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Exam (elaborations)

CITI TRAINING AND BELMONT REPORT 2025 QUESTIONS AND ANSWERS

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CITI TRAINING AND BELMONT REPORT 2025 QUESTIONS AND ANSWERS

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Uploaded on
July 8, 2025
Number of pages
118
Written in
2024/2025
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Questions & answers

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CITI TRAINING AND BELMONT
REPORT 2025 QUESTIONS AND
ANSWERS


Three principles of Belmont Report - ....ANSWER ...-Respect for Persons


Beneficence

Justice

The Belmont Report


Principle of Beneficence - ....ANSWER ...-MAXIMIZATION of benefits and

MINIMIZATION of risks

T/F

Belmont Report indicates it is necessary to rigorously avoid conflicts of interest -

....ANSWER ...-TRUE


The Belmont Report


Respect for Person - ....ANSWER ...-Requires that subjects freely choose to

participate in research (voluntariness) and that they are adequately informed about a

study (informed consent)




...©️ 2025, ALL RIGHTS RESERVED 1

,The Belmont Report defines and delineates... - ....ANSWER ...-"Practice" and

"Research"

The Belmont Report


The Principle of Justice - ....ANSWER ...-Research benefit and burden distribution

and that selection of subjects is fair.

T/F

The Belmont report describes the necessity to effectively manage conflicts of interest -

....ANSWER ...-FALSE


Students in Research

The history of ethical regulations in human subjects research began with the -

....ANSWER ...-Nuremberg Code


Nuremberg Code - ....ANSWER ...-Human subjects research guidelines and

regulations


Year of the Nuremberg Code - ....ANSWER ...-1949


Additional resources regarding IRB approval process - ....ANSWER ...-Faculty

advisor/Research Mentor

IRB office

Human subjects research websites


What element must be included in an informed consent? - ....ANSWER ...-All

foreseeable risks and discomforts




...©️ 2025, ALL RIGHTS RESERVED 2

,Which type of IRB review does not require and IRB approval but DOES require a

Determination by the IRB? - ....ANSWER ...-If the study qualifies for

EXEMPTION


Another name for the "Exempt" status - ....ANSWER ...-the Common Rule


stated in Title 45 Part 46 Subpart A


How can faculty researchers avoid coercion of student subjects? - ....ANSWER ...-

Avoid using their own students in their research

Name the type of Review: Research study that involves use of educational tests, survey,

interviews, or observations of public behavior without identifiable information. -

....ANSWER ...-Exempt Review category 2


Name the type of review: A study involving data collected that could have an impact on

human subject's careers and it contains identifiers of the subjects. -

....ANSWER ...-Full Board Review


Type of review that qualifies if no identification of subjects and/or their responses would

reasonably place them at risk of criminal or civil liability or be damaging to the subjects

financial standing, employability, insurability, reputation, or be stigmatizing, unless

reasonable and appropriate protections will be implemented so that risks related to

invasion of privacy and breach of confidentiality are no greater than minimal -

....ANSWER ...-Expedited review


Type of review: data that is collected does not meet definition of human subjects

research as stated by federal regulations. No info ABOUT human ie. info about a

business - ....ANSWER ...-Not Human Subjects




...©️ 2025, ALL RIGHTS RESERVED 3

, Federal regulations define human subjects as "living individual about whom an

investigator conducting research obtains"...? (2 components) - ....ANSWER ...-

"1.data through intervention or interaction with the individual

2. identifiable private information"


Name the 3 responsibilities the IRB is charged with - ....ANSWER ...-1. Protecting

the rights and welfare of human subjects

2. Assuring that all applicable institutional policies and federal regulations related to

research with human subjects are followed

3. Reviewing subject recruitment materials and strategies

T/F


IRB's investigate scientific misconduct - ....ANSWER ...-False


T/F

IRB's do not review manuscripts prior to submission for publication -

....ANSWER ...-True


DHHS


FDA - ....ANSWER ...-Depts. IRB's review for current policies


-Department of Health and Human Services

-Food and Drug Administration

Name the study that links most directly to the establishment of the National Research

Act in 1974 and ultimately the Belmont Report and Federal regulations for human




...©️ 2025, ALL RIGHTS RESERVED 4

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