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June 2016
HUMAN SUBJECTS RESEARCH - Back

Research Participant 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 Epic.

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 located.

If you have questions about the Information Sheet, please contact Karen Roz at rozka@jhmi.edu or 410-955-7682.


Upcoming Symposium: New Frontiers in 3D Printing at Johns Hopkins University

The Johns 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 following areas:

  • Customization and personalization of medical products, drugs and equipment
  • Training simulations
  • Cost-effectiveness
  • Increased productivity
  • The democratization of design and manufacturing
  • Enhanced collaboration

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 Crowley.


Johns Hopkins Institute for Clinical and Translational Research

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 ICTR website.


Johns Hopkins Clinical Research Network

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: http://ictr.johnshopkins.edu/clinical/clinical-resources/human-subjects-research-core/jhcrn/.


JHM HSR Recertification Training

Effective March 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.

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?

  • For Principal Investigators (PIs), recertification will include 4 required online modules and 1 in-person activity (the 100 points system will no longer be used). The list of in-person activities will include a variety of instructor-led courses and in-person workshops offered throughout the calendar year. A combination of the 4 required modules and 1 of the in-person activities will result in the completion of PI recertification.
  • For all other study team members, recertification will include 4 required online modules and 2 additional courses available for choosing. A combination of the 4 required modules and 2 additional course available for choosing will result in the completion of study team recertification.

Exceptions:

  • Non-affiliated study team members and Clinical Research Network (CRN) study team members may submit their compliance training recertification for Basic Human Subjects Research (BHSR) from CITI, their local institution or another institution, such as NIH.
  • For eIRB applications that are determined to be not human subjects research (NHSR), recertification is not required.
  • Johns Hopkins Bloomberg School of Public Health (SPH) and Homewood study team members can submit human subjects recertification certificates from their local institution. Please note: SPH and Homewood are on a 5-year recertification. We will accept certificates that are <5 years old.

How do I register?





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June 2016 articles:
Research Participant Financial Responsibility Information Sheet
Upcoming Symposium: New Frontiers in 3D Printing at Johns Hopkins University
Johns Hopkins Institute for Clinical and Translational Research
Johns Hopkins Research Network
JHM HSR Recertification Training
 
Visit Animal Care and Use Committee Website
Current Classes
"Interinstitutional Assurance" Agreement
Health, Safety, and Environment (HSE) presents: Safety in Research Updates
Pew-Stewart Scholars Program for Cancer Research
Harrington Scholar-Innovator Award
Department of Defense Peer Reviewed Cancer Research Program (PRCRP)
Edward Mallinckrodt, Jr. Foundation Research Grants
Funding for Prostate Cancer Research
International Research Scholars Program
Lupus Research Institute - New Research Grants for Novel Approaches To Lupus
Lupus Research Institute - Dr. William E. Paul Distinguished Innovator Awards in Lupus and Autoimmunity
NIH Director's Early Independence Awards (DP5)
Department of Defense Peer Reviewed Medical Research Program (PRMRP) Funding Opportunities for Fiscal Year 2016
NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization

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Upcoming Deadlines for June and August

June Events at the Genetic Resources Core Facility
       

 

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