Homewood Institutional Review Board
Continuing Review of Research
Protocol No.
Principal Investigator:
Title of Project:
Reviewer(s):
The above-referenced project was IRB-approved initially after an expedited review process. IRBapproval will soon expire and the research is now due for continuing review. When you have read the
application material, please complete this review form and return it to the HIRB office .
Considerations for Continuing Review
Study History
1. Have additional subjects been enrolled since the last review?
Yes
No
2. Have any subjects withdrawn or been removed from the research since the last IRB review?
Yes
No
3. Have there been any adverse events, or unanticipated problems involving risks to participants,
or others?
Yes
No
If YES, explain what risks, and how to minimize
4. Have there been any complaints about the research since the last IRB approval?
Yes
No
5. Are there any significant new findings that may relate to the subject’s willingness to continue?
Yes
No
6. Has any new information become available relevant to this research that could alter the IRB’s assessment of
risk:benefit ratio?
Yes
No
If YES, explain further
Comments:
Changes or Amendments
1. Have there been any changes to the research protocol (e.g., procedures, consent process, investigators,
recruitment) since the last IRB review?
Yes
No
2. If YES, have the changes affected the Risk/Benefit ratio since the last review?
Yes (explain)
No
Comments:
Informed Consent
1. Is the current or proposed consent process still adequate and complete?
2. If children are the subjects of the research,
a) will Parental consent be obtained?
Yes
If NO, is it justified?
Yes
Yes
No
No
b) will the investigators obtain child’s assent?
Yes
No
N/A
If YES, is the Assent appropriate to the age or comprehension of the participants?
If NO, is it justified?
Page 1 of 2
Yes
No …if NO, explain
Yes
No
No
ContReview10/21/09
Comments:
Reviewer Recommendation
I recommend the following:
I approve
I recommend approval pending the following… (see additional comments)
I disapprove (see additional comments)
The review period is:
One year
Less than one year, the recommended interval is (specify):
Following the enrollment of a specified # of participants (specify #):
Other
Additional Comments:
________________________________________
Reviewer’s Signature
Page 2 of 2
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Date
ContReview10/21/09