RESEARCH
An overview of research ethics and learning from the past Jayne Hardicre
R
esearch is essential to the development and improvement of health care. It is essential to our healthcare delivery, services, programmes, treatments and techniques. Without research, we would sit in status quo, we would not have an empirical body of evidence underpinning our practice, services or commissioning. Put simply, without research we would never move forward nor would we be able to assess the effectiveness and efficiency of what we actually do now. Research is now considered core NHS business (Department of Health (DH), 2006) with many health professionals enjoying the excitement and challenges of a variety of research-related careers. The National Institute for Health Research (NIHR) network is the clinical research delivery arm of the NHS. A report released in 2013 by the NIHR showed that more than 630 000 NHS patients in England took part in clinical research in 2012 with 99% of NHS Trusts in England now actively engaged in research (NIHR, 2013). Of course, research participants are central to this success. Research participants offer their time voluntarily, often without any gain to themselves, and often under the most trying of personal circumstances. Clinical research nurses and allied health professionals (AHPs) strive to undertake high-quality research while maximising research patients’ experience. They must ensure that high-quality data is captured while protecting the patients from harm (Hardicre, 2014). This paper will explore the ethics of clinical research with a focus on protecting patients from harm.
What is ‘research ethics’?
important that any risks are minimised and do not compromise the dignity, rights, safety and wellbeing of the people who consent to take part (DH, 2011). Ethical research practice is fundamental to this aim. Research incorporates a variety of designs, methodologies and complexities. It can range from the simplest of questionnaires to the testing of first-in-man ‘medicinal products’, and the risks to the participant are clearly very different between these two. Long and Johnson (2007) argue that all research could be potentially harmful to patients, whether it be through the testing of new drugs or devices or by seeking evidence about sensitive topics. Either of these could cause inadvertent emotional distress and potential damage to the participant (Royal College of Nursing (RCN), 2009). Human research also involves a wide variety of target populations, some of which are vulnerable, lack full competence to consent or may form part of a population associated with heightened risks. Research ethics are a set of moral principles informing and guiding research practice. Research ethics have a particular focus on ethical issues that may be raised when involving humans as research participants. There are many research ethics codes available and most broadly concentrate on the following main themes or principles: ■■ Protecting the participant
© 2014 MA Healthcare Ltd
Accepted for publication: April 2014
British Journal of Nursing, 2014, Vol 23, No 9
a high standard of research and reforming research with ethical integrity and soundness, such as the process of informed consent, protection of confidentiality and the management of risk ■■ Ensuring transparency of the whole research process (Figure 1). ■■ Planning
Research ethics and legislation Sadly, research ethics has not always underpinned the practice of researchers or that of institutions. This section will briefly outline some of the most infamous unethically performed examples of research leading to the development of the ethical codes of practice we have in place today.
Nazi human experimentation (WWII) Following the Second World War, at the Nuremberg trials held in 1945, it was revealed that countless experiments were performed on prisoners in the Nazi concentration camps by members of the medical profession. Many of the experiments were designed to help the German military in combat situations. There are too many torturous experiments to describe within this article but the results of the experiments were commonly death, disfigurement or permanent disability. Of those who survived this medical torture, many were then killed in order to further examine the effects of their work at post mortem.
Generate a research idea
Develop research hypothesis/ question/aims
Design study
Obtain relevant ethical & institutional approvals
Disseminate results
Write research report
Analyse the data
Conduct the study
While research is essential for improving and developing effective healthcare services, it can sometimes involve an element of risk because it may involve trying something new. It is Jayne Hardicre is Lecturer in Nursing, Adult Specialty, University of Salford and Research Ethics Committee Member, Salford.
