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Table of Contents
Think
Assess
Patient: Autonomy
Practitioner: Beneficence & Nonmaleficence
Public Policy: Justice
Conclude
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45. Research on Human Subjects
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Every medical practitioner must be rich in knowledge, not only of that written in books; patients should be the book. Patients will never mislead the medical practitioner.
~ Paracelsus
Consent Crisis
The Case of the Unethical Researcher
Dr. Smith, a well-known researcher, had just published a groundbreaking study on a new cancer treatment. However, rumors began to circulate that Dr. Smith had violated ethical guidelines and conducted research on human subjects without their informed consent.
Medical student Sarah and her mentor, Dr. Johnson, decided to investigate the matter. They reviewed the Belmont Report and Common Rule 45CFR46, which outlined the ethical principles for research on human subjects. They learned that the principles of Respect for Persons (Autonomy), Beneficence (do good & do no harm), and Public Policy (Justice) were critical to research integrity.
Sarah and Dr. Johnson started their investigation by looking into whether the human subjects in Dr. Smith’s study had provided informed consent. They discovered that some of the participants were elderly and had difficulty understanding the consent form’s language. Additionally, some of the patients had severe illnesses, and it was unclear if they were capable of making an informed decision.
Further investigation revealed that Dr. Smith had not obtained Institutional Review Board (IRB) approval before conducting the study, as required by federal law 45 Code of Federal Regulation 46 (45CFR46) or the Common Rule. The IRB’s role is to ensure that all research on human subjects complies with ethical guidelines.
Dr. Smith had also selected research participants based on ease of access, such as patients from nursing homes and institutions. This action violated the Public Policy principle of Justice, which prohibits burdening one social group for the benefit of another.
Sarah and Dr. Johnson reported their findings to the institution’s IRB, and an investigation was launched. It was found that Dr. Smith had indeed violated ethical guidelines and conducted research on human subjects without their informed consent. The study was deemed unethical and invalid.
As a result, Dr. Smith faced severe consequences, including the loss of funding and denial of publication in academic journals. The institution also implemented additional training and monitoring programs for all researchers to ensure ethical compliance.
The case of Dr. Smith serves as a reminder of the importance of adhering to ethical principles in research on human subjects. Medical practitioners must prioritize the protection of human subjects by obtaining informed consent, ensuring nonmaleficence, promoting beneficence, and selecting research participants fairly. It is crucial to have self-regulation and independent oversight to prevent past injustices and ensure the responsible conduct of research.
Abstract
The Belmont Report outlines three ethical principles of biomedical and behavioral research: Respect for Persons: Autonomy (informed consent), Beneficence (do good & do no harm), and Public Policy: Justice (be fair). These principles were formalized in 1979 to protect the rights of human research subjects and were later legislated by the federal law 45 Code of Federal Regulation 46 (45CFR46) also known as the Common Rule. This law mandates the formation of Institutional Review Boards (IRBs) to ensure ethical compliance in all biomedical and behavioral research involving human subjects. The principle of Respect for Persons (Autonomy) requires informed consent from the research subject, while Beneficence encompasses the obligations of nonmaleficence (do no harm) and beneficence (do good). The principle of Public Policy (Justice) requires fair human subject selection and prohibits burdening one social group for the benefit of another. Researchers must follow these principles to ensure ethical and moral compliance and to avoid penalties such as loss of federal funding and denial of publication in academic journals.
**
Think
[45:1] Critical to research integrity are the three principles of biomedical and behavioral research:
- 1. Respect for Persons: autonomy (informed consent) authorization from the research subject
- 2. Beneficence: professional researcher’s obligations of:
a) nonmaleficence (do no harm) to the research subject, and
b) beneficence (do good) to the research subject
3. Public Policy: 4) Justice (fair human subject selection)
[45:2] These three principles were defined in the 1979 Belmont Report guidelines for research on human subjects. They were developed and formalized, with the protection of human research subjects being its central focus. The biomedical and behavior ethics principles are generalizable and are derivable from, consistent with, or at least not in contradiction with most worldviews.
