Podcast
Questions and Answers
What is the primary ethical principle that must be prioritized in research involving human subjects?
What is the primary ethical principle that must be prioritized in research involving human subjects?
- Obtaining data with minimal errors
- Maintaining safety and human rights (correct)
- Prioritizing financial gain from research
- Expediting the research process
Which ethical principle emphasizes the right of individuals to decide whether or not to participate in research?
Which ethical principle emphasizes the right of individuals to decide whether or not to participate in research?
- Self-determination (correct)
- Autonomy
- Beneficence
- Justice
According to the Belmont Report, which principle requires that research must not cause harm and should maximize benefits?
According to the Belmont Report, which principle requires that research must not cause harm and should maximize benefits?
- Justice
- Respect for persons
- Beneficence (correct)
- Confidentiality
Which of the following is a requirement when conducting research with vulnerable populations?
Which of the following is a requirement when conducting research with vulnerable populations?
What should be made explicit in the informed consent process according to ethical research considerations?
What should be made explicit in the informed consent process according to ethical research considerations?
Which of the following actions is morally unjustifiable in research involving human subjects?
Which of the following actions is morally unjustifiable in research involving human subjects?
What is a critical consideration when assessing the risks of a research study?
What is a critical consideration when assessing the risks of a research study?
What significant ethical principle is highlighted in the Nuremberg Code?
What significant ethical principle is highlighted in the Nuremberg Code?
Which document established foundational ethical guidelines for human research after World War II?
Which document established foundational ethical guidelines for human research after World War II?
Which statement best describes the principle of justice in research ethics?
Which statement best describes the principle of justice in research ethics?
What unethical practice was central to the Tuskegee Syphilis Study?
What unethical practice was central to the Tuskegee Syphilis Study?
In the Declaration of Helsinki, what is essential for therapeutic research?
In the Declaration of Helsinki, what is essential for therapeutic research?
Which of the following best describes a requirement in the Nuremberg Code?
Which of the following best describes a requirement in the Nuremberg Code?
What was a key outcome of the unethical practices observed during research in WWII?
What was a key outcome of the unethical practices observed during research in WWII?
What aspect differentiates nontherapeutic research in the Declaration of Helsinki?
What aspect differentiates nontherapeutic research in the Declaration of Helsinki?
Which historical event prompted the establishment of ethical guidelines in research?
Which historical event prompted the establishment of ethical guidelines in research?
What is the main purpose of Research Ethics Boards (REBs)?
What is the main purpose of Research Ethics Boards (REBs)?
Which requirement is NOT a part of the composition of Research Ethics Boards?
Which requirement is NOT a part of the composition of Research Ethics Boards?
Which of the following roles does the REB play in research projects?
Which of the following roles does the REB play in research projects?
What type of research is categorized as exempt by the REB?
What type of research is categorized as exempt by the REB?
Which of the following is a primary concern for REBs during the review process?
Which of the following is a primary concern for REBs during the review process?
What is a necessary qualification for members of Research Ethics Boards?
What is a necessary qualification for members of Research Ethics Boards?
What does the expedited review category for research imply?
What does the expedited review category for research imply?
Which of these statements about REB training is accurate?
Which of these statements about REB training is accurate?
What aspect of research involving Indigenous Peoples is emphasized for effective outcomes?
What aspect of research involving Indigenous Peoples is emphasized for effective outcomes?
Which of the following best describes community engagement in research?
Which of the following best describes community engagement in research?
How can research benefit Indigenous communities specifically?
How can research benefit Indigenous communities specifically?
What is a potential attitude of some Indigenous communities towards research projects?
What is a potential attitude of some Indigenous communities towards research projects?
What is an essential requirement for researchers when engaging with Indigenous communities?
What is an essential requirement for researchers when engaging with Indigenous communities?
In what ways might a community choose to engage in a research project?
In what ways might a community choose to engage in a research project?
What historical criticism has been noted regarding research conducted involving Indigenous Peoples?
What historical criticism has been noted regarding research conducted involving Indigenous Peoples?
What is a significant form of community involvement researchers may seek to establish?
What is a significant form of community involvement researchers may seek to establish?
