Questions and Answers
According to the authors, which response contains the four common abuses giving rise to vulnerability?
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for?
Which is an example of a situation where deferential vulnerability might be a factor?
When an IRB is reviewing a research study considering vulnerability, which factor should they assess?
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A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. What type of vulnerability does this illustrate?
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Under HIPAA, retrospective research on collections of PHI generally falls under which category?
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HIPAA's protections for health information used for research purposes:
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PHI covered under HIPAA includes which of the following?
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HIPAA includes in its definition of 'research' activities related to:
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A covered entity may use or disclose PHI without authorization for all of the following EXCEPT:
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What is the term for management controls built into a research study?
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The PHS regulations about financial conflict of interests require which party to disclose significant conflicts?
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During an IRB meeting, an IRB member who has a potential COI with a study under review should:
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An example of an institutional COI is:
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When must researchers submit COI disclosures to comply with the PHS regulation?
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What does the Belmont Report summarize?
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Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
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The Belmont Report's principle of respect for persons incorporates two ethical convictions: one that individuals should be treated as autonomous agents, and the second that:
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Which of the following are the three principles discussed in the Belmont Report?
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What is the Nuremberg Code?
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What did the National Research Act of 1974 establish?
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Which of the following is included in the Nuremberg Code?
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What did 45 CFR 46 raise to regulatory status?
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Which of the following brought increased public attention to the problems with the IRB system?
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What was the result of the Beecher article?
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Informed consent is considered an application of which Belmont principle?
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Why is the use of prisoners in research a concern under the Belmont principle of Justice?
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What confidentiality procedure is important in a longitudinal study following children and collecting information about illegal activities?
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Which additional protection can researchers include to safeguard subject privacy and data confidentiality?
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When dealing with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?
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What characterizes the scenario where a research file containing aggregated data is left in a car and the car is stolen?
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Which situation constitutes both a breach of confidentiality and a violation of subjects' privacy?
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Which is an example of a situation where deferential vulnerability might be a factor?
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When reviewing a research study, what should an IRB consider regarding potential subjects' vulnerability?
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Identify the groups protected in federal regulations (45 CFR 46):
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What type of vulnerability do individuals who cannot comprehend information and make decisions about participation in research have?
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Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:
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Study Notes
Belmont Report (1979)
- Establishes ethical principles for protecting human research subjects: respect for persons, beneficence, and justice.
- Released by the National Commission for the Protection of Human Subjects and serves as a foundation for federal regulations.
Beneficence in Research
- Principle of beneficence emphasizes maximizing benefits and minimizing risks in research.
- It obligates researchers to do no harm and ensure subject well-being.
Respect for Persons
- Involves treating individuals as autonomous agents and providing protection for those with diminished autonomy.
- Individuals with reduced autonomy should not be excluded from research to ensure their access to potential benefits.
Main Principles of the Belmont Report
- Identifies three key principles: respect for persons, beneficence, and justice.
Nuremberg Code
- Sets forth ethical principles essential for permissible medical experiments.
- Developed post-World War II as a response to unethical research practices witnessed during the Nazi regime.
National Research Act of 1974
- Established the National Commission for the Protection of Human Subjects.
- Identified guidelines for ethical research conduct and basic ethical principles for human subjects.
Key Requirement of the Nuremberg Code
- Voluntary consent of research subjects is mandatory.
Regulatory Milestone (45 CFR 46)
- Elevated the US Public Health Service policy regarding human subjects research from 1966 to a regulatory status.
IRB System and Public Attention
- The death of Jesse Gelsinger highlighted significant problems within the Institutional Review Board (IRB) system and drew public scrutiny.
Result of Beecher Article
- Exposed ethical abuses in US research and clarified that unethical practices extend beyond historical examples like Nazi research.
Informed Consent as Respect for Persons
- Essential for honoring individual autonomy and promoting voluntary decision-making for research participation.
Vulnerability of Prisoners
- Ethical principle of justice prevents using prisoners in research that only serves broader societal benefits.
Confidentiality in Sensitive Research
- A Certificate of Confidentiality offers the highest level of protection against compelled disclosure of identifiable information.
