HRPP Contacts
IRB-A
Cheree Dubose, 949-824-6068
Human Research Protections Program
News Brief
Matt Kinder, 949-824-9819
Kristen Jorgensen, 949-824-5746
Tahseen Mozaffar, MD, Chair, 714456-2332
Revised AE-UP Reporting Module
IRB-B
Theresa Sanchez, 949-824-2125
The Adverse Event-Unanticipated Problem (AE-UP) Reporting Module has been revised to reduce the
Samantha Pash, 949-824-5622
reporting burden for investigators by narrowing the scope of reportable events/problems, and to capture those
Debbie Melamud, 949-824-2576
events that could potentially be unanticipated problems involving risk to subjects or others. Events that
are considered to be unanticipated problems must be reported to the IRB, appropriate UCI officials, the
Robert Burger, MD, Chair, 714-
funding agency or study sponsor, and federal department or agency heads including the Office of Human
456-7974
Research Protections (OHRP), the Food and Drug Administration (FDA), when applicable.
IRB-C
Anthony Saldana, 949-824-6662
What Needs to be Reported?
Lead Researchers are to report any unexpected, internal adverse events or external adverse events that occur
Jessica Sheldon, 949-824-7114
anytime during the conduct of the research study or during the follow-up period after the research, which in
Christina McGoldrick, 949-824-
the opinion of the UCI Investigator includes the following components:
4779
Ruth Mulnard, RN, DNSc, Chair,
•
Unexpected, in terms of nature, severity, or frequency, given (a) the research procedures that are
described in the IRB-approved documents, such as the protocol and informed consent document; and (b)
the characteristics of the subject population being studied;
•
Related or possibly related to participation in the research (possibly related means there is a
reasonable possibility that the incident, experience, or problem may have been caused by the
procedures involved in the research); and
•
Suggests that the research places subjects at a greater risk of harm (including physical, psychological,
economic, or social harm) than was previously known or recognized.
949-824-7016
Associate Director, Research
Protections
Karen Allen, 949-824-1558
Assistant Vice Chancellor,
Research Administration
Christina Hansen, 949-824-5677
Did you Know…
•
The IRB sends email
notices to Lead
Researchers when it is
time to submit for
continuing renewal?
•
Modification requests can
be submitted for IRB
review concurrently with a
continuing review
application?
Office of Research
Administration
4199 Campus Drive
University Tower, Suite 300
Irvine, CA 92697-7600
Phone: 949-824-4768
Fax: 949-824-1465
Web: www.rgs.uci.edu/ora/
September 2007
While all events and problems should be reported to a study sponsor, not all events need to be reported to
the IRB. For instance, expected adverse events and protocol deviations do not need to be reported to the
IRB.
New Reporting Timeframes
Most reportable events and problems are to be reported within 10 working days; however, internal serious
adverse events, protocol violations, changes to the protocol without prior IRB approval to eliminate an
apparent immediate hazard to a research subject, and other events/problems involving subjects or others that
are unexpected, related or possibly related to the research, and caused harm to others or places others at a
greater risk of harm as a result of the research, must be reported to the IRB within 5 working days.
For detailed information about report timeframes and a complete list of reportable events and problems, see
the AE-UP webpage and AE-UP reporting module.
Determining the Level of IRB Review
All human subjects research protocols fall into one of three levels of committee review: exempt, expedited or
full committee. Investigators should become familiar with the levels of review and allow enough lead time
for review and approval to occur. Exempt and Expedited protocols are reviewed on a rolling basis by one or
more experienced IRB members; full committee protocols must be received by a given meeting deadline. See
the meeting deadline calendar for details.
Exempt: To qualify, research must fall into six (6) federally-defined exempt categories. These categories
present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments.
Expedited: To qualify for an expedited review, research must fall into nine (9) federally-defined expedited
categories. These categories involve collection of samples and data in a manner that is not anonymous and
that involves no more than minimal risk to subjects.