What are the essential elements that must be present in informed consent?
What are the essential elements that must be present in informed consent?
What is the primary purpose of recognizing individual autonomy in research?
What is the primary purpose of recognizing individual autonomy in research?
What does the term 'voluntariness' signify in the context of informed consent?
What does the term 'voluntariness' signify in the context of informed consent?
Which statement is true regarding the Informed Consent Form?
Which statement is true regarding the Informed Consent Form?
What must researchers do regarding the comprehension of informed consent?
What must researchers do regarding the comprehension of informed consent?
What is typically implied by self-administered questionnaires in terms of consent?
What is typically implied by self-administered questionnaires in terms of consent?
Which of the following is NOT a responsibility of researchers regarding consent?
Which of the following is NOT a responsibility of researchers regarding consent?
What must researchers ensure in relation to confidentiality in the Informed Consent Form?
What must researchers ensure in relation to confidentiality in the Informed Consent Form?
Under what circumstance might researchers choose to use deception in their study?
Under what circumstance might researchers choose to use deception in their study?
What must researchers do when deception is used in their studies?
What must researchers do when deception is used in their studies?
Which of the following describes deception by omission?
Which of the following describes deception by omission?
What is the potential effect on participants even after they are debriefed about the deception?
What is the potential effect on participants even after they are debriefed about the deception?
What type of misconduct is a researcher at risk of if they do not disclose omissions in their data reporting?
What type of misconduct is a researcher at risk of if they do not disclose omissions in their data reporting?
In outcomes research focusing on patient care, which aspect would be deemed most significant to evaluate?
In outcomes research focusing on patient care, which aspect would be deemed most significant to evaluate?
Which of the following groups is considered a vulnerable subject in research settings?
Which of the following groups is considered a vulnerable subject in research settings?
What misconception is there regarding informed consent in research?
What misconception is there regarding informed consent in research?
Flashcards
Declaration of Helsinki
Declaration of Helsinki
A set of ethical principles for medical research involving human subjects, emphasizing informed consent and minimizing risks.
Informed Consent
Informed Consent
The process of ensuring that research participants understand the risks and benefits of participating in a study and freely agree to participate.
Belmont Report (1979)
Belmont Report (1979)
A foundational document outlining three core ethical principles for research involving human subjects: respect for persons, beneficence, and justice.
Respect for Persons
Respect for Persons
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Beneficence
Beneficence
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Justice
Justice
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Vulnerable Populations
Vulnerable Populations
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Risk-Benefit Analysis
Risk-Benefit Analysis
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Indigenous Research
Indigenous Research
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Community Engagement
Community Engagement
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Indigenous Perspectives and Priorities
Indigenous Perspectives and Priorities
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Benefits of Research for a Community
Benefits of Research for a Community
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Community Involvement in Research
Community Involvement in Research
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Shared or Sole Leadership Role
Shared or Sole Leadership Role
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Strengthening Research Capacity
Strengthening Research Capacity
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Monitoring Research
Monitoring Research
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Nuremberg Code
Nuremberg Code
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Protection from harm
Protection from harm
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Right to withdraw
Right to withdraw
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Tuskegee Syphilis Study
Tuskegee Syphilis Study
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Therapeutic research
Therapeutic research
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Nontherapeutic research
Nontherapeutic research
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Elements of Informed Consent
Elements of Informed Consent
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Knowledge (Informed Consent)
Knowledge (Informed Consent)
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Comprehension (Informed Consent)
Comprehension (Informed Consent)
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Voluntariness (Informed Consent)
Voluntariness (Informed Consent)
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Informed Consent Form
Informed Consent Form
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Types of Consent
Types of Consent
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Deception in Research
Deception in Research
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Ethical Considerations with Deception
Ethical Considerations with Deception
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Deception by Omission
Deception by Omission
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False Feedback Deception
False Feedback Deception
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Perseverance Effect
Perseverance Effect
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Scientific Misconduct
Scientific Misconduct
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Vulnerable Subjects
Vulnerable Subjects
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Informed Consent Process
Informed Consent Process
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Research Ethics Boards (REBs)
Research Ethics Boards (REBs)
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REB Members
REB Members
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Full Board Review
Full Board Review
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Expedited Review
Expedited Review
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Exempt Review
Exempt Review
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Investigator-Subject Relationship
Investigator-Subject Relationship
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Assessing Risk & Benefit
Assessing Risk & Benefit
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Consent Forms & Process
Consent Forms & Process
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Study Notes
Ethical Issues in Research
- Nursing research has developed guidelines to protect human participants, including the Nuremberg Code (1947) and the Declaration of Helsinki (1964).
