IRB Final Exam Study Test.
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations
(45 CFR 46)?
Honesty, Trust, Respect
Informed consent, IRB review, Research Integrity
Respect for Persons, Beneficence, Justice
Protections for Pregnant Women, Prisoners, Children - CORRECT ANSWER Respect for Persons,
Beneficence, Justice
An "autonomous person" is someone who:
Has reached the legal age to provide informed consent in the State.
Is willing to accept certain risks if the research will benefit others in the future.
Understands the risks and benefits of his or her participation and is able to make a voluntary decision if
adequate information is provided.
Meets all eligibility criteria for a study and asks the investigator if she or he may participate. - CORRECT
ANSWER Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided.
45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to evaluate risks to subjects,
protection against these risks, potential benefits of the research and the importance of the knowledge
to be gained.
true or false - CORRECT ANSWER False
An institutionally designated authority, other than the investigator, should determine that proposed
studies are exempt from regulatory requirements.
True
False - CORRECT ANSWER true
, All research that involves interaction or intervention with humans or human samples/data, whether
they are alive or dead, is human subjects research.
True
False - CORRECT ANSWER false
The Belmont Report is significant because:
It was written by the National Commission for the Protection of Human Subjects.
It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
Belmont is another word for individual autonomy and respect.
It was a seminal document about the concept of informed consent. - CORRECT ANSWER It articulated
ethical principles that formed the basis for the HHS Human Subjects Regulations.
The three fundamental principle of Informed consent are
Voluntariness, Equipoise, Respect
Voluntariness, Comprehension, Disclosure
Benefits, Comprehension, Privacy
Disclosure, Equipoise, Privacy - CORRECT ANSWER Voluntariness, Comprehension, Disclosure
Communities may grant emergency waivers of informed consent for research involving pregnant women
in the community who are in active labor and call Emergency Medical Services.
True
False - CORRECT ANSWER false
f informed consent information is presented orally, it must be documented using a short form that
states that all of the required elements were presented orally.
True
False - CORRECT ANSWER true
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations
(45 CFR 46)?
Honesty, Trust, Respect
Informed consent, IRB review, Research Integrity
Respect for Persons, Beneficence, Justice
Protections for Pregnant Women, Prisoners, Children - CORRECT ANSWER Respect for Persons,
Beneficence, Justice
An "autonomous person" is someone who:
Has reached the legal age to provide informed consent in the State.
Is willing to accept certain risks if the research will benefit others in the future.
Understands the risks and benefits of his or her participation and is able to make a voluntary decision if
adequate information is provided.
Meets all eligibility criteria for a study and asks the investigator if she or he may participate. - CORRECT
ANSWER Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided.
45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to evaluate risks to subjects,
protection against these risks, potential benefits of the research and the importance of the knowledge
to be gained.
true or false - CORRECT ANSWER False
An institutionally designated authority, other than the investigator, should determine that proposed
studies are exempt from regulatory requirements.
True
False - CORRECT ANSWER true
, All research that involves interaction or intervention with humans or human samples/data, whether
they are alive or dead, is human subjects research.
True
False - CORRECT ANSWER false
The Belmont Report is significant because:
It was written by the National Commission for the Protection of Human Subjects.
It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
Belmont is another word for individual autonomy and respect.
It was a seminal document about the concept of informed consent. - CORRECT ANSWER It articulated
ethical principles that formed the basis for the HHS Human Subjects Regulations.
The three fundamental principle of Informed consent are
Voluntariness, Equipoise, Respect
Voluntariness, Comprehension, Disclosure
Benefits, Comprehension, Privacy
Disclosure, Equipoise, Privacy - CORRECT ANSWER Voluntariness, Comprehension, Disclosure
Communities may grant emergency waivers of informed consent for research involving pregnant women
in the community who are in active labor and call Emergency Medical Services.
True
False - CORRECT ANSWER false
f informed consent information is presented orally, it must be documented using a short form that
states that all of the required elements were presented orally.
True
False - CORRECT ANSWER true
