Ethical Issues in Nursing Research
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Questions and Answers

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?

  • Self-determination (correct)
  • Autonomy
  • Beneficence
  • Justice

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?

<p>Demonstration of the appropriateness of their involvement (D)</p> Signup and view all the answers

What should be made explicit in the informed consent process according to ethical research considerations?

<p>All risks and benefits (D)</p> Signup and view all the answers

Which of the following actions is morally unjustifiable in research involving human subjects?

<p>Brutal or inhumane treatment of subjects (C)</p> Signup and view all the answers

What is a critical consideration when assessing the risks of a research study?

<p>Minimal risks should align with the research objectives (A)</p> Signup and view all the answers

What significant ethical principle is highlighted in the Nuremberg Code?

<p>Informed consent (C)</p> Signup and view all the answers

Which document established foundational ethical guidelines for human research after World War II?

<p>The Nuremberg Code (C)</p> Signup and view all the answers

Which statement best describes the principle of justice in research ethics?

<p>It ensures that everyone is treated fairly. (D)</p> Signup and view all the answers

What unethical practice was central to the Tuskegee Syphilis Study?

<p>Deliberate withholding of treatment (B)</p> Signup and view all the answers

In the Declaration of Helsinki, what is essential for therapeutic research?

<p>Results must benefit participants (A)</p> Signup and view all the answers

Which of the following best describes a requirement in the Nuremberg Code?

<p>Participants must engage voluntarily and can withdraw at any time. (C)</p> Signup and view all the answers

What was a key outcome of the unethical practices observed during research in WWII?

<p>Establishment of the Nuremberg Code (D)</p> Signup and view all the answers

What aspect differentiates nontherapeutic research in the Declaration of Helsinki?

<p>Benefits might emerge in the future for participants. (B)</p> Signup and view all the answers

Which historical event prompted the establishment of ethical guidelines in research?

<p>The Nuremberg Trials post-WWII (A)</p> Signup and view all the answers

What is the main purpose of Research Ethics Boards (REBs)?

<p>To ensure ethical standards are met regarding human subjects (B)</p> Signup and view all the answers

Which requirement is NOT a part of the composition of Research Ethics Boards?

<p>At least two members must be from within the institution (D)</p> Signup and view all the answers

Which of the following roles does the REB play in research projects?

<p>Assessing recruitment fairness and risk-benefit analysis (A)</p> Signup and view all the answers

What type of research is categorized as exempt by the REB?

<p>Low risk, non-sensitive, short duration studies (C)</p> Signup and view all the answers

Which of the following is a primary concern for REBs during the review process?

<p>Evaluating consent processes and autonomy (C)</p> Signup and view all the answers

What is a necessary qualification for members of Research Ethics Boards?

<p>Expertise that reflects cultural and professional diversity (B)</p> Signup and view all the answers

What does the expedited review category for research imply?

<p>Minimal risk and non-sensitive topics are involved (B)</p> Signup and view all the answers

Which of these statements about REB training is accurate?

<p>REB members must have training in scientific misconduct prevention (A)</p> Signup and view all the answers

What aspect of research involving Indigenous Peoples is emphasized for effective outcomes?

<p>Community participation in design and execution (C)</p> Signup and view all the answers

Which of the following best describes community engagement in research?

<p>Engagement that includes formal agreements and ongoing interactions (C)</p> Signup and view all the answers

How can research benefit Indigenous communities specifically?

<p>Training community members in research skills (C)</p> Signup and view all the answers

What is a potential attitude of some Indigenous communities towards research projects?

<p>Monitoring without active involvement (C)</p> Signup and view all the answers

What is an essential requirement for researchers when engaging with Indigenous communities?

<p>Understanding and aligning with community priorities and perspectives (A)</p> Signup and view all the answers

In what ways might a community choose to engage in a research project?

<p>Through formal and informal consultations with community members (A)</p> Signup and view all the answers

What historical criticism has been noted regarding research conducted involving Indigenous Peoples?

