Edinboro University Institutional Review Board Human Subjects Protocol Continuing Review Report

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Edinboro University
Institutional Review Board
Human Subjects Protocol Continuing Review Report
Principal Investigator:
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IRB Protocol #:
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IRB Protocol Title:
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IRB Approval Category:
Expedited
Co-Principal Investigator:
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Date of Original Approval:
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Full Review
1) Current Status of Research:
Research extension request (Check if you would like to request an extension on an already approved research)
Check whichever apply:
project has not yet started
participant recruitment and data collection is on-going
participant enrollment is closed but data collection procedures are still underway
all data collection activities have been completed; renewal is needed for data analysis only
other (please explain Click here to enter text.
2) How many subjects have participated up to this date? Click here to enter text.
3) Have any subjects withdrawn from participation? Yes
If yes, please describe: Click here to enter text.
No
4) Have there been any unanticipated problems or adverse effects on the subjects? Yes
If yes, please describe: Click here to enter text.
5) Are the current informed consent/assent documents still accurate and complete? Yes
If no, please include the new consent. Click here to enter text.
6) Is the study protocol being followed as approved? Yes
If no, please describe: Click here to enter text.
No
No
7) Did any subjects enrolled on this protocol have complaints? Yes
If yes, please describe: Click here to enter text.
8) Have any changes to personnel been made? Yes
If yes, please describe: Click here to enter text.
No
No
No
9) Expected date of complete: Click here to enter text.
10) Will there be any changes to the previously approved protocol? Yes
If yes, describe any proposed changes to the project:
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No
Signatures:
I understand that I am the primary responsible party for legal and ethical performance of this project. I certify that I this information is complete
and correct, and confirm that I will continue the project in accordance with all governing laws, regulations and institutional policies.
5/29/16
Principal Investigator’s Signature
Email can serve as an electronic signature
Return completed form to the EU IRB Chair at [email protected]
Date
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