Additional Privacy Protections
- Measures include securing data access, anonymizing responses, and aggregating results to protect subjects' identities.
Focus Groups and Confidentiality
- Researchers cannot guarantee confidentiality in focus groups due to the inability to control discussions among participants.
Privacy and Confidentiality Breaches
- If personal identifiers are not included in a data file, there is neither a privacy violation nor a confidentiality breach.
Characteristics Leading to Breach of Confidentiality
- Sharing identifiable data contrary to confidentiality agreements constitutes both a breach of confidentiality and violation of privacy.
Deferential Vulnerability
- Situations such as physician-patient relationships can create deferential vulnerability, affecting informed consent.
Considerations for IRB Assessments
- IRBs must evaluate the power dynamics between researchers and subjects which may indicate vulnerability.
Protected Groups Under Federal Regulations
- Additional protections are mandated for pregnant women, prisoners, and children, ensuring their unique vulnerabilities are acknowledged.
Cognitive or Communicative Vulnerability
- Individuals unable to make informed decisions due to cognitive limitations are considered to have cognitive or communicative vulnerability.
Medical Vulnerability
- Individuals with serious illnesses may face exploitation due to desperation for treatment, increasing their medical vulnerability.
Common Abuses Leading to Vulnerability
- Historical abuses include physical control, coercion, undue influence, and manipulation impacting subjects' rights and safety.
Situational Cognitive Vulnerability
- Individuals who can process information but face situational constraints are recognized as experiencing situational cognitive vulnerability.### Vulnerability in Research
- Vulnerability types include capacity-related, communicative, economic, and deferential vulnerabilities.
- Capacity-related vulnerability arises when subjects lack the ability to make informed choices, often during distractions or emergencies.
- Communicative vulnerability occurs when subjects can’t effectively exercise their capacity due to limited communication abilities.
- Economic vulnerability affects subjects disadvantaged in social goods distribution, such as income or healthcare.
Deferential Vulnerability
- Deferential vulnerability relates to informal power dynamics, which can stem from social inequalities (gender, race, class).
- Risks arise as informed consent may not be fully voluntary due to power imbalances, increasing susceptibility to coercion.
Institutional Review Board (IRB) Considerations
- IRBs must assess power differentials between researchers and subjects to determine vulnerability.
- Adequate description of the subject population and their situational contexts is crucial for IRB reviews.
- Considerations include potential coercion risks affecting voluntary consent.
Inducements in Research
- Inducements can produce undue influence, altering decision-making in potential subjects and compromising risk-benefit evaluations.
- While some inducements may seem harmless, they might lead to ethical violations regarding consent.
Economic Vulnerability Example
- Participation in a study for free or reduced-cost treatment illustrates economic vulnerability, where subjects may enroll against better judgment due to financial need.
HIPAA and Research
- Retrospective research requires patient authorization or a waiver according to HIPAA regulations.
- HIPAA protections for health information used in research supplement existing Common Rule and FDA protections, not replace them.
Protected Health Information (PHI)
- PHI includes identifiable health information created or held by covered entities, extending to both U.S. and non-U.S. residents.
- HIPAA defines research as systematic investigations aimed at developing generalizable knowledge.
Disclosure Requirements under HIPAA
- Covered entities can disclose PHI without authorization under specific conditions, including preparatory research activities.
- Significant financial conflict of interests (COI) must be disclosed by researchers per PHS regulations, specifically when submitting proposals.
Institutional Conflicts of Interest (COIs)
- Institutional COIs arise when financial interests may influence research conducted under an organization’s oversight, such as funding for facility construction from an industry sponsor.
IRB Protocol for COIs
- IRB members with potential conflicts must disclose them but are prohibited from voting on related studies to maintain integrity in reviews.
Timing for COI Disclosures
- Researchers must submit COI disclosures no later than the time of proposal submission to comply with PHS regulations when seeking NIH funding.
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Description
Test your knowledge on the Belmont Report and its ethical principles regarding the protection of human research subjects. This quiz focuses on the key concepts of respect for persons, beneficence, and justice as established in 1979. Perfect for those involved in research ethics and compliance.
