- Email: [email protected]
Revisiting the guiding principles of research ethics
Perspectives
Book Revisiting the guiding principles of research ethics The revelation that South Korea’s Hwang Woo Suk fabricated stem cell research does more than simply highlight the importance of a considered research ethic. It demands a critical approach to research practice and the ethical guidelines that should inform that practice. The possibility that such extensive fraud could take place has brought into question the integrity of the peer-review process and the demands of honesty within the research community, among many other issues. The need for ethical deliberation about research practice does not exist in a vacuum, however. There are long-standing principles that can guide the ethical conduct of research. The release of the Belmont Report in 1979 was a watershed moment for the field of bioethics in general, and for research ethics in particular. The report delineated three principles that continue to guide ethical deliberation about the use of human beings in research: respect for individuals (controversially restated as autonomy), beneficence/non-malevolence, and justice. Although the Belmont Report did not anticipate all of the issues in research ethics that have arisen in recent years— issues of international justice in research, for example—its principles address the most central ethical concerns with regard to the use of human beings in clinical research. In the essentials, the Belmont Report got it right. That is the judgment expressed in Belmont Revisited, a judgment we largely share. Belmont Revisited is a collection of papers to honour the report’s 25th anniversary. Written by authors who were involved in the original report, together with scholars who have had major roles in the intervening discussions of the ethics of research with human beings, the papers are historically grounded and ethically sophisticated. They will be informative for readers who wish to learn about the www.thelancet.com Vol 367 February 4, 2006
report’s origins and influence on public policy and clinical medicine, as well as for readers who want to reflect on the influence, application, and interpretation of the ethical principles of respect for individuals, beneficence, and justice. That Belmont Revisited takes its guidance and sympathies from the
“Issues in research ethics now extend far beyond the exploitation of human participants and abuses of consent that generated the Belmont Report. “ original report is the volume’s strength, but also its weakness. Issues in research ethics now extend far beyond the exploitation of human participants and abuses of consent that generated the Belmont Report. The volume might have been more useful if it had addressed how, and whether, the report principles can address these newly pressing questions. Consider conflicts of interest in research. It is widely acknowledged that the selection of research questions and the interpretation of research results can been influenced by the economic incentives of pharmaceutical companies and university research budgets. The International Committee of Medical Journal Editors has called for authors to make full disclosure of any potential conflicts of interest. The Belmont Report required systematic assessment of the risks and benefits of research, including attention to study design, before research might be offered to research participants for their consent. Yet neither the report nor Belmont Revisited attends to the current pervasiveness of conflicts of interest in research involving human beings and the specific risks these conflicts might pose for such participants. Absent also is any discussion of whether conflicts should be addressed by investigators
who disclose any financial incentives during the informed consent process, or whether more radical steps are needed, such as restricting physicians who are also investigators from enrolling their own patients in research. Or consider the tensions between the requirement of informed consent and the imperative, rooted in justice, to provide adequately researched treatment to vulnerable populations. This tension plays out in debates about the permissibility of nontherapeutic research on children or adults with dementia, or about required inclusion of women and minorities in research. Internationally, trials of short-course antiretroviral agents to reduce maternal-to-fetal transmission of HIV/AIDS have been controversial. Although short-course therapy reduces vertical transmission, it is not the standard of care available in more affluent nations and it puts treated women and potentially their partners at greater risk of resistant disease. Belmont Revisited attends to problems of exclusion and group stereotyping in research. Its one truly innovative proposal is that respect for individuals ought to be extended to respect for communities in research, including delineation of community characteristics and risks, and the possibility of consent through community leadership. It does not, however, attend more systematically to issues of international justice in research. Belmont Revisited also makes no attempt to address social and behavioural research. Despite the fact that the original report was charged to “identify the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects”, Belmont Revisited poses the question as “Which principles should govern biomedical research and practice?”. The practice of drawing from examples in biomedical research is
Belmont Revisited: Ethical Principles for Research with Human Subjects James F Childress, Eric M Meslin, Harold Shapiro, eds. Georgetown University Press, 2005. Pp 279. US$29·95. ISBN 1-58901-062-0.
