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Questions and Answers
Questions and Answers
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
- Maximizing sample sizes regardless of harm
- Conducting research without consent
- Ignoring participant well-being
- Ensuring that risks are reasonable in relationship to anticipated benefits (correct)
What is the primary ethical violation in the Harvard 'Tastes, Ties, and Time (T3)' study?
What is the primary ethical violation in the Harvard 'Tastes, Ties, and Time (T3)' study?
Failure to protect research subjects from deductive disclosure
Which study is linked most directly to the establishment of the National Research Act in 1974?
Which study is linked most directly to the establishment of the National Research Act in 1974?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
What does the Belmont principle of beneficence require?
What does the Belmont principle of beneficence require?
According to the Belmont Report, what expresses the principle of justice?
According to the Belmont Report, what expresses the principle of justice?
What is defined as identifiable private information under federal regulations?
What is defined as identifiable private information under federal regulations?
Provide an example of research with human subjects as per federal regulations.
Provide an example of research with human subjects as per federal regulations.
What type of information does the Census data represent?
What type of information does the Census data represent?
Provide an example of research with human subjects according to federal regulations.
Provide an example of research with human subjects according to federal regulations.
What is a medical record an example of?
What is a medical record an example of?
What action can a researcher expect if they submit a study to the IRB concerning oral histories of Bill Gates' acquaintances?
What action can a researcher expect if they submit a study to the IRB concerning oral histories of Bill Gates' acquaintances?
Provide an example of research with human subjects according to federal regulations.
Provide an example of research with human subjects according to federal regulations.
Provide an example of research with human subjects according to federal regulations.
Provide an example of research with human subjects according to federal regulations.
What should an investigator do after a serious adverse drug experience occurs?
What should an investigator do after a serious adverse drug experience occurs?
For how long must consent documents, IRB correspondence, and research records be kept?
For how long must consent documents, IRB correspondence, and research records be kept?
When may expedited review of a new study be used by the IRB?
When may expedited review of a new study be used by the IRB?
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if?
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if?
How often must IRB continuing review of an approved protocol occur?
How often must IRB continuing review of an approved protocol occur?
What issue may arise regarding parental permission in research involving children at a clinic?
What issue may arise regarding parental permission in research involving children at a clinic?
What is a general requirement for informed consent?
What is a general requirement for informed consent?
In which scenario would it NOT be appropriate to provide subjects with information about missing elements of consent?
In which scenario would it NOT be appropriate to provide subjects with information about missing elements of consent?
When may a waiver of documentation of informed consent be granted?
When may a waiver of documentation of informed consent be granted?
What must researchers provide potential subjects as part of the consent process?
What must researchers provide potential subjects as part of the consent process?
What constitutes both a breach of confidentiality and a violation of subjects' privacy?
What constitutes both a breach of confidentiality and a violation of subjects' privacy?
How are data made anonymous?
How are data made anonymous?
What is true about providing confidentiality to focus group participants?
What is true about providing confidentiality to focus group participants?
What confidentiality procedure protects against compelled disclosure of identifiable information in a longitudinal study?
What confidentiality procedure protects against compelled disclosure of identifiable information in a longitudinal study?
What best characterizes the situation where a researcher leaves a research file in a stolen car containing aggregated numerical data?
What best characterizes the situation where a researcher leaves a research file in a stolen car containing aggregated numerical data?
What consideration was relevant to the IRB's determination regarding a secondary analysis using a CDC database?
What consideration was relevant to the IRB's determination regarding a secondary analysis using a CDC database?
What is true about a physician reviewing medical records of patients in a study?
What is true about a physician reviewing medical records of patients in a study?
What does the incident of a stolen laptop containing patient identifiers constitute?
What does the incident of a stolen laptop containing patient identifiers constitute?
What was NOT included as possibly leading to vulnerability according to NBAC?
What was NOT included as possibly leading to vulnerability according to NBAC?
What type of vulnerability might an acutely ill person face?
What type of vulnerability might an acutely ill person face?
What are the four common abuses that give rise to vulnerability in research?
What are the four common abuses that give rise to vulnerability in research?
Identify groups protected in federal regulations under 45 CFR 46.
Identify groups protected in federal regulations under 45 CFR 46.
What constitutes an 'undue influence' in research inducements?
What constitutes an 'undue influence' in research inducements?
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Study Notes
Study Notes
Ethical Principles in Research
- Beneficence involves ensuring that research risks are justified by potential benefits.
- The Belmont principle of beneficence mandates that potential benefits must outweigh risks of harm.
- Justice relates to fair outcomes in the selection of research subjects.
Historical Context of Research Ethics
- The National Research Act (1974) and the Belmont Report were significantly influenced by the Tuskegee Study of Untreated Syphilis.
- Ethical violations in research can arise when subjects are not protected from risks like deductive disclosure, as seen in the Harvard T3 study.
Human Subjects Research Regulations
- Federal regulations define human subjects as living individuals from whom data is collected through interaction or identifiable private information.
- Research involving human subjects must ensure informed consent without exculpatory language that waives legal rights.
Consent and IRB Oversight
- Consent documents must be retained for at least three years post-study completion.
- The IRB reviews studies to ensure ethical standards are met and must conduct continuing reviews annually.
- Changes to IRB-approved protocols can be implemented without prior approval if critical for participant health.
Research Scenarios and Ethics
- Studies involving children or using identifiable data, like medical records, must carefully consider consent and confidentiality.
- A waiver for documentation of informed consent may be granted when the primary risk is confidentiality breach.
Confidentiality and Data Handling
- Data anonymization is achieved by destroying all identifying information.
- Breaches of confidentiality occur when identifiable data are disclosed contrary to agreements.
- Researchers should secure Certificates of Confidentiality for studies involving sensitive information to protect against compelled disclosures.
Vulnerable Populations and Ethical Concerns
- Certain groups, including pregnant women, prisoners, and children, receive additional protections under federal regulations.
- Research inducements may lead to undue influence if they affect potential subjects' ability to weigh risks and benefits appropriately.
Additional Considerations
- Situational cognitive vulnerability can arise in acutely ill individuals, increasing risks during participation.
- Historical abuses rooted in physical control, coercion, undue influence, and manipulation have highlighted the need for rigorous ethical standards in research.
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