Training Sessions: Preparing for NIH's Single IRB Review Requirement
As of January 2018*, all competing National Institutes
of Health (NIH) grant applications for multi-site research require a
plan for use of a single IRB. This training will review NIH's new policy
for single IRB review and its implications; discuss how JHU will address
the single IRB review requirement; provide advice on how to continue
to provide a safe, ethical research environment while participating
in single IRB studies and offer practical tips for grant applications,
including budget development. Investigators and study team members preparing
grant applications subject to these new requirements are encouraged
to attend one of the upcoming training sessions listed below. Please
register via this link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=698882
Tuesday 7/18, 10a.m. - 11 a.m.
Thursday 7/27, 1 p.m. - 2 p.m.
Tuesday 8/8, 1 p.m. - 2 p.m.
Wednesday 8/16, 11 a.m. - 12 p.m.
Thursday 9/7, 10 a.m. - 11 a.m.
Tuesday 9/12, 1 p.m. - 2p.m.
*January 25, 2018 is the currently proposed
implementation deadline for NIH's Policy on single IRB review.
A Department of Medicine faculty member is a PI
on a large NHLBI R24 "national infrastructure" grant. This
NIH grant aims to provide resources for longitudinal clinical research
studies. The following resources are freely available from the project's
The changes in IRB review fees include the following:
*No fees are assessed for changes in research qualifying for expedited review.
The JHM IRB review
fees for commercially funded human subjects research studies are listed
in the chart below. See the
memo from Daniel Ford, M.D., M.P.H. regarding the increase.
WIRB Studies: Effective
October 1, 2013 any remaining open studies at WIRB initially submitted
by JHU SOM investigators must be converted to eIRB studies and then
terminated at WIRB. The only exceptions to this are studies currently
being directly billed to the study sponsors. The JHU SOM will not pay
any WIRB fees effective 10/1/13.
If you need to speak
to someone at the JHM OHSR/IRB regarding these changes use the following
Effective September 25, 2017, the NIH requires
that all grant applications for domestic, multi-site, non-exempt human
subject research studies include a proposal for the use of a single
IRB ("sIRB") to review the research for all participating
domestic sites. The JHSPH IRB, the SOM IRB, and the Homewood IRB are
working together to address the new NIH requirement for sIRB. When sIRB
services are required by a Sponsor, and a JHU PI wants JHU to serve
as the study's sIRB, the SOM IRB will review all requests for
sIRB services, and if approved, will serve as the University's sIRB
for all divisions. JHU has signed on to the SMART IRB Reliance
agreement, and investigators are urged to make sure that their collaborators
have either signed on to this form of reliance agreement, or are willing
to sign on.
All other reliance requests will be managed
by the IRB associated with the PI's division. Please contact JHMIRBreliance@jhmi.edu
with questions about the SOM IRB sIRB process.
JHM IRB is willing to review requests for reliance on an external IRB as well as requests for JHM to act as the IRB of record. Typically, requests for reliance are submitted to our IRB at two time points:
The first step in the reliance request process
is to complete a reliance
request. The JHM IRB reliance team will review the information provided
in the reliance
request and will contact you with next steps.
For more information about the JHM reliance,
please visit: http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html
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
The Johns Hopkins Medicine Human Research Protection
Program has developed a compliance training recertification requirement
for researchers who are engaged in human subjects research. To better
align the Johns Hopkins recertification policy with peer institutions
and funding agencies, as well as be consistent with study team member
recertification requirements, effective March 1, 2016,
PIs will be required to complete HSR training recertification every
3 years. Study team members must complete recertification within
3 years of their initial HSR compliance training, and then complete
recertification every 3 years.
HSR recertification 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?
Please note: you MUST enroll in the
available modules and lectures using the links provided above. You will
receive credit for only those items listed within your recertification