representative (e.g. lasting power of attorney)
committees to safeguard vulnerability. For
A person who is NOT connected to the ■ Nominated consultee
example, is it acceptable for a heart surgeon to
trial, for example a doctor who is A person independent of the research
approach a patient about to undergo surgery
responsible for medical treatment but not appointed in accordance with the Department
involved in the trial or a medic nominated of Health guidance (e.g. independent mental
to discuss taking part in his/her trial if that
by the healthcare provider capacity advocate (IMCA)) surgeon is the one who who is performing the
operation? Would this influence the patient’s
A legal representative can be asked to give Consultees are not asked to give consent
consent on behalf of an adult lacking capacity to on behalf of the adult, but rather to provide decision to take part? Would the patient feel
do so himself/herself. an opinion on the views and feelings of the like an unpopular person if he/she declined?
potential participant. Would he/she really believe that refusal would
*CTIMP: Clinical trial of an investigational medicinal product. not affect his/her care in anyway?
Voluntariness can only ever be demonstrated
researchers must be fully conversant with all is happy to continue. This must be clearly when a decision is made to take part in
elements of the trial in order to discuss the documented. research without any coercion or influence.
requirements of participation in full.
Whatever the type or design of research, Voluntariness Competence
consent in research should be considered a It is important that potential participants Having discussed information giving and
process rather than a one-off event. Figure 1 understand that that taking part in a study is voluntariness the next issue to be explored
outlines this process and is typical of the steps voluntary and that if they do decide to take is competence. In order to achieve valid
researchers work through when a patient is part that they can withdraw their participation informed consent, the potential participants
approached to participate in research. at any time without any impact on their quality must demonstrate understanding of the study
This process may involve the researcher of care. In addition, volunteering must be free and what participation entails. Researchers
returning to the patient and/or family several from undue coercion and this can include spend a significant amount of time assessing
times to discuss the research prior to consent remuneration (payment). It is acceptable that this understanding during the consent process.
being obtained and the consent form being participants receive compensation for time The Mental Capacity Act (MCA) (2005)
signed. The researcher discusses the study in and travel expenses and this is discussed as part covers England and Wales and states that a
detail and answers any questions until all are of the consent process. However, these should person must be presumed to have capacity
satisfied with completeness of understanding. never be extended to excessive inducements. unless proven otherwise (see also The Adults
Alternatively, another method may involve One must consider the impact of the with Incapacity (Scotland) Act). Complying
information about a study being sent through nurse/doctor/researcher patient relationship with the MCA, researchers assess understanding
the post where the potential participant on voluntariness. There are always careful and capacity using the following questions.
reads the study information sheet and then considerations of vulnerable groups within Can the potential participant:
telephones the research team for more research. The needs of vulnerable groups such ■■ Understand the information given to him/
information if they are interested in taking as children, adults with learning difficulties, her about the study?
part. The researcher would then give more those who lack capacity or even prisoners are ■■ Retain that information long enough to be
detailed information about the study and then carefully considered. These vulnerable groups able to make a decision?
arrange a mutually convenient time to meet can only be included in a study if the research ■■ Weigh up the information available to make
to discuss further. After this, the potential cannot be undertaken without them being that decision?
participant may give agreement to take part in included and as such are subject to extra ■■ Communicate his/her decision?
the study and sign the consent form. provisions during the consent process. If the potential participant has difficulties
Once consent is obtained it is important to It could be argued that all patients within in any one of these areas he/she must be
© 2014 MA Healthcare Ltd

check this again at every visit. If involvement a healthcare relationship could be vulnerable. deemed not to have capacity at that time and
in a study involves several visits, it is important For example, a patient may say, ‘Whatever you as such cannot consent to participate in the
that the researcher reviews the research with think is best, nurse, if you think it’s good for research. This may exclude the patient from
the participant again and checks that he/she me, then that’s fine by me’. This is a frequent participating in the study if there is no specific

