A human subject is defined as a living individual about whom an ...

[Bob-Dole]

A human subject is defined as a living individual about whom an investigator conducting research obtains:
 
  a. data without direct or indirect interaction or intervention.
  b. information that is not expected to be made public.
  c. no diagnostic information and does not manipulate the subjects environment.
  d. information without any communication/contact during the research.

Question 2

The nurse is preparing to conduct a study involving the post-prandial blood sugars in patients who have received intensive diabetic rehabilitation versus diabetics undergoing usual care. In order for the consent to be valid, the nurse would have to:
 
  a. change the language of the consent.
  b. keep explanations to a minimum to reduce stress.
  c. keep potential risks undisclosed.
  d. insist that the participant sign the consent right away.

[ynlevi]

Answer to Question 1

ANS: B
A human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information (Office of Human Research Protection, 2008, para. 3). Interventions may include procedures such as gathering diagnostic information or manipulating the subject's environment. Interaction refers to any communication or contact during the research. Private information includes anything not expected to be made public, such as a medical record.

Answer to Question 2

ANS: A
Research participants require an explanation of the study in which they are subjects. Any information provided needs to be in a language that is understandable to them. Procedures and the purpose of the study need to be explained. The manner in which subject anonymity and confidentiality will be protected needs to be explained. Any potential harm, including physical or mental discomfort, and possible benefits from participation should be explained. Questions should be answered so that participants fully understand the research and their part in the process. All subjects need to be given time to decide about participation. Study participants are voluntary, may withdraw at any time, or may choose not to complete tasks.

[Bob-Dole]

TYSM

[Jossy]

Gracias!