The purpose of this form is to provide information about changes to an approved project.
Instructions: / Complete the required sections.
Sections marked with an asterisk ( * ) are required.
Sections marked with a double asterisk ( ** ) are required if applicable.
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1805 Sigma Chi NE | Tel: (505) 277-2644
Website: irb.unm.edu | Email:
Project Identification
* IRB reference number: / * Project title:
Principal Investigator of Record
* The Principal Investigator of record is: (select one) / Principal Investigator / Responsible Faculty
*Name: / * Phone: / *Email:
*Department: / *University Status(e.g. tenure track or visiting faculty, instructor, staff, etc.):
* Affiliation: / Main Campus / UNM Branch Campus: / External Partner:
Additional Contact Person
** The contact person for this project is: (select one) / Student Investigator / Project Coordinator
** Name: / ** Phone: / ** Email:
** Department: / ** University Status(e.g. undergraduate, master’s or PhD student, staff, etc.):
Certification
* Signature below certifies that the information provided on this form is accurate and that the above titled research is in full compliance with the regulations, laws, and institutional requirements/policies governing human research.It is understood that the proposed changes to the project must be approved by the IRB prior to implementation.
Principal Investigator/Responsible Faculty / Student Investigator
*Signature / Date / ** Signature / Date
New Principal Investigator of Record
** As the new Principal Investigator, I agree to accept the responsibility for and oversight of the conduct and compliance of this project.
** Name / ** Signature / ** Date
In the opinion of the Principal Investigator…
*The amendment impacts risk for currently enrolled or future participants by: / Remaining the same / Decreasing / Increasing
** If risk is increasing, state new risk(s) and/or provide a descriptionof how risk to participants increasedand justification for increasing risk.
*The amendment is the result of a related or new reportable event: / No / Yes
IMPORTANT! Submit an Event Report if the amendment is the result of a related or new reportable event.
Amendment Information
* Identify the scope of the amendment:
(check all that apply) / Change project procedures/protocol(project design, methods, data management, etc.)
Change project documents (consent, recruitment, study instruments, etc.)
Change project funding
Change project team members
Change Principal Investigator of Record
* As of today… / Has not started / In process / Complete / Not applicable
Participant enrollment:
Collection of participant data through interactions or interventions:
Data analysis:
* Will participants be notified of the changes?
(check all that apply) / No participants will be notified of these changes
Current participants will be notified of these changes
Former participants will be notified of these changes
** Describe the process for notifying participants of the changes, if applicable:
* Has the funding of this project changed? / Yes, the project is now funded. / Yes, the project is no longer funded. / No changes to funding.
**Is the project funded? / No / Yes. Provide the following information:
** Title of funded project (i.e. Grant title):
** PI for funded project (i.e. Grant PI):
** Type of award: / Prime Award / Subaward / Contract / Other:
** Funding awarded to: / UNM / Other. Describe:
** Name of Funding Source: / ** Cayuse Project Number:
IMPORTANT! If applicable, provide a copy of the complete grant application.
*Will the project be submitted for federal funding? / No | N/A / Yes. Which agency(ies)?
*Did you meet with OIRB staff for a consult prior to this submission? / No Yes
Summary of the Amendment
*Provide a detailed descriptionof the proposed changes.
* Include an itemized list of documents that are being changed.
Limit: 250words
Amendment Applicationv01.19.18
UNM Office of the Institutional Review Board
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