The Belmont Report’s three principles of 1) respect for persons, 2) beneficence, and 3) justice, are equivalent to the four principles that biomedical ethics and medical ethics use: 1) autonomy (informed consent), 2) beneficence (do good), nonmaleficence (do no harm), and 4) justice (be fair). Nonmaleficence (do no harm) is the first thing that is talked about in the Belmont Report under beneficence (do good), but since nonmaleficence (do no harm) is a principle of inaction, rather than action, it is not explicitly included in the Belmont Report listings of the three principles of action. Medical ethics includes nonmaleficence (do no harm) as “do no harm” is one of the core medical principles since even before the Hippocratic Oath:
I will keep them from harm and injustice.
[45:3] To implement and administer these biomedical and behavior principles for guiding all research involving human subjects, Congress legislated federal law 45 Code of Federal Regulation 46 (45CFR46), also known as the Common Rule. In addition to establishing additional protections for certain groups, such as prisoners, and children, it also established Institutional Review Boards (IRB). The Institutional Review Board (IRB) is a mandated diverse group of overseers that every institution conducting research on human subjects must have to ensure human subject protection compliance.
[45:4] Congress legislated these Institutional Review Boards (IRB) in response to the individual, institutional, and systematic injustices accompanying research on human subjects. Unjust research practices arose because the biomedical and behavioral professions failed to self-regulate research to protect human subjects.
[45:5] The straw that broke the camel’s back was the public outcry that occurred when the American public found out that the Center for Disease Control (CDC), American Medical Association (AMA), and the National Medical Association (NMA) were fully supportive of the infamous Syphilis Study at Tuskegee conducted on 600 African American males from 1932-1972. The human research subject abuse at Tuskegee was the catalyst for the Belmont Report’s exposition of the three biomedical and behavioral principles of ethics and the stimulus for Congress to pass federal law (Common Rule 45CFR46) mandating moral compliance and the formation of Institutional Review Boards (IRB) for every institution in the country that conducts any biomedical and behavioral research on human subjects.
[45:6] Penalty for Institutional Review Boards (IRB) non-compliance is the researcher(s) publication(s) in academic journals being denied without IRB approval, and the loss of federal funding for the entire institution.
Assess
Human Subject: 1) Autonomy
[45:7] The Belmont Report and Common Rule 45CFR46 federally mandate that all human subject participants provide autonomous informed consent for research authorization. Research subject autonomy (informed consent) requires that the researcher explains to the human subject in clear and understandable language that is age, education, mentally appropriate, fully understood, and documented in writing the following information:
- 1. procedures to be performed,
- 2. purpose of the research,
- 3. risks and benefits of the procedures,
- 4. alternatives including no treatment, and have the
- 5. opportunity to ask questions and to withdraw from the research at any time.
[45:8] Autonomy is based on the liberal notion that the human subject is in the best position to determine what will maximize the subject’s best interests according to their reasonable goals, values, and priorities.
Researcher: 2) Beneficence & 3) Nonmaleficence
[45:9] Researchers using the principle of nonmaleficence (do no harm) are not to expose human subjects to risk greater than minimal if at all possible. Common Rule: 45CFR46.102(i) defines minimal risks as follows:
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
[45:10] Greater than minimal risk research requires ongoing monitoring by the principal investigator, the Institutional Review Board (IRB), and may require monitoring by an independent Data and Safety Monitory Board (DSMB).
[45:11] The researcher has the professional obligation of beneficence (do good) of conducting research on human subjects that maximize benefits to the human subject. Benefit is defined by the research subject’s reasonable goals, values, and priorities, and medical standards of care.
Public Policy: 4) Justice
[45:12] Researchers, when selecting human subject participants have a social obligation of justice (be fair), not to burden one social group for the benefit of another social group. There must be fair procedures and outcomes in the selection of research subjects, both individually and socially.
[45:13] Researchers are prohibited by federal law (Common Rule 45CFR46) from selecting research participants based on ease of access, such as incarcerated prisoners, institutionalized mentally infirm, nursing home residents, and educational settings. The Belmont Report and federal law (Common Rule 45CFR46) has special protections for vulnerable populations such as prisoners, children, and the mentally infirm requiring that the Institutional Review Board (IRB) has increased protections and designated representatives for such groups when conducting the research approval assessment.
Conclude
[45:14] It is vital for the medical practitioner to recognize the failures and weaknesses of any organization that independently tries to self-regulate without independent, pluralistic, and diverse oversight and representation by affected vulnerable populations. Self-regulation along with independent checks and balances are always necessary. The biomedical and behavioral research principles and requirements are the foundation for ethical analysis of research on human subjects.