<p>Many researchers have not engaged with Indigenous perspectives effectively. (C)</p> Signup and view all the answers

What is a significant form of community involvement researchers may seek to establish?

<p>Formal negotiations with community leadership (A)</p> Signup and view all the answers

What are the essential elements that must be present in informed consent?

<p>Knowledge, Comprehension, and Voluntariness (B)</p> Signup and view all the answers

What is the primary purpose of recognizing individual autonomy in research?

<p>To ensure voluntary participation and protect those with limited autonomy (D)</p> Signup and view all the answers

What does the term 'voluntariness' signify in the context of informed consent?

<p>Participants have the right to refuse to participate without coercion (A)</p> Signup and view all the answers

Which statement is true regarding the Informed Consent Form?

<p>It should outline the risks and how they can be minimized. (C)</p> Signup and view all the answers

What must researchers do regarding the comprehension of informed consent?

<p>Explain the research details without using jargon that may confuse participants (C)</p> Signup and view all the answers

What is typically implied by self-administered questionnaires in terms of consent?

<p>Implied consent is assumed through the return of the completed questionnaires. (C)</p> Signup and view all the answers

Which of the following is NOT a responsibility of researchers regarding consent?

<p>Ensuring permanent participation of all subjects (D)</p> Signup and view all the answers

What must researchers ensure in relation to confidentiality in the Informed Consent Form?

<p>Researchers are obliged to outline how confidentiality will be maintained. (A)</p> Signup and view all the answers

Under what circumstance might researchers choose to use deception in their study?

<p>When revealing study details may alter participant behavior (C)</p> Signup and view all the answers

What must researchers do when deception is used in their studies?

<p>Offer a comprehensive debriefing after the study (A)</p> Signup and view all the answers

Which of the following describes deception by omission?

<p>Researchers use vague terms to describe research procedure (A)</p> Signup and view all the answers

What is the potential effect on participants even after they are debriefed about the deception?

<p>Residual doubt about the researchers' honesty (D)</p> Signup and view all the answers

What type of misconduct is a researcher at risk of if they do not disclose omissions in their data reporting?

<p>Scientific misconduct (B)</p> Signup and view all the answers

In outcomes research focusing on patient care, which aspect would be deemed most significant to evaluate?

<p>Overall evaluation of patient outcomes (D)</p> Signup and view all the answers

Which of the following groups is considered a vulnerable subject in research settings?

<p>Mentally disabled individuals (B)</p> Signup and view all the answers

What misconception is there regarding informed consent in research?

<p>It is synonymous with an informed consent form (D)</p> Signup and view all the answers

Flashcards

Declaration of Helsinki

A set of ethical principles for medical research involving human subjects, emphasizing informed consent and minimizing risks.

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)

A foundational document outlining three core ethical principles for research involving human subjects: respect for persons, beneficence, and justice.

Respect for Persons

Recognizing the individual autonomy of research participants, allowing them the freedom to choose whether or not to participate in research.

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Beneficence

The ethical principle that aims to minimize harm and maximize benefits for research participants.

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Justice

Ensuring that all individuals are treated fairly and equitably in research, including access to benefits and risks.

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Vulnerable Populations

Groups of individuals who may be at increased risk of harm in research due to factors like age, health status, or socioeconomic circumstances.

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Risk-Benefit Analysis

Evaluating the potential risks and benefits of a research study to determine if the benefits justify the potential risks to participants.

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Indigenous Research

Research involving First Nations, Inuit, and Métis Peoples of Canada, often led by non-Indigenous researchers historically.

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Community Engagement

The interaction between researchers and Indigenous communities relevant to a research project.

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Indigenous Perspectives and Priorities

The unique views and goals of Indigenous communities that should be considered in research.

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Benefits of Research for a Community

The positive outcomes of research for Indigenous communities, including knowledge gain, skills training, and addressing community priorities.

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Community Involvement in Research

The level of participation of a community in a research project, ranging from full collaboration to limited involvement.