- Before World War II, few guidelines existed to protect human research subjects. This led to many deaths during experiments.
- The Nazi Program of Research used prisoners of war.
- The Nuremberg Code, arising from the Nuremberg Trials, was instrumental in establishing principles for protecting human participants in research. Key elements include protection from risk or harm, informed consent, the right to withdraw, and adequate qualifications for researchers.
- The Nuremberg Code set basic principles for ethical behavior in research.
Unethical Studies
- The Tuskegee Syphilis Study (1932-1972) was conducted by the U.S. Public Health Service. Researchers studied the effects of untreated syphilis on 400 impoverished African American men.
- A crucial part of the study was that participants were deliberately not given treatment, even when effective medications like penicillin became available, to observe the natural progression of the illness.
Declaration of Helsinki
- The Declaration of Helsinki differentiates between therapeutic and non-therapeutic research.
- Therapeutic research aims to benefit participants, while the results of non-therapeutic research may not immediately benefit participants but may do so in the future.
- Subjects must be informed of any risks before enrollment.
- Legally authorized representatives may grant permission for subjects who lack the capacity to provide informed consent.
Other Ethical Concerns
- Deception can be necessary in research in some situations, but it must outweigh the risks.
- Examples of deception can include vague descriptions or false feedback about test results to observe impacts on self-esteem.
- The perseverance effect, where participants continue to be affected by deception even after they are debriefed and the deception is revealed/explained, must be considered.
- The ethical principle of "respect for persons" recognizes autonomy, the freedom to choose to participate or not in research. This principle also encourages acknowledging individual's choices based on their beliefs and values. It also involves protecting vulnerable populations like children and those impaired.
- The Belmont Report (1979) identifies three basic, underlying principles: respect for persons, beneficence, and justice.
- The Belmont Report emphasizes that risks of research should be minimized, and benefits must be made explicit in informed consent.
- Appropriate inclusion and exclusion of participants is crucial to ensure the fairness of research. Deception in research must be minimized and justify risks in such situations. Debriefing should always follow any deception used.
- Scientific misconduct/misrepresenting data (e.g., omitting data from analysis) may negatively affect the quality and reliability and be unethical.
- There's a difference between the process of informed consent and the informed consent form. A form is a tool, but the process requires participants' understanding, ability to voluntarily agree, and ongoing communication.
- Special considerations are needed for vulnerable participants like children, prisoners, the mentally disabled, economically disadvantaged, educationally disadvantaged, or with subtle vulnerability (substance abuse, pregnancy, language barriers).
- Approval criteria for research studies, such as the minimization of risks, the balancing of risks and benefits, subject selection criteria, informed consent procedures, and the protection of privacy/confidentiality of participants, enhance ethical standards for research involvement.
- There are different categories for reviewing research ethics boards (Exempt, Expedited, Full-Board Review); the categorizations vary based on the level of risk involved in the research.
- The Canadian Nurses Association (CNA)'s code of ethics provides ethical standards emphasizing compassionate care, promoting wellbeing, respecting informed decisions, upholding dignity, privacy/confidentiality, justice and accountability.
- When reviewing research ethics, essential questions include if the study was approved by the IRB (institutional review board), whether informed consent was obtained from the subject, if the subject was legally authorized to give consent (e.g., legally representative), whether rights were protected during sampling and data processes, whether privacy was preserved in and after the study, and if the benefit/risk ratio was acceptable.
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Description
Explore the critical ethical guidelines in nursing research, including the Nuremberg Code and Declaration of Helsinki. This quiz delves into historical unethical studies, such as the Tuskegee Syphilis Study, highlighting the importance of protecting human participants in research.