[45:15] In summary, the ethical principles outlined in the Belmont Report and enforced by the Common Rule (45CFR46) are essential for maintaining the integrity and moral compliance of research involving human subjects. By understanding and adhering to these principles, researchers can ensure that their work is conducted ethically and that the rights and well-being of human subjects are protected. Moreover, it highlights the importance of self-regulation coupled with independent oversight to prevent past injustices and ensure the responsible conduct of research.
**
45. Review Questions
1. The three principles of biomedical and behavioral research are 1) Respect for Persons: autonomy (informed consent), 2) Beneficence (do good) & nonmaleficence (do no harm), and 3) Justice (be fair).
2. The biomedical and behavioral research principles were developed and formalized, with the primary goal of protecting the principal investigator from professional, institutional, and public accountability.
3. Congress legislated federal law 45 Code of Federal Regulation 46 (45CFR46), also known as the Common Rule implementing the Belmont Report principles and establishing Institutional Review Boards (IRB).
4. Penalty for research human subject noncompliance with the Belmont Report’s biomedical and behavioral principles of ethics:
5. Research subject autonomy (informed consent) requires that the researcher explains to the human subject in clear and understandable language that is age, education, mentally appropriate, fully understood, and documented in writing the following information:
6. Greater than minimal risk research requires ongoing monitoring by the principal investigator, the Institutional Review Board (IRB), and may require monitoring by an independent Data and Safety Monitory Board (DSMB).
7. There must be fair procedures and outcomes in selecting research subjects, both individually and socially.
**
CORRECT! 🙂
[45:1] Critical to research integrity are the three principles of biomedical and behavioral research:
Respect for Persons: autonomy (informed consent) authorization from the research subject
Beneficence: professional researcher obligations of:
a) nonmaleficence (do no harm) to the research subject, and
b) beneficence (do good) to the research subject
3. Public Policy: 4) Justice (fair human subject selection)
Wrong 😕
[45:1] Critical to research integrity are the three principles of biomedical and behavioral research:
Respect for Persons: autonomy (informed consent) authorization from the research subject
Beneficence: professional researcher obligations of:
a) nonmaleficence (do no harm) to the research subject, and
b) beneficence (do good) to the research subject
3. Public Policy: 4) Justice (fair human subject selection)
Wrong 😕
[45:2] These three principles were first defined in the 1979 Belmont Report guidelines for research on human subjects. The principles were developed and formalized, with the protection of human research subjects being its central focus. The biomedical and behavior ethics principles are generalizable principles that are derivable from, consistent with, or at least not in contradiction with most worldviews that are serious about morality.
The Belmont Report’s three principles of 1) respect for persons, 2) beneficence, and 3) justice, are equivalent to the four principles that biomedical ethics and medical ethics use: 1) autonomy (informed consent), 2) beneficence (do good), nonmaleficence (do no harm), and 4) justice (be fair). Nonmaleficence (do no harm) is the first thing that is talked about in the Belmont report under beneficence (do good), but since nonmaleficence (do no harm) is a principle of inaction, rather than action, it is not explicitly included in the Belmont Report when listing the three principles of action. Medical ethics includes nonmaleficence (do no harm) as “do no harm” is one of the core medical principles since before the Hippocratic Oath:
I will keep them from harm and injustice.
CORRECT! 🙂
[45:2] These three principles were first defined in the 1979 Belmont Report guidelines for research on human subjects. The principles were developed and formalized, with the protection of human research subjects being its central focus. The biomedical and behavior ethics principles are generalizable principles that are derivable from, consistent with, or at least not in contradiction with most worldviews that are serious about morality.
The Belmont Report’s three principles of 1) respect for persons, 2) beneficence, and 3) justice, are equivalent to the four principles that biomedical ethics and medical ethics use: 1) autonomy (informed consent), 2) beneficence (do good), nonmaleficence (do no harm), and 4) justice (be fair). Nonmaleficence (do no harm) is the first thing that is talked about in the Belmont report under beneficence (do good), but since nonmaleficence (do no harm) is a principle of inaction, rather than action, it is not explicitly included in the Belmont Report when listing the three principles of action. Medical ethics includes nonmaleficence (do no harm) as “do no harm” is one of the core medical principles since before the Hippocratic Oath:
I will keep them from harm and injustice.
