History and Ethical Principle3

History and Ethical Principles - SBE CITI Training
questions with complete solutions

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)

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

, 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

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