Podcast
Questions and Answers
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
True (A)
What does fabrication involve according to the U.S. Federal Research Misconduct Policy?
What does fabrication involve according to the U.S. Federal Research Misconduct Policy?
Making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report.
What does falsification involve according to the U.S. Federal Research Misconduct Policy?
What does falsification involve according to the U.S. Federal Research Misconduct Policy?
Purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results.
Which strategy is the most effective in preventing research misconduct?
Which strategy is the most effective in preventing research misconduct?
To have a finding of misconduct, the action must have been committed intentionally, knowingly, or recklessly.
To have a finding of misconduct, the action must have been committed intentionally, knowingly, or recklessly.
What type of research misconduct occurs if someone intentionally removes data points to generate a deceptive conclusion?
What type of research misconduct occurs if someone intentionally removes data points to generate a deceptive conclusion?
What is ghost authorship?
What is ghost authorship?
What two main criteria does the National Science Foundation (NSF) use to evaluate grant proposals?
What two main criteria does the National Science Foundation (NSF) use to evaluate grant proposals?
Management plans are often created to eliminate conflicts of interest.
Management plans are often created to eliminate conflicts of interest.
The Belmont Report's principle of respect for persons incorporates ethical convictions that individuals should be treated as autonomous agents and:
The Belmont Report's principle of respect for persons incorporates ethical convictions that individuals should be treated as autonomous agents and:
What are the three principles discussed in the Belmont Report?
What are the three principles discussed in the Belmont Report?
Informed consent is considered an application of which Belmont principle?
Informed consent is considered an application of which Belmont principle?
What did 45 CFR 46 raised to regulatory status in 1974?
What did 45 CFR 46 raised to regulatory status in 1974?
What requirement was included in the Nuremberg Code?
What requirement was included in the Nuremberg Code?
What event brought increased public attention to issues with the IRB system?
What event brought increased public attention to issues with the IRB system?
What did the National Research Act of 1974 establish?
What did the National Research Act of 1974 establish?
Census data is an example of what type of information?
Census data is an example of what type of information?
According to federal regulations, which study meets the definition of research with human subjects?
According to federal regulations, which study meets the definition of research with human subjects?
Is an experiment on gender-related stereotypes in math and subsequent performance with human subjects?
Is an experiment on gender-related stereotypes in math and subsequent performance with human subjects?
What criteria must research meet to be eligible for exemption according to federal regulations?
What criteria must research meet to be eligible for exemption according to federal regulations?
What should an investigator do if a subject experiences a serious, unanticipated adverse drug experience?
What should an investigator do if a subject experiences a serious, unanticipated adverse drug experience?
For how long is an investigator required to keep consent documents and research records?
For how long is an investigator required to keep consent documents and research records?
When may an IRB use expedited review for a new proposed study?
When may an IRB use expedited review for a new proposed study?
How often must an IRB conduct continuing reviews of protocols with greater than minimal risk?
How often must an IRB conduct continuing reviews of protocols with greater than minimal risk?
What is an example of a situation where time is key in assessing risk of harm in research?
What is an example of a situation where time is key in assessing risk of harm in research?
What is the most accurate statement about risks in social and behavioral sciences research?
What is the most accurate statement about risks in social and behavioral sciences research?
What is the primary purpose of a Certificate of Confidentiality?
What is the primary purpose of a Certificate of Confidentiality?
What are the three categories of risk of harm in social and behavioral sciences?
What are the three categories of risk of harm in social and behavioral sciences?
What should be done if disclosure of a subject's involvement in a study is potentially harmful?
What should be done if disclosure of a subject's involvement in a study is potentially harmful?
What constitutes exculpatory language in a consent form?
What constitutes exculpatory language in a consent form?
What must researchers provide during the consent process?
What must researchers provide during the consent process?
What characterizes a situation where a research file is lost but identifying information was not retained?
What characterizes a situation where a research file is lost but identifying information was not retained?
What example constitutes both a breach of confidentiality and a violation of subjects' privacy?
What example constitutes both a breach of confidentiality and a violation of subjects' privacy?
What confidentiality procedure protects against compelled disclosure in a longitudinal study?
What confidentiality procedure protects against compelled disclosure in a longitudinal study?
What should IRBs consider regarding potential subject populations?
What should IRBs consider regarding potential subject populations?
