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Protecting human subjects: Informed consent revisited: Part II
SPOTLIGHT ON RESEARCH Protecting Human Subjects: Informed Consent Revisited: Part II JoAnne D. Whitney, PhD, RN
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J WOCN 2001;28:230-2. Copyright © 2001 by the Wound, Ostomy and Continence Nurses Society. 1071-5754/2001/$35.00 + 0 21/1/118051 doi:10.1067/mjw.2001.118051
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art I of “Protecting Human Subjects” in the July 2001 issue of Journal of WOCN introduced the major ethical principles that guide obtaining informed consent for participation in studies. This topic is timely for several reasons. In the past year, major funding bodies (eg, National Institutes of Health) and Institutional Review Boards at universities across the United States have mandated that investigators receive additional training in the area of obtaining informed consent. In addition, growth in the number of studies being conducted, the introduction of technologically advanced therapies for clinical testing, and the nature of emerging therapies require renewed vigilance to ensure that research is conducted ethically. Treatments involving genetic manipulation provide an example. Emerging genetic therapies create opportunities to advance treatment and at the same time may place an additional burden on potential participants with regard to the level and amount of information they must digest when they consider whether to participate in a study. In this research-intensive environment, it is essential that the rights of the individual be respected and protected and that the consent process facilitates informed consent and ensures that it is achieved. The major ethical principles that guide the conduct of research that involve humans are defined as respect, beneficence, and justice.1,2 Part I of this article discussed the principle of respect for persons. This principle honors individual autonomy and ensures the right of choice. Respect for the freedom to choose is based largely on a consent process that provides sufficient information, uses an approach and format that allows adequate comprehension of what is involved, and supports the person in making an informed decision about whether to participate. Respect is the first principle. In addition, the principles of beneficence and justice are also necessary to protect human subjects.
THE PRINCIPLE OF BENEFICENCE According to the Belmont report,1 when the term beneficence is used in the context of research, it represents an obligation on the part of the investigator to persons who are in a study. This obligation is twofold and includes the concepts of “doing no harm” and “limiting harm and maximizing benefits” related to study participation. These concepts may not be as clearcut as they seem at first glance. The Belmont report further clarifies that the avoidance of harm often comes at the expense of understanding what is harmful. In other words, sometimes we gain an understanding of harm only in the process of conducting a study. Risks are always associated with participation in research. Potential risks may be physical (eg, the risk of falling may be increased in a study that tests an exercise intervention in older people) or psychological (eg, emotional distress caused by the demands of participation in the study). In addition, risks may vary by population, gender, age, ethnicity, and setting. To maintain the principle of beneficence, the likelihood of benefit must be greater than the known or potential risks associated with a study. Further, it is important that potential subjects understand the relative risks and benefits of a study. These risks and benefits must be clearly and simply communicated during the consent process. In practical terms, all risks should be explained, including what action will be taken should consequences occur, and any benefits should not be overor underemphasized.3 “Exactly who benefits?” is a critical question in discussing beneficence. People who are approached to enroll in studies may experience confusion or a misunderstanding because they believe that participation will result in some benefit despite possible risks.4 However, generally it is not the case that participation results in
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some benefit. In most studies, benefits are not realized by the actual participants but rather by future patients and by society as a whole. Therefore, the importance of maximizing benefits and keeping risks at a minimum are crucial elements of any study. Risks are balanced against longterm gains such as knowledge and treatment advancements that may be of benefit to many people. The development and use of well-thought-out and carefully designed study procedures and the establishment of a competent research team will help ensure that study benefits are maximized and risks of harm are minimized. In addition, the principle of beneficence for a specific study is addressed and upheld when we pursue answers to important clinical questions and when we are truly uncertain about whether a new or older treatment is most effective.5