Full Committee: Proposed human subject research which does not fall into either the exempt or expedited
review categories must be submitted for full committee review. This is the most rigorous level of review and,
accordingly, is reserved for research projects that present more than minimal risks to subjects.
September 2007
Page 2
Why Does the IRB Conduct Continuing Review?
Except for human research studies that have been granted Exempt registration, DHHS and FDA regulations
require the IRB to continually review ongoing research at intervals appropriate to the potential risk to
participants, but at least annually.
While initial IRB review is based on the researcher's best assessment of the anticipated benefits, risk, and
procedures, the continuing review process is important because it is based on the conduct of the
study. Actual risk can be evaluated and preliminary results can be used to assess the risk/benefit ratio.
Additionally, the risk/benefit ratio may change not only because of unexpected results and effects of the
research intervention itself, but because new knowledge resulting from related research may affect the balance.
Taking the time to provide detailed information requested on the form will prevent delays in continuing
review and approval of the study. It is important to be responsive to the questions on the continuing review
application so that the IRB can conduct a meaningful and thorough review.
Prepare the submission 90 days in advance for full committee protocols; 60 days in advance for
expedited protocols:
1.
“The [Federal]
Regulations make
no provision for
any grace period
extending the
conduct of the
research beyond
the expiration of
IRB approval.”
-OHRP guidance
on Continuing
Review
Consider subject accrual, study progress and the informed consent process. Were there any
problems with obtaining informed consent? Any subject withdrawals? Do modifications to the recruitment
or consenting process need to be made?
2.
Review any unanticipated problems and adverse events that have been reported to the IRB. Are there any events that should be
considered at the time of continuing review? Based on the Lead Researcher’s assessment of expected and unexpected events, has the
frequency or seriousness of the expected risks been greater than expected?
3.
Multi-center studies: Is there any additional information from the Sponsor or Coordinating Center that should be reported to
the IRB? Be sure to provide any data safety monitoring reports and/or interim reports from sponsors and coordinating centers.
4.
Reassess investigator financial interests. Has any study team member’s financial interests in the study changed in the last year?
See the COI disclosure requirements for more information.
5.
Review all modifications/amendments to the study over the last year. Determine if additional modifications need to be submitted
for IRB review and approval.
6.
Review the risks and benefits of the study. Has there been a change in the risk/benefit profile? Take into account information
gathered during the past year such as interim results, reportable events/problems, and/or changes in scientific knowledge.
Submit the continuing application 60 days in advance (for full committee protocols); 30-45 days in advance (for expedited
protocols). Please do not submit continuing protocol applications any earlier than these suggested timeframes.
Importance of Avoiding Lapses in Approval
Lapses in IRB approval should be avoided at all costs ~ planning is everything!
Protocol lapses can be detrimental to a research design and may impact subject safety and welfare. The IRB sends reminder emails to
Lead Researchers, Faculty Sponsors (when applicable) and Administrative Contacts to assist with continuing application submission
planning and to avoid lapses in approval. The e-mail reminder is sent 90 days prior to the expiration date for full committee studies and 60
days prior to expiration for expedited studies. A final reminder is sent 30 days before protocol expiration, followed by an expiration memo.
What happens if there is a lapse in IRB approval?
If the IRB has not approved a research study by the study expiration date, the protocol expires and all research activities must stop. This
includes: recruitment and informed consent procedures; collection of data/information from or about living individuals; all research-related
interventions or interactions with currently enrolled subjects;* and analyses involving identifiable human subjects data.
*Exception: when lapses are unavoidable, research-related interventions or interactions with enrolled subjects may continue if the IRB
determines that stopping the research would jeopardize the rights or welfare of current subjects. Upon protocol expiration the Lead
Researcher must submit by email a coded list of research subjects for whom expiration of the research would cause harm and what
interventions may occur during the lapse.
The IRB Chair will review the list and allow individual participants to continue participating in the research interventions or interactions only
when it is determined that it is in their best interest to continue. However, any information collected during the lapse in approval may not
be used for research.