Human Research Review Committee (HRRC-IRB)

Supported by the Human Research Protections Office

 

HRRC Home > Forms > Submitting a Change or Amendment to a Study

 

    

 

Submitting a Change or Amendment to a Study

 

Special note:  Is your study affiliated with the VA?  If so, the VA has a new requirement that any amendments must first go through the VA Research Office prior to being submitted to the HRRC.

 

 

Any changes to your approved research study should be submitted using the following form:

 

ü Amendment/Change Form (Word)                     

 

 

Items that may be required with the Amendment/Change Form

 

ü  Attachment 1: Additional Investigators List

 

ü If using Attachment 1 to add new Investigators to the study, the following PDF forms must be filled out by every investigator listed on attachment 1.

Conflict of Interest Statement for UNM Employees

OR

Conflict of Interest Statement for non-UNM Employees

 

ü  Attachment 8: Waiver of informed consent/HIPAA

 

ü If Revised - Consent and/or HIPAA Form

 

ü Adverse Event Forms
 

ü If Revised - submit a new protocol with changes highlighted, and one clean copy (electronic document)  Protocol Guidelines.

 

 

 

ACCEPTABLE METHODS OF SUBMISSION FOR AMENDMENTS, PROGRESS REPORTS, and REACTIVIATIONS:

 

When you have the above documents ready to send you have three options to get them to us with a signature.

 

 

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