Valid informed consent in research: an introduction Jayne Hardicre
‘A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form’ (ICH, GCP E6 1.28) Parahoo (2006) offers a similar definition as: ‘The process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits.’ (Parahoo, 2006) Nurses are accountable for their professional practice and should always act in the best interests of patients, clients and research participants. The key principle in obtaining informed consent to research is to put the potential participant’s needs first (Royal College of Nursing, 2011). In order for a patient or subject to take part in a research Jayne Hardicre is Lecturer in Nursing, Adult Specialty, University of Salford Accepted for publication: May 2014
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Box 1. Twenty elements of valid informed consent Based on International Conference on Harmonisation for Good Clinical Practice E6 (R1) 1996 (Section 4.8.10) ■■ That
the trial involves research (i.e. we don’t know the answer) purpose of the trial ■■ The trial treatment(s) and possible randomisation to treatment options (if applicable) ■■ The trial procedures ■■ Participant responsibilities ■■ Which aspects of the trial are experimental ■■ The reasonably foreseeable risks of participation ■■ The reasonably expected benefits. If there are none you must make them aware of this ■■ The alternative procedure(s) or course(s) of treatment and their potential benefits and risks ■■ Compensation and/or treatment available to the participant in the event of trial-related injury ■■ Pro-rata payments, if any, to the participant for taking part in the trial ■■ Anticipated expense payments, if any, to the participant for taking part in the trial ■■ Participation is voluntary and that he/she may refuse to participate or withdraw from the trial at any time ■■ Must agree that regulatory authority(ies), study monitors or auditors may access the original medical records for verification of clinical trial procedures ■■ That records identifying the participant will be kept confidential and the publication will not reveal their identity ■■ That the participant or legally acceptable representative will be informed of new information relevant to participation in the trial ■■ Contact details of a person or team to contact for further information and advice ■■ The circumstances and/or reasons why participation in the trial may be terminated ■■ The expected duration of participation ■■ The approximate number of people being recruited into the trial. ■■ The
study he/she must give explicit consent and this consent can only be obtained following a full and comprehensive discussion about the study including the risks and benefits of taking part.This is called valid informed consent.This article will discuss some of the complexities of valid informed consent in research involving adults and how researchers achieve this in practice. The term ‘research participant’ will be used throughout this paper to embrace other descriptors such as research patient or subject.
Research in the NHS Research is essential to the provision and development of effective, efficient and safe health and social care. New treatments, medicines, regimens, practices and services are developed through research. Put simply, research underpins where we are today and will inform what we do tomorrow (Hardicre, 2013).
Research is now regarded as core NHS business (Department of Health (DH), 2006). A report released by the National Institute for Health Research (NIHR) in 2013 indicated that 99% of NHS Trusts in England now actively engage in clinical research with 630 000 NHS patients taking part in research in 2012 (NIHR, 2013). Clinical research would not be possible at all if it were not for the hundreds of thousands of patients who volunteer their time, bodies and minds to it. Research nurses and allied health professionals (AHPs) put huge efforts put into maximising research participants’ experience while also protecting their safety and rights throughout the whole of the research journey.
Valid informed consent Respect for the patients’ right to choose and make an informed choice is at the core of ethical research and clinical practice. Whether consent
© 2014 MA Healthcare Ltd
T
he process of informed consent is at the very heart of ethical research practice and underpins the design and management of research and clinical trials. Informed consent is essential to protect the rights and safety of patients in research and is the major consideration when ethical and institutional approvals are granted prior to studies being undertaken. There are many definitions of informed consent as applied to research and many have their routes in the guidelines of the International Conference on Harmonisation (ICH) for Good Clinical Practice (ICH, 1996):
British Journal of Nursing, 2014, Vol 23, No 11
British Journal of Nursing.Downloaded from magonlinelibrary.com by 193.061.135.034 on April 29, 2015. For personal use only. No other uses without permission. . All rights reserved.
RESEARCH
Invitation to participate
Time to consider
Discussion with patient (and family)
Assess understanding of what is involved
Agreement to participate, consent given
Consent to continue prior to and at every contact
Figure 1. The consent process in research
is being sought for clinical or research purposes, it is clear that patients need information in order to make an informed choice. At its most basic level there are three elements of consent (Beauchamp and Childress, 2009): ■■ Adequate information: full information about the research so that the patients know exactly what they are consenting to ■■ Voluntariness: an understanding that they are under no obligation to agree to take part and if they do decide to take part they are free to withdraw at any time ■■ Competence: that the patient is capable of understanding what participation entails and has the capacity to make a free and informed choice. It should be recognised at this point that there are differences between consenting for clinical care and consenting for research participation. Obtaining consent for clinical care is to benefit an individual patient and this care is underpinned by a body of evidence. By contrast, when a patient consents to participate in research, this is undertaken to develop this body of evidence for future patients and may not be of any direct benefit to the participant himself/herself. It is being undertaken because we don’t yet have the answers or because we don’t know which method or treatment is best. This is sometimes referred to as ‘clinical equipoise’, a state of genuine uncertainty as to the advantages or disadvantages of each treatment option in a clinical trial. The following sections will briefly discuss each of the three elements to consent in relation to consent for clinical research.