THE PRINCIPLE OF JUSTICE The principle of justice asserts that no single group should bear the burden or reap the benefits of research. In addition, the principle of justice sets up the expectation that all subjects will be treated equitably and fairly. In some cases in the past, people have been enrolled in studies on the basis of convenience or easy availability. Regrettably, history recounts such unethical studies as the experiments conducted on prisoners by the Nazi regime during World War II and the United States Public Health Service study of untreated syphilis in adult, African American men.6 Justice, as defined in the Belmont report, addresses the issue of unethical studies by establishing an ethical standard of treatment that applies to all persons but particularly those who are vulnerable or unprotected and who historically have borne the risks and burdens of participating in studies.1 In addition, the principle of justice calls for research to be conducted so that people who potentially stand to benefit from participating in a study or from the results of a study are offered the opportunity to participate.7 Keeping these points in mind, the equitable selection of persons to participate in studies is an important component of the principle of justice. When the standard of justice is implemented, subjects are selected without discrimination and not on the basis of convenience or easy access. Individuals are enrolled with full informed
Whitney 231
consent and are selected from populations to whom the study aims and potential beneficial results will apply. In recent years, the perspective on subject selection has broadened and focused on both equitable inclusion of persons without unjustified exclusion of specific groups.3 Throughout the years, some studies have used very narrow inclusion criteria and have in effect excluded a number of groups that may have benefited from the application of findings. Because they were not included in these studies, results and ultimately treatments were not as likely to be offered to these groups. Women, older people, and children are examples of those who in some cases have been excluded unjustly from participating in studies. The current emphasis on protecting human subjects attempts to balance subject selection fairly, to continue to protect vulnerable populations, and at the same time to answer the specific study aims reliably.4,7 Studies designed to fulfill the principle of justice avoid exploitation or neglect of specific groups, and in doing so are more likely to produce results that can be applied more generally because they are not based on the study of a very narrowly defined population. The issues and concerns pertaining to the protection of research participants are complex. Conducting studies ethically and adequately protecting subjects requires careful planning of the study design and methods and begins long before the first participant is enrolled.5 Many aspects of the protection of human subjects must be considered. Important steps include the following: •attending to the clarity and educational level of information; •developing methods to assess the subjects’ understanding of the study requirements; •creating an environment in which individuals are free to decide whether to participate; •taking action to minimize harm and maximize benefits; •providing clear information about the potential risks associated with participation; and •developing inclusion and exclusion criteria that identify the most appropriate target population for the study and ensure access to groups that in past have been underrepresented in studies. The principles of respect, beneficence, and justice guide the planning of studies and the way they are conducted. If we
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232 Whitney
design clinical studies thoughtfully and use these basic principles, the interests of both participants and researchers will be preserved, knowledge will be advanced, and, ultimately, care will be improved. REFERENCES 1. Department of Health and Human Services. The Belmont report. Ethical principles and guidelines for the protection of human subjects of research [online], 1979. Available from: URL: http://ohrop. osophs.dhhhs.gov/humansubjects/guidance/ belmont.html 2. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects [online], October 2000. Available from: URL: http://www.wits.ac.za/ bopejtocs/helsinki.html
3. University of Washington Human Subjects Division. Resource book: the ethical conduct of research involving human subjects [online], 2000. Available from: URL: http://depts.washington. edu/hsd 4. Kahn JP. Moving from compliance to conscience. Why we can and should improve on the ethics of clinical research. Arch Intern Med 2001;161:925-8. 5. Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. CMAJ 1997;156:1153-7. 6. Burns N, Grove SK. The practice of nursing research, 3rd ed. Philadelphia: WB Saunders; 1997. 7. Weijer C. Selecting subjects for participation in clinical research: one sphere of justice. J Med Ethics 1999;25:31-6.
Publisher’s Award for Original Research The Publisher’s Manuscript Award for Original Research is awarded to the author(s) of a manuscript that makes a significant contribution to WOC nursing. This award is designed to recognize excellence in the field. Manuscripts will be judged for their scholarship, originality, and relevance to WOC nursing. All manuscripts that are published within a volume (calendar year) and meet the eligibility requirements are evaluated for the award, which is presented at the WOCN Annual Conference the following spring. In the event an insufficient number of manuscripts are published within a volume, those published manuscripts will be held for consideration for the award the following year. The award is composed of an honorarium in the amount of $500 and a plaque. The check is issued in the name of the corresponding author, and the plaque includes the names of all authors. The eligibility requirements are as follows: Research report must be original and not published or submitted for publication elsewhere. Manuscript must be 2000 words or more. It is not necessary to be a member of the WOCN or have graduated from a WOCN Educational Program or an ET Nursing Education Program to compete for the award. The manuscript cannot be authored by any member of the Editorial Board. All eligible manuscripts are evaluated by the Journal’s Editorial Board.
