IRB Continuation/Change Form

Section 1

1. Please provide

First Name Last Name

Phone Number Extension Email

**Please check to be sure your phone number and email address are correct.

2. Are you a

Faculty Member

Staff Member

Student

Other

3. If you are a student, please supply the contact information for your supervising faculty member: (leave N/A in all fields if you are not a student.)

First Name Last Name

Phone Number Extension Email

4. Original IRB Reference Number

5. Project Title

6. Project Type

7. If your project is funded:

State the name of the funder:

State the grant ID number:

State the length of project period:

8. You will be informed of the IRB's decision via email

Do you require a signed hard copy of the IRB's decision for your records? Yes No

Section 2

1. What is the status of your study?

If you chose "Other", please provide an explanation:

N/A if "Other" is not chosen as the status of the study.

2. Total number of participants approved for the study:

3. Number of participants enrolled since last IRB review (continuing or initial):

4. Number of participants enrolled in the study to date :

5. If actual total enrollment is different from the original project enrollment, provide an explanation:

N/A if there is no difference in total enrollment

6. Has your relationship with the study sponsor changed since the IRB review in any way which might require conflict of interest disclosure (e.g. stock purchases, royalty payments, patents, Board position, etc.)??

Yes

7. Have there been any changes in Principal Investigator, Co-Investigators or staff?

Yes

If yes, please explain:

N/A if answer above is "No"

8. Summarize preliminary information about any results and/or trends (DO NOT LEAVE BLANK):

9. Describe any unanticipated problems in the conduct of the study (if none, state "none"):

State "None" if no unanticipated problems have occurred

10. Has the risk/benefit relationship for subjects changed from the initial expectation?

Yes

If yes, describe what has changed from the initial expectations:

N/A if "No" is chosen above

11. List and Explain any other changes in the study or study period originally approved by the IRB (if none, state "none"):

**Please note: All current consent/assent forms, even if unchanged from original submission, should be submitted directly to the OSP IRB administrator, via email or hard copy. Please include your name and IRB reference number on all documents.

Please check your answers carefully before submitting.

Completed submissions will result in a confirmation email which will contain your data as submitted to the email address you provided.. If you do not receive a confirmation, please contact Office of Research Compliance at 245-2314.