What does it mean if a subject participates in a drug study due to financial constraints?
What does it mean if a subject participates in a drug study due to financial constraints?
What form of vulnerability might an otherwise competent person who is acutely ill experience?
What form of vulnerability might an otherwise competent person who is acutely ill experience?
What are the four common abuses that create vulnerability according to the authors?
What are the four common abuses that create vulnerability according to the authors?
When is a disclosure accounting required under HIPAA?
When is a disclosure accounting required under HIPAA?
What is protected health information (PHI) under HIPAA?
What is protected health information (PHI) under HIPAA?
Can recruiting into research qualify as an activity 'preparatory to research'?
Can recruiting into research qualify as an activity 'preparatory to research'?
Under HIPAA, when can a covered entity disclose PHI without authorization?
Under HIPAA, when can a covered entity disclose PHI without authorization?
The HIPAA 'minimum necessary' standard applies to all human subjects research that uses PHI without an authorization.
The HIPAA 'minimum necessary' standard applies to all human subjects research that uses PHI without an authorization.
Who can researchers consult if unsure about HIPAA research requirements?
Who can researchers consult if unsure about HIPAA research requirements?
How do HIPAA's protections for health information used for research purposes relate to the Common Rule and FDA?
How do HIPAA's protections for health information used for research purposes relate to the Common Rule and FDA?
When is a 'disclosure accounting' not required under HIPAA?
When is a 'disclosure accounting' not required under HIPAA?
Under HIPAA, what is required for retrospective research involving PHI?
Under HIPAA, what is required for retrospective research involving PHI?
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Study Notes
Research Misconduct
- Research misconduct refers to actions that breach the ethical standards in research, including fabrication, falsification, and plagiarism.
- Federal funding agencies usually depend on institutions to respond first to allegations of misconduct.
Fabrication and Falsification
- Fabrication: Involves making up data or results and recording them as if they were real.
- Falsification: Entails manipulating research materials or results to inaccurately represent the research.
Prevention Strategies
- Good mentoring serves as the most effective strategy to prevent research misconduct.
Misconduct Findings
- To determine if misconduct occurred, the action must be intentional, knowing, or reckless.
Ghost Authorship
- Ghost authorship happens when the writer of a manuscript is not acknowledged as an author.
NSF Grant Proposals
- The National Science Foundation evaluates grant proposals based on intellectual merit and broader impacts.
Conflicts of Interest
- Management plans are created to mitigate the impact of conflicts of interest, but complete elimination may sometimes be necessary.
Belmont Report Principles
- Key principles include Respect for Persons, Beneficence, and Justice.
- Respect for persons involves treating individuals as autonomous agents and protecting those with diminished autonomy.
Informed Consent
- Informed consent upholds the Belmont principle of Respect for Persons, ensuring subjects receive information at an appropriate comprehension level.
- Consent forms cannot contain exculpatory language that waives legal rights.
Regulatory Framework
- 45 CFR 46 established regulations for human subjects in research, enhancing policies from previous guidelines.
- The Nuremberg Code emphasizes the necessity of voluntary consent for research subjects.
IRB and Adverse Events
- Any serious adverse event in a clinical trial must be reported to the IRB in a timely manner per institutional policies.
Research Eligibility
- Research can qualify for exemption from IRB review if it fits specific categories detailed in federal regulations.
- Activities involving minimal risk can undergo expedited review processes by the IRB.
Vulnerability in Research
- Vulnerability may stem from power differentials, economic challenges, and situational cognitive factors.
- In qualitative studies, recognizing and addressing these vulnerabilities is critical for ethical research practices.
Confidentiality Protections
- Certificates of Confidentiality safeguard identifiable data from compulsory legal disclosures.
- Proper confidentiality measures must be implemented to shield studies from potential harm due to forced information release.
HIPAA Regulations
- HIPAA governs the privacy of health information, mandating that identifiable health data used in research has appropriate protections.
- "Minimum necessary" standards apply to all research utilizing protected health information (PHI) without authorization.
- Disclosure accounting is necessary for research involving PHI lacking explicit authorization, with exemptions for limited data sets.
Research Preparatory Activities
- Discussions regarding recruitment into research may qualify as "preparatory to research" but must comply with HIPAA regulations.
These notes highlight essential aspects involved in research ethics, misconduct prevention, informed consent, and the implications of HIPAA in research contexts.
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