The nurse who is reading a research report has concerns about the ...

[kamilo84]

The nurse who is reading a research report has concerns about the ethical aspects of the study. Which information should reassure the nurse that the study was undertaken in an ethical manner?
 
  1. The report states that the principle investigator of the study is a nationally renowned physician.
  2. The company that manufactures the medical device used in the research funded the study.
  3. The study design reveals that no physical harm to participants was possible.
  4. The study was reviewed and approved by an Institutional Review Board.

Question 2

A 9-year-old patient has been diagnosed with leukemia. The patient's parents have given consent to enroll the child in a clinical trial of a new chemotherapy regimen. What is the nurse's primary obligation in this scenario?
 
  1. Start the trial medications as soon as possible.
  2. Be certain all laboratory and diagnostic studies necessary for the trial are completed.
  3. Advocate for the patient by requiring the child's assent to participate in the study.
  4. Be certain to explain all procedures and nursing interventions to the patient as well as to the parents.

[qytan]

Answer to Question 1

4
Rationale 1: Whereas most researchers are honest and ethical, just having a well-known principle investigator does not assure the study was conducted ethically.
Rationale 2: Having a potential conflict of interest such as funding from the company who stands to gain financially from research findings may compromise the study's design, ethics, and findings.
Rationale 3: The ethics of research are in place to protect from any harm, not just physical harm.
Rationale 4: The purpose of the Institutional Review Board is to review study proposals to assure that they meet federal government guidelines.
Global Rationale:

Answer to Question 2

3
Rationale 1: This is an important nursing action, but not the most important in this scenario.
Rationale 2: This is an important nursing action, but not the most important in this scenario.
Rationale 3: Once a child is over 7 years of age, the child must give assent to the study, even if the parents have given consent.
Rationale 4: This is an important nursing action, but not the most important in this scenario.
Global Rationale: