Human Subjects Research Ethics

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Questions and Answers

What significant event occurred in 1979 related to the ethical foundation of research involving human subjects?

The establishment of the IRB

The introduction of informed consent regulations

The release of the Belmont Report (correct)

The first US Federal Policy for human subject protection

Which principle is NOT part of the ethical foundation outlined in the Belmont Report?

Beneficence

Confidentiality (correct)

Respect for persons

Justice

What does the principle of 'respect for persons' emphasize in the context of research ethics?

All participants must receive equal treatment

Individuals must be protected regardless of their autonomy

Individuals are autonomous agents entitled to protection (correct)

Participants should have limited information about the study

In what year was the first US Federal Policy for the protection of human subjects established?

1953 Signup and view all the answers

Which aspect is included in the informed consent process according to the outlined criteria?

Clear communication of risks involved Signup and view all the answers

What is required for the electronic submission of all projects?

A Cayuse account Signup and view all the answers

Which statement is true regarding non-research projects?

They do not necessitate a COI Disclosure. Signup and view all the answers

Who is primarily responsible for ensuring all study team members complete the CITI training?

The Principal Investigator (PI) Signup and view all the answers

What must be completed for research projects in Cayuse?

CITI training and COI disclosure Signup and view all the answers

What does the Cayuse Submission Smart Form require from the user?

Answers to relevant questions based on the project Signup and view all the answers

What does the submission process involve after the PI certifies the project?

Email communication with further instructions Signup and view all the answers

What is necessary to set up before initiating a project in Cayuse?

A CITI account and a Cayuse account Signup and view all the answers

Which of the following is NOT required for non-research projects?

Conflict of Interest disclosure Signup and view all the answers

What is one key reason for the existence of Institutional Review Boards (IRBs)?

To address past abuses in human rights research Signup and view all the answers

What principle requires that participants in research understand the information presented to them?

Informed consent Signup and view all the answers

Which of the following best describes the principle of beneficence in research ethics?

The goal of maximizing possible benefits while minimizing harm Signup and view all the answers

Why are vulnerable populations given extra protection in research studies?

They often lack the ability to provide voluntary consent Signup and view all the answers

What is a significant ethical concern that led to the formation of IRBs?

The historical exploitation of certain groups in research Signup and view all the answers

What best characterizes the comprehension of participants in research studies?

Participants should have thorough understanding before agreeing to participate Signup and view all the answers

Which statement is true regarding voluntary participation in research?

Participation can be terminated by a participant at any time Signup and view all the answers

What aspect of research is highlighted by the necessity of IRBs in regards to vulnerable populations?

Providing extra layers of protection against exploitation Signup and view all the answers

What is required for a Waiver of HIPAA Authorization to be granted?

Meeting specific criteria Signup and view all the answers

Which of the following can be classified as test articles in human subject research?

Electronic products Signup and view all the answers

What aspect of consent is NOT typically addressed in informed consent documentation?

Insurance requirements Signup and view all the answers

What type of data set requires a signed Data Use & Transfer Agreement?

Limited data set Signup and view all the answers

Which form of risk is associated with questions that require participants to 're-live' traumatic events?

Psychological risks Signup and view all the answers

What is the main concern when personal information could damage a participant's reputation or status in the community?

Social risk Signup and view all the answers

Which of the following is a crucial component of the informed consent process?

Ensuring participant understanding Signup and view all the answers

In the context of research, what does a de-identified data set specifically refer to?

Data set with all 18 identifier categories removed Signup and view all the answers

What is a potential outcome of using sensitive survey questions that touch on traumatic experiences?

Participant withdrawal from the study Signup and view all the answers

Which of the following best describes the primary purpose of informed consent?

To ensure participants are making an informed decision about their involvement Signup and view all the answers

What is a potential consequence of revealing a participant's information in research?

Possibility of job loss Signup and view all the answers

In the context of quality improvement, which element is primarily focused on measuring outcomes before and after implementation?

Program evaluation Signup and view all the answers

Which of the following does NOT characterize evidence-based practice projects?

Findings are designed to be generalizable Signup and view all the answers

What defines human subjects research according to the OHRP or FDA?

Research involving living individuals Signup and view all the answers

What method is NOT typically included in quality improvement strategies?

Randomized controlled trials Signup and view all the answers

What is the main focus of synthesis of findings in literature?

Identification of best practice recommendations Signup and view all the answers

Which factor is NOT a concern regarding the legal implications of research?

Compliance with quality improvement standards Signup and view all the answers

What is a characteristic of studies designed to be generalizable?

Use of comparison or control groups Signup and view all the answers

Which statement about research involving control subjects is incorrect?