© 2014 MA Healthcare Ltd
Adequate information There are many types of research a patient may be approached to participate in.These can range from simple non-sensitive surveys to early-stage drug trials.What is common between the two is the depth of information required for potential participants when considering whether or not this is something they would wish to volunteer themselves for. The ICH (1996) outlined the 20 elements of valid informed consent for clinical trials (Box 1).These 20 elements should
British Journal of Nursing, 2014, Vol 23, No 11
be included in participant information sheets (the information sheets about the research) and should also be discussed with the potential participant. Although initially developed for the more complex clinical trials, these 20 elements can also underpin other research designs or methods to ensure completeness of information. Research ethics committees review all participant information sheets and trial-related documents to ensure that the information included accurately reflects all elements of research, making sure the potential participants will be fully aware of: ■■ What the research is about ■■ Why it is being done ■■ What the purpose of the study is and what will happen to the results ■■ What will be expected of them if they agree to participate ■■ How long they will be required to participate in the study ■■ What the risks of participation could be and any potential benefits ■■ That information about them will remain confidential and anonymous ■■ That they do not have to participate and that if they do agree they are free to withdraw at any time. It is important that all participant information sheets and research-related information be comprehensive yet written in non-technical language to aid understanding. They should be as free from jargon as possible and should never include abbreviations. There are many patient and public involvement groups interested in the development of research. In addition to being involved in the identification of research priorities, it may also be possible for researchers to ask the groups to consider the participant information sheets to check for completeness of understanding. Also of use are readability tools such as the SMOG index (simplified measure of gobbledygook). The National Institute of Adult Continuing Education (NIACE) provides useful resources on this including a SMOG calculator (http:// tinyurl.com/mt36p8l). There is often a discussion about how
much time should be given to allow for valid informed consent. This is an important factor from the patient’s point of view but is also dictated by the type of research itself. The research protocol will outline this time allocation and can range from hours to months. If, for example, the research involves emergency situations, such as patients admitted to accident and emergency with trauma or stroke, and the research involves the trial of a drug to be administered within the first 3 hours of admission, then this clearly dictates the time a patient or family has to consider participation (Box 2). At the other end of the spectrum, a study may be investigating the experiences of childbirth using focus groups. The research design may be such that a mother can be approached via her midwife and could have up to 3 months to consider participation. The time allowed prior to consent is also examined carefully by research ethics committees who ensure that the time allocated is indeed appropriate for the research design and aims, thus allowing maximal available time for consideration. The Box 2. Consent in emergency situations Emergency research poses its own set of challenges in terms of providing information about research and obtaining valid informed consent. Emergency research is when: needs to be given urgently, and ■■ It is necessary to take urgent action for the purposes of the study. ■■ Treatment
In some emergency situations: ■■ Potential participants may lack capacity to give consent themselves ■■ Obtaining consent from a legal representative/consulting others is not reasonably practicable. Further guidance on this specific research area is provided by the Health Research Authority and Medical Research Council: ■ http://tinyurl.com/qhh3are
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CTIMP*
trial
Medicines for Human Use (Clinical trial) Regulations (2004) ■ Must have specific reasons for inclusion ■ Direct benefit outweighs foreseeable risk
Voluntariness
Competence
It is important that potential participants understand that that taking part in a study is voluntary and that if they do decide to take part that they can withdraw their participation at any time without any impact on their quality of care. In addition, volunteering must be free from undue coercion and this can include remuneration (payment). It is acceptable that participants receive compensation for time and travel expenses and this is discussed as part of the consent process. However, these should never be extended to excessive inducements. One must consider the impact of the nurse/doctor/researcher patient relationship on voluntariness. There are always careful considerations of vulnerable groups within research. The needs of vulnerable groups such as children, adults with learning difficulties, those who lack capacity or even prisoners are carefully considered. These vulnerable groups can only be included in a study if the research cannot be undertaken without them being included and as such are subject to extra provisions during the consent process. It could be argued that all patients within a healthcare relationship could be vulnerable. For example, a patient may say, ‘Whatever you think is best, nurse, if you think it’s good for me, then that’s fine by me’. This is a frequent
Having discussed information giving and voluntariness the next issue to be explored is competence. In order to achieve valid informed consent, the potential participants must demonstrate understanding of the study and what participation entails. Researchers spend a significant amount of time assessing this understanding during the consent process. The Mental Capacity Act (MCA) (2005) covers England and Wales and states that a person must be presumed to have capacity unless proven otherwise (see also The Adults with Incapacity (Scotland) Act). Complying with the MCA, researchers assess understanding and capacity using the following questions. Can the potential participant: ■■ Understand the information given to him/ her about the study? ■■ Retain that information long enough to be able to make a decision? ■■ Weigh up the information available to make that decision? ■■ Communicate his/her decision? If the potential participant has difficulties in any one of these areas he/she must be deemed not to have capacity at that time and as such cannot consent to participate in the research. This may exclude the patient from participating in the study if there is no specific
Non CTIMP trial
See also Medicines for Human Use (Clinical Trials) Amendment no. 2 Regulations (2006) 2006/2984
Mental Capacity Act (2005) ■ Research must be about the patient’s condition or treatment ■ Research cannot be carried out if confined to only those with capacity ■ Possible benefits not disproportionate to burden
If unable to give consent, who can be involved?
If unable to give consent, who can be involved?
Personal legal representative Suitable by virtue of the relationship to the adult i.e. family member ■ Professional legal representative A person who is NOT connected to the trial, for example a doctor who is responsible for medical treatment but not involved in the trial or a medic nominated by the healthcare provider ■
A legal representative can be asked to give consent on behalf of an adult lacking capacity to do so himself/herself.
Personal consultee Family member, carer (unpaid) or nominated third party ■ (e.g. lasting power of attorney) ■ Nominated consultee A person independent of the research appointed in accordance with the Department of Health guidance (e.g. independent mental capacity advocate (IMCA)) ■
Consultees are not asked to give consent on behalf of the adult, but rather to provide an opinion on the views and feelings of the potential participant.
*CTIMP: Clinical trial of an investigational medicinal product.
researchers must be fully conversant with all elements of the trial in order to discuss the requirements of participation in full. Whatever the type or design of research, consent in research should be considered a process rather than a one-off event. Figure 1 outlines this process and is typical of the steps researchers work through when a patient is approached to participate in research. This process may involve the researcher returning to the patient and/or family several times to discuss the research prior to consent being obtained and the consent form being signed. The researcher discusses the study in detail and answers any questions until all are satisfied with completeness of understanding. Alternatively, another method may involve information about a study being sent through the post where the potential participant reads the study information sheet and then telephones the research team for more information if they are interested in taking part. The researcher would then give more detailed information about the study and then arrange a mutually convenient time to meet to discuss further. After this, the potential participant may give agreement to take part in the study and sign the consent form. Once consent is obtained it is important to check this again at every visit. If involvement in a study involves several visits, it is important that the researcher reviews the research with the participant again and checks that he/she
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is happy to continue. This must be clearly documented.
demonstration of the underlying unequal distribution of power within the nurse-patient relationship. Here the patient may agree to whatever the ‘expert’ says. This must be at the forefront of all researchers’ minds, ensuring that the very nature of their relationship does not exert unintended pressure on potential participants. Researchers frequently hear, ‘If you think it’s going to be helpful then I’ll do it’ or ‘If it will help you with your numbers then I’ll do it’. This is not acceptable as valid informed consent because the patient does not demonstrate any understanding of the elements of the study. The potential of professional influence is also considered by research ethics committees to safeguard vulnerability. For example, is it acceptable for a heart surgeon to approach a patient about to undergo surgery to discuss taking part in his/her trial if that surgeon is the one who who is performing the operation? Would this influence the patient’s decision to take part? Would the patient feel like an unpopular person if he/she declined? Would he/she really believe that refusal would not affect his/her care in anyway? Voluntariness can only ever be demonstrated when a decision is made to take part in research without any coercion or influence.