■■ Conducting
Figure 1. Simplified stages of the research process
483
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
Tuskegee Syphilis Study 1932–1972 The Tuskegee Syphilis study has become notoriously known as a racist and unethical medical experiment involving AfricanAmerican males. It ran from 1932 to 1972 with over 600 participants. Of these, 399 had syphilis while 201 were free from syphilis. All participants were from a poor socioeconomic group and had low educational levels. For taking part in the study, the men were given hot meals, medical insurance for simple treatments and free burial insurance. The men were not told they had syphilis but were informed they had ‘bad blood’. The men attended clinics for blood sampling and were given what they thought was treatment for their bad blood but were actually given aspirin, placebos or vitamin tablets. Even after 1947 when penicillin became the standard treatment of choice, none of the men received it. After a public outcry in 1972, the study was stopped at which point only 74 of the 399 participants who were diagnosed as having syphilis were still alive. Of those 325 men who died, 28 had died of syphilis, 100 died of related complications, 40 of their wives
had been infected and 19 of their children were born with congenital syphilis. This men in this vulnerable group were coerced into participating in this experiment and were denied the truth when agreeing to take part. The researchers were dishonest and denied the men both their diagnosis and the standard treatment for syphilis. When this was released in 1947, the researchers continued to observe the effects of untreated syphilis.
The Willowbrook Study The Willowbrook Study was conducted within a State School for children with learning disabilities between 1963 and 1966. The purpose of the study was to study hepatitis when left untreated and also to investigate the effects of gamma globulin as a treatment. At the time, the school already had a problem with hepatitis with some children having been diagnosed. Although the institution was said to be closed to new incoming students as a result of overcrowding, in truth, it only took on children whose mothers agreed to them participating in the research study. This may have added influence to the parents’ decisions to sign consent forms, particularly because there was nowhere else for the children to go to at that time. Reports include allegations that the innocent children were deliberately infected with the hepatitis virus. In the earlier stages of the study, children were fed extracts of stools from known infected children and, later, children were injected with the virus. After a period of observation where researchers studied the
Box 1. Nuremberg Code 1947 ■■ Obtaining
voluntary, informed consent is essential. The research participant must be fully informed of all aspects of the research to enable him or her to make a fully informed decision as to whether or not to take part ■■ The research should be to obtain results which are for the good of society, not unnecessary in nature and not obtainable by other means ■■ The research should be based upon a prior knowledge of the history of the disease or problem under study (including animal research) and the results should justify the research being undertaken ■■ The study should be conducted as to avoid all unnecessary physical or mental suffering and injury ■■ No experiment should be conducted, where there is an apriori reason to believe that death or disabling injury will occur ■■ The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment ■■ Proper preparations should be made and adequate facilities provided to protect the participant against risks of injury, disability, or death ■■ The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the research study ■■ The participant is able to withdraw from the study at any time ■■ During the course of the study, the scientist in charge must be prepared to terminate the research, if he has probable cause to believe that a continuation of the study is likely to result in injury, disability, or death to the experimental subject Source: Nuernberg Military Tribunals, 1949
484
disease when left untreated, children were then injected with the developing vaccine. While this study did in fact help to develop the hepatitis vaccine, it created public outcry as a result of highly vulnerable children being infected with hepatitis. Many questioned the amount of information actually given to the parents before they gave consent for their child to participate in the trial and also how much their decision was influenced by being offered a place within the school. This study is still heavily debated with the researchers adding that most of the children would have contracted hepatitis anyway. What this, and the other two studies described in this article, did raise was the need for the protection of the right of human subjects.
Moving forward Looking back at the history of research and clinical trials, many examples of unethical research can be found. So what did we learn from them? The three examples described within this article highlight problems with consent, coercion, targeting vulnerable groups, dishonesty and a lack of regard for human rights. It was clear that ethical codes needed to be developed to underpin research practice and this started with the development of the Nuremberg Code of 1947 following the Nuremberg trials (Box 1). This became the foundation of the many later codes that were developed giving guidance and assurance that research involving human subjects would be conducted in an ethical manner. Central to The Nuremberg Code of 1947 was the need to obtain voluntary, informed consent: ‘The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision’. (Nuernberg Military Tribunals, 1949) The ethical principles outlined in the Nuremberg Code were then further elaborated upon by the World Medical Association
© 2014 MA Healthcare Ltd
None of those who were experimented on gave their consent and all could be classed as vulnerable. There was abuse of all moral codes and large-scale disregard of many ethical principles with a complete disregard for mankind. During the Nuremberg Trial, several of the doctors argued that there was no international law regarding human experimentation.