CORRECT! 🙂
[45:3] To implement and administer these biomedical and behavior principles for guiding all research involving human subjects, Congress legislated federal law 45 Code of Federal Regulation 46 (45CFR46), also known as the Common Rule. In addition to establishing additional protections for certain groups, such as prisoners, and children, it also established Institutional Review Boards (IRB). The Institutional Review Board (IRB) is a mandated diverse group of overseers that every institution conducting research on human subjects must have to ensure human subject protection compliance.
Wrong 😕
[45:3] To implement and administer these biomedical and behavior principles for guiding all research involving human subjects, Congress legislated federal law 45 Code of Federal Regulation 46 (45CFR46), also known as the Common Rule. In addition to establishing additional protections for certain groups, such as prisoners, and children, it also established Institutional Review Boards (IRB). The Institutional Review Board (IRB) is a mandated diverse group of overseers that every institution conducting research on human subjects must have to ensure human subject protection compliance.
Wrong 😕
[45:6] Penalty for Institutional Review Boards (IRB) non-compliance is the researcher(s) publication(s) in academic journals being denied without IRB approval and loss of federal funding for the entire institution.
CORRECT! 🙂
[45:6] Penalty for Institutional Review Boards (IRB) non-compliance is the researcher(s) publication(s) in academic journals being denied without IRB approval and loss of federal funding for the entire institution.
Wrong 😕
[45:7] The Belmont Report and Common Rule 45CFR46 federally mandate that all human subject participants provide autonomous informed consent for research authorization. Research subject autonomy (informed consent) requires that the researcher explains to the human subject in clear and understandable language that is age, education, mentally appropriate, fully understood, and documented in writing the following information:
1. procedures to be performed,
2. purpose of the research,
3. risks of harm and benefits of the procedures,
4. alternatives including no treatment, and have the
5. opportunity to ask questions and to withdraw from the research at any time.
CORRECT! 🙂
[45:7] The Belmont Report and Common Rule 45CFR46 federally mandate that all human subject participants provide autonomous informed consent for research authorization. Research subject autonomy (informed consent) requires that the researcher explains to the human subject in clear and understandable language that is age, education, mentally appropriate, fully understood, and documented in writing the following information:
1. procedures to be performed,
2. purpose of the research,
3. risks of harm and benefits of the procedures,
4. alternatives including no treatment, and have the
5. opportunity to ask questions and to withdraw from the research at any time.
Wrong 😕
[45:10] Greater than minimal risk research requires ongoing monitoring by the principal investigator, the Institutional Review Board (IRB), and may require monitoring by an independent Data and Safety Monitory Board (DSMB).
CORRECT! 🙂
[45:10] Greater than minimal risk research requires ongoing monitoring by the principal investigator, the Institutional Review Board (IRB), and may require monitoring by an independent Data and Safety Monitory Board (DSMB).
CORRECT! 🙂
[45:12] Researchers, when selecting human subject participants have a social obligation of justice (be fair), not to burden one social group for the benefit of another social group. There must be fair procedures and outcomes in the selection of research subjects, both individually and socially.
Wrong 😕
[45:12] Researchers, when selecting human subject participants have a social obligation of justice (be fair), not to burden one social group for the benefit of another social group. There must be fair procedures and outcomes in the selection of research subjects, both individually and socially.
45. Clinical Vignettes
1. Mrs. Lucy Mitchell is a 78-year-old retired sales clerk who is admitted to the hospital with severe dehydration and confusion. She has been diagnosed with advanced dementia and cannot provide informed consent for a new study investigating the effectiveness of a new treatment for dementia. Her daughter, who has medical power of attorney, believes that the new treatment could be helpful for her mother and wants her to be enrolled in the study. The research team explains the study and its risks and benefits to the daughter, but Ms. Mitchell refuses to participate. What should the research team do?
2. Mr. Aaron Rogers is a 75-year-old retired business man with early-stage Alzheimer's disease. His daughter, who is his primary caregiver, is interested in enrolling him in a clinical trial for a new medication that may slow the progression of the disease. The medication has not yet been approved by the FDA and there is some risk of adverse effects.
