Department of Defense Flashcards
What does IRB stand for?
Institutional Review Board
True or False: The Department of Defense (DoD) has its own set of regulations for human research.
True
Fill in the blank: The DoD requires that all human research involving _____ must be reviewed by an IRB.
human subjects
What is the primary purpose of an IRB?
To protect the rights and welfare of human research subjects.
Which DoD instruction outlines the requirements for human research?
DoD Instruction 3216.02
True or False: All research involving human subjects must comply with both federal and DoD regulations.
True
What is the minimum age for individuals to provide informed consent in DoD research?
18 years old
Multiple Choice: Which of the following is NOT a function of an IRB?
A) Review research protocols
B) Approve funding
C) Monitor ongoing research
D) Ensure informed consent
B) Approve funding
What type of research requires a waiver of consent under DoD regulations?
Research involving minimal risk and no adverse effects on subjects.
Fill in the blank: The DoD requires that research involving _____ must ensure additional protections for vulnerable populations.
vulnerable subjects
True or False: The IRB must include members with diverse backgrounds and expertise.
True
What is the role of the Institutional Official in the IRB process?
To ensure compliance with IRB decisions and oversee research activities.
Multiple Choice: Which of the following is a requirement for informed consent in DoD research?
A) It must be written in legal jargon.
B) It must be voluntary.
C) It can be obtained after the research begins.
D) It must be signed by a witness.
B) It must be voluntary.
What must researchers provide to the IRB before conducting human research?
A complete research protocol and informed consent documents.
True or False: The DoD allows for expedited review of certain types of research.
True
Which populations are considered vulnerable according to DoD regulations?
Children, prisoners, pregnant women, and individuals with impaired decision-making capacity.
Fill in the blank: The IRB must review research proposals at least _____ times a year.
once
What happens if a researcher does not comply with IRB requirements?
The research may be suspended or terminated.
Multiple Choice: Which of the following is NOT a criterion for IRB approval?
A) Risks to subjects are minimized.
B) The research has funding.
C) The selection of subjects is equitable.
D) Informed consent will be sought.
B) The research has funding.
What is the significance of the Belmont Report in relation to DoD human research?
It outlines ethical principles and guidelines for research involving human subjects.
True or False: Researchers are required to report adverse events to the IRB.
True
What does the term ‘minimal risk’ refer to in the context of human research?
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life.
Fill in the blank: The DoD mandates that research involving _____ must comply with additional security requirements.
classified information
What must researchers do if they wish to make changes to an approved research protocol?
Submit an amendment to the IRB for approval.
Multiple Choice: Which of the following is a key ethical principle outlined in the Belmont Report?
A) Justice
B) Profit
C) Efficiency
D) Innovation
A) Justice
True or False: Consent forms must be provided in a language understandable to the participants.
True
What is the role of the DoD’s Human Research Protection Office?
To oversee and ensure compliance with human research protections within the DoD.
