1 Rev. 07/07
UNIVERSITY OF ARKANSAS FORT SMITH
IRB Request for Continuing Review
Reviewing IRB IRB STUDY NUMBER:
Type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.
SECTION I: INVESTIGATOR INFORMATION
Principal Investigator:
Name (Last, First, Middle Initial):
Department: Phone: E-Mail:
Additional Study Contact:
Name: Phone: E-Mail:
Project Title:
Funding Status: NA Funded
Funding Source: Sponsor Number:
SECTION II: CURRENT STUDY STATUS
Place an X on the line for ONGOING Open Enrollment or ONGOING Closed Enrollment
____ ONGOING – O
PEN TO ENROLLMENT
Date study was initiated:
Projected date of completion:
(Select one below)
Enrollment of new participants or review of records/specimens continues
No participants have been enrolled to date. Please explain:
Please check here if the study is currently suspended (temporarily) and indicate the reason(s) for the
suspension:
_____ ONGOING – CLOSED TO ENROLLMENT
Date study was initiated:
Projected date of completion:
Re-consenting/re-authorizing
NOT re-consenting/re-authorizing
(Select one)
Participants are still receiving research-related intervention or interaction.
Participants have completed research-related interventions; however, long-term follow-up continues. Long term
follow-
up includes research interactions that involve no more than minimal risk to subjects, or collection of
follow-up data from procedures or interventions that would be done as p
art of routine clinical care. Research
interventions which would not be performed for clinical purposes are considered research-related intervention are
not considered follow-up.
Participants have completed all research-related intervention or interaction and long-term follow-up has been
completed. The remaining research activities are limited only to data analysis that may require access to records
and/or specimens.
Check here if the study is currently suspended (temporarily) and indicate the reason(s) for the suspension:
IRB Form v12/01/2012
2
SECTION III: INVESTIGATOR STATEMENT OF COMPLIANCE
By submitting this form, the Principal Investigator assures that all information provided is accurate. He or She
assures that procedures
performed under this project will be conducted in strict accordance with federal
regulations and University policies and procedures that govern research involving human subjects. He or She
acknowledges that he or she has the resources required to conduct research in a way that will protect the rights
and welfare of participants, and that he or she will employ sound study design which m
inimizes risks to
subjects. He or She agrees to submit any change to the project (e.g. change in principal investigator, research
methodology, subject recruitment procedures, etc.) to the Board in the Change in Protocol form for UAFS IRB
approval prior to implementation.
SECTION IV: IRB APPROVAL
For Human Subjects Office Use Only
Type of review: Full Board
Expedited, Category: Approved for a period of: one (1) year
STATUS OF STUDY: ONGOING
This continuing review has been reviewed and approved as meeting the criteria for IRB approval as outlined in
45 CFR 46.111(a) by the University of Arkansas Fort Smith IRB. Based on the criteria for determining the
frequency of continuing review and the level of risk, this study will expire on: ___________________. If the
study is not re-approved prior to that date, all research activities must cease on that date, including enrollment of
new subjects, intervention/interaction with current participants, and analysis of identified data.
Authorized IRB Signature: IRB Approval Date:
Printed Name of IRB Member:
click to sign
signature
click to edit
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