Assurance # FWA-4025
APPLICATION FOR CONTINUATION OF APPROVAL OF
RESEARCH INVOLVING THE USE OF HUMAN SUBJECTS
NOTE: For research in progress, current policy requires that IRB (Institutional Review Board) obtain continuing assurance at least
annually that no procedural changes have occurred in your research project involving the use of human subjects. Any unanticipated risks
to the subjects, or new information that may affect the risk/benefit assessment must be promptly reported to, and reviewed by,
the Institutional Review Board (IRB). Continuing review of non-exempt projects is required until the investigator no longer
retains any identifiers (e.g., names, code numbers, pseudonyms, demographics) that could link the data to the subjects.
PROJECT INFORMATION
PRINCIPAL INVESTGATOR(s):
phone:
Status:
DEPARTMENT:
E-mail:
PROJECT TITLE:
PROJECT UPDATE
The Office of Human Research Protections within the federal government now requires that you provide the
following information at least annually. Please make a selection from the list below (check one) that most
closely describes the status of your project and provide answers to the questions at the top of Page 2. Attach
a separate page if additional explanation is necessary.
This project is continuing as described in the original, approved, IRB application. Identifiable data
continues to be obtained from research subjects/participants. [A “clean” (unstamped) copy of the informed
consent document* is attached to obtain an updated approval stamp.]
This project is continuing but approval to make minor revisions is requested. The revisions may not be
implemented until IRB approval is granted. [Attached are a description of the requested revisions,
including justification, and a “clean” (unstamped) copy of the informed consent document* to obtain an
updated approval stamp. If significant changes have occurred a new “Institutional Review” application
form must be completed and submitted for review.]
This project is continuing as previously approved but subject recruitment is complete; analysis of
identifiable data continues. (No consent/assent form is attached.)
Subject recruitment is complete and all identifiers have been removed from data. Only analysis of
unidentifiable data continues. (No further continuing review will be required.)
This project has been completed or discontinued.
*The request for continuation of approval will not be considered unless it is accompanied by the current consent form. If you are
requesting to modify it since the project was approved, the requested changes should be highlighted. If your consent process does not
involve the use of a hard-copy consent form, please confirm this and indicate whether or not any changes are being requested.
Please complete for ALL projects (even if complete or discontinued):
1. Provide the number of subjects who have participated in this study
a. since last year’s approval:
b. since the beginning of the study:
c. the number of participants you were approved to run
If you have exceeded (or are coming close to exceeding) the number that was originally approved, please
provide a request to increase the number of participants to a specific amount.
2. Provide on a separate page, an explanation if any of the following have occurred (Do not leave blank; if
none, enter “0”):
a.
b.
c.
d.
The number of adverse events or unanticipated problems involving risks to subjects or others
The number of subjects who withdrew from the research
The number of complaints about the research
Any recent literature, findings, or other relevant information that impacts your study, keeping in mind that
the primary concern is the potential risk (physical, emotional, or otherwise), to the subjects.
CERTIFICATION
No changes, except those discussed in the attached explanation section (if any), have been made to the protocol
previously approved by the IRB.
Signature of Principal Investigator
Date
Signature of Faculty Advisor
Date
(Student project only)
If you have any questions about completing this form contact the Office of Research Compliance (ORC) at 7538588. Our office location is Lowden Hall room 301.
Office Use Only
Date Continuation received:
Number of participants approved:
Review Committee:
Date of initial approval:
Date of Continuation approval(s):
Review Category:
OSP #