1. |
Heading |
Project title |
|
|
Project number |
|
|
Name of principle investigator |
2. |
Introduction |
Voluntary nature of participation |
|
|
Possibility of benefiting or not |
|
|
Choice to not enroll/discontinue |
3. |
Why is the study being done? |
|
4. |
How many people will take part in the study? |
|
5. |
What is involved in the study? |
|
6. |
How long will I be in the study? |
Withdrawal by investigator, physician, or sponsor |
7. |
What are the risks of the study? |
|
8. |
Are there any benefits? |
|
9. |
What other options are there? |
|
10. |
What about confidentiality? |
|
11. |
What are the costs? |
|
12. |
Policy/procedures for research related injury |
|
13. |
Compensation for participation |
|
14. |
What are my rights as a participant? |
|
15. |
Who do I call if I have questions or problems? |
|