CITI Training Responsible Conduct Quiz

Questions and Answers

Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.

True

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?

Purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results.

Which strategy is the most effective in preventing research misconduct?

Good mentoring Signup and view all the answers

To have a finding of misconduct, the action must have been committed intentionally, knowingly, or recklessly.

True Signup and view all the answers

What type of research misconduct occurs if someone intentionally removes data points to generate a deceptive conclusion?

Falsification Signup and view all the answers

What is ghost authorship?

A situation where the individual who wrote the manuscript is not listed as an author. Signup and view all the answers

What two main criteria does the National Science Foundation (NSF) use to evaluate grant proposals?

Intellectual merit and broader impacts Signup and view all the answers

Management plans are often created to eliminate conflicts of interest.

False Signup and view all the answers

The Belmont Report's principle of respect for persons incorporates ethical convictions that individuals should be treated as autonomous agents and:

Persons with diminished autonomy are entitled to protection. Signup and view all the answers

What are the three principles discussed in the Belmont Report?

Justice Signup and view all the answers

Informed consent is considered an application of which Belmont principle?

Respect for Persons Signup and view all the answers

What did 45 CFR 46 raised to regulatory status in 1974?

The US Public Health Service policy of 1966 concerning clinical research and human beings. Signup and view all the answers

What requirement was included in the Nuremberg Code?

The requirement of voluntary consent of subjects. Signup and view all the answers

What event brought increased public attention to issues with the IRB system?

The death of research subject Jesse Gelsinger. Signup and view all the answers

What did the National Research Act of 1974 establish?

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Signup and view all the answers

Census data is an example of what type of information?

Public information Signup and view all the answers

According to federal regulations, which study meets the definition of research with human subjects?

A study of twenty 4th grade classrooms varying reading instruction time and collecting assessments. Signup and view all the answers

Is an experiment on gender-related stereotypes in math and subsequent performance with human subjects?

Yes Signup and view all the answers

What criteria must research meet to be eligible for exemption according to federal regulations?

All activities must fall into one of eight designated categories. Signup and view all the answers

What should an investigator do if a subject experiences a serious, unanticipated adverse drug experience?

Report it in a timely manner according to IRB guidelines. Signup and view all the answers

For how long is an investigator required to keep consent documents and research records?

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

When may an IRB use expedited review for a new proposed study?

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

How often must an IRB conduct continuing reviews of protocols with greater than minimal risk?

At least annually. Signup and view all the answers

What is an example of a situation where time is key in assessing risk of harm in research?

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

What is the most accurate statement about risks in social and behavioral sciences research?

Risks are specific to time, situation, and culture. Signup and view all the answers

What is the primary purpose of a Certificate of Confidentiality?

To protect identifiable research information from compelled disclosure. Signup and view all the answers

What are the three categories of risk of harm in social and behavioral sciences?

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

What should be done if disclosure of a subject's involvement in a study is potentially harmful?

Seek a waiver of documentation of informed consent. Signup and view all the answers

What constitutes exculpatory language in a consent form?

Language that waives or appears to waive a subject's legal rights. Signup and view all the answers

What must researchers provide during the consent process?

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

What characterizes a situation where a research file is lost but identifying information was not retained?

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

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

A faculty member makes identifiable data about sexual behavior available to students despite assurances of de-identification. Signup and view all the answers

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

Obtaining a Certificate of Confidentiality. Signup and view all the answers

What should IRBs consider regarding potential subject populations?

Whether there is a power differential between researchers and subjects. Signup and view all the answers

What does it mean if a subject participates in a drug study due to financial constraints?

This is an example of economic vulnerability. Signup and view all the answers

What form of vulnerability might an otherwise competent person who is acutely ill experience?

Situational cognitive vulnerability. Signup and view all the answers

What are the four common abuses that create vulnerability according to the authors?

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

When is a disclosure accounting required under HIPAA?

For all human subjects research using PHI without an authorization from the data subject. Signup and view all the answers

What is protected health information (PHI) under HIPAA?

Identifiable health information created or held by covered entities and their business associates. Signup and view all the answers

Can recruiting into research qualify as an activity 'preparatory to research'?

Yes, at least for the initial contact if handled by a healthcare provider. Signup and view all the answers

Under HIPAA, when can a covered entity disclose PHI without authorization?

For treatment purposes Signup and view all the answers

The HIPAA 'minimum necessary' standard applies to all human subjects research that uses PHI without an authorization.

True Signup and view all the answers

Who can researchers consult if unsure about HIPAA research requirements?

An organizational IRB or Privacy Board, privacy official, or security official. Signup and view all the answers

How do HIPAA's protections for health information used for research purposes relate to the Common Rule and FDA?

They supplement those protections. Signup and view all the answers

When is a 'disclosure accounting' not required under HIPAA?

For limited data sets. Signup and view all the answers

Under HIPAA, what is required for retrospective research involving PHI?

Either an authorization or meeting one of the criteria for a waiver of authorization. Signup and view all the answers

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 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.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Test your knowledge on research misconduct and federal policies with this CITI training quiz. Each flashcard will challenge your understanding of crucial definitions and procedures associated with responsible research conduct.