NIH Certification Quiz

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Section Quiz

You got 6 correct out of 6.

Please answer all questions below

  1. The Belmont Report is significant because:
    1. It was written by the National Commission for the Protection of Human Subjects.
    2. It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
    3. Belmont is another word for individual autonomy and respect.
    4. It was a seminal document about the concept of informed consent.
  2. 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.
    1. True
    2. False
  3. Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule?
    1. Subpart A which describes the required protections for all human subjects
    2. Subparts B, C , and D which deal with protections for certain vulnerable subjects
    3. Subpart E which addresses the registration of IRBs
    4. All of the above
  4. What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
    1. Honesty, Trust, Respect
    2. Informed consent, IRB review, Research Integrity
    3. Respect for Persons, Beneficence, Justice
    4. Protections for Pregnant Women, Prisoners, Children
  5. All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research. 
    1. True
    2. False
  6. Which of the following should be eliminated or minimized in the research design?
    1. Coercion
    2. Research risks
    3. Repeated recruitment of research participants for new protocols
    4. All of the above

Section Quiz

You got 6 correct out of 6.

Please answer all questions below

  1. 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.
    1. True
    2. False
  2. One of the requirements of informed consent is that subjects must be told whether they are eligible to receive compensation if they are injured as a result of their participation in the research.
    1. True
    2. False
  3. The regulations strongly suggest but do not require that the informed consent process be delivered in a language that is understandable to the subject
    1. True
    2. False
  4. 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.
    1. True
    2. False
  5. After informed consent for a research study is given, a research participant must complete the study.
    1. True
    2. False
  6. Why might an individual have diminished autonomy?
    1. They are a neonate.
    2. They are incarcerated or involuntarily confined.
    3. They are unconscious.
    4. All of the above.

Section Quiz

You got 5 correct out of 5.

Please answer all questions below

  1. 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.
    1. True
    2. False
  2. When appropriate, research data should be ___________ to prevent accidental disclosure of private information.
    1. De-identified
    2. Maintained in multiple secure places
    3. Published only in scientific journals
  3. Risk to research subjects includes:
    1. Physical, psychological, social, legal or economic harm that may reasonably be anticipated as a result of participation in research
    2. The probability that a certain harm will occur from disclosure of findings
    3. Unforeseen physical harm that is possible from participation in therapeutic research
    4. All of the above
  4. Risks to research participants must be completely eliminated for the study to be considered ethical. 
    1. True
    2. False
  5. There must be equipoise in order to justify conducting a clinical trial. 
    1. True
    2. False

Section Quiz

You got 4 correct out of 4.

Please answer all questions below

  1. The use of placebo in a clinical trial may be justified:
    1. When there is agreement about whether the standard treatment is more effective than a placebo
    2. For conditions where there is no approved, effective treatment
    3. When the risks posed by placebo are significant and withholding the current standard therapy could lead to serious or permanent harm
    4. All of the above
  2. Children must be included in all NIH-supported human subjects research unless:
    1. The researcher is not a pediatrician
    2. Past experience has shown it is time-consuming and expensive to recruit children
    3. There are scientific and ethical reasons to exclude them
    4. The researcher does not possess the pediatric equipment necessary to involve children in the proposed research
  3. Which of the following is TRUE regarding applications for NIH-funded research overseas?
    1. It is illegal to spend NIH funds in research overseas
    2. Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies
    3. Research conducted overseas is only subject to local regulations and policies
    4. Research conducted overseas need not address human subjects protections
  4. In localities where community consent is the norm,
    1. A family member’s consent for another individual may be sufficient, as long as community consent is given
    2. Federal regulations preclude the conduct of PHS-funded research
    3. Community consent to participate in the research study is sufficient and no IRB approval is required
    4. In addition to the cultural norm, individual informed consent is required

 

 

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