IRB Reviewer Worksheet for Continuing Review
Protocol ID
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Protocol Title
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Reviewer Name
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First Name
Last Name
Email
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To approve research the following minimum criteria must be present:
I have reviewed the following documents (check all that apply):
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IRB application for Continuing Review
Study protocol
Informed Consent documents
DSMB/Safety Monitoring Committee Report(s)
Relevant information relating to participants’ risks and benefits
Other (please specify)
Are there any important changes in the risks, benefits or protocol schedule that you believe have an impact on the IRB’s approval of this protocol?
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Yes
No
If yes, please explain?
In your judgment, do the benefits of this study continue to outweigh the risks?
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Yes
No
Uncertain
If no or uncertain, why?
Do you recommend that the IRB approve continuation of this study?
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Yes
No
Uncertain
If no or uncertain, why?
Points to Consider
Are the actual risks and benefits as anticipated?
Have any subjects been seriously harmed?
Has the IRB been informed of any unforeseen problems or accidents that may have occurred?
Should the IRB request that the investigator(s) submit scheduled progress reports?
Should the investigator(s) submit progress reports more often than annually
Since the last IRB review, have subjects been informed of any important new information that might affect their willingness to continue participating in the research?
Have any new findings, knowledge, or adverse effects come to light that should be, but have not been, communicated to subjects?
Does the progress of the project together with the results of other new research indicate that the IRB should either impose special precautions or relax special requirements it had previously imposed?
Do the consent documents need to be revised?
Has due care been used to reduce risks and increase the likelihood of benefit
Are the procedures agreed upon at the beginning of the research still being used?
Does the protocol adequately provide for continuing assessment of the balance between risks and benefits?
Should IRB approval be continued, or should approval be suspended or terminated?
When should the IRB next review the project (taking into account what has been learned about the actual risk to subjects since the project first received IRB approval)?
The following areas must be considered by the reviewers in the continuing review process:
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Degree of risk to subject
Number of subjects studied
Qualifications and experience of the investigator(s)
Prior IRB experience with investigator(s)
Vulnerability of the subject population
Study sponsor recommendations
Consent process and content, including HIPAA compliant Authorization language
New published data in the study’s subject field
Lag time between initial review and enrollment of 1st subject
The primary and secondary reviewers should consider each of the above items but is not limited to them.
Recommendation Approval
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Yes
No
Approval Period
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1 Year
Other
Comments
Reviewer Signature
Today's Date
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Month
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Day
Year
Date
SUBMIT
Should be Empty: