Ethical Principles in Human Research

Questions and Answers

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?

Failure to protect research subjects from deductive disclosure

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?

Potential benefits justify the risks of harm Signup and view all the answers

According to the Belmont Report, what expresses the principle of justice?

Fair outcomes in the selection of research subjects Signup and view all the answers

What is defined as identifiable private information under federal regulations?

Living human beings with data obtained through interaction or intervention Signup and view all the answers

Provide an example of research with human subjects as per federal regulations.

A developmental psychologist videotapes interactions between toddlers and caregivers Signup and view all the answers

What type of information does the Census data represent?

Public information Signup and view all the answers

Provide an example of research with human subjects according to federal regulations.

A study of 4th grade classrooms varying the timing of reading instruction Signup and view all the answers

What is a medical record an example of?

Private information Signup and view all the answers

What action can a researcher expect if they submit a study to the IRB concerning oral histories of Bill Gates' acquaintances?

The IRB will not review this study because it is not research as defined by federal regulations Signup and view all the answers

Provide an example of research with human subjects according to federal regulations.

An experiment on gender-related stereotypes in math Signup and view all the answers

Provide an example of research with human subjects according to federal regulations.

A cognitive psychologist enrolls students for a study on mood effects Signup and view all the answers

What should an investigator do after a serious adverse drug experience occurs?

Report the adverse drug experience in a timely manner as per IRB policies Signup and view all the answers

For how long must consent documents, IRB correspondence, and research records be kept?

For a minimum of three years after completion of the study Signup and view all the answers

When may expedited review of a new study be used by the IRB?

When the study involves no more than minimal risk Signup and view all the answers

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if?

Changes must be immediately implemented for the health and well-being of the subject Signup and view all the answers

How often must IRB continuing review of an approved protocol occur?

At least annually Signup and view all the answers

What issue may arise regarding parental permission in research involving children at a clinic?

Parents might feel pressure to give permission for their children's data to be used Signup and view all the answers

What is a general requirement for informed consent?

No informed consent may include any exculpatory language Signup and view all the answers

In which scenario would it NOT be appropriate to provide subjects with information about missing elements of consent?

When assigned to activities based on an undesirable physical characteristic Signup and view all the answers

When may a waiver of documentation of informed consent be granted?

When the principal risk is a breach of confidentiality Signup and view all the answers

What must researchers provide potential subjects as part of the consent process?

Information at the appropriate reading comprehension level Signup and view all the answers

What constitutes both a breach of confidentiality and a violation of subjects' privacy?

Making identifiable data about sexual behavior available to graduate students Signup and view all the answers

How are data made anonymous?

By destroying all identifiers connected to the data Signup and view all the answers

What is true about providing confidentiality to focus group participants?

The researcher cannot control what participants repeat about others outside the group Signup and view all the answers

What confidentiality procedure protects against compelled disclosure of identifiable information in a longitudinal study?

Securing a Certificate of Confidentiality Signup and view all the answers

What best characterizes the situation where a researcher leaves a research file in a stolen car containing aggregated numerical data?

There was neither a violation of privacy nor a breach of confidentiality Signup and view all the answers

What consideration was relevant to the IRB's determination regarding a secondary analysis using a CDC database?

The researcher will not be interacting with subjects and the data has no identifiers Signup and view all the answers

What is true about a physician reviewing medical records of patients in a study?

The study is human subject research which is eligible for expedited review Signup and view all the answers

What does the incident of a stolen laptop containing patient identifiers constitute?

A breach of confidentiality Signup and view all the answers

What was NOT included as possibly leading to vulnerability according to NBAC?

High potential for individual benefit from participating in research Signup and view all the answers

What type of vulnerability might an acutely ill person face?

Situational cognitive vulnerability Signup and view all the answers

What are the four common abuses that give rise to vulnerability in research?

Physical control, coercion, undue influence, and manipulation Signup and view all the answers

Identify groups protected in federal regulations under 45 CFR 46.

Pregnant women, prisoners, children Signup and view all the answers

What constitutes an 'undue influence' in research inducements?

Inducements alter a potential subject's decision-making processes Signup and view all the answers

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 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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Description

Explore the key ethical principles that guide human subjects research, including beneficence, justice, and the importance of informed consent. This quiz delves into historical contexts and federal regulations impacting research ethics, highlighting significant events like the Tuskegee Study. Test your knowledge about the ethical framework necessary for conducting responsible research.

Ethical Principles in Human Research

Questions and Answers

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

What is the primary ethical violation in the Harvard 'Tastes, Ties, and Time (T3)' study?

Which study is linked most directly to the establishment of the National Research Act in 1974?

What does the Belmont principle of beneficence require?

According to the Belmont Report, what expresses the principle of justice?

What is defined as identifiable private information under federal regulations?

Provide an example of research with human subjects as per federal regulations.

What type of information does the Census data represent?

Provide an example of research with human subjects according to federal regulations.

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?

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?

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?

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?

What issue may arise regarding parental permission in research involving children at a clinic?

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?

When may a waiver of documentation of informed consent be granted?

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?

How are data made anonymous?

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 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 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 was NOT included as possibly leading to vulnerability according to NBAC?

What type of vulnerability might an acutely ill person face?

What are the four common abuses that give rise to vulnerability in research?

Identify groups protected in federal regulations under 45 CFR 46.

What constitutes an 'undue influence' in research inducements?

Study Notes

Ethical Principles in Research

Historical Context of Research Ethics

Human Subjects Research Regulations

Consent and IRB Oversight

Research Scenarios and Ethics

Confidentiality and Data Handling

Vulnerable Populations and Ethical Concerns

Additional Considerations

Studying That Suits You

Description

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