British Journal of Nursing, 2014, Vol 23, No 9
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
RESEARCH
© 2014 MA Healthcare Ltd
(WMA) in 1964 with the development of the Declaration of Helsinki. This declaration is updated regularly with the latest revision being The Declaration of Helsinki: ethical principles for medical research involving human subjects (WMA, 2013). The Declaration of Helsinki outlines essential ethical principles for medical research involving human subjects and is regarded as the most important document in the history of research ethics. It is cited in most major guidelines and in various research regulations in over a dozen countries. It is such an important document and it is often recommended that it is read in full if you are engaged in the development and management of research studies and clinical trials. The Declaration of Helsinki was later embraced by the International Conference on Harmonisation guidelines for Good Clinical Practice (ICH-GCP) (ICH, 1996). Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and wellbeing of trial subjects are protected, and that the results of the clinical trials are credible and accurate (Medicines and Healthcare products Regulatory Agency (MHRA), 2014). Many researchers now must be ICH-GCP trained and, as such, this further embeds the ethical principles of research, the protection of participants from harm and the development of high-quality research into the national research agenda. There are many other influences driving ethically sound clinical research practice. These are outlined in Figure 2. The Research Governance Framework for Health and Social Care (DH, 2005) sets out the broad principles for good research governance. While this may not be an ethical code itself, it is built upon and further expands essential elements of good clinical practice (in research) and is another important framework guiding the conduct, performance and quality of NHS research. Also of great important is Good Research Practice: principles and guidelines (Medical Research Council (MRC), 2012) primarily developed for MRC researchers but very useful to other researchers as well.
Maintaining ethical research practice Having discussed the importance of ethical codes of practice and some of the important ethical codes and guidelines driving ethical practice, it is now important to see how
British Journal of Nursing, 2014, Vol 23, No 9
these are a embedded within research in the NHS. Research involving human subjects, let’s call them patients, in the NHS requires strict approval, governance and monitoring. A researcher cannot write a study protocol and then go ahead and recruit patients into their study without a strict set of assessments and approvals in place. This process is often regarded as lengthy and long-winded but at the end of the day, these steps are in place to protect our patients from harm while maximising the quality of the research undertaken. All research involving NHS patients must receive a favourable opinion from an NHS Research Ethics Committee (REC). There are currently more than 80 RECs across the UK, each consisting of up to 18 members, onethird of whom are lay members. They review research applications and give their opinion about the proposed participant involvement and whether or not they feel it is ethical. Their role is to safeguard the rights, safety, dignity
and wellbeing of research participants. REC members spend many hours reading research ethical approval applications individually and then spend additional time together as a committee debating the same. All NHS trusts also have their own research and development (R&D) department. Without their local approval, even with a favourable opinion from an ethics committee, a study would not be able to proceed. Applications must be sought for R&D approval in order for the research study to begin. In addition to this, dependent on the trial and what is being investigated or tested, there may also be the requirement for approval from the MHRA. The intricacies and complexities of research applications and approvals will be discussed in more detail in future article within this series but what can be seen here is that at the centre of these processes are the patients themselves. On a very basic level, the work behind all of these codes, guidelines and recommendations is the protection of patients participating in
ICH-GCP
Medicines and Healthcare products Regulatory Agency
Nuremberg Code
Royal College of Nursing
Medical Research Council
Research Governance Framework
NHS Research Governance
Research Participant
National Institute for Health Research
Laws, Statutory Instruments University Codes of Ethical Practice
Researcher as patient advocate Health Research Authority
Declaration of Helsinki
Figure 2. Some of the influences driving ethical research practice ICH-GCP = International Conference on Harmonisation: Good Clinical Practice
485
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
research and the maximisation of the quality of the research through to its publication. It is not within the scope of this article to discuss the multilayers of laws and statutes involved in research, which also exist to safeguard and protect but they do cut through many of the recommendations and approvals required prior to any research getting beyond the proposal stage of development.