Table 1. Research and consent with adults lacking capacity
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RESEARCH ethical approval to include those who lack capacity to consent for themselves. The Mental Capacity Act (2005) states that research with individuals (adults) who lack the capacity to consent must have the ethics of the research scrutinised and approved by an ‘appropriate body’. An ‘appropriate body’ is defined in law. In England, the ‘appropriate body’ is the research ethics committee recognised by the Secretary of State. In Wales, the ‘appropriate body’ must be a research ethics committee recognised by the Welsh Assembly Government. Approval to include participants who lack capacity to consent for themselves in research studies will only ever be given if the research cannot be undertaken without their inclusion, the research is about the patient’s condition (or treatment), and the possible benefits of participation are not disproportionate to burden or risk. If the research ethics committee has given approval to include patients lacking capacity to consent to research then provisions are made for another person to be approached (Table 1). This person is known as either a personal legal representative or a personal consultee. Depending on the trial design, a representative or consultee is approached to either give consent on behalf of the patient lacking capacity or to give an opinion that this is
something that the person would have wanted to do if he/she had capacity to consider it for himself/herself. If a personal representative or consultee is not available then a professional legal representative or nominated consultee can be approached. The researcher would approach these individuals to obtain valid informed consent (or approval via opinion) in exactly the same way, ensuring completeness of information, time to consider and decide without undue coercion and establishing understanding of what participation in the research would involve.
Summary Obtaining valid informed consent for research is a complex process spanning not only the initial point of consent to participate, but also continued consent to continue for the duration of the study. Obtaining valid informed consent is at the heart of ethical research practice and is underpinned by law. Researchers undergo specific training in this area to ensure that every participant has completeness of understanding of what participation involves and that they are free to withdraw their consent at any time. This article has highlighted some of the main issues in obtaining consent from adults for research participation, and recommended BJN resources for further reading.
Critiquing Nursing Research About the book
The fundamentals of the book, however, remain the same. It focuses specifically on critiquing nursing research and the increasing requirement for nurses to become conversant with research and understand its link with the use of evidence to underpin practice.
John Cutcliffe and Martin Ward
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 first, plus additional material on psychiatric research and critiquing nursing research when writing a dissertation. 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 all student nurses, teachers and academics.
About the authors
Dr John R. Cutcliffe holds the ‘David G. Braithwaite’ Professor of Nursing Endowed Chair at the University of Texas (Tyler); he is also an Adjunct Professor of Psychiatric Nursing at Stenberg 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 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 Co-ordinator of Mental Health Nursing Studies at the University of Malta and Chair of the Expert Panel of Horatio - European Psychiatric Nurses, based in the Netherlands. From 1995 to 2000 he held the post of Director of Mental Health for the 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. In 1997, both authors were instrumental in designing and launching the NPNR National Journal Club.
Very suitable as students have to undertake a dissertation where they critique three pieces of nursing research.
© 2014 MA Healthcare Ltd
ISBN 978-1-85642-316-8
9
Order your copies by visiting
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CritiquingNRes3.indd 1
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+44(0)1722 716 935
■ Adults
Lacking Capacity to Consent to Research. Online course from University of Leicester and University of Bristol■ https://connect.le.ac.uk/alctoolkit/ C (2008) Conducting research with people not having the capacity to consent to their participation: a practical guide for researchers. British Psychological Society. http://tinyurl.com/nlmdwq9 (accessed 28 May 2014)
■ Dobson
of Health (2005) Research Governance Framework for Health and Social Care. 2nd edn. http://tinyurl.com/pu9t6pm (accessed 28 May 2014)
■ Department
Conflict of interest: none. Beauchamp TL, Childress JF (2009) Principles of Biomedical Ethics, 6th edn. Oxford University Press, Oxford Department of Health (2006) Best Research for Best Health. A new national health research strategy. http://tinyurl.com/blbltek (accessed 28 May 2014) Hardicre J (2013) An exploration of the role of the research nurse and its impact. Br J Nurs 22(3): 168-9 International Conference on Harmonisation (1996) Guidelines for Good Clinical Practice E6(R1). http://tinyurl.com/4duczor (accessed 28 May 2014) National Institute for Health Research (2013) Figures show “new high” in NHS patients participating in clinical research. http://tinyurl.com/kxryg2w (accessed 28 May 2014) Parahoo K (2006) Nursing Research: Principles, Process and Issues. 2nd edn. Palgrave Macmillan,Basingstoke Royal College of Nursing (2011) Informed consent in health and social care research. RCN guidance for nurses. 2nd edn. http:// tinyurl.com/3733msm
Critiquing Nursing Research 2nd edition
John Cutcliffe and Martin Ward Foreword by Professor Kevin Gournay John Cutcliffe and Martin Ward
ISBN-13: 978-1-85642-316-8; 234 x 156 mm; paperback; 244 pages; publication November 2006; £25.99
Critiquing Nursing Research
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 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.
