International Codes and Standards Flashcards
What does IRB stand for in the context of international codes and standards?
Institutional Review Board
True or False: IRB’s primary role is to ensure the ethical treatment of human subjects in research.
True
Fill in the blank: The IRB is responsible for reviewing research proposals to assess their ________ to ethical standards.
compliance
What is the primary purpose of international codes and standards in research?
To ensure ethical practices and protect human subjects across different countries.
Which document outlines the basic ethical principles for research involving human subjects?
The Belmont Report
Multiple Choice: Which of the following is NOT a principle outlined in the Belmont Report? A) Respect for Persons B) Beneficence C) Justice D) Profitability
D) Profitability
What is the role of informed consent in IRB processes?
Informed consent ensures that participants are fully aware of the research and its risks before agreeing to participate.
True or False: IRBs can approve research that poses minimal risk to participants.
True
What does the term ‘minimal risk’ refer to in IRB standards?
The risk of harm or discomfort anticipated in the research is not greater than that encountered in daily life.
Fill in the blank: The IRB must consist of at least five members with varying ________ and ________.
backgrounds, expertise
What is the significance of the Declaration of Helsinki in relation to IRBs?
It provides ethical guidelines for medical research involving human subjects.
Multiple Choice: Which organization is known for developing international guidelines for good clinical practice? A) WHO B) FDA C) IRB D) NIH
A) WHO
What is the main function of the Common Rule in the context of IRBs?
It establishes the federal regulations for the protection of human subjects in research.
True or False: IRBs only review research conducted within the United States.
False
Fill in the blank: An IRB can require modifications to research proposals to ensure ________ protection.
participant
What is the term used for the ongoing review of research projects by an IRB?
Continuing review
Multiple Choice: Which of the following is a key function of an IRB? A) Conducting the research B) Reviewing research proposals C) Funding research D) Recruiting participants
B) Reviewing research proposals
What must researchers do if they want to make changes to an approved research study?
They must submit an amendment to the IRB for review and approval.
True or False: All research involving human subjects requires IRB review.
False
What is the purpose of a risk-benefit analysis in IRB reviews?
To evaluate whether the potential benefits of the research outweigh the risks to participants.
Fill in the blank: The ________ principle requires that research be conducted fairly and equitably.
Justice
What is the role of confidentiality in research reviewed by an IRB?
To protect the privacy of participants and the data collected from them.
Multiple Choice: Which of the following is a common ethical concern addressed by IRBs? A) Data analysis B) Participant recruitment C) Informed consent D) Funding sources
C) Informed consent
What is the significance of the Nuremberg Code in the context of IRB regulations?
It established fundamental ethical principles for conducting research involving human subjects.
True or False: IRBs can approve research that involves deception if it is justified.
True
