UNIVERSITY OF ST. THOMAS Institutional Review Board (IRB)

Consent Form Checklist

Before sending in you application, please check to make sure your consent form meets all the requirements (for an model, please download a consent form template under "Forms").

1. Have provisions been made to obtain consent from all individuals related to the study?

2. Are Provisions for obtaining consent adequate?

3. Does the consent form:

a. Use a clear language appropriate for subjects?

b. Name the primary investigators and their department and university affiliation?

c. Clearly state the purpose of the study

d. Indicate precisely what the subject will be asked to do?

e. Specify any potential risk?

f. State the expected benefits?

g. Discuss arrangements made for confidentiality/anonymity?

h. Explain the voluntary nature of the study?

i. Make provision for subjects to withdraw at any time without penalty?

j. Include name and phone number of Primary investigator? advisor, if applicable? IRB?

k. include an offer to answer questions?

l. Provide for a copy to be given to subjects?