Useful websites and sources of further reading
The new and updated edition of the best-selling book 25/03/2011 09:41
British Journal of Nursing, 2014, Vol 23, No 11
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‘A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form’ (ICH, GCP E6 1.28) Parahoo (2006) offers a similar definition as: ‘The process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits.’ (Parahoo, 2006) Nurses are accountable for their professional practice and should always act in the best interests of patients, clients and research participants. The key principle in obtaining informed consent to research is to put the potential participant’s needs first (Royal College of Nursing, 2011). In order for a patient or subject to take part in a research Jayne Hardicre is Lecturer in Nursing, Adult Specialty, University of Salford Accepted for publication: May 2014
564
Box 1. Twenty elements of valid informed consent Based on International Conference on Harmonisation for Good Clinical Practice E6 (R1) 1996 (Section 4.8.10) ■■ That
the trial involves research (i.e. we don’t know the answer) purpose of the trial ■■ The trial treatment(s) and possible randomisation to treatment options (if applicable) ■■ The trial procedures ■■ Participant responsibilities ■■ Which aspects of the trial are experimental ■■ The reasonably foreseeable risks of participation ■■ The reasonably expected benefits. If there are none you must make them aware of this ■■ The alternative procedure(s) or course(s) of treatment and their potential benefits and risks ■■ Compensation and/or treatment available to the participant in the event of trial-related injury ■■ Pro-rata payments, if any, to the participant for taking part in the trial ■■ Anticipated expense payments, if any, to the participant for taking part in the trial ■■ Participation is voluntary and that he/she may refuse to participate or withdraw from the trial at any time ■■ Must agree that regulatory authority(ies), study monitors or auditors may access the original medical records for verification of clinical trial procedures ■■ That records identifying the participant will be kept confidential and the publication will not reveal their identity ■■ That the participant or legally acceptable representative will be informed of new information relevant to participation in the trial ■■ Contact details of a person or team to contact for further information and advice ■■ The circumstances and/or reasons why participation in the trial may be terminated ■■ The expected duration of participation ■■ The approximate number of people being recruited into the trial. ■■ The
study he/she must give explicit consent and this consent can only be obtained following a full and comprehensive discussion about the study including the risks and benefits of taking part.This is called valid informed consent.This article will discuss some of the complexities of valid informed consent in research involving adults and how researchers achieve this in practice. The term ‘research participant’ will be used throughout this paper to embrace other descriptors such as research patient or subject.
Research in the NHS Research is essential to the provision and development of effective, efficient and safe health and social care. New treatments, medicines, regimens, practices and services are developed through research. Put simply, research underpins where we are today and will inform what we do tomorrow (Hardicre, 2013).
Research is now regarded as core NHS business (Department of Health (DH), 2006). A report released by the National Institute for Health Research (NIHR) in 2013 indicated that 99% of NHS Trusts in England now actively engage in clinical research with 630 000 NHS patients taking part in research in 2012 (NIHR, 2013). Clinical research would not be possible at all if it were not for the hundreds of thousands of patients who volunteer their time, bodies and minds to it. Research nurses and allied health professionals (AHPs) put huge efforts put into maximising research participants’ experience while also protecting their safety and rights throughout the whole of the research journey.
Valid informed consent Respect for the patients’ right to choose and make an informed choice is at the core of ethical research and clinical practice. Whether consent
© 2014 MA Healthcare Ltd
T
he process of informed consent is at the very heart of ethical research practice and underpins the design and management of research and clinical trials. Informed consent is essential to protect the rights and safety of patients in research and is the major consideration when ethical and institutional approvals are granted prior to studies being undertaken. There are many definitions of informed consent as applied to research and many have their routes in the guidelines of the International Conference on Harmonisation (ICH) for Good Clinical Practice (ICH, 1996):
British Journal of Nursing, 2014, Vol 23, No 11
British Journal of Nursing.Downloaded from magonlinelibrary.com by 193.061.135.034 on April 29, 2015. For personal use only. No other uses without permission. . All rights reserved.
RESEARCH
Invitation to participate
Time to consider
Discussion with patient (and family)
Assess understanding of what is involved
Agreement to participate, consent given
Consent to continue prior to and at every contact
Figure 1. The consent process in research
is being sought for clinical or research purposes, it is clear that patients need information in order to make an informed choice. At its most basic level there are three elements of consent (Beauchamp and Childress, 2009): ■■ Adequate information: full information about the research so that the patients know exactly what they are consenting to ■■ Voluntariness: an understanding that they are under no obligation to agree to take part and if they do decide to take part they are free to withdraw at any time ■■ Competence: that the patient is capable of understanding what participation entails and has the capacity to make a free and informed choice. It should be recognised at this point that there are differences between consenting for clinical care and consenting for research participation. Obtaining consent for clinical care is to benefit an individual patient and this care is underpinned by a body of evidence. By contrast, when a patient consents to participate in research, this is undertaken to develop this body of evidence for future patients and may not be of any direct benefit to the participant himself/herself. It is being undertaken because we don’t yet have the answers or because we don’t know which method or treatment is best. This is sometimes referred to as ‘clinical equipoise’, a state of genuine uncertainty as to the advantages or disadvantages of each treatment option in a clinical trial. The following sections will briefly discuss each of the three elements to consent in relation to consent for clinical research.