Summary This article has introduced the reader to research ethics. In order to show the development of the codes of ethics and guidelines in use today, it has briefly reviewed the most infamous unethical research studies. Learning from these traumatic and often cruel moments in history gave impetus to the development of international ethical guidelines, driving research conduct and protecting the rights and safety of those participating in studies today. Research within the NHS would not exist without the hundreds of thousands of patients
Pioneering Theories in Nursing 781856 424004
Austyn Snowden, Allan Donnell, Tim Duffy
ISBN 1-85642-400-6
who volunteer their time and indeed their ‘selves’ to research. Researchers have a duty to those patients, to treat them with the dignity, respect and care they would afford any patient. In addition to serving as researchers, they must also must act as patient advocates to ensure that every stage of the research process embraces all elements of ethical codes and frameworks— and patients should expect nothing less. BJN Conflict of interest: none The main points of the Nuremberg Code 1947 can be accessed at http://tinyurl.com/pqkxpek The British Psychological Society (2010) Code of Human Research Ethics. http://tinyurl.com/6zlqw6s (accessed 25 April 2014) Department of Health (2005) Research Governance Framework for Health and Social Care, 2nd edn. DH, London. http://tinyurl.com/cupej9z (accessed 25 April 2014) Department of Health (2006) Best Research for Best Health. A new national health research strategy. http:// tinyurl.com/blbltek (accessed 25 April 2014) Department of Health (2011) Governance arrangements for research ethics committees: A harmonised edition.
DH, London. http://tinyurl.com/ow2z8b3 (accessed 25 April 2014) Hardicre J (2014) Embedding the 6 Cs into clinical research practice and management. Br J Nurs 23(7): 365-7 International Conference on Harmonisation (1996) Guideline for Good Clinical Practice E6(R1). http:// tinyurl.com/4duczor (accessed 25 April 2014) Long T, Johnson M, eds (2007) Research ethics in the real world: issue and solutions for health and social care. Churchill Livingstone, London Medicines and Healthcare products Regulatory Agency (2014) Good Clinical Practice: Background. http:// tinyurl.com/os443bo (accessed 25 April 2014) Medical Research Council (2012) Good research practice: Principles and guidelines. http://tinyurl.com/7dqbn6u (accessed 25 April 2014) Nuernberg Military Tribunals (1949) Trials of War Criminals before the Nuernberg Military Tribunals Tribunals under Control Council Law No. 10. Volume II, Nuernberg, October 1946-April 1949. U.S. Government Printing Office, Washington: 181-2. http://tinyurl.com/m4qs4dy (accessed 25 April 2014) National Institute for Health Research (2013) Figures show “new high” in NHS patients participating in clinical research. http://tinyurl.com/kxryg2w (accessed 25 April 2014) Royal College of Nursing (2009) Research ethics: RCN guidance for nurses, 3rd edn. http://bit.ly/1eCnbZy (accessed 25 April 2014) World Medical Association (2013) WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. http://tinyurl.com/ cf6rwem (accessed 25 April 2014)
PIONEERING Pioneering THEORIES IN NURSING Theories in Nursing Austyn Snowden, Allan Donnell, Tim Duffy Fascinating reading outlining and discussing the main theories and practice of nursing Easy to read format with each chapter presenting biographical profiles Text encourages reflective thinking on nursing theories and their contribution to current nursing practice
Austyn Snowden, Allan Donnell, Tim Duffy
ISBN-13: 978-1-85642-400-4; ISBN-10: 978-1-85642-4006; 297 x 210 mm; paperback; 220 pages; publication April 2010; £19.99
16/3/10 11:47:34
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© 2014 MA Healthcare Ltd
Foreword by Sir George Castledine
British Journal of Nursing, 2014, Vol 23, No 9
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
An overview of research ethics and learning from the past Jayne Hardicre
R
esearch is essential to the development and improvement of health care. It is essential to our healthcare delivery, services, programmes, treatments and techniques. Without research, we would sit in status quo, we would not have an empirical body of evidence underpinning our practice, services or commissioning. Put simply, without research we would never move forward nor would we be able to assess the effectiveness and efficiency of what we actually do now. Research is now considered core NHS business (Department of Health (DH), 2006) with many health professionals enjoying the excitement and challenges of a variety of research-related careers. The National Institute for Health Research (NIHR) network is the clinical research delivery arm of the NHS. A report released in 2013 by the NIHR showed that more than 630 000 NHS patients in England took part in clinical research in 2012 with 99% of NHS Trusts in England now actively engaged in research (NIHR, 2013). Of course, research participants are central to this success. Research participants offer their time voluntarily, often without any gain to themselves, and often under the most trying of personal circumstances. Clinical research nurses and allied health professionals (AHPs) strive to undertake high-quality research while maximising research patients’ experience. They must ensure that high-quality data is captured while protecting the patients from harm (Hardicre, 2014). This paper will explore the ethics of clinical research with a focus on protecting patients from harm.
