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  3. NR 505 Week 3 Quiz 

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:

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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.

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