© 2014 MA Healthcare Ltd
Adequate information There are many types of research a patient may be approached to participate in.These can range from simple non-sensitive surveys to early-stage drug trials.What is common between the two is the depth of information required for potential participants when considering whether or not this is something they would wish to volunteer themselves for. The ICH (1996) outlined the 20 elements of valid informed consent for clinical trials (Box 1).These 20 elements should
British Journal of Nursing, 2014, Vol 23, No 11
be included in participant information sheets (the information sheets about the research) and should also be discussed with the potential participant. Although initially developed for the more complex clinical trials, these 20 elements can also underpin other research designs or methods to ensure completeness of information. Research ethics committees review all participant information sheets and trial-related documents to ensure that the information included accurately reflects all elements of research, making sure the potential participants will be fully aware of: ■■ What the research is about ■■ Why it is being done ■■ What the purpose of the study is and what will happen to the results ■■ What will be expected of them if they agree to participate ■■ How long they will be required to participate in the study ■■ What the risks of participation could be and any potential benefits ■■ That information about them will remain confidential and anonymous ■■ That they do not have to participate and that if they do agree they are free to withdraw at any time. It is important that all participant information sheets and research-related information be comprehensive yet written in non-technical language to aid understanding. They should be as free from jargon as possible and should never include abbreviations. There are many patient and public involvement groups interested in the development of research. In addition to being involved in the identification of research priorities, it may also be possible for researchers to ask the groups to consider the participant information sheets to check for completeness of understanding. Also of use are readability tools such as the SMOG index (simplified measure of gobbledygook). The National Institute of Adult Continuing Education (NIACE) provides useful resources on this including a SMOG calculator (http:// tinyurl.com/mt36p8l). There is often a discussion about how
much time should be given to allow for valid informed consent. This is an important factor from the patient’s point of view but is also dictated by the type of research itself. The research protocol will outline this time allocation and can range from hours to months. If, for example, the research involves emergency situations, such as patients admitted to accident and emergency with trauma or stroke, and the research involves the trial of a drug to be administered within the first 3 hours of admission, then this clearly dictates the time a patient or family has to consider participation (Box 2). At the other end of the spectrum, a study may be investigating the experiences of childbirth using focus groups. The research design may be such that a mother can be approached via her midwife and could have up to 3 months to consider participation. The time allowed prior to consent is also examined carefully by research ethics committees who ensure that the time allocated is indeed appropriate for the research design and aims, thus allowing maximal available time for consideration. The Box 2. Consent in emergency situations Emergency research poses its own set of challenges in terms of providing information about research and obtaining valid informed consent. Emergency research is when: needs to be given urgently, and ■■ It is necessary to take urgent action for the purposes of the study. ■■ Treatment
In some emergency situations: ■■ Potential participants may lack capacity to give consent themselves ■■ Obtaining consent from a legal representative/consulting others is not reasonably practicable. Further guidance on this specific research area is provided by the Health Research Authority and Medical Research Council: ■ http://tinyurl.com/qhh3are
565
British Journal of Nursing.Downloaded from magonlinelibrary.com by 193.061.135.034 on April 29, 2015. For personal use only. No other uses without permission. . All rights reserved.
