Author Question: A researcher is applying for institutional review board (IRB) approval, and the form specifies that ... (Read 103 times)

abc · **on:** Jul 8, 2018

A researcher is applying for institutional review board (IRB) approval, and the form specifies that the researcher indicate the probable level of risk.

The research creates situations in which the RN research subjects are placed in unusual code-like situations in which they do not know what action to take, and actors play the parts of other healthcare providers. The RN subjects are then asked to describe their feelings and their levels of confidence as they go through 15 scenarios. What level of risk does this study pose?
a. No anticipated effects
b. Temporary discomfort
c. Unusual discomfort
d. Risk of permanent harm

Question 2

A researcher receives permission to use the information in a hospital data set, without patient identifiers. What level of subject consent is required?

a. Partial: the subjects must all be notified that their data is being re-used.
b. None.
c. Partial: the subjects must all be notified if the results are published.
d. Full: all subjects must be contacted and must agree to have their data used.

choc0chan · **Reply #1 on:** Jul 8, 2018

Answer to Question 1

ANS: B
Studies that cause temporary discomfort are described as minimal-risk studies, in which the discomfort encountered is similar to what the subject would experience in his or her daily life and ceases with the termination of the study. Many nursing studies require the subjects to complete questionnaires or participate in interviews, which usually involve minimal risk. The physical discomforts might be fatigue, headache, or muscle tension. The emotional and social risks might entail the anxiety or embarrassment associated with responding to certain questions. The economic risks might consist of the time spent participating in the study or travel costs to the study site. Participation in many nursing studies is considered a mere inconvenience for the subject, with no foreseeable risks of harm. Most clinical nursing studies examining the impact of a treatment involve minimal risk.

Answer to Question 2

ANS: B
Covered entities (healthcare provider, health plan, and healthcare clearinghouse) may use and disclose a limited data set to a researcher for a study without an individual subject's authorization or an IRB waiver.