Administrative Amendment Application for Minor Changes to Research
PI Name:
IRB No. :
Study Title:
I. WHAT KIND OF CHANGE TO RESEARCH ARE YOU SUBMITTING? SELECT ALL THAT APPLY.
Change to study funding: describe new funding below and provide documentation:
Administrative change to consent form (e.g., contact information for PI, investigator, or IRB, and version number, date)

Attach tracked and clean versions of the revised consent documents
Change to recruitment materials or instruments consistent with approved aims of research that add no risk to subjects

Attach tracked and clean version of revised instruments
Change to study personnel (not Principal Investigator – that change requires an Amendment Application)

Proceed to section II below.
IIA. ADDITION OF CO-INVESTIGATOR(S) AND STUDY TEAM MEMBER(S) WHO WILL INTERFACE WITH PARTICIPANTS AND/OR
THEIR IDENTIFIABLE PRIVATE INFORMATION. List students here if they are working as study team members on your study
and not on their own research projects. Provide training certificates (Ethics, and HIPAA if PHI is involved), and
Investigator Agreement for each new investigator and study team member. (Add additional personnel by
attachment.) Note: Study contact may be added to the study by email to the IRB office at jhsph.irboffice@jhu.edu.
1.
Name:
Financial Conflict of Interest with the Study?
Email Address:
Y
N
If from another institution, Name:
Describe New/Changed Role in the study:
2.
Name:
Financial Conflict of Interest with the Study?
Email Address:
Y
N
If from another institution, Name:
Describe New/Changed Role in the study:
B.
ADDITION OF STUDENT INVESTIGATOR(S): “STUDENT INVESTIGATORS” ARE, BY DEFINITION, WORKING ON THEIR OWN
RESEARCH UNDER THE SUPERVISION OF THE STUDY PI. (Add additional student investigators by attachment.) Provide
training certificates (Ethics, and HIPAA if PHI is involved), and Investigator Agreement for each new student investigator.
1.
New Student Investigator Name:
Financial Conflict of Interest with the Study?
Email Address:
Y
N
Y
N
Academic Degree Program:
Describe role in the study:
2.
New Student Investigator Name:
Financial Conflict of Interest with the Study?
Email Address:
Academic Degree Program:
Describe role in the study:
C. DELETION OF INVESTIGATORS AND STUDY TEAM MEMBERS: List personnel who are leaving the study.
Principal Investigator SIGNATURE
__________________________________________________________________
Signature of Principal Investigator
_______________
Date
Please submit all documentation via email to jhsph.irboffice@jhu.edu . We will accept receipt from the PI’s email address as equivalent to
the PI’s actual signature. If you must submit by hard copy, return the original signed by the PI and all documentation to: JHSPH IRB Office,
Suite E1100, 615 North Wolfe St, Baltimore, MD 21205.
Administrative Amendment for Minor Changes 9Jun2015
This is an administrative/minor amendment. The reviewer does not have a personal or financial conflict of interest with this research.
All HSR Training Certificate(s)/Investigator Agreement(s) are present (attached or already on file).
Funding change documentation is attached (if relevant)
APPROVE
Reviewer Name (print):
Reviewer Signature:
Administrative Amendment for Minor Changes 9Jun2015
Date: