NR 505 Week 3 Quiz Answers, NIH Training
Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects:
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.
An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements.
Which of the following should … eliminated or minimized in the research design?
When might human subjects research require investigators to obtain informed consent?
After informed consent for a research study is given, a research participant must complete the study.
In general, informed consent should … a process rather than a one-time event nr 505 week 3 quiz
In order to participate in research, children must …
For research involving pregnant women, participation requires …
Why might an individual have diminished autonomy?
Risks to research participants must … completely eliminated for the study to … considered ethical.
When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
There must be equipoise in order to justify conducting a clinical trial.
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
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.
Children must … included in all NIH-supported human subjects research unless nr 505 week 3 quiz
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.
Which of the following is TRUE regarding applications for NIH-funded research overseas?
In localities where community consent is the norm,
An “autonomous person” is someone who:
The Belmont Report is significant because:
A “systematic investigation designed to develop or contribute to generalizable knowledge” may include:
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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.
Requirements specific to informed consent for prisoners include adequate assurance that parole boards do not consider a prisoner?s participation in making decisions regarding parole.
The regulations strongly suggest but do not require that the informed consent process … delivered in a language that is understandable to the subject
According to the regulations, to … approvable, research participation must provide a tangible benefit to the individual research subjects.
Risk to research subjects includes:
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.
Social justice and individual justice are different and distinct, yet compatible, concepts.
It is ethical to use deceptive methods in research when the scientific goals of the project can … achieved by non-deceptive methods.
Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule Waivers of informed consent can … granted by which of the following:
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.
Which of the following most accurately describes clinical equipoise nr 505 week 3 quiz
When appropriate, research data should ___________ to prevent accidental disclosure of private information.
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.
Therapeutic misconception is the tendency for investigators to overemphasize the benefits of research to society while incorrectly minimizing the risks to a particular patient.
An example of a 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.
NIH has specific policies addressing:
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 potentially therapeutic agents in children.
IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:
A study proposing to involve pregnant adolescents who are … in a juvenile detention center … if:
The three fundamental principle of Informed consent are
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 … gained.
Research involving prisoners requires both specific IRB membership and approval by OHRP to signify that the proposed research falls within the permissible research categories.