What is ‘research ethics’?
important that any risks are minimised and do not compromise the dignity, rights, safety and wellbeing of the people who consent to take part (DH, 2011). Ethical research practice is fundamental to this aim. Research incorporates a variety of designs, methodologies and complexities. It can range from the simplest of questionnaires to the testing of first-in-man ‘medicinal products’, and the risks to the participant are clearly very different between these two. Long and Johnson (2007) argue that all research could be potentially harmful to patients, whether it be through the testing of new drugs or devices or by seeking evidence about sensitive topics. Either of these could cause inadvertent emotional distress and potential damage to the participant (Royal College of Nursing (RCN), 2009). Human research also involves a wide variety of target populations, some of which are vulnerable, lack full competence to consent or may form part of a population associated with heightened risks. Research ethics are a set of moral principles informing and guiding research practice. Research ethics have a particular focus on ethical issues that may be raised when involving humans as research participants. There are many research ethics codes available and most broadly concentrate on the following main themes or principles: ■■ Protecting the participant
© 2014 MA Healthcare Ltd
Accepted for publication: April 2014
British Journal of Nursing, 2014, Vol 23, No 9
a high standard of research and reforming research with ethical integrity and soundness, such as the process of informed consent, protection of confidentiality and the management of risk ■■ Ensuring transparency of the whole research process (Figure 1). ■■ Planning
Research ethics and legislation Sadly, research ethics has not always underpinned the practice of researchers or that of institutions. This section will briefly outline some of the most infamous unethically performed examples of research leading to the development of the ethical codes of practice we have in place today.
Nazi human experimentation (WWII) Following the Second World War, at the Nuremberg trials held in 1945, it was revealed that countless experiments were performed on prisoners in the Nazi concentration camps by members of the medical profession. Many of the experiments were designed to help the German military in combat situations. There are too many torturous experiments to describe within this article but the results of the experiments were commonly death, disfigurement or permanent disability. Of those who survived this medical torture, many were then killed in order to further examine the effects of their work at post mortem.
Generate a research idea
Develop research hypothesis/ question/aims
Design study
Obtain relevant ethical & institutional approvals
Disseminate results
Write research report
Analyse the data
Conduct the study
While research is essential for improving and developing effective healthcare services, it can sometimes involve an element of risk because it may involve trying something new. It is Jayne Hardicre is Lecturer in Nursing, Adult Specialty, University of Salford and Research Ethics Committee Member, Salford.