387
Perspectives
appropriate: research participants may enter studies under a therapeutic misconception, and risks in phase I trials especially may be life-threatening. However, research in the social and behavioural sciences poses different challenges for interpreting, applying, and expanding the Belmont principles. Consider deception in research. In the biomedical sciences, the ethical use of deception is modelled on placebo studies in drug trials, in which participants are told that they may or may not receive the investigational drug, but they are not deceived with regard to the possibility they might receive placebo or the risks of the therapy being tested. On most accounts, this use of deception in placebo studies maintains respect for individuals, since it does not undermine the potential research participant’s decision process
to enter into the study. However, the placebo model is inapposite to some social and behavioural research that may require some form of deception. The standard here is that the research poses no more than minimal risk, and at the end of the research the participants are fully debriefed and allowed the option to withdraw their data from the study. This example suggests that the process of informed consent, evaluation of risk, and effectiveness of debriefing may require serious reconsideration. Other features of the social and behavioural sciences that pose different challenges to the Belmont principles include an assessment of the types of psychological and social risks that participants are exposed to, and how these differ from the types of health risks associated with biomedical research.
The inclusion of such issues from social and behavioural research has the potential to inform the application and expansion of the Belmont principles in the biomedical arena as well. At the very least, a wider appreciation for how principles are applied in such domains should provide ethical guidance in emerging research, and for the psychosocial dimensions of biomedical research—for example, in pain research. Had it addressed these and other questions, Belmont Revisited might have been as important to research ethics as was the original Belmont Report itself. As it is, Belmont Revisited provides useful history and careful analysis, but limited new direction for the ethics of research with human beings.
Bryan Benham, Leslie Francis [email protected]
In brief Book A story of siblings and schizophrenia
Relative Stranger: A Life After Death Mary Loudon. Canongate, 2006. Pp 384. £16·99. ISBN 1-841-95675-9.
388
Much progress has been made in society’s attitude towards mental illness. The days of burning so-called witches at the stake, or chaining “lunatics” in asylums are thankfully long gone. But despite this greater understanding, florid psychotic illness—particularly schizophrenia—still arouses shame and stigma in some quarters. That such stigma endures may reflect the ignorance and fear engendered by the personality disturbance and character disintegration that can characterise schizophrenia. Public misconceptions are fuelled by the tabloid press, which pounces on cases of violence by the mentally ill and instills in the minds of the uninformed a mixture of fear, hysteria, and horrified voyeurism. When Mary Loudon discovered that her semi-estranged elder sister had died, the wounds of bereavement were ripped raw by the deep sorrow
of contemplating a sibling who had virtually isolated herself from her family. In an attempt to come to terms with this event, Loudon felt a compulsion to explore her sister’s life. Relative Stranger is a moving, thoughtful, and honest portrayal of this search. Through visiting her sister’s home and talking to those who knew her, fragments of knowledge coalesce to paint a picture of her sister’s life. Although there is profound sadness at the inevitable destruction that schizophrenia wrought, there is also comfort gained from insights into the daily life her sister led, the people who cared about and for her, and the principles that guided her life. Loudon’s book is a personal journey that she had to make to put to rest the ghosts and demons that the premature death of a sick and sometimes despairing sibling are bound to bring. But it is also a perceptive and sensitive exploration of the
judgments that society makes on the value of people’s lives. Loudon is unflinchingly honest, and confesses her own value judgments—for example, her sadness at the deterioration in her sister’s artistic talent from outstanding to mediocre. She comes to recognise that any life that is savoured and enjoyed is worthwhile, and that judging others by one’s own conventional criteria and standards lacks humility and compassion. Loudon’s sister did not kill herself as 10% of schizophrenics do, but died of natural causes, so she was spared the wrenching despair that such an act leaves in its wake. This book will offer balm to many who have loved and lost a person with severe mental illness, and challenges many of the myopic misconceptions and generalisations that are ascribed to those who live with mental illness.