Control subjects often experience the same conditions as participants Signup and view all the answers

What is likely to be a priority in a quality improvement project?

Enhancing internal processes Signup and view all the answers

Which of the following is a common strategy in the assessment of qualitative interventions?

Incorporating focus group feedback Signup and view all the answers

What is a critical ethical consideration when conducting research with human subjects?

Confidentiality and protection of identity must be maintained Signup and view all the answers

Which aspect is often emphasized in practices and strategies for improving quality outcomes?

Evidence-based decision-making Signup and view all the answers

In research design, what factor distinguishes quality projects from traditional studies?

Emphasis on site-specific findings Signup and view all the answers

What is the primary function of an Institutional Review Board (IRB)?

To protect the rights and welfare of human research subjects Signup and view all the answers

Which of the following is a requirement for risks in research as outlined by regulatory criteria?

Risks to subjects should be minimized and reasonable in relation to anticipated benefits Signup and view all the answers

What characterizes 'minimal risk' according to the guidelines?

Harm is equivalent to that encountered in daily life or routine exams Signup and view all the answers

What does HIPAA primarily seek to protect?

The privacy of individually identifiable health information Signup and view all the answers

Informed consent must be obtained in what manner?

In a way that ensures participants understand it is a research study Signup and view all the answers

What constitutes a conflict of interest in research settings?

If researchers have financial stakes in the study’s outcome Signup and view all the answers

The concept of distributive justice in research indicates what?

Equitable distribution of research burdens and benefits Signup and view all the answers

What is a responsibility of the HHS Office for Civil Rights in relation to HIPAA?

To oversee compliance with the HIPAA Privacy Rule Signup and view all the answers

What types of subjects require additional protections during research studies?

Vulnerable subjects who may be at increased risk Signup and view all the answers

What is a key aspect of data monitoring in research?

It ensures the safety of subjects and compliance with protocols Signup and view all the answers

What must researchers do if they wish to use Protected Health Information (PHI)?

Obtain signed authorization from participants Signup and view all the answers

Which scenario could be deemed a breach of confidentiality in research?

Release of identifiable health information without consent Signup and view all the answers

Why is it essential to minimize coercion or undue influence in obtaining consent from research participants?

To ensure participants are voluntarily making informed decisions Signup and view all the answers

What is the role of conflict of interest management in research?

To prevent research misconduct and maintain ethical standards Signup and view all the answers

Study Notes

Human Subjects Research and Ethical Considerations

Historical Context: Early research lacked ethical oversight, leading to abuses like the Tuskegee Syphilis Study, the Nazi Medical War Crimes, and other unethical experiments.
Ethical Principles (Belmont Report): Developed in 1979, this report outlines three key ethical principles for research involving human subjects:
- Respect for Persons: Individuals are autonomous agents; those with diminished autonomy deserve additional protection. Informed consent is crucial, ensuring participants fully understand the study.
- Beneficence: Maximize benefits and minimize risks; research benefits must outweigh any potential harm.
- Justice: Fair and equitable distribution of research burdens and benefits; vulnerable populations must not bear a disproportionate burden of risk.
Institutional Review Boards (IRBs): IRBs are established to protect research subjects; they conduct prospective reviews of research proposals, ensuring ethical conduct.
Types of Research:
- Quality Improvement (QI) or Evidence-Based Practice (EBP) projects: Not designed to be generalizable; often focused on internal processes and quality outcomes at a specific site. May not qualify as human subjects research.
- Research projects: Designed to be generalizable and involve methods like pre/post measures, comparison groups, or randomization. These projects adhere to rigorous research methodologies.
Federal Regulations & HIPAA: U.S. regulations aim to protect research subjects. HIPAA (Health Insurance Portability and Accountability Act) safeguards protected health information (PHI) used in research when applicable. Additional steps are required when using PHI for research, often requiring specific IRB/privacy board approval. De-identified data, or data with all identifying information removed, falls outside human research protection.

Institutional Review Board (IRB) Process

Pre-submission tasks: Project categorization (QI/EBP or research); creating CITI accounts and Cayuse accounts; completing CITI modules and COI disclosures.
Submission process: Using Cayuse submission forms to address project-relevant questions.
Approval and study/project conduct: IRBs review and approve or request changes. Following approved protocols and using approved forms during project execution.
Changes and closure: Reporting any project changes to the IRB, submitting closure reports (for research projects only) once the project is completed.

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Description

Explore the fundamental ethical principles guiding human subjects research, including historical abuses and the ethical standards outlined in the Belmont Report. Understand the role of Institutional Review Boards (IRBs) in safeguarding participants' rights and welfare in research studies.