3. Mr. Tyler Johnson, a 75-year-old retired high school math teacher, is diagnosed with a rare type of cancer. His oncologist recommends a new treatment that is being tested in a clinical trial. The treatment has shown promising results in earlier phases of testing, but is not yet approved by the FDA. Mr. Johnson is interested in participating in the trial, but his wife and children are concerned about the potential risks and want him to stick with conventional treatment options.
4. Mr. Matthew Morris is a 70-year-old retired Security officer with early-stage prostate cancer. His practitioner has recommended that he participate in a randomized clinical trial comparing two standard treatments for prostate cancer. Mr. Morris is interested in participating but is concerned about the risks and benefits of the treatments. He is particularly worried about the possibility of adverse effects and the potential impact on his quality of life. Which of the following is the most appropriate response by the research team?
5. Mr. Brandon Thomas, a 75-year-old retired accountant, was recently diagnosed with stage IV lung cancer. He has been started on chemotherapy, but his prognosis remains poor. His two children, a daughter and a son, are very involved in his care and attend all of his medical appointments. During one of his appointments, they learned about a clinical trial for a new cancer treatment and were eager to enroll their father in the study. Mr. Thomas was initially hesitant, but after much persuasion from his children, he agreed to participate in the study. After several weeks of participating in the clinical trial, Mr. Thomas began to experience significant side effects and discomfort. Despite the urging of his children to continue in the study, he decided that he wanted to discontinue his participation. However, his children strongly disagreed, insisting that he continue in the study as they believe it is the best option for their father. Which of the following is the most ethical course of action for the research team to take in this situation?
Wrong 😕
Explanation: The Belmont Report and the Common Rule mandate that human research subjects have the right to make autonomous, informed decisions about their participation in research [45:7]. However, in situations where a patient lacks decisional capacity, a surrogate decision-maker may be consulted to make decisions on the patient's behalf [45:8]. In this case, Ms. Mitchell lacks decisional capacity due to advanced dementia, and her daughter is acting as her surrogate decision-maker [45:15]. However, the principle of respect for persons requires that the research team respect the autonomy of the patient even when a surrogate is involved. In this case, Ms. Mitchell has refused to participate in the study, and the research team should respect her decision even if her daughter believes that it would be in her best interest to participate [45:7]. The research team must not enroll Ms. Mitchell in the study without her consent or overrule her decision [45:9]. Additionally, it is important to note that the surrogate's decision-making authority is not absolute and should always be guided by the patient's known wishes and values, as well as the patient's best interests [45:16]. In this case, the research team should respect Ms. Mitchell's refusal to participate in the study, as it is in line with her known wishes and values, even though her daughter may disagree.
CORRECT! 🙂
Explanation: The Belmont Report and the Common Rule mandate that human research subjects have the right to make autonomous, informed decisions about their participation in research [45:7]. However, in situations where a patient lacks decisional capacity, a surrogate decision-maker may be consulted to make decisions on the patient's behalf [45:8]. In this case, Ms. Mitchell lacks decisional capacity due to advanced dementia, and her daughter is acting as her surrogate decision-maker [45:15]. However, the principle of respect for persons requires that the research team respect the autonomy of the patient even when a surrogate is involved. In this case, Ms. Mitchell has refused to participate in the study, and the research team should respect her decision even if her daughter believes that it would be in her best interest to participate [45:7]. The research team must not enroll Ms. Mitchell in the study without her consent or overrule her decision [45:9]. Additionally, it is important to note that the surrogate's decision-making authority is not absolute and should always be guided by the patient's known wishes and values, as well as the patient's best interests [45:16]. In this case, the research team should respect Ms. Mitchell's refusal to participate in the study, as it is in line with her known wishes and values, even though her daughter may disagree.
CORRECT! 🙂
Explanation: The principle of respect for persons requires that research subjects provide informed consent for their participation in the study [45:1]. In the case of Mr. Rogers, if he has decisional capacity, he should be fully informed about the nature and risks of the study and be given the opportunity to provide his informed consent [45:7]. If he lacks decisional capacity, the research team should follow established procedures for identifying an appropriate surrogate decision maker to provide informed consent on his behalf [45:7]. In either case, the research team must prioritize Mr. Rogers's best interests and minimize the risks of the study [45:1]. It is not ethical to enroll Mr. Rogers in the study without his consent or solely based on his daughter's agreement, as this would violate the principles of respect for persons and autonomy [45:1]. The research team must ensure that Mr. Rogers's rights and interests are protected at all times [45:1].