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 RESEARCH

ethical approval to include those who lack something that the person would have wanted Useful websites and sources
capacity to consent for themselves. to do if he/she had capacity to consider it for
The Mental Capacity Act (2005) states that himself/herself. If a personal representative or
of further reading
research with individuals (adults) who lack consultee is not available then a professional ■ Adults Lacking Capacity to Consent to
the capacity to consent must have the ethics legal representative or nominated consultee Research. Online course from University of
of the research scrutinised and approved by can be approached. Leicester and University of Bristol■
an ‘appropriate body’. An ‘appropriate body’ The researcher would approach these https://connect.le.ac.uk/alctoolkit/
is defined in law. In England, the ‘appropriate individuals to obtain valid informed consent ■ Dobson C (2008) Conducting research with
body’ is the research ethics committee (or approval via opinion) in exactly the same people not having the capacity to consent
recognised by the Secretary of State. In Wales, way, ensuring completeness of information, to their participation: a practical guide for
the ‘appropriate body’ must be a research time to consider and decide without undue researchers. British Psychological Society.
http://tinyurl.com/nlmdwq9 (accessed 28
ethics committee recognised by the Welsh coercion and establishing understanding of what
May 2014)
Assembly Government. participation in the research would involve.
Approval to include participants who lack ■ Department of Health (2005) Research
capacity to consent for themselves in research Summary Governance Framework for Health and Social
studies will only ever be given if the research Obtaining valid informed consent for Care. 2nd edn. http://tinyurl.com/pu9t6pm
(accessed 28 May 2014)
cannot be undertaken without their inclusion, research is a complex process spanning not
the research is about the patient’s condition only the initial point of consent to participate,
(or treatment), and the possible benefits of but also continued consent to continue for Conflict of interest: none.
participation are not disproportionate to the duration of the study. Obtaining valid Beauchamp TL, Childress JF (2009) Principles of Biomedical Ethics,
burden or risk. informed consent is at the heart of ethical 6th edn. Oxford University Press, Oxford
Department of Health (2006) Best Research for Best Health. A
If the research ethics committee has given research practice and is underpinned by new national health research strategy. http://tinyurl.com/blbltek
approval to include patients lacking capacity to law. Researchers undergo specific training (accessed 28 May 2014)
Hardicre J (2013) An exploration of the role of the research
consent to research then provisions are made in this area to ensure that every participant nurse and its impact. Br J Nurs 22(3): 168-9
International Conference on Harmonisation (1996) Guidelines
for another person to be approached (Table has completeness of understanding of what for Good Clinical Practice E6(R1). http://tinyurl.com/4duczor
1). This person is known as either a personal participation involves and that they are free (accessed 28 May 2014)
National Institute for Health Research (2013) Figures show
legal representative or a personal consultee. to withdraw their consent at any time. This “new high” in NHS patients participating in clinical research.
Depending on the trial design, a representative article has highlighted some of the main http://tinyurl.com/kxryg2w (accessed 28 May 2014)
Parahoo K (2006) Nursing Research: Principles, Process and Issues.
or consultee is approached to either give issues in obtaining consent from adults for 2nd edn. Palgrave Macmillan,Basingstoke
Royal College of Nursing (2011) Informed consent in health and
consent on behalf of the patient lacking research participation, and recommended social care research. RCN guidance for nurses. 2nd edn. http://
capacity or to give an opinion that this is resources for further reading.  BJN tinyurl.com/3733msm

Critiquing Nursing Research About the book

This second edition of Critiquing Nursing Research retains the features which
made the original book a
best-seller while incorporating new material in order to expand its applicability.
In addition to reviewing and
Critiquing
Critiquing Nursing Research

updating the material of the original text, the authors have added two further
chapters: the first focuses on
how to critique research as part of the work of preparing a dissertation; and
the second on mental health
research agendas throughout Europe.

Nursing Research
The fundamentals of the book, however, remain the same. It focuses specifically
on critiquing nursing research

John Cutcliffe and Martin Ward

and the increasing requirement for nurses to become conversant with research
and understand its link with
the use of evidence to underpin practice.
Having read this book, nurses should be more familiar with the approaches
and techniques involved in
critiquing nursing research and be able to utilise some of these skills and techniques
in their own efforts to
critique. Accordingly, they will be better placed to make informed judgements
regarding the quality of the
research paper and the value of the evidence reported.

 This second edition retains all the successful features of the

As nurse education around the world increasingly moves towards an all-graduate
discipline, it is vital for
nurses to have the ability to critique research in order to benefit practice.
This book is the perfect tool for
those seeking to gain or develop precisely that skill and is a must-have for

2nd edition
all student nurses, teachers and
academics.

first, plus additional material on psychiatric research and

About the authors
critiquing nursing research when writing a dissertation.
Dr John R. Cutcliffe holds the ‘David G. Braithwaite’ Professor of Nursing Endowed
Texas (Tyler); he is also an Adjunct Professor of Psychiatric Nursing at Stenberg
Chair at the University of
College International School
of Nursing, Vancouver, Canada and a Visiting Professor at the University of
Ulster, United Kingdom. He is an
Associate Editor for the Journal of Psychiatric and Mental Health Nursing
and an Assistant Editor for the
International Journal of Nursing Studies. John’s clinical background is in psychiatric

 Very suitable as students have to undertake a dissertation

and general nursing, having
worked as a clinician and then as an educator in the United Kingdom. He
is an international scholar having
worked in universities in four different countries: England, Northern Ireland,
Canada and the United States.
Martin Ward is an Independent Mental Health Nursing Consultant; he is also

where they critique three pieces of nursing research.

Co-ordinator of Mental Health
Nursing Studies at the University of Malta and Chair of the Expert Panel
Nurses, based in the Netherlands. From 1995 to 2000 he held the post of
of Horatio - European Psychiatric
Director of Mental Health for the
John Cutcliffe and Martin Ward
Royal College of Nursing. Martin has been a Trustee of the English Health
Advisory Service (HAS) and a
member of the HAS Inspectorate and has also been involved with work with
the World Health Organisation.
Foreword by Professor Kevin Gournay
In 1997, both authors were instrumental in designing and launching the NPNR
National Journal Club.
ISBN-13: 978-1-85642-316-8; 234 x 156 mm; paperback; 244 pages;
publication November 2006; £25.99
John Cutcliffe and Martin Ward

ISBN 978-1-85642-316-8
© 2014 MA Healthcare Ltd

9 781856 423168

Order your copies by visiting or call our Hotline

www.quaybooks.co.uk
The new and updated edition of the best-selling book
www.quaybooks.co.uk CritiquingNRes3.indd 1 +44(0)1722 716 935 25/03/2011 09:41

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