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UMCP IRB Continuing Review Application
Rev. 10/21/13
University of Maryland College Park
Institutional Review Board
Continuing Review Application
1) Participant Enrollment to Date
 This is required to ensure equitable subject selection according to the populations
identified in the approved IRB protocol. Participant numbers in this table should reflect
all participants enrolled over the entire course of the study, not since the last
Continuing Review.
Adults
Population
Male
Female
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Race Not Collected
White/Caucasian
African American
Hispanic
Native American
Asian/ Pacific Islander
Other
TOTAL
Gender
Not
Collected
0
0
0
0
0
0
0
0
Children/Adolescents
Gender
Male
Female
Not
Collected
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Total
To Update the Totals, Enter a number (0 if none) into all cells above, then select the entire table and press F9.
 Indicate the number of participants currently approved for this protocol. This number
can be found in Section 2 of your Initial Application or Amendment or Continuing
Review if an increase in enrollment was requested. Address over-enrollment in the
Section 7 below.
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2) Data and Safety Monitoring
 Required for protocols presenting greater than minimal risk. State if project was
monitored during the previous approval period and provide a summary of the reviews
findings, if any.
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For all queries and additional information contact: irb@umd.edu
0
0
0
0
0
0
0
0
UMCP IRB Continuing Review Application
Rev. 10/21/13
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3) Open to Enrollment
 State if protocol will remain open to participant enrollment. If not, please state why. Also
state the number of participant withdrawals, if any, and the reason for withdrawal. If
enrollment will remain open a copy of the consent form(s) must be included with your
application.
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4) Project Summary
 Provide a summary of the study progress to date. This should include any interim findings
(positive/negative), problems encountered, goals for upcoming approval period and a
projected completion date (i.e. March 2016).
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5) Problem History
 Provide a summary of any adverse events and/or unanticipated problems involving risks
to participants or others. This should also include any participant complaints. Please
discuss how these problems were handled.
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6) Additional Information
 Provide a summary of any relevant literature, additional risks to participation that have
been identified and any other relevant information.
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7) Deviations
 Indicate whether there were deviations to the currently IRB Approved protocol and why
these occurred. A deviation is any difference in study conduct from the criteria or
activities prescribed in the IRB Approved protocol, which may or may not affect the
participants’ rights, safety, welfare and/or the integrity of the study.
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For all queries and additional information contact: irb@umd.edu
UMCP IRB Continuing Review Application
Rev. 10/21/13
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8) Request for Approval of New Changes
 The IRB Office does not recommend submitting Amendment requests during the
Continuing Review process as this will increase the turnaround time for these
applications. However, if the requested modifications are minor (for example: editorial or
research staff changes, increase in participant numbers) please make the changes to the
project/supporting documents and clearly identify the changes in the space below. See
Section 11 for additional information regarding changes requested during this transaction.
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9) Conflict of Interest
 Indicate if any Conflict of Interest (COI) issues exist that were not previously reported to
the IRB Office. If there is a new COI issue, describe the potential COI, including a plan to
mitigate the conflict and how the conflict may affect the level of risk to study participants.
Please see the UMCP policy on COI at: http://www.umresearch.umd.edu/RCO/coi.html
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10) Funding Sources/Research Support
 Provide the names of any organization, including Federal agencies, providing
funding/support for the research protocol.
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11) Protocol/Consent Forms
 If minor changes are being made during this Continuing Review Application, a copy of the
updated documents (project, surveys, advertisements, etc.) must be included with the
application.
 If the project will remain open to participant enrollment, please upload a copy of the
consent form(s) with your Continuing Review application. If more than one consent form
(Parent Consent, Assent, Group A, Group B, etc.) will be used for this protocol please list
them below and upload with the application.
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For all queries and additional information contact: irb@umd.edu
UMCP IRB Continuing Review Application
Rev. 10/21/13
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PLEASE NOTE: Missing information and documents will result in a delay of IRB review. Please
DO NOT upload a copy of your previous IRB Approval Letter or stamped consent form with your
Renewal Application. If protocol will remain open to participant enrollment, please upload a
copy of the consent form(s) with your Continuing Review application.
THE IRB OFFICE WILL NO LONGER STAMP CONSENT FORMS. THE CONSENT
FORMS IN YOUR APPROVED IRBNET PACKET MUST BE USED. THESE ARE YOUR
APPROVED CONSENT FORMS.
REQUIRED SIGNATURES
The Principal Investigator, Co-Investigator, and/or Student Investigator, in electronically signing this
Continuing Review Application on IRBNet, certify that they have conducted research in accordance
with the IRB-approved protocol and that any consent forms used in connection with the project have
been retained by the Principal Investigator unless otherwise indicated in this Continuing Review
Application.
For all queries and additional information contact: irb@umd.edu