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Shared or Sole Leadership Role

Indigenous communities leading or co-leading research projects, ensuring their perspectives and priorities are central.

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Strengthening Research Capacity

Developing research skills among community members through training, empowering them to participate actively in research.

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Monitoring Research

A community's oversight of a research project to ensure it adheres to agreed-upon conditions and ethical guidelines.

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Nuremberg Code

A set of ethical principles for human research established after World War II in response to Nazi medical experiments. It emphasizes informed consent, protection from harm, and the right to withdraw from research.

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Protection from harm

Ensuring that research participants are protected from physical, psychological, or social harm during the study.

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Right to withdraw

Participants in research have the freedom to stop participating at any time, without repercussions.

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Tuskegee Syphilis Study

A study in the US where African American men with syphilis were denied treatment to observe the disease's progression, a major ethical violation.

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Therapeutic research

Research where participants directly benefit from the findings or treatments studied.

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Nontherapeutic research

Research where participants do not directly benefit from the study, but future individuals may gain knowledge or benefits from the findings.

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Elements of Informed Consent

Informed consent emphasizes three key elements: knowledge, comprehension, and voluntariness. Researchers have a duty to inform participants about the research, ensuring they understand it, and have the freedom to decline participation.

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Knowledge (Informed Consent)

Participants must be informed about the research, including its purpose, procedures, risks, potential benefits, and the rights of participants.

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Comprehension (Informed Consent)

Participants should understand the information provided in a language they can comprehend, using clear and simple terms.

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Voluntariness (Informed Consent)

Participants must have the freedom to choose whether or not to participate without coercion or undue influence.

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Informed Consent Form

A written document that outlines the details of a research study, including its purpose, procedures, risks, benefits, and participant rights. It serves as a record of informed consent.

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Types of Consent

There are different types of consent, like written consent, which is typically signed, and implied consent, which is assumed when participants return self-administered questionnaires, signifying voluntary participation.

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Deception in Research

The act of misleading participants about the true purpose or nature of a study, sometimes deemed necessary when full disclosure could influence behavior.

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Ethical Considerations with Deception

Deception in research is only justified if the benefits outweigh the risks to participants. Researchers must debrief participants afterward to address any potential harm and ensure understanding.

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Deception by Omission

A type of deception where researchers intentionally leave out crucial information or use vague terms to describe the study.

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False Feedback Deception

Researchers provide participants with false information about their performance, often on a test or task, to observe the effect on their behavior or self-perception.

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Perseverance Effect

When participants continue to be affected by deception even after being fully debriefed, potentially doubting the researcher's honesty or the validity of the study.

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Scientific Misconduct

Failing to disclose the use of all collected data in a study analysis, potentially leading to biased results and misleading conclusions.

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Vulnerable Subjects

Individuals who may be at increased risk of harm during research due to age, ability, social status, or other factors. They require extra protection and ethical considerations.

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Informed Consent Process

A crucial step in research ethics involving clear communication with participants about the nature of the study, potential risks and benefits, and their rights and responsibilities.

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Research Ethics Boards (REBs)

Committees that review research projects involving humans to ensure ethical standards are met and participants' rights are protected.

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REB Members

REBs must have at least five diverse members qualified by experience and expertise. They represent various backgrounds, including non-scientists.

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Full Board Review

The highest level of ethical review for research proposals, involving a complete evaluation by all REB members.

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Expedited Review

A faster review process for minimal risk research, where the potential harms are no greater than those of everyday life.

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Exempt Review

The lowest level of review for research posing no risk to participants, such as educational projects.

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Investigator-Subject Relationship

The interaction between researchers and participants, requiring transparency, respect, and clear communication.

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Assessing Risk & Benefit

Weighing the potential harms and benefits of the study before deciding if it is ethical to proceed.

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Consent Forms & Process

A document explaining the study and outlining the risks and benefits of participation, ensuring informed consent.

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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.

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