Which is considered an essential element of the informed consent ...

[haleyc112]

Which is considered an essential element of the informed consent form for a research study?
 
  a. The witnessing signature of an authorized party
  b. The listing of members of the agency's IRB
  c. Explanation of whom to contact regarding any area of the study
  d. List of subject's assignment to intervention group or control group

Question 2

How should a completed and signed informed consent form be handled?
 
  a. It is turned over to the agency's institutional review board (IRB) for safekeeping.
  b. It is sent to the National Institutes of Health Office of Research Integrity.
  c. It is filed in a locked filing cabinet, separate from data generated by the study.
  d. It is copied, with one given to the participant and the other held by the researcher.

[carolinefletcherr]

Answer to Question 1

ANS: C

Feedback
A A witnessing signature is not required.
B Members of the IRB do not need to be listed on the consent form.
C Consent forms must include identification of investigators.
D Consent forms do not indicate in what group a participant will be placed.

Answer to Question 2

ANS: D

Feedback
A The IRB does not hold records of informed consent.
B The National Institutes of Health (NIH) does not hold informed consent documents.
C All materials from a study should be secured in the same location.
D The participant and researcher should both receive a copy of the informed consent document.