Status Report and Change/Renewal/Termination Form
COCE Institutional Review Board
According to SNHU’s policy regarding research involving human subjects, this form is to be submitted to the COCE Institutional Review Board annually by investigators until the research is completed. The purpose of this form is to monitor the protection of human subjects by ongoing research. Any changes in recruitment, informed consent, instrumentation, or methods, which may have resulted in increased risk to subjects, should be reported, and a request for renewed approval must be submitted. Renewal of approval for ongoing research, which remains unchanged since the initial proposal should be noted. If the research has been completed, please make the appropriate notation in this form.
Projects can only be approved for one year at a time. Completed forms must be received at 30 days before your protocol expiration date to ensure there is no lapse in COCE IRB approval.
PI Name:
Address:
City: State: Zip Code:
E-mail: Phone:
Department/office (If applicable):
Co-PI Name(s):
Study Title:
Project Approval Date (i.e. one year before the protocol expiration date listed in your Research Review Notification Form):
Funding Source Sponsor (if applicable):
Current Project Expiration Date (listed on your Research Review Notification Form):
Please check the box that indicates the current status of your project:
Research is ongoing, and changes regarding human subjects have been made. (Documentation of revisions must be attached to your email.)
Research is ongoing, no changes regarding human subjects have been made.
Research is completed or project terminated. Date of completion or termination: ______
Discovery of unanticipated risks to human subjects. (Documentation of any identified risks must be attached to your email.)
What are you requesting? (check one)
Research extension with no changes in procedure
Research extension with changes in procedure (please note proposed changes on following pages and highlight in approved protocol submission)
Termination of study as of (enter date)
To date, how many participants have been enrolled in the study?
How many participants were indicated in the original intended sample size?
Provide an abstract of findings or summary of progress to date:
Please provide a justification for the request to extend the study:
State any changes being made to the originally approved protocol and provide justification for the requested changes.
Please also attach amended material to your email, as applicable (highlight all changes).
Certification:
I/We certify that the information supplied on this form and in accompanying attachments is complete and accurate and that no procedures other than those disclosed on this form will be used in this protocol. I/We will promptly report to COCE IRB all research-related accidents, injuries, complaints, problems, or breeches of confidentiality. I/We will report any significant new findings that may affect the risks and benefits to the subjects and other participants in writing to the research participants and to COCE IRB.
PI Signature: ______Date:
Co-PI Signature: Date:
Co-PI Signature: Date:
Co-PI Signature: Date:
Faculty Advisor Signature: Date:
COCE Institutional Review Board
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