This award is funded by the Journal of WOCN and Mosby, Inc
P
J WOCN 2001;28:230-2. Copyright © 2001 by the Wound, Ostomy and Continence Nurses Society. 1071-5754/2001/$35.00 + 0 21/1/118051 doi:10.1067/mjw.2001.118051
230
art I of “Protecting Human Subjects” in the July 2001 issue of Journal of WOCN introduced the major ethical principles that guide obtaining informed consent for participation in studies. This topic is timely for several reasons. In the past year, major funding bodies (eg, National Institutes of Health) and Institutional Review Boards at universities across the United States have mandated that investigators receive additional training in the area of obtaining informed consent. In addition, growth in the number of studies being conducted, the introduction of technologically advanced therapies for clinical testing, and the nature of emerging therapies require renewed vigilance to ensure that research is conducted ethically. Treatments involving genetic manipulation provide an example. Emerging genetic therapies create opportunities to advance treatment and at the same time may place an additional burden on potential participants with regard to the level and amount of information they must digest when they consider whether to participate in a study. In this research-intensive environment, it is essential that the rights of the individual be respected and protected and that the consent process facilitates informed consent and ensures that it is achieved. The major ethical principles that guide the conduct of research that involve humans are defined as respect, beneficence, and justice.1,2 Part I of this article discussed the principle of respect for persons. This principle honors individual autonomy and ensures the right of choice. Respect for the freedom to choose is based largely on a consent process that provides sufficient information, uses an approach and format that allows adequate comprehension of what is involved, and supports the person in making an informed decision about whether to participate. Respect is the first principle. In addition, the principles of beneficence and justice are also necessary to protect human subjects.
THE PRINCIPLE OF BENEFICENCE According to the Belmont report,1 when the term beneficence is used in the context of research, it represents an obligation on the part of the investigator to persons who are in a study. This obligation is twofold and includes the concepts of “doing no harm” and “limiting harm and maximizing benefits” related to study participation. These concepts may not be as clearcut as they seem at first glance. The Belmont report further clarifies that the avoidance of harm often comes at the expense of understanding what is harmful. In other words, sometimes we gain an understanding of harm only in the process of conducting a study. Risks are always associated with participation in research. Potential risks may be physical (eg, the risk of falling may be increased in a study that tests an exercise intervention in older people) or psychological (eg, emotional distress caused by the demands of participation in the study). In addition, risks may vary by population, gender, age, ethnicity, and setting. To maintain the principle of beneficence, the likelihood of benefit must be greater than the known or potential risks associated with a study. Further, it is important that potential subjects understand the relative risks and benefits of a study. These risks and benefits must be clearly and simply communicated during the consent process. In practical terms, all risks should be explained, including what action will be taken should consequences occur, and any benefits should not be overor underemphasized.3 “Exactly who benefits?” is a critical question in discussing beneficence. People who are approached to enroll in studies may experience confusion or a misunderstanding because they believe that participation will result in some benefit despite possible risks.4 However, generally it is not the case that participation results in
JWOCN Volume 28, Number 5
some benefit. In most studies, benefits are not realized by the actual participants but rather by future patients and by society as a whole. Therefore, the importance of maximizing benefits and keeping risks at a minimum are crucial elements of any study. Risks are balanced against longterm gains such as knowledge and treatment advancements that may be of benefit to many people. The development and use of well-thought-out and carefully designed study procedures and the establishment of a competent research team will help ensure that study benefits are maximized and risks of harm are minimized. In addition, the principle of beneficence for a specific study is addressed and upheld when we pursue answers to important clinical questions and when we are truly uncertain about whether a new or older treatment is most effective.5
THE PRINCIPLE OF JUSTICE The principle of justice asserts that no single group should bear the burden or reap the benefits of research. In addition, the principle of justice sets up the expectation that all subjects will be treated equitably and fairly. In some cases in the past, people have been enrolled in studies on the basis of convenience or easy availability. Regrettably, history recounts such unethical studies as the experiments conducted on prisoners by the Nazi regime during World War II and the United States Public Health Service study of untreated syphilis in adult, African American men.6 Justice, as defined in the Belmont report, addresses the issue of unethical studies by establishing an ethical standard of treatment that applies to all persons but particularly those who are vulnerable or unprotected and who historically have borne the risks and burdens of participating in studies.1 In addition, the principle of justice calls for research to be conducted so that people who potentially stand to benefit from participating in a study or from the results of a study are offered the opportunity to participate.7 Keeping these points in mind, the equitable selection of persons to participate in studies is an important component of the principle of justice. When the standard of justice is implemented, subjects are selected without discrimination and not on the basis of convenience or easy access. Individuals are enrolled with full informed
