Financial Responsibility Information Sheet
The Prospective Reimbursement Analysis (PRA) process
began in 2008. All clinical research studies submitted after July 1,
2008 that have the potential to generate a hospital or professional
fee have been reviewed by Clinical Research Support Services (CRSS)
and investigators and the IRBs were notified when a PRA was required.
The PRA determines what potential charges are considered standard of
care or research. Cost information from the PRA has been included in
the study consent forms and, unfortunately, the result was the creation
of a consent form that was even longer than desired.
In order to streamline the consent form and present
cost information in a more meaningful manner, we decided to remove the
cost information from the consent form and present it in a separate
Insurance and Research Participant Financial Responsibility Information
Sheet. All studies submitted to the JHM IRB after January 1, 2010 that
require a PRA must use the Information Sheet. The Information Sheet
contains information about participant costs that may be associated
with research, and the Cost section of the consent form will reference
the Information Sheet. The participant should be given a copy of the
Information Sheet with the consent form. The Information Sheet should
be signed and processed with the consent into the research chart and
CRSS uploads the Information Sheet in eIRB under
the Stamped Documents tab, where other approved documents such as consent
forms, recruitment materials, PRA and insurance clearance forms are
If you have questions about the Information Sheet,
please contact Karen Roz at firstname.lastname@example.org
Hopkins Institute for Clinical and Translational Research, and the
Departments of Neurosurgery
and Biomedical Engineering
are hosting a half-day symposium, "New Frontiers in 3D Printing
at Johns Hopkins University," on June 10 from 1 p.m. to 5 p.m.
at the Mountcastle Auditorium, Pre-Clinical Teaching Building (PCTB),
located on 725 North Wolfe Street. Event check-in, refreshments and
a vendor fair will begin at 12:30 p.m. All faculty and staff are encouraged
to attend. The event will showcase the broad spectrum of 3D printing
applications in translational research and patient care.
Keynote speakers include Andy Christensen, founding
CEO of Medical Modelling Inc. and Dr. Katherine Barsness, associate
professor in Pediatric Surgery and Medical Education at Northwestern
University. They and other speakers will address 3D printing in the
The event is free and registration is required.
To RSVP visit: https://3dprintingeventjune10.eventbrite.com
To learn more about the event, download
the event flyer.
For more information, contact Kelly
The Johns Hopkins Institute for Clinical
and Translational Research (ICTR) offers many clinical resources for
faculty and student investigators, including outpatient and inpatient
space for studies in clinical research units, patient recruitment tools,
collaboration opportunities, and various tools to protect patient data.
To see all the services offered by the ICTR, visit the
The Johns Hopkins Clinical Research Network (JHCRN)
is an all-in-one resource for linking investigators to regional community-hospital
based collaborators for the success of investigator-initiated and industry
funded studies. Please visit the JHCRN website to learn more about this
1, 2016, The Johns Hopkins Medicine Human Research Protection Program
requires Principal Investigators (PIs) to complete HSR recertification
training every 3 years, and then complete recertification
every 3 years. This is now consistent with study team member recertification,
which is also required every 3 years.
is required for NEW APPLICATION submissions only (all study team members)
and CHANGE IN RESEARCH submissions (only study team members being added
- not existing study team members). If the required recertification
courses have not been completed by the PI and all study team members
prior to submission of the new application, the application will be
returned to the PI.
Who needs it?
How do I register?