Transcript Submitting Research Changes to the IRB

SUBMITTING RESEARCH CHANGES TO THE IRB
Note in Progress Report
and send tracked and
clean versions with
Progress Report (no
Amendment Form
Required)
Study Instruments and
Recruitment Materials
Only
Wording clarifications
Send with Administrative
Amendment Application
for Minor Changes
Change to study funding
Change to recruitment
materials or instruments
consistent with approved
aims of research that add
no risk to subjects
Change to study personnel,
including coinvestigators, student
investigators, study team
members
Corrections to grammatical
or typo errors
Send with Amendment
Application
Administrative change to
consent form (e.g.,
contact information for PI,
investigator, or IRB, and
version number, date)
ALL OTHER CHANGES
Tips on Submitting Changes
 Corrected or clarified study instruments and recruitment materials submitted with
tracked changes with the progress report should have new version numbers.
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The Progress Report note should clarify why the changes were made. Once approved, they will be listed in your
Progress Report approval letter. Deletion of questions should be submitted on the Administrative Amendment form.
 A minor amendment involving a new question or data field

An example for a study on diabetes, adding a question about smoking history is consistent with the study objective and
adds no additional risk. Adding a question about gun ownership is not consistent with the original study objective and
would require a standard Amendment Application.
 Adding new study personnel
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
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In general, only people who are going to interact with study participants, obtain informed consent, or access/use
identifiable information need to be added to the study team. Researchers who are receiving de-identified datasets do
not need to be added to the study team, however, the PI should inform the IRB about any new uses of study data
beyond the approved study objectives.
Submit current human subjects research ethics training certificates and Investigator Agreements when you add new
investigator and study team members. The JHSPH IRB training requirements may be found here:
http://www.jhsph.edu/offices-and-services/institutional-review-board/training/.
HIPAA training is required if a study involves access, collection, or use of protected health information from a U.S.
covered entity. The School of Medicine’s HIPAA training is accessible through “MyLearning.” The course is called
“HIPAA for Research.” MyLearning is accessible through the “MyJHU” portal under the “Education” icon.