CTIMP*
trial
Medicines for Human Use (Clinical trial) Regulations (2004) ■ Must have specific reasons for inclusion ■ Direct benefit outweighs foreseeable risk
Voluntariness
Competence
It is important that potential participants understand that that taking part in a study is voluntary and that if they do decide to take part that they can withdraw their participation at any time without any impact on their quality of care. In addition, volunteering must be free from undue coercion and this can include remuneration (payment). It is acceptable that participants receive compensation for time and travel expenses and this is discussed as part of the consent process. However, these should never be extended to excessive inducements. One must consider the impact of the nurse/doctor/researcher patient relationship on voluntariness. There are always careful considerations of vulnerable groups within research. The needs of vulnerable groups such as children, adults with learning difficulties, those who lack capacity or even prisoners are carefully considered. These vulnerable groups can only be included in a study if the research cannot be undertaken without them being included and as such are subject to extra provisions during the consent process. It could be argued that all patients within a healthcare relationship could be vulnerable. For example, a patient may say, ‘Whatever you think is best, nurse, if you think it’s good for me, then that’s fine by me’. This is a frequent
Having discussed information giving and voluntariness the next issue to be explored is competence. In order to achieve valid informed consent, the potential participants must demonstrate understanding of the study and what participation entails. Researchers spend a significant amount of time assessing this understanding during the consent process. The Mental Capacity Act (MCA) (2005) covers England and Wales and states that a person must be presumed to have capacity unless proven otherwise (see also The Adults with Incapacity (Scotland) Act). Complying with the MCA, researchers assess understanding and capacity using the following questions. Can the potential participant: ■■ Understand the information given to him/ her about the study? ■■ Retain that information long enough to be able to make a decision? ■■ Weigh up the information available to make that decision? ■■ Communicate his/her decision? If the potential participant has difficulties in any one of these areas he/she must be deemed not to have capacity at that time and as such cannot consent to participate in the research. This may exclude the patient from participating in the study if there is no specific
Non CTIMP trial
See also Medicines for Human Use (Clinical Trials) Amendment no. 2 Regulations (2006) 2006/2984
Mental Capacity Act (2005) ■ Research must be about the patient’s condition or treatment ■ Research cannot be carried out if confined to only those with capacity ■ Possible benefits not disproportionate to burden
If unable to give consent, who can be involved?
If unable to give consent, who can be involved?
Personal legal representative Suitable by virtue of the relationship to the adult i.e. family member ■ Professional legal representative A person who is NOT connected to the trial, for example a doctor who is responsible for medical treatment but not involved in the trial or a medic nominated by the healthcare provider ■
A legal representative can be asked to give consent on behalf of an adult lacking capacity to do so himself/herself.
Personal consultee Family member, carer (unpaid) or nominated third party ■ (e.g. lasting power of attorney) ■ Nominated consultee A person independent of the research appointed in accordance with the Department of Health guidance (e.g. independent mental capacity advocate (IMCA)) ■
Consultees are not asked to give consent on behalf of the adult, but rather to provide an opinion on the views and feelings of the potential participant.
*CTIMP: Clinical trial of an investigational medicinal product.
researchers must be fully conversant with all elements of the trial in order to discuss the requirements of participation in full. Whatever the type or design of research, consent in research should be considered a process rather than a one-off event. Figure 1 outlines this process and is typical of the steps researchers work through when a patient is approached to participate in research. This process may involve the researcher returning to the patient and/or family several times to discuss the research prior to consent being obtained and the consent form being signed. The researcher discusses the study in detail and answers any questions until all are satisfied with completeness of understanding. Alternatively, another method may involve information about a study being sent through the post where the potential participant reads the study information sheet and then telephones the research team for more information if they are interested in taking part. The researcher would then give more detailed information about the study and then arrange a mutually convenient time to meet to discuss further. After this, the potential participant may give agreement to take part in the study and sign the consent form. Once consent is obtained it is important to check this again at every visit. If involvement in a study involves several visits, it is important that the researcher reviews the research with the participant again and checks that he/she
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is happy to continue. This must be clearly documented.
demonstration of the underlying unequal distribution of power within the nurse-patient relationship. Here the patient may agree to whatever the ‘expert’ says. This must be at the forefront of all researchers’ minds, ensuring that the very nature of their relationship does not exert unintended pressure on potential participants. Researchers frequently hear, ‘If you think it’s going to be helpful then I’ll do it’ or ‘If it will help you with your numbers then I’ll do it’. This is not acceptable as valid informed consent because the patient does not demonstrate any understanding of the elements of the study. The potential of professional influence is also considered by research ethics committees to safeguard vulnerability. For example, is it acceptable for a heart surgeon to approach a patient about to undergo surgery to discuss taking part in his/her trial if that surgeon is the one who who is performing the operation? Would this influence the patient’s decision to take part? Would the patient feel like an unpopular person if he/she declined? Would he/she really believe that refusal would not affect his/her care in anyway? Voluntariness can only ever be demonstrated when a decision is made to take part in research without any coercion or influence.
