December 2008: Continuing Reviews

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New York University Langone Medical Center/School of Medicine
Institutional Review Board
Continuing Education
Continuing Reviews
December 2008
Definition of Continuing Review
Regulations require the IRB to perform a “substantive and meaningful” review of all human subjects’ research no less
than once per year or more frequently based on the risk exposed to subjects. The IRB can decide to review research
more often than once per year if the IRB has concerns.
How is a Continuing Review submitted?
Principal Investigators are required to provide the following information for review: (1) Completed application for
continuing review; (2) New Protocol Application, revised (if applicable); (3) Most recent approved consent form; (4)
New information received about any part of the study; (4) Unanticipated Problems/Reportable Events not reported
to the IRB and summary of events reported over the approved period; (5) summary of Amendments reviewed and
approved by the IRB.
How should you review this information? AND what questions should you should be asking to make the
continuation determination?
First, ensure you have all the completed documentation required to proceed with your review. If anything is missing,
please contact the IRB office right away.
As with new studies the IRB must make 45 CFR 46.111 findings at the time of continuing review. In order to
ensure the research study continues to meet the regulatory criteria required under 45 CFR46.111 a reviewer
should evaluate:
(1) Enrollment numbers - Are the enrollment #s on track? Did the PI over enroll? If yes, was a justification
provided or an amendment approved previously? Will the researchers be able to answer the research question in
the time frame allotted with the current enrollment?
(2) Equity of enrollment selection – Is a certain population being targeted without justification?
(3) Reportable events/Unanticipated Problems – Has the risk/benefit ratio changed based on reported
problems/events? Should any changes be made to the consent form based on events received? Should the IRB
request that progress reports be submitted at regular intervals, more often than annually?
(4) Modifications completed since the most recent review – Have any changes been made to the study that could
affect the risk/benefit ratio? Was the project amended without IRB approval?
(5) New information – Has any new information become available? If yes, does it affect the most recently
risk/benefit ratio determination? Is there a DSMB and do they have any new information for the IRB? Are any
changes needed based on the DSMB’s information? Is there new information that should be, but has not yet been,
conveyed to enrolled subjects?
(6) Progression – Is the study progressing as expected and should it continue? If not progressing, was a
justification provided?
(7) Subject complaints, if applicable. What have the subjects complained about? Is it relevant to the 45 CFR 46.111
findings? Were these complaints resolved or are they presently on-going?
(8) Informed Consent – Have all subjects been consented properly (before any screening has taken place)? Are
there any concerns about the informed consent process? Have subject complaints about the consent process been
received? Is the consent process still adequate and appropriate or are changes required? Has consent been
appropriately documented for enrolled subjects?
(9) Protocol and consent document- Are both current and incorporate all amendments that have been approved?
(10) Vulnerable Populations- Are the determinations required by the Subparts still acceptable since the most recent
review? Should the subjects’ competency be reassessed?
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What if something is missing and you cannot complete your review or make a determination of one of the
findings?
Communicate and contact the Principal Investigator directly. This will ensure all appropriate and accurate
information is reviewed. Communicate with the IRB office board staff regarding communications/changes made to
ensure all documentation is received and retained. Remember if one of the 111 findings cannot be determined, the
project may not be approved.
Your review is complete, how do you present your review at the meeting?
Start by stating what action is appropriate for the continuation. For example, this continuation should be granted
approval. This project may be approved due to the following PROVIDE EVIDENCE……
This is the time to present all of the 111 findings. You will present each finding and determine that the most recent
approval findings have not been changed since the most recent approval. For vulnerable populations, ensure Subpart determinations have also not been changed. This information must be verbalized at the meeting for inclusion in
the minutes to stay in compliance with the regulations. Ensure that the research review intervals do not need to be
changed.
You are a researcher and an IRB member. From what point of view should you be reviewing?
As an IRB member you are in the position of an evaluator of the study. This will assist in your understanding of
boundaries and time constraints. Sometimes we forget our roles as IRB members by reviewing in the researcher’s
perspective. This happens especially when members are researchers themselves.
Evaluation:
 Evaluator is “concerned”- protecting a population point of view
 Leads to decisions
 Conducted for a well defined audience; other IRB members
 Time bound
Research:
 Researcher is intrigued or curious- testing a hypothesis
 Leads to conclusions
 Conducted without knowing who will use results
 Has it own schedule.
When in doubt, remember where the information is:
*Continuing Review Application and Reviewer’s Checklist =111 Findings*
OR
Call the Principal Investigator/Research Team or IRB office if you need more information or
have any questions. If all questions are cleared before the meeting a continuation review will
more than likely lead to approval!
References:
IRB Member Handbook (Second Edition)- Amdur and Bankert
Ohio State University Presentation- (Navigating the IRB Process, December 2006)
45 CFR 46
IRB New Member Orientation Power Point
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