Research Ethics Flashcards
What does IRB stand for?
Institutional Review Board
True or False: The primary purpose of an IRB is to protect the rights and welfare of human research subjects.
True
Fill in the blank: An IRB must review research involving human subjects to ensure that it meets ethical standards and ________ requirements.
regulatory
What are the three ethical principles outlined in the Belmont Report?
Respect for persons, beneficence, and justice
Multiple Choice: Which of the following is NOT a function of an IRB? A) Reviewing research proposals B) Monitoring ongoing research C) Conducting the research D) Ensuring informed consent
C) Conducting the research
What is informed consent?
A process by which a research participant voluntarily confirms their willingness to participate after being informed of the relevant details.
True or False: An IRB can approve a study that does not meet ethical standards if it is deemed scientifically valuable.
False
What is the role of the IRB chair?
To lead the IRB and ensure that all members are engaged in the review process.
Fill in the blank: The ________ principle requires that the benefits and burdens of research be distributed fairly among all groups.
justice
What is the difference between expedited and full board review?
Expedited review is for research involving minimal risk, while full board review is for studies with greater than minimal risk.
Multiple Choice: Which of the following is a key requirement for informed consent? A) Coercion B) Clarity C) Ambiguity D) Secrecy
B) Clarity
What is a vulnerable population in research ethics?
Groups that may be at increased risk of coercion or undue influence, such as children, prisoners, or individuals with cognitive impairments.
True or False: IRB approval is only required for federally funded research.
False
What must researchers provide to the IRB during the review process?
A detailed research proposal, including methods, consent forms, and potential risks.
Fill in the blank: The principle of ________ requires researchers to minimize harm and maximize benefits to participants.
beneficence
What is the significance of the Common Rule?
It is a federal policy that outlines the basic provisions for IRBs and the protection of human subjects.
Multiple Choice: Which of the following is an example of a conflict of interest? A) A researcher studying a drug they developed B) A researcher with no personal stake in the study C) A researcher collaborating with an independent institution D) None of the above
A) A researcher studying a drug they developed
What is the purpose of continuing review by the IRB?
To ensure the ongoing protection of participants and assess any new risks or changes in the research.
True or False: Researchers can modify a study without IRB approval if the changes are minor.
False
What is a waiver of consent?
An IRB may grant a waiver of consent if the research involves minimal risk and does not adversely affect the rights and welfare of participants.
Fill in the blank: The IRB must consist of at least ________ members with varying backgrounds.
five
What is the IRB’s role in ensuring participant privacy?
To evaluate the adequacy of measures taken to protect the confidentiality of participant data.
Multiple Choice: Which of the following is NOT typically required in an IRB application? A) Research design B) Participant demographics C) Researcher’s personal biography D) Consent process
C) Researcher’s personal biography
What does ‘minimal risk’ mean in the context of research?
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life.