Table 1. Research and consent with adults lacking capacity
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RESEARCH ethical approval to include those who lack capacity to consent for themselves. The Mental Capacity Act (2005) states that research with individuals (adults) who lack the capacity to consent must have the ethics of the research scrutinised and approved by an ‘appropriate body’. An ‘appropriate body’ is defined in law. In England, the ‘appropriate body’ is the research ethics committee recognised by the Secretary of State. In Wales, the ‘appropriate body’ must be a research ethics committee recognised by the Welsh Assembly Government. Approval to include participants who lack capacity to consent for themselves in research studies will only ever be given if the research cannot be undertaken without their inclusion, the research is about the patient’s condition (or treatment), and the possible benefits of participation are not disproportionate to burden or risk. If the research ethics committee has given approval to include patients lacking capacity to consent to research then provisions are made for another person to be approached (Table 1). This person is known as either a personal legal representative or a personal consultee. Depending on the trial design, a representative or consultee is approached to either give consent on behalf of the patient lacking capacity or to give an opinion that this is
something that the person would have wanted to do if he/she had capacity to consider it for himself/herself. If a personal representative or consultee is not available then a professional legal representative or nominated consultee can be approached. The researcher would approach these individuals to obtain valid informed consent (or approval via opinion) in exactly the same way, ensuring completeness of information, time to consider and decide without undue coercion and establishing understanding of what participation in the research would involve.
Summary Obtaining valid informed consent for research is a complex process spanning not only the initial point of consent to participate, but also continued consent to continue for the duration of the study. Obtaining valid informed consent is at the heart of ethical research practice and is underpinned by law. Researchers undergo specific training in this area to ensure that every participant has completeness of understanding of what participation involves and that they are free to withdraw their consent at any time. This article has highlighted some of the main issues in obtaining consent from adults for research participation, and recommended BJN resources for further reading.
Critiquing Nursing Research About the book
The fundamentals of the book, however, remain the same. It focuses specifically on critiquing nursing research and the increasing requirement for nurses to become conversant with research and understand its link with the use of evidence to underpin practice.
John Cutcliffe and Martin Ward
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 first, plus additional material on psychiatric research and critiquing nursing research when writing a dissertation. 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 all student nurses, teachers and academics.
About the authors
Dr John R. Cutcliffe holds the ‘David G. Braithwaite’ Professor of Nursing Endowed Chair at the University of Texas (Tyler); he is also an Adjunct Professor of Psychiatric Nursing at Stenberg 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 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 Co-ordinator of Mental Health Nursing Studies at the University of Malta and Chair of the Expert Panel of Horatio - European Psychiatric Nurses, based in the Netherlands. From 1995 to 2000 he held the post of Director of Mental Health for the 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. In 1997, both authors were instrumental in designing and launching the NPNR National Journal Club.
Very suitable as students have to undertake a dissertation where they critique three pieces of nursing research.
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ISBN 978-1-85642-316-8
9
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■ Adults
Lacking Capacity to Consent to Research. Online course from University of Leicester and University of Bristol■ https://connect.le.ac.uk/alctoolkit/ C (2008) Conducting research with people not having the capacity to consent to their participation: a practical guide for researchers. British Psychological Society. http://tinyurl.com/nlmdwq9 (accessed 28 May 2014)
■ Dobson
of Health (2005) Research Governance Framework for Health and Social Care. 2nd edn. http://tinyurl.com/pu9t6pm (accessed 28 May 2014)
■ Department
Conflict of interest: none. Beauchamp TL, Childress JF (2009) Principles of Biomedical Ethics, 6th edn. Oxford University Press, Oxford Department of Health (2006) Best Research for Best Health. A new national health research strategy. http://tinyurl.com/blbltek (accessed 28 May 2014) Hardicre J (2013) An exploration of the role of the research nurse and its impact. Br J Nurs 22(3): 168-9 International Conference on Harmonisation (1996) Guidelines for Good Clinical Practice E6(R1). http://tinyurl.com/4duczor (accessed 28 May 2014) National Institute for Health Research (2013) Figures show “new high” in NHS patients participating in clinical research. http://tinyurl.com/kxryg2w (accessed 28 May 2014) Parahoo K (2006) Nursing Research: Principles, Process and Issues. 2nd edn. Palgrave Macmillan,Basingstoke Royal College of Nursing (2011) Informed consent in health and social care research. RCN guidance for nurses. 2nd edn. http:// tinyurl.com/3733msm
Critiquing Nursing Research 2nd edition
John Cutcliffe and Martin Ward Foreword by Professor Kevin Gournay John Cutcliffe and Martin Ward
ISBN-13: 978-1-85642-316-8; 234 x 156 mm; paperback; 244 pages; publication November 2006; £25.99
Critiquing Nursing Research
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 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.
Useful websites and sources of further reading
The new and updated edition of the best-selling book 25/03/2011 09:41
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