Whitney 231
consent and are selected from populations to whom the study aims and potential beneficial results will apply. In recent years, the perspective on subject selection has broadened and focused on both equitable inclusion of persons without unjustified exclusion of specific groups.3 Throughout the years, some studies have used very narrow inclusion criteria and have in effect excluded a number of groups that may have benefited from the application of findings. Because they were not included in these studies, results and ultimately treatments were not as likely to be offered to these groups. Women, older people, and children are examples of those who in some cases have been excluded unjustly from participating in studies. The current emphasis on protecting human subjects attempts to balance subject selection fairly, to continue to protect vulnerable populations, and at the same time to answer the specific study aims reliably.4,7 Studies designed to fulfill the principle of justice avoid exploitation or neglect of specific groups, and in doing so are more likely to produce results that can be applied more generally because they are not based on the study of a very narrowly defined population. The issues and concerns pertaining to the protection of research participants are complex. Conducting studies ethically and adequately protecting subjects requires careful planning of the study design and methods and begins long before the first participant is enrolled.5 Many aspects of the protection of human subjects must be considered. Important steps include the following: •attending to the clarity and educational level of information; •developing methods to assess the subjects’ understanding of the study requirements; •creating an environment in which individuals are free to decide whether to participate; •taking action to minimize harm and maximize benefits; •providing clear information about the potential risks associated with participation; and •developing inclusion and exclusion criteria that identify the most appropriate target population for the study and ensure access to groups that in past have been underrepresented in studies. The principles of respect, beneficence, and justice guide the planning of studies and the way they are conducted. If we
JWOCN September 2001
232 Whitney
design clinical studies thoughtfully and use these basic principles, the interests of both participants and researchers will be preserved, knowledge will be advanced, and, ultimately, care will be improved. REFERENCES 1. Department of Health and Human Services. The Belmont report. Ethical principles and guidelines for the protection of human subjects of research [online], 1979. Available from: URL: http://ohrop. osophs.dhhhs.gov/humansubjects/guidance/ belmont.html 2. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects [online], October 2000. Available from: URL: http://www.wits.ac.za/ bopejtocs/helsinki.html
3. University of Washington Human Subjects Division. Resource book: the ethical conduct of research involving human subjects [online], 2000. Available from: URL: http://depts.washington. edu/hsd 4. Kahn JP. Moving from compliance to conscience. Why we can and should improve on the ethics of clinical research. Arch Intern Med 2001;161:925-8. 5. Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. CMAJ 1997;156:1153-7. 6. Burns N, Grove SK. The practice of nursing research, 3rd ed. Philadelphia: WB Saunders; 1997. 7. Weijer C. Selecting subjects for participation in clinical research: one sphere of justice. J Med Ethics 1999;25:31-6.
Publisher’s Award for Original Research The Publisher’s Manuscript Award for Original Research is awarded to the author(s) of a manuscript that makes a significant contribution to WOC nursing. This award is designed to recognize excellence in the field. Manuscripts will be judged for their scholarship, originality, and relevance to WOC nursing. All manuscripts that are published within a volume (calendar year) and meet the eligibility requirements are evaluated for the award, which is presented at the WOCN Annual Conference the following spring. In the event an insufficient number of manuscripts are published within a volume, those published manuscripts will be held for consideration for the award the following year. The award is composed of an honorarium in the amount of $500 and a plaque. The check is issued in the name of the corresponding author, and the plaque includes the names of all authors. The eligibility requirements are as follows: Research report must be original and not published or submitted for publication elsewhere. Manuscript must be 2000 words or more. It is not necessary to be a member of the WOCN or have graduated from a WOCN Educational Program or an ET Nursing Education Program to compete for the award. The manuscript cannot be authored by any member of the Editorial Board. All eligible manuscripts are evaluated by the Journal’s Editorial Board.
This award is funded by the Journal of WOCN and Mosby, Inc