Wrong 😕
Explanation: The principle of respect for persons requires that research subjects provide informed consent for their participation in the study [45:1]. In the case of Mr. Rogers, if he has decisional capacity, he should be fully informed about the nature and risks of the study and be given the opportunity to provide his informed consent [45:7]. If he lacks decisional capacity, the research team should follow established procedures for identifying an appropriate surrogate decision maker to provide informed consent on his behalf [45:7]. In either case, the research team must prioritize Mr. Rogers's best interests and minimize the risks of the study [45:1]. It is not ethical to enroll Mr. Rogers in the study without his consent or solely based on his daughter's agreement, as this would violate the principles of respect for persons and autonomy [45:1]. The research team must ensure that Mr. Rogers's rights and interests are protected at all times [45:1].
CORRECT! 🙂
Explanation: The principle of respect for persons (autonomy) requires that individuals have the right to make their own decisions regarding their healthcare, including whether to participate in research [45:1]. The fact that Mr. Johnson has a rare type of cancer and the standard treatments have not been effective for him may make participating in the clinical trial a more appealing option. While it is important to consider the opinions of his family, ultimately the decision to participate in the trial should be made by Mr. Johnson himself [45:1]. As stated in the Belmont Report, "an agreement to participate in research constitutes a valid consent only if voluntarily given" [45:2]. Therefore, it is necessary for the research team to respect Mr. Johnson's autonomy and allow him to make his own decision about participation in the clinical trial, even if his family disagrees [45:1].
Wrong 😕
Explanation: The principle of respect for persons (autonomy) requires that individuals have the right to make their own decisions regarding their healthcare, including whether to participate in research [45:1]. The fact that Mr. Johnson has a rare type of cancer and the standard treatments have not been effective for him may make participating in the clinical trial a more appealing option. While it is important to consider the opinions of his family, ultimately the decision to participate in the trial should be made by Mr. Johnson himself [45:1]. As stated in the Belmont Report, "an agreement to participate in research constitutes a valid consent only if voluntarily given" [45:2]. Therefore, it is necessary for the research team to respect Mr. Johnson's autonomy and allow him to make his own decision about participation in the clinical trial, even if his family disagrees [45:1].
CORRECT! 🙂
Explanation: The most appropriate response by the research team is to provide Mr. Morris with accurate and complete information about the study and the two treatment options, but ultimately let him make the final decision. This is consistent with the principle of respect for persons, which requires that research participants are treated as autonomous individuals capable of making their own decisions [45:1][45:8]. It is essential to inform Mr. Morris that the study is based on clinical equipoise, meaning that the two treatment options being compared are expected to be equally effective or beneficial [45:2]. This would help him understand that there is no guarantee of benefit from being a research subject, and that his participation is essential for advancing scientific knowledge and improving future treatments [45:1]. The research team should also provide Mr. Morris with all of the information he needs to make an informed decision, including the potential risks and benefits of each treatment, and the potential impact on his quality of life [45:1][45:9]. This would ensure that he is fully informed and able to make the decision that is best for him. It is important to note that while the research team should provide accurate and complete information, they should not use false or misleading information to convince Mr. Morris to participate. Doing so would be unethical and could compromise the integrity of the study [45:1].
Wrong 😕
Explanation: The most appropriate response by the research team is to provide Mr. Morris with accurate and complete information about the study and the two treatment options, but ultimately let him make the final decision. This is consistent with the principle of respect for persons, which requires that research participants are treated as autonomous individuals capable of making their own decisions [45:1][45:8]. It is essential to inform Mr. Morris that the study is based on clinical equipoise, meaning that the two treatment options being compared are expected to be equally effective or beneficial [45:2]. This would help him understand that there is no guarantee of benefit from being a research subject, and that his participation is essential for advancing scientific knowledge and improving future treatments [45:1]. The research team should also provide Mr. Morris with all of the information he needs to make an informed decision, including the potential risks and benefits of each treatment, and the potential impact on his quality of life [45:1][45:9]. This would ensure that he is fully informed and able to make the decision that is best for him. It is important to note that while the research team should provide accurate and complete information, they should not use false or misleading information to convince Mr. Morris to participate. Doing so would be unethical and could compromise the integrity of the study [45:1].
