Ethics in Human Subjects Research

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Questions and Answers

Which of the following statements best characterizes what occurred?

There was neither a violation of privacy nor a breach of confidentiality. (correct)

The subjects' privacy has been violated.

The confidentiality of the data has been breached.

The release of aggregate data constitutes a violation of privacy.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

Participants may reveal sensitive information outside the group. (correct)

The researcher guarantees confidentiality.

Participants cannot disclose what was said in the group.

Using pseudonyms ensures confidentiality.

Which of the following constitutes both a breach of confidentiality and a violation of subjects' privacy?

A researcher gives identifiable data to others after promising confidentiality. (correct)

Participants disclose their information willingly.

Data is reported in aggregate form.

A faculty member discloses non-identifiable data.

Data are made anonymous by

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

In a longitudinal study that will follow children and collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Securing a Certificate of Confidentiality. (B) Signup and view all the answers

The researcher's failure to protect research subjects from deductive disclosure of identity is the primary ethical violation in which of the following studies?

Tastes, Ties, and Time (T3) study (A) Signup and view all the answers

The use of a consent form in research is an example of which Belmont principle?

Respect for persons (C) Signup and view all the answers

This study might be determined to be violating which principle of the Belmont Report?

Justice (B) Signup and view all the answers

A cognitive psychologist studying the effect of mood on problem-solving behaviors qualifies as research with human subjects.

True (A) Signup and view all the answers

What principle expresses the requirement that the benefits and burdens of the research are equitably distributed?

Justice Signup and view all the answers

What type of information does a medical record include?

Private information Signup and view all the answers

The Belmont principle of beneficence requires that risks to subjects are reasonable in relation to what?

Anticipated benefits Signup and view all the answers

This study would qualify as which type of review?

Exempt research (A) Signup and view all the answers

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

Ensuring that risks are reasonable in relationship to anticipated benefits (B) Signup and view all the answers

What is the primary purpose of a Certificate of Confidentiality?

Protect identifiable research information from compelled disclosure Signup and view all the answers

Who provides additional protections for prisoners under HHS regulations?

The federal regulations Signup and view all the answers

What should your informed consent form describe?

All foreseeable risks and discomforts Signup and view all the answers

The ongoing review of an approved study posing more than minimal risk must occur within _______ of the approval date.

12 months Signup and view all the answers

Which principle requires that the selection of subjects is fair?

Justice Signup and view all the answers

According to federal regulations, research is eligible for exemption if:

The research falls into one of eight categories of activity (C) Signup and view all the answers

If the disclosure of a subject's involvement in a specific research study can be potentially harmful, what should be obtained?

A waiver of documentation of informed consent Signup and view all the answers

Risks in social and behavioral sciences research can be specific to time, situation, and culture.

True (A) Signup and view all the answers

What are the three categories that risks of harm in social and behavioral research generally fall into?

Invasion of privacy, breach of confidentiality, study procedures Signup and view all the answers

Identify an example of when situation and time are key to assessing the risk of harm in a research study.

Asking women if they have had an abortion Signup and view all the answers

Study Notes

Ethical Violations in Research

Primary ethical violation in the "Tastes, Ties, and Time (T3)" study was the risk of deductive disclosure of identities of research subjects.
Ethical issues in other studies may include physical harms or unanticipated psychological harm.

Belmont Principles in Research

Consent forms exemplify the Belmont principle of respect for persons, ensuring subjects understand participation is voluntary and informed.
Beneficence requires risks to subjects to be justified in relation to anticipated benefits.
Justice mandates equitable distribution of benefits and burdens in research; convenience should not dictate subject selection.

Human Subjects Research Definition

A cognitive psychologist’s study on mood and problem-solving behaviors qualifies as research involving human subjects due to interaction with living individuals.
Interviews or analyses that do not involve direct interaction with subjects, or do not seek private information, fall outside the definition of human subjects research.

Justice Principle in Research

Selecting a single school for a study on a tutoring program violates the principle of justice as it could lead to an unrepresentative population based solely on convenience.

Private Information Classification

Medical records are classified as private information due to identifiable details expected to remain confidential.

Risks and Benefits Context

Beneficence in research requires that anticipated benefits outweigh risks to participants, applicable in both minimal and greater-than-minimal risk studies.

Exempt Research

Research involving non-identifiable data generally qualifies for exemption from IRB review.
Exemption categories are specified in federal regulations and require oversight to ensure compliance.

Continuing Review Requirements

Continuing review of high-risk studies must occur within 12 months of initial approval to reassess risks and participant numbers.

Additional Vulnerable Populations

HHS regulations provide additional protections for prisoners in research settings, unlike other vulnerable groups.

Risks may be context-dependent, influenced by timing, culture, and societal norms; emotional distress cannot be mitigated solely through anonymization.

Breaches of Confidentiality

Risks in social and behavioral research typically include invasion of privacy, breaches of confidentiality, and risks related to study procedures.
Certificates of Confidentiality are designed to protect sensitive research information from legal disclosures.

Focus Group Confidentiality

Researchers cannot guarantee confidentiality in focus groups, as participants may disclose information outside the group setting.

Privacy and Confidentiality Violations

A clear breach occurs when identifiable data, promised to remain confidential, is disclosed without participant consent, impacting both confidentiality and privacy rights.### Confidentiality and Privacy Rights
There was no breach of confidentiality, but subjects' autonomy over their personal information was violated.
Researchers who promise exclusive access to identifiable data but share it with others violate both confidentiality and subjects' privacy.

Data Anonymization

Anonymity is achieved by removing all identifiers from data.
Presenting data in aggregate form protects identities but does not ensure anonymity.
Safeguards like keeping keys secure and confidentiality agreements protect identifiable information but do not erase identity links.
True anonymity requires complete disconnection between subjects and their data.

Protection in Longitudinal Studies

Securing a Certificate of Confidentiality protects against compelled disclosure of identifiable information.
Data encryption, pseudonyms, and waiving consent documentation do not fully shield individual identities.
Research data can be subpoenaed unless a Certificate of Confidentiality is obtained, which offers the highest level of protection for subjects.

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Description

Explore the critical ethical considerations in human subjects research, including the Belmont principles and common violations. This quiz highlights the importance of informed consent, beneficence, and justice in ensuring ethical research practices.