■■ Conducting
Figure 1. Simplified stages of the research process
483
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
Tuskegee Syphilis Study 1932–1972 The Tuskegee Syphilis study has become notoriously known as a racist and unethical medical experiment involving AfricanAmerican males. It ran from 1932 to 1972 with over 600 participants. Of these, 399 had syphilis while 201 were free from syphilis. All participants were from a poor socioeconomic group and had low educational levels. For taking part in the study, the men were given hot meals, medical insurance for simple treatments and free burial insurance. The men were not told they had syphilis but were informed they had ‘bad blood’. The men attended clinics for blood sampling and were given what they thought was treatment for their bad blood but were actually given aspirin, placebos or vitamin tablets. Even after 1947 when penicillin became the standard treatment of choice, none of the men received it. After a public outcry in 1972, the study was stopped at which point only 74 of the 399 participants who were diagnosed as having syphilis were still alive. Of those 325 men who died, 28 had died of syphilis, 100 died of related complications, 40 of their wives
had been infected and 19 of their children were born with congenital syphilis. This men in this vulnerable group were coerced into participating in this experiment and were denied the truth when agreeing to take part. The researchers were dishonest and denied the men both their diagnosis and the standard treatment for syphilis. When this was released in 1947, the researchers continued to observe the effects of untreated syphilis.
The Willowbrook Study The Willowbrook Study was conducted within a State School for children with learning disabilities between 1963 and 1966. The purpose of the study was to study hepatitis when left untreated and also to investigate the effects of gamma globulin as a treatment. At the time, the school already had a problem with hepatitis with some children having been diagnosed. Although the institution was said to be closed to new incoming students as a result of overcrowding, in truth, it only took on children whose mothers agreed to them participating in the research study. This may have added influence to the parents’ decisions to sign consent forms, particularly because there was nowhere else for the children to go to at that time. Reports include allegations that the innocent children were deliberately infected with the hepatitis virus. In the earlier stages of the study, children were fed extracts of stools from known infected children and, later, children were injected with the virus. After a period of observation where researchers studied the
Box 1. Nuremberg Code 1947 ■■ Obtaining
voluntary, informed consent is essential. The research participant must be fully informed of all aspects of the research to enable him or her to make a fully informed decision as to whether or not to take part ■■ The research should be to obtain results which are for the good of society, not unnecessary in nature and not obtainable by other means ■■ The research should be based upon a prior knowledge of the history of the disease or problem under study (including animal research) and the results should justify the research being undertaken ■■ The study should be conducted as to avoid all unnecessary physical or mental suffering and injury ■■ No experiment should be conducted, where there is an apriori reason to believe that death or disabling injury will occur ■■ The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment ■■ Proper preparations should be made and adequate facilities provided to protect the participant against risks of injury, disability, or death ■■ The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the research study ■■ The participant is able to withdraw from the study at any time ■■ During the course of the study, the scientist in charge must be prepared to terminate the research, if he has probable cause to believe that a continuation of the study is likely to result in injury, disability, or death to the experimental subject Source: Nuernberg Military Tribunals, 1949
484
disease when left untreated, children were then injected with the developing vaccine. While this study did in fact help to develop the hepatitis vaccine, it created public outcry as a result of highly vulnerable children being infected with hepatitis. Many questioned the amount of information actually given to the parents before they gave consent for their child to participate in the trial and also how much their decision was influenced by being offered a place within the school. This study is still heavily debated with the researchers adding that most of the children would have contracted hepatitis anyway. What this, and the other two studies described in this article, did raise was the need for the protection of the right of human subjects.
Moving forward Looking back at the history of research and clinical trials, many examples of unethical research can be found. So what did we learn from them? The three examples described within this article highlight problems with consent, coercion, targeting vulnerable groups, dishonesty and a lack of regard for human rights. It was clear that ethical codes needed to be developed to underpin research practice and this started with the development of the Nuremberg Code of 1947 following the Nuremberg trials (Box 1). This became the foundation of the many later codes that were developed giving guidance and assurance that research involving human subjects would be conducted in an ethical manner. Central to The Nuremberg Code of 1947 was the need to obtain voluntary, informed consent: ‘The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision’. (Nuernberg Military Tribunals, 1949) The ethical principles outlined in the Nuremberg Code were then further elaborated upon by the World Medical Association
© 2014 MA Healthcare Ltd
None of those who were experimented on gave their consent and all could be classed as vulnerable. There was abuse of all moral codes and large-scale disregard of many ethical principles with a complete disregard for mankind. During the Nuremberg Trial, several of the doctors argued that there was no international law regarding human experimentation.
