Podcast
Questions and Answers
What is required for individual justice in research participation?
What is required for individual justice in research participation?
- The selection of participants can be based on convenience.
- Benefits must outweigh risks for all participants.
- Risks must be shared by a diverse population. (correct)
- Only marginalized groups must benefit from research.
What is the main objective of the migraine intervention trial?
What is the main objective of the migraine intervention trial?
- To evaluate dietary influences on migraine prevalence
- To test the efficacy of acupuncture versus a placebo
- To determine the effectiveness of acupuncture alongside oral medication (correct)
- To analyze the side effects of acupuncture on different populations
Which concept is primarily concerned with the appropriateness of placing burdens on already burdened individuals?
Which concept is primarily concerned with the appropriateness of placing burdens on already burdened individuals?
- Social justice (correct)
- Individual justice
- Therapeutic misconception
- Equitable distribution
How do the researchers plan to ensure a fair representation of participants in the migraine trial?
How do the researchers plan to ensure a fair representation of participants in the migraine trial?
What ethical consideration is involved when including vulnerable populations in research?
What ethical consideration is involved when including vulnerable populations in research?
Which principle does the migraine intervention trial successfully fulfill?
Which principle does the migraine intervention trial successfully fulfill?
In the context of justice in research, what does the term 'undue burden' refer to?
In the context of justice in research, what does the term 'undue burden' refer to?
Which of the following aspects is NOT part of the Justice section's examination in research ethics?
Which of the following aspects is NOT part of the Justice section's examination in research ethics?
What is a significant issue with the esophageal cancer study's recruitment strategy?
What is a significant issue with the esophageal cancer study's recruitment strategy?
Why is it problematic for the esophageal cancer study to have a limited participant pool?
Why is it problematic for the esophageal cancer study to have a limited participant pool?
What aspect was crucial to assess in deciding the inclusivity of women in the esophageal cancer study?
What aspect was crucial to assess in deciding the inclusivity of women in the esophageal cancer study?
What is a primary concern regarding the geographic representation in the esophageal cancer study?
What is a primary concern regarding the geographic representation in the esophageal cancer study?
In research ethics, what principle addresses the fairness in participant selection like in the migraine trial?
In research ethics, what principle addresses the fairness in participant selection like in the migraine trial?
What is the primary reason for conducting a separate, age-specific study in children?
What is the primary reason for conducting a separate, age-specific study in children?
Which of the following statements is true regarding the requirements for research involving children?
Which of the following statements is true regarding the requirements for research involving children?
According to the definition provided, who qualifies as a child in research settings?
According to the definition provided, who qualifies as a child in research settings?
What is the inclusion policy regarding the age of individuals participating in research?
What is the inclusion policy regarding the age of individuals participating in research?
What aspect must be carefully analyzed to justify children's participation in certain studies?
What aspect must be carefully analyzed to justify children's participation in certain studies?
What is the significance of including children in research as outlined in the document?
What is the significance of including children in research as outlined in the document?
Which group must approve special cases for children's participation in research?
Which group must approve special cases for children's participation in research?
In which circumstance might the participation of children in research be justified despite the risks?
In which circumstance might the participation of children in research be justified despite the risks?
What can be inferred about the data availability in adults related to assessing potential risks for children?
What can be inferred about the data availability in adults related to assessing potential risks for children?
Under what condition may researchers consider employing incomplete disclosure or deception in their study?
Under what condition may researchers consider employing incomplete disclosure or deception in their study?
What must be true for informed consent to be waived in a research study involving deception?
What must be true for informed consent to be waived in a research study involving deception?
What is a primary consideration when deciding whether to debrief participants after a study involving deception?
What is a primary consideration when deciding whether to debrief participants after a study involving deception?
When is it acceptable for researchers to withhold critical information during the informed consent process?
When is it acceptable for researchers to withhold critical information during the informed consent process?
For research that involves minimal risk, what should researchers ensure when using incomplete disclosure?
For research that involves minimal risk, what should researchers ensure when using incomplete disclosure?
What ethical concern does incomplete disclosure and deception pose in research?
What ethical concern does incomplete disclosure and deception pose in research?
When is debriefing considered inappropriate after a study involving deception?
When is debriefing considered inappropriate after a study involving deception?
Which of the following is NOT a criterion for waiving informed consent?
Which of the following is NOT a criterion for waiving informed consent?
What might researchers need to assess before using deception in their study?
What might researchers need to assess before using deception in their study?
What should participants be informed of regarding incomplete disclosure before agreeing to participate in a study?
What should participants be informed of regarding incomplete disclosure before agreeing to participate in a study?
What main benefit does debriefing provide to research participants?
What main benefit does debriefing provide to research participants?
What is a crucial consideration when conducting research in resource-poor settings?
What is a crucial consideration when conducting research in resource-poor settings?
Which of the following should researchers consider when planning studies in foreign countries?
Which of the following should researchers consider when planning studies in foreign countries?
How should the benefits of research to local populations be handled according to ethical standards?
How should the benefits of research to local populations be handled according to ethical standards?
What should investigators do to protect participants during international research?
What should investigators do to protect participants during international research?
Why is it necessary to think about the post-study access to interventions for participants?
Why is it necessary to think about the post-study access to interventions for participants?
Which of the following represents an ethical concern in international research?
Which of the following represents an ethical concern in international research?
What aspect of participant welfare is addressed through debriefing?
What aspect of participant welfare is addressed through debriefing?
What should researchers consider regarding the treatment that emerges from their study?
What should researchers consider regarding the treatment that emerges from their study?
What role does fairness play in conducting international research?
What role does fairness play in conducting international research?
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Study Notes
The Principle of Justice in Research
- The principle of justice in research dictates that all individuals should be treated fairly and equitably.
- Fairness in research can be broken down into individual justice and social justice
- Individual justice requires that the benefits of research are offered to a diverse population.
Fair and Just Treatment
- Research should consider the ability of research participants to bear burdens and whether placing further burdens on already burdened persons is appropriate.
Inclusion in Research
- The principles of inclusion can be seen in the research process.
- Research should be inclusive of different populations including women, minorities, and children.
- Women and minorities should be included in proportion to the rates of disease or condition.
The Case of Esophageal Cancer
- A study on genetic factors associated with esophageal cancer should include a diverse population to accurately represent the disease in different populations.
- Not including a diverse population may lead to a study that is not generalizable to the population of the country.
Selection of Populations for Clinical Research
- When choosing participants for clinical research, researchers must consider the specific goals of the research and whether a diverse population is necessary.
- The goal of research is to ensure the findings are generalizable to the wider population.
- If the study is anticipated to result in widespread benefits and there is minimal risk associated with the study, the inclusion of a diverse population is necessary.
Incomplete Disclosure and Deception
- Research participants should be fully informed about the risks and benefits of participating in research.
- There may be instances where incomplete disclosure or deception is necessary for research, however careful consideration must be taken before engaging.
- For example, only if incomplete disclosure is essential to the research and is not harmful to the research participant.
- Debriefing involves informing participants after the study of any deception or incomplete disclosure.
Debriefing
- Debriefing is generally considered appropriate, however, it must depend on whether the disclosure would result in harm.
Fairness in International Research
- Researchers must ensure that fair standards are used when conducting research in other countries, particularly countries where resources are scarce.
- Researchers should consider the benefits that will be given to participants in clinical research after the study is complete.
- Researchers should also consider how any effective treatment emerging from the research could be provided to the rest of the population.
The NIH Guidelines
- The National Institutes of Health (NIH) provides guidance for research participants regarding the need for continued treatment for research participants in HIV/AIDS antiretroviral studies.
Terminology on Justice
- The principle of justice is intertwined with terms like:
- Undue burden
- Equitable distribution
- Permission and assent
- Deception/incomplete disclosure
- Community consent
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