WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Request for Annual Renewal of Human Subjects Research
With Modification or Addendum to Previously Approved Study
Western Carolina University
Please complete and submit this form and any attachments electronically to irb@wcu.edu
I.
STUDY STATUS
Principal Investigator (PI):
(NOTE: the PI must be a WCU faculty or staff member. If the study was originally approved with a student named
as the PI, this MUST be updated upon renewal.)
Department:
WCU IRB Number:
Study Title:
Funding Source, if applicable:
Status of current study:
Active
All interactions with participants have ended. Remaining research activities are limited to
data analysis.
Inactive. Anticipated start date if study has not yet begun: Click here to enter a date.
II.
CONFLICT OF INTEREST
Since the last review, have any new known or potential conflicts of interest related to this research been
identified? Conflict of interest relates to situations in which financial or other personal considerations may
compromise or involve the potential/have the appearance for compromising an investigator’s objectivity in
meeting University responsibilities including research activities (see University policy 54).
No
Yes. If yes, describe the known or potential conflicts of interest and how participants will be
protected from the influence of competing interests:
III.
ADDITIONAL QUESTIONS
Please answer the following questions based on the information since original approval or latest
renewal (as applicable).
1. Have there been any modifications to this protocol since the last review?
No
Western Carolina University
IRB Continuing Review and Modification Request Form
May 2015
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Yes. Please respond to “modification/addendum type” questions in Section V below.
2. Have there been any complaints, unanticipated problems, or serious adverse events?
No
Yes. If yes, please ensure an “Adverse Event Form” or “Deviation or Violation Event Form” was
submitted to the Institutional Review Board:
3. Since the last review, have there been any findings from the study or relevant literature that may impact
the study; a participants’ willingness to continue participation; or the risk associated with participating in
the research?
No
Yes. If yes, provide detailed explanation:
IV.
Progress/Final Report
Please briefly describe the progress of the study to date. If you are terminating the study, please submit
a brief final report:
V.
Modification/Addendum Type (Check all that apply.)
1.
Name
Modification to research personnel
Email
PI Status
Choose an item.
WCU Status*
Choose an item.
Choose an item.
Choose an item.
Choose an item.
Choose an item.
Choose an item.
Choose an item.
Action
Choose an
item.
Choose an
item.
Choose an
item.
Choose an
item.
*If adding an unaffiliated member without an institutional IRB, please include a completed “Unaffiliated Investigator Form”
2. This modification/addendum changes the original IRB application in the following ways: (Check all that
apply.)
Changes the intended use of data collected.
Changes the known or potential conflicts of interests related to this research.
Adds/deletes/modifies participant population and recruitment
Changes approved informed consent/assent forms.
Western Carolina University
IRB Continuing Review and Modification Request Form
May 2015
WCU IRB Registration Number:
Date Received by the Office of Research Administration:
WCU IRB Reviewer:
Section above to be completed by the Office of Research Administration
Modifies study procedures.
Increases/modifies risks to subjects enrolled in the study.
Modifies study confidentiality and safeguards.
3. For any box checked in question 2, describe the modification/addendum:
4. For modifications and addendums, attach revised protocol and/or consent form, if appropriate. Please
highlight any and all changes and submit any new materials. Check items to be attached:
Updated consent form
Letter(s) of Agreement if new/revised
Instruments (i.e. survey questions, interview questions)
Other (describe):
By submitting this request, the Principal Investigator accepts responsibility for ensuring that all members of the
research team follow the study procedures as described in the IRB approved application, comply with all IRB
communication, and uphold the rights and welfare of all study participants.
Investigator name and email address together constitute an electronic signature to this application.
Date
PI Name
Western Carolina University
IRB Continuing Review and Modification Request Form
May 2015
PI Email Address