British Journal of Nursing, 2014, Vol 23, No 9
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
RESEARCH
© 2014 MA Healthcare Ltd
(WMA) in 1964 with the development of the Declaration of Helsinki. This declaration is updated regularly with the latest revision being The Declaration of Helsinki: ethical principles for medical research involving human subjects (WMA, 2013). The Declaration of Helsinki outlines essential ethical principles for medical research involving human subjects and is regarded as the most important document in the history of research ethics. It is cited in most major guidelines and in various research regulations in over a dozen countries. It is such an important document and it is often recommended that it is read in full if you are engaged in the development and management of research studies and clinical trials. The Declaration of Helsinki was later embraced by the International Conference on Harmonisation guidelines for Good Clinical Practice (ICH-GCP) (ICH, 1996). Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and wellbeing of trial subjects are protected, and that the results of the clinical trials are credible and accurate (Medicines and Healthcare products Regulatory Agency (MHRA), 2014). Many researchers now must be ICH-GCP trained and, as such, this further embeds the ethical principles of research, the protection of participants from harm and the development of high-quality research into the national research agenda. There are many other influences driving ethically sound clinical research practice. These are outlined in Figure 2. The Research Governance Framework for Health and Social Care (DH, 2005) sets out the broad principles for good research governance. While this may not be an ethical code itself, it is built upon and further expands essential elements of good clinical practice (in research) and is another important framework guiding the conduct, performance and quality of NHS research. Also of great important is Good Research Practice: principles and guidelines (Medical Research Council (MRC), 2012) primarily developed for MRC researchers but very useful to other researchers as well.
Maintaining ethical research practice Having discussed the importance of ethical codes of practice and some of the important ethical codes and guidelines driving ethical practice, it is now important to see how
British Journal of Nursing, 2014, Vol 23, No 9
these are a embedded within research in the NHS. Research involving human subjects, let’s call them patients, in the NHS requires strict approval, governance and monitoring. A researcher cannot write a study protocol and then go ahead and recruit patients into their study without a strict set of assessments and approvals in place. This process is often regarded as lengthy and long-winded but at the end of the day, these steps are in place to protect our patients from harm while maximising the quality of the research undertaken. All research involving NHS patients must receive a favourable opinion from an NHS Research Ethics Committee (REC). There are currently more than 80 RECs across the UK, each consisting of up to 18 members, onethird of whom are lay members. They review research applications and give their opinion about the proposed participant involvement and whether or not they feel it is ethical. Their role is to safeguard the rights, safety, dignity
and wellbeing of research participants. REC members spend many hours reading research ethical approval applications individually and then spend additional time together as a committee debating the same. All NHS trusts also have their own research and development (R&D) department. Without their local approval, even with a favourable opinion from an ethics committee, a study would not be able to proceed. Applications must be sought for R&D approval in order for the research study to begin. In addition to this, dependent on the trial and what is being investigated or tested, there may also be the requirement for approval from the MHRA. The intricacies and complexities of research applications and approvals will be discussed in more detail in future article within this series but what can be seen here is that at the centre of these processes are the patients themselves. On a very basic level, the work behind all of these codes, guidelines and recommendations is the protection of patients participating in
ICH-GCP
Medicines and Healthcare products Regulatory Agency
Nuremberg Code
Royal College of Nursing
Medical Research Council
Research Governance Framework
NHS Research Governance
Research Participant
National Institute for Health Research
Laws, Statutory Instruments University Codes of Ethical Practice
Researcher as patient advocate Health Research Authority
Declaration of Helsinki
Figure 2. Some of the influences driving ethical research practice ICH-GCP = International Conference on Harmonisation: Good Clinical Practice
485
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
research and the maximisation of the quality of the research through to its publication. It is not within the scope of this article to discuss the multilayers of laws and statutes involved in research, which also exist to safeguard and protect but they do cut through many of the recommendations and approvals required prior to any research getting beyond the proposal stage of development.
