Study Title:

Principal Investigator:

1. This research study is being done:

a. To make me better

b. To see if a treatment is safe

c. To see if a treatment works

2. Everyone in this study will receive the same treatment.

True False

3. One possible benefit of the research study is that I will be cured.

True False

4. One possible risk of the research study is that I might die.

True False

5. There are no other options for my health care.

True False

6. It will not cost me anything to be in this study.

True False

7. If I do not participate in this research study there are other treatments, drugs, or

things I can do for my illness or condition.

a. There are no alternatives and I have to be in the study to be treated.

b. I can receive different treatment.

c. I can receive the same treatment even if I am not in the study.

8. Participation in this research is voluntary.

True False

9. If I decide to participate in this research study, I can change my mind and withdraw from

the study at any time.

True False

10. The study doctor and staff and individuals from the government who are responsible for

being sure that research is done correctly may review my study records.

True False