NR 505 Week 3 Quiz
Question no 1
Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects:
Question no 2
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
Question no 3
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
Question no 4
All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.
Question no 5
An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements.
Question no 6
Which of the following should … eliminated or minimized in the research design?
Question no 7
When might human subjects research require investigators to obtain informed consent?
Question no 8
After informed consent for a research study is given, a research participant must complete the study.
Question no 9
In general, informed consent should … a process rather than a one-time event nr 505 week 3 quiz
Question no 10
In order to participate in research, children must …
Question no 11
For research involving pregnant women, participation requires …
Question no 12
Why might an individual have diminished autonomy?
Question no 13
Risks to research participants must … completely eliminated for the study to … considered ethical.
Question no 14
When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
Question no 15
There must … equipoise in order to justify conducting a clinical trial.
Question no 16
What is an appropriate method for maintaining the confidentiality of private information obtained from human subjects?
Question no 17
If a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.
Question no 18
Children must … included in all NIH-supported human subjects research unless nr 505 week 3 quiz
Question no 19
For HIV antiretroviral treatment trials conducted in developing countries, the NIH expects investigators/contractors to address the provision of antiretroviral treatment to trial participants after their completion of participation in the clinical trial.
Question no 20
Which of the following is TRUE regarding applications for NIH-funded research overseas?
Question no 21
In localities where community consent is the norm,
Question no 22
An “autonomous person” is someone who:
Question no 23
The Belmont Report is significant because:
Question no 24
A “systematic investigation designed to develop or contribute to generalizable knowledge” may include:
STATUS
Question no 25
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.
Question no 26
Are requirements specific to informed consent for prisoners include an adequate assurance that parole boards do not consider a prisoner?s participation in making decisions regarding parole.
Question no 27
The regulations strongly suggest but do not require that the informed consent process … delivered in a language that is understandable to the subject
Question no 28
According to the regulations, approvable, research participation must provide a tangible benefit to the individual research subjects.
Question no 29
The risk to research subjects includes:
Question no 30
Financial compensation of individual research participants is one way to achieve a favorable ratio of benefit to risk, provided that the amount does not constitute undue inducement.
Question no 31
Social justice and individual justice are different and distinct, yet compatible, concepts.
Question no 32
It is ethical to use deceptive methods in research when the scientific goals of the project can … achieved by non-deceptive methods.
Question no 33
Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule
Question no 34
Waivers of informed consent can … granted by which of the following:
Question no 35
One of the requirements of informed consent is that subjects must … told whether they are eligible to receive compensation if they are injured as a result of their participation in the research.
Question no 36
Which of the following most accurately describes clinical equipoise nr 505 week 3 quiz
Question no 37
When appropriate, research data should ___________ to prevent accidental disclosure of private information.
Question no 38
Because the expedited IRB review process is generally … for certain types of minimal risk research, it is less stringent than review by the full IRB.
Question no 39
The therapeutic misconception is the tendency for investigators to overemphasize the benefits of research to society while incorrectly minimizing the risks to a particular patient.
Question no 40
An example of potential economic risk to a research subject is the potential negative impact research may have on the employment or promotion potential of a research subject.
Question no 41
NIH has specific policies addressing:
Question no 42
Excluding children from participation in research, while well-intentioned, may deny children the benefits of participation and prevent the collection of sufficient data about the possible effects of potential therapeutic agents in children.
Question no 43
IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:
Question no 44
A study proposing to involve pregnant adolescents who are … in a juvenile detention center … if:
Question no 45
The three fundamental principles of Informed consent is
Question no 46
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 gain.
Question no 47
Research involving prisoners requires both specific IRB membership and approval by OHRP to signify that the proposed research falls within the permissible research categories.