Leyla Sanai [email protected]
www.thelancet.com Vol 367 February 4, 2006
Book Revisiting the guiding principles of research ethics The revelation that South Korea’s Hwang Woo Suk fabricated stem cell research does more than simply highlight the importance of a considered research ethic. It demands a critical approach to research practice and the ethical guidelines that should inform that practice. The possibility that such extensive fraud could take place has brought into question the integrity of the peer-review process and the demands of honesty within the research community, among many other issues. The need for ethical deliberation about research practice does not exist in a vacuum, however. There are long-standing principles that can guide the ethical conduct of research. The release of the Belmont Report in 1979 was a watershed moment for the field of bioethics in general, and for research ethics in particular. The report delineated three principles that continue to guide ethical deliberation about the use of human beings in research: respect for individuals (controversially restated as autonomy), beneficence/non-malevolence, and justice. Although the Belmont Report did not anticipate all of the issues in research ethics that have arisen in recent years— issues of international justice in research, for example—its principles address the most central ethical concerns with regard to the use of human beings in clinical research. In the essentials, the Belmont Report got it right. That is the judgment expressed in Belmont Revisited, a judgment we largely share. Belmont Revisited is a collection of papers to honour the report’s 25th anniversary. Written by authors who were involved in the original report, together with scholars who have had major roles in the intervening discussions of the ethics of research with human beings, the papers are historically grounded and ethically sophisticated. They will be informative for readers who wish to learn about the www.thelancet.com Vol 367 February 4, 2006
report’s origins and influence on public policy and clinical medicine, as well as for readers who want to reflect on the influence, application, and interpretation of the ethical principles of respect for individuals, beneficence, and justice. That Belmont Revisited takes its guidance and sympathies from the
“Issues in research ethics now extend far beyond the exploitation of human participants and abuses of consent that generated the Belmont Report. “ original report is the volume’s strength, but also its weakness. Issues in research ethics now extend far beyond the exploitation of human participants and abuses of consent that generated the Belmont Report. The volume might have been more useful if it had addressed how, and whether, the report principles can address these newly pressing questions. Consider conflicts of interest in research. It is widely acknowledged that the selection of research questions and the interpretation of research results can been influenced by the economic incentives of pharmaceutical companies and university research budgets. The International Committee of Medical Journal Editors has called for authors to make full disclosure of any potential conflicts of interest. The Belmont Report required systematic assessment of the risks and benefits of research, including attention to study design, before research might be offered to research participants for their consent. Yet neither the report nor Belmont Revisited attends to the current pervasiveness of conflicts of interest in research involving human beings and the specific risks these conflicts might pose for such participants. Absent also is any discussion of whether conflicts should be addressed by investigators
who disclose any financial incentives during the informed consent process, or whether more radical steps are needed, such as restricting physicians who are also investigators from enrolling their own patients in research. Or consider the tensions between the requirement of informed consent and the imperative, rooted in justice, to provide adequately researched treatment to vulnerable populations. This tension plays out in debates about the permissibility of nontherapeutic research on children or adults with dementia, or about required inclusion of women and minorities in research. Internationally, trials of short-course antiretroviral agents to reduce maternal-to-fetal transmission of HIV/AIDS have been controversial. Although short-course therapy reduces vertical transmission, it is not the standard of care available in more affluent nations and it puts treated women and potentially their partners at greater risk of resistant disease. Belmont Revisited attends to problems of exclusion and group stereotyping in research. Its one truly innovative proposal is that respect for individuals ought to be extended to respect for communities in research, including delineation of community characteristics and risks, and the possibility of consent through community leadership. It does not, however, attend more systematically to issues of international justice in research. Belmont Revisited also makes no attempt to address social and behavioural research. Despite the fact that the original report was charged to “identify the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects”, Belmont Revisited poses the question as “Which principles should govern biomedical research and practice?”. The practice of drawing from examples in biomedical research is
Belmont Revisited: Ethical Principles for Research with Human Subjects James F Childress, Eric M Meslin, Harold Shapiro, eds. Georgetown University Press, 2005. Pp 279. US$29·95. ISBN 1-58901-062-0.