Summary This article has introduced the reader to research ethics. In order to show the development of the codes of ethics and guidelines in use today, it has briefly reviewed the most infamous unethical research studies. Learning from these traumatic and often cruel moments in history gave impetus to the development of international ethical guidelines, driving research conduct and protecting the rights and safety of those participating in studies today. Research within the NHS would not exist without the hundreds of thousands of patients
Pioneering Theories in Nursing 781856 424004
Austyn Snowden, Allan Donnell, Tim Duffy
ISBN 1-85642-400-6
who volunteer their time and indeed their ‘selves’ to research. Researchers have a duty to those patients, to treat them with the dignity, respect and care they would afford any patient. In addition to serving as researchers, they must also must act as patient advocates to ensure that every stage of the research process embraces all elements of ethical codes and frameworks— and patients should expect nothing less. BJN Conflict of interest: none The main points of the Nuremberg Code 1947 can be accessed at http://tinyurl.com/pqkxpek The British Psychological Society (2010) Code of Human Research Ethics. http://tinyurl.com/6zlqw6s (accessed 25 April 2014) Department of Health (2005) Research Governance Framework for Health and Social Care, 2nd edn. DH, London. http://tinyurl.com/cupej9z (accessed 25 April 2014) Department of Health (2006) Best Research for Best Health. A new national health research strategy. http:// tinyurl.com/blbltek (accessed 25 April 2014) Department of Health (2011) Governance arrangements for research ethics committees: A harmonised edition.
DH, London. http://tinyurl.com/ow2z8b3 (accessed 25 April 2014) Hardicre J (2014) Embedding the 6 Cs into clinical research practice and management. Br J Nurs 23(7): 365-7 International Conference on Harmonisation (1996) Guideline for Good Clinical Practice E6(R1). http:// tinyurl.com/4duczor (accessed 25 April 2014) Long T, Johnson M, eds (2007) Research ethics in the real world: issue and solutions for health and social care. Churchill Livingstone, London Medicines and Healthcare products Regulatory Agency (2014) Good Clinical Practice: Background. http:// tinyurl.com/os443bo (accessed 25 April 2014) Medical Research Council (2012) Good research practice: Principles and guidelines. http://tinyurl.com/7dqbn6u (accessed 25 April 2014) Nuernberg Military Tribunals (1949) Trials of War Criminals before the Nuernberg Military Tribunals Tribunals under Control Council Law No. 10. Volume II, Nuernberg, October 1946-April 1949. U.S. Government Printing Office, Washington: 181-2. http://tinyurl.com/m4qs4dy (accessed 25 April 2014) National Institute for Health Research (2013) Figures show “new high” in NHS patients participating in clinical research. http://tinyurl.com/kxryg2w (accessed 25 April 2014) Royal College of Nursing (2009) Research ethics: RCN guidance for nurses, 3rd edn. http://bit.ly/1eCnbZy (accessed 25 April 2014) World Medical Association (2013) WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. http://tinyurl.com/ cf6rwem (accessed 25 April 2014)
PIONEERING Pioneering THEORIES IN NURSING Theories in Nursing Austyn Snowden, Allan Donnell, Tim Duffy Fascinating reading outlining and discussing the main theories and practice of nursing Easy to read format with each chapter presenting biographical profiles Text encourages reflective thinking on nursing theories and their contribution to current nursing practice
Austyn Snowden, Allan Donnell, Tim Duffy
ISBN-13: 978-1-85642-400-4; ISBN-10: 978-1-85642-4006; 297 x 210 mm; paperback; 220 pages; publication April 2010; £19.99
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© 2014 MA Healthcare Ltd
Foreword by Sir George Castledine
British Journal of Nursing, 2014, Vol 23, No 9
British Journal of Nursing. Downloaded from magonlinelibrary.com by 138.253.100.121 on November 27, 2015. For personal use only. No other uses without permission. . All rights reserved.