CORRECT! 🙂
Explanation: The most ethical course of action in this situation is for the research team to respect Mr. Thomas's decision to withdraw from the study, even if his children disagree [45:1]. It is essential to obtain informed consent from the research subject, and if the subject decides to participate in research, it must be voluntary [45:7]. Regardless of his decisional capacity, Mr. Thomas has the right to refuse to participate or to withdraw from the research at any time. While his children's opinions may be important, the ultimate decision rests with Mr. Thomas and his right to autonomous informed consent [45:1, 45:7]. It is not ethical to pressure or force Mr. Thomas to continue in the study against his wishes, even if his children believe it is in his best interest [45:11]. Seeking legal action against Mr. Thomas to force him to remain in the study would be a violation of his autonomy and is not an ethical option [45:1]. The research team must prioritize Mr. Thomas's well-being and respect his right to make decisions regarding his participation in the study [45:1, 45:7].
Wrong 😕
Explanation: The most ethical course of action in this situation is for the research team to respect Mr. Thomas's decision to withdraw from the study, even if his children disagree [45:1]. It is essential to obtain informed consent from the research subject, and if the subject decides to participate in research, it must be voluntary [45:7]. Regardless of his decisional capacity, Mr. Thomas has the right to refuse to participate or to withdraw from the research at any time. While his children's opinions may be important, the ultimate decision rests with Mr. Thomas and his right to autonomous informed consent [45:1, 45:7]. It is not ethical to pressure or force Mr. Thomas to continue in the study against his wishes, even if his children believe it is in his best interest [45:11]. Seeking legal action against Mr. Thomas to force him to remain in the study would be a violation of his autonomy and is not an ethical option [45:1]. The research team must prioritize Mr. Thomas's well-being and respect his right to make decisions regarding his participation in the study [45:1, 45:7].
**
45. Reflection Vignettes
1. Ms. Jane Smith, a 32-year-old teacher, has agreed to participate in a research study investigating the effectiveness of a new medication for treating anxiety. After undergoing a thorough informed consent process, including a detailed explanation of the study's procedures, possible risks and benefits, and an opportunity to ask questions, she agrees to participate. During the study, Ms. Smith begins experiencing significant side effects from the medication, which cause her to feel extremely anxious and uncomfortable. Despite efforts to address her concerns and adjust her treatment, Ms. Smith ultimately decides that she no longer wishes to participate in the study. In response the practitioner should first acknowledge the patient's decision to withdraw from the research study and provide reassurance that their decision will be respected. The practitioner should also explain the potential consequences of withdrawing from the study, such as incomplete data and a potential loss of potential benefits for the patient and future patients. The practitioner should also discuss alternative treatments or options for the patient and make sure they have appropriate medical care moving forward. Finally, the practitioner should document the patient's decision and the reasons for their withdrawal in the medical record.
Think
Assess
Patient: Autonomy
Practitioner: Beneficence & Nonmaleficence
Public Policy: Justice
Conclude
**
2. Ms. Samantha Lee, a 45-year-old research physician, has conducted studies in a local nursing home for the past year. She has noticed that it is much easier to conduct research on institutionalized subjects as the subjects are all at the same location, have efficient access to them, and better control subject compliance. However, her study is now being criticized for not including a diverse enough sample population since the majority of her subjects are institutionalized. Dr. Lee should inform the institutional review board (IRB) of the concerns about lack of diversity. The IRB is responsible for ensuring that research studies are conducted in an ethical and safe manner and can review the study protocol to determine if it meets ethical standards. If the study does not meet ethical standards or poses potential harm to the patients, the IRB can request modifications to the study or even reject it. Dr. Lee can also consult with an ethics committee or seek guidance from professional organizations or colleagues to ensure that she is following ethical guidelines in her practice.Researchers have found that it is much easier to conduct research on institutionalized subjects, as the subjects are all at the same location, have efficient access to them, and better control subject compliance.
Think
Assess
Patient: Autonomy
Practitioner: Beneficence & Nonmaleficence
Public Policy: Justice
Conclude
***
