Managing Investigational Product Returns from Research Participants
Recordkeeping and Record Retention requires sponsors
to maintain adequate records showing the receipt, shipment, or other
disposition of an investigational drug. Included in the disposition
of the investigational drug products (IP) is the documentation of IP
that is returned from research subjects. For more details about this
important guideline, visit https://www.hopkinsmedicine.org/institutional_review_board/
Policy on Registration of Clinical Trials was updated in October
2019 to assist all investigators in meeting registration and results
reporting requirements including those for NIH-funded clinical trials.
The Registration of clinical trials on ClinicalTrials.gov guidance was
also updated December 2019.
Beginning 7/1/2019, the Human Subjects Research Recertification courses will be updated. The recertification course for study team members and PI's will now include the same 4 online courses. The required four online courses are: An Overview of Research with Vulnerable Subjects, Genetics Research, Records Based Research, and Good Clinical Practice. While PI's are still required to complete an in-person course as part of recertification, study team members are no longer required to complete an additional 2 online electives. All study team members and PIs must complete HSR re-certification every three years.
Since the HSR recertification now includes the Good Clinical Practice (GCP), the HSR recertification will also satisfy NIH's GCP training requirements.
For more information on required training see https://www.hopkinsmedicine.org/institutional_review_board/training_requirements/.
The Insurance and Research Participant Responsibility Information Sheet is required for all studies that have a Prospective Reimbursement Analysis (PRA) and contains information about participant costs that may be associated with research. The section of the consent form outlining any costs to participants must reference the Information Sheet for applicable studies. CRSS will upload the approved 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 located.
The Information Sheet should be discussed with research participants as part of the consent process. Receipt of the form is documented by research participants via signature on the informed consent form. Note, the requirement to also sign the information sheet has been eliminated.
The JHM IRB bills for review of commercially-funded studies with financial support in excess of $10,000. The fees collected from reviewing commercially-funded studies help fund services provided by the IRB. To help cover the costs of IRB review for study closures and the compliance monitoring activities for select commercially-funded studies, the IRB review fees will be modified as of August 1, 2018.
The changes in IRB review fees include the following:
Any new study submitted on or after August
1, 2018 will be subject to the new fee schedule. After reviewing fee
structures at similar institutions conducting human subjects research,
we have determined the new fees to be in line or below the national
average. For more information including a table with the new fees, visit
The Clinical and Translational Science award (CTSA) Collaborative Data and Safety Monitoring Board (DSMB) Workgroup identified a need to provide guidance, training and resources in DSMB practices for investigator-initiated research studies. To promote clinical and translational research, the CTSA Collaborative DSMB Workgroup, supported by NCATS, has produced an online DSMB Training Manual with a focus on investigator-initiated studies. This manual provides information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs. To read more about the manual and to access the manual, visit: https://ictr.johnshopkins.edu/news_announce/data-and-safety-monitoring-board-training-manual-now-available/
Good Clinical Practice or 'GCP' training for investigators
and study-team members is increasingly becoming required by institutions,
sponsors, and the NIH. This 90 minute course will explain the elements
of the International Conference for Harmonization's (ICH) principles
and specific guidelines for Good Clinical Practice. Attendees will be
introduced to the GCP Principles, and will explore investigator responsibilities
in human subject research, focusing on the areas of trial conduct (experience,
resources, and physician duties); performance (communication with the
IRB, protocol compliance, and investigational product management); ethical
research (safety oversight and informed consent); and recording/reporting
(data acquisition, progress summaries, and safety-event reporting).
These training sessions are held the fourth Friday
of each month. Register here: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
Please note the following
information for clinical investigators from Dr. Daniel Ford, Vice Dean
for Clinical Investigation. You may also get more information at our
Clinical Research Revenue Cycle Resources web page: https://www.hopkinsmedicine.org/research/
If you are conducting NIH-funded research that
involves human subjects, or are considering applying to NIH for support
of such research, please note important changes that may affect how
First, familiarize yourself with the new PHS
Human Subject and Clinical Trial Information form. For application
due dates of January 25, 2018, and beyond, you will be required to use
an updated application forms package (FORMS-E), which includes the new
human subject and clinical trial form. This form requests human subject
and clinical trials information at the study level using discrete form
fields, which is a change from current practice. Contract proposals
will also require this information. Learn
about the new form here.
Second, take a moment
to answer these four questions about your current or proposed research:
If the answer to all
four questions is yes, then your proposed research meets the NIH
definition of a clinical trial. Clarified and broadened in 2014,
the definition encompasses a wide range of trial types: mechanistic,
exploratory/developmental, pilot/feasibility, behavioral, and more.
NIH expanded the clinical trial definition in response to widespread
calls from diverse stakeholders for improved reporting of research milestones
and outcomes, and for assuring maximal transparency.
Need help determining
whether your study would be considered by NIH to be a clinical trial?
See the NIH webpage
on the definition that includes case studies, FAQs and other resources
that can help. Still unsure? Contact your NIH program official or the
scientific point of contact listed on the funding opportunity announcement
to which you are applying.
yourself with NIH policy changes related to enhancing stewardship of
NIH made a number of
policy changes to improve the stewardship of clinical trials across
the life cycle of the trial. Familiarize yourself with all that is changing,
Improving the design,
efficiency, and transparency of clinical trials is important because
The NIH has developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.
Please review this information carefully.
Your attention to detail will be critical to ensuring successful funding
of your clinical trial awards.
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
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
A funding partnership among seven prestigious
universities - including the Johns Hopkins Institute for Clinical and
Translational Research - are awarding nearly $300,000 to scientists
working on collaborative research among their institutes that will explore
widely ranging health concerns, from creating tumor-destroying viruses
to decreasing the large numbers of mentally ill in the criminal justice
The Sharing Partnership for Innovative Research
in Translation (SPIRiT) consortium has offered this funding of research
since 2012, awarding more than $1 million to 12 collaboration projects.
The SPIRiT consortium is made up of six National
Institutes of Health (NIH) Clinical and Translational Science Awards
(CTSA) Programs, including the Johns
Hopkins University Institute for Clinical and Translational Research,
of Pennsylvania's Institute for Translational Medicine and Therapeutics,
University of Pittsburgh's Clinical and Translational Science Institute,
in St. Louis' Institute of Clinical and Translational Sciences,
Yale University's Center
for Clinical Investigation, and the
Institute for Translational Medicine (ITM), a partnership between
the University of Chicago and Rush.
For more information on the Johns Hopkins
awardee for this program as well as details on the individual projects,
visit our webpage.
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 network.