387
Perspectives
appropriate: research participants may enter studies under a therapeutic misconception, and risks in phase I trials especially may be life-threatening. However, research in the social and behavioural sciences poses different challenges for interpreting, applying, and expanding the Belmont principles. Consider deception in research. In the biomedical sciences, the ethical use of deception is modelled on placebo studies in drug trials, in which participants are told that they may or may not receive the investigational drug, but they are not deceived with regard to the possibility they might receive placebo or the risks of the therapy being tested. On most accounts, this use of deception in placebo studies maintains respect for individuals, since it does not undermine the potential research participant’s decision process
to enter into the study. However, the placebo model is inapposite to some social and behavioural research that may require some form of deception. The standard here is that the research poses no more than minimal risk, and at the end of the research the participants are fully debriefed and allowed the option to withdraw their data from the study. This example suggests that the process of informed consent, evaluation of risk, and effectiveness of debriefing may require serious reconsideration. Other features of the social and behavioural sciences that pose different challenges to the Belmont principles include an assessment of the types of psychological and social risks that participants are exposed to, and how these differ from the types of health risks associated with biomedical research.
The inclusion of such issues from social and behavioural research has the potential to inform the application and expansion of the Belmont principles in the biomedical arena as well. At the very least, a wider appreciation for how principles are applied in such domains should provide ethical guidance in emerging research, and for the psychosocial dimensions of biomedical research—for example, in pain research. Had it addressed these and other questions, Belmont Revisited might have been as important to research ethics as was the original Belmont Report itself. As it is, Belmont Revisited provides useful history and careful analysis, but limited new direction for the ethics of research with human beings.
Bryan Benham, Leslie Francis [email protected]
In brief Book A story of siblings and schizophrenia
Relative Stranger: A Life After Death Mary Loudon. Canongate, 2006. Pp 384. £16·99. ISBN 1-841-95675-9.
388
Much progress has been made in society’s attitude towards mental illness. The days of burning so-called witches at the stake, or chaining “lunatics” in asylums are thankfully long gone. But despite this greater understanding, florid psychotic illness—particularly schizophrenia—still arouses shame and stigma in some quarters. That such stigma endures may reflect the ignorance and fear engendered by the personality disturbance and character disintegration that can characterise schizophrenia. Public misconceptions are fuelled by the tabloid press, which pounces on cases of violence by the mentally ill and instills in the minds of the uninformed a mixture of fear, hysteria, and horrified voyeurism. When Mary Loudon discovered that her semi-estranged elder sister had died, the wounds of bereavement were ripped raw by the deep sorrow
of contemplating a sibling who had virtually isolated herself from her family. In an attempt to come to terms with this event, Loudon felt a compulsion to explore her sister’s life. Relative Stranger is a moving, thoughtful, and honest portrayal of this search. Through visiting her sister’s home and talking to those who knew her, fragments of knowledge coalesce to paint a picture of her sister’s life. Although there is profound sadness at the inevitable destruction that schizophrenia wrought, there is also comfort gained from insights into the daily life her sister led, the people who cared about and for her, and the principles that guided her life. Loudon’s book is a personal journey that she had to make to put to rest the ghosts and demons that the premature death of a sick and sometimes despairing sibling are bound to bring. But it is also a perceptive and sensitive exploration of the
judgments that society makes on the value of people’s lives. Loudon is unflinchingly honest, and confesses her own value judgments—for example, her sadness at the deterioration in her sister’s artistic talent from outstanding to mediocre. She comes to recognise that any life that is savoured and enjoyed is worthwhile, and that judging others by one’s own conventional criteria and standards lacks humility and compassion. Loudon’s sister did not kill herself as 10% of schizophrenics do, but died of natural causes, so she was spared the wrenching despair that such an act leaves in its wake. This book will offer balm to many who have loved and lost a person with severe mental illness, and challenges many of the myopic misconceptions and generalisations that are ascribed to those who live with mental illness.
Leyla Sanai [email protected]
www.thelancet.com Vol 367 February 4, 2006