Question

1. The Informed Consent Document should be written in lay terms at the level of a high school graduate

   1. True
   2. False
2. Question 10

   10 Points

   If you provide payments to your subjects, they should be limited to compensation for time and effort and out-of-pocket expenses, so they are not so high they could be considered coercive

   1. True
   2. False

• Question 11

  10 Points

  An important element of the informed consent document is an explicit statement that participation in research is completely voluntary and that the subject will not be penalized if he or she decides not to participate or withdraws during the study.

  1. True
  2. False

• Question 12

  10 Points

  Only the principal investigator needs to have a copy of the informed consent document.

  1. True
  2. False

• Question 13

  10 Points

  Which of the following would likely be of little or no concern to an IRB?

  1. The information provided in your informed consent document

  2. The risk/benefit ratio for the subjects involved in the project

  3. The source of funding you have obtained for the project

  4. The information presented in any subject recruitment flyers of advertisements.

  5. The means you will use to protect the confidentiality of subjects' data

• Question 14

  10 Points

  Which of the following is not a normal element of the IRB application that must be reviewed by the IRB?

  1. The informed consent document

  2. The proposed research protocol

  3. The amount of compensation to the subjects, if any

  4. The amount of compensation for the research staff

• Question 15

  10 Points

  If you will be doing nothing more to your subjects than would be done in routine physical or psychological evaluations and presents no greater than normal risks of daily living, you should categorize your study as:

  1. Minor increase over minimal risk

  2. Moderate risk

  3. No more than minimal risk

  4. High Risk

Answer 1

9. The Informed Consent Document should be written in lay terms at the level of a high school graduate.

(False)

The Informed Consent Document should be written in lay terms at the 8th-grade level. Because there are many patients or study participants who are not graduate.

10. If you provide payments to your subjects, they should be limited to compensation for time and effort and out-of-pocket expenses, so they are not so high they could be considered coercive.

(True)

According to the food and Drug Administration payments should be limited to compensation for time and effort, they are not so high that they could be considered coercive.

11. An important element of the informed consent document is an explicit statement that participation in research is completely voluntary and that the subject will not be penalized if he or she decides not to participate or withdraws during the study.

(True)

Informed consent should document clearly in detail that participation in research is completely voluntary and that the subject will not be penalized if he or she decides not to participate or withdraws during the study. Because the researcher can not force anyone to participate in his research.

12. Only the principal investigator needs to have a copy of the informed consent document.

(False)

A copy of the informed consent document should be given to the participant and another copy kept with the principal investigator.

13. The source of funding you have obtained for the project is no concern to an IRB.

Other things are important to get approval from IRB like..

1. The information provided in your informed consent document

2. The risk/benefit ratio for the subjects involved in the project

3. The information presented in any subject recruitment flyers of advertisements.