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June 2018

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research

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

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
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/

In July 2014, a fee schedule adjustment for hospital inpatient and outpatient services charged to clinical trial budget accounts was implemented. The change reduced standard rates for services from the hospital charge master. The adjustments approximate 100% of Medicare facility rates for Government/Not for Profit sponsor organizations and 150% for Pharmaceutical firm/For Profit sponsor organizations.

The Johns Hopkins Medicine Revenue Cycle Management staff work with your study team to ensure monthly statements reflect accurate research charges due from your study internal order (IO#) account. The Executive Committee for Clinical Research Billing, made up of senior research, legal, compliance and financial executives for Johns Hopkins Medicine reviewed the existing rate reduction percentages and approved changes that will become effective for statements generated after March 1, 2018.

All hospital statement services after the implementation date will be reduced to 35.7% of the facility charge master for Government/Not for Profit sponsor organizations and 53.6% of the facility charge master for Pharmaceutical firm/For Profit sponsor organizations. These reductions will allow us to stay close to our target of 100% Medicare and 150% Medicare for research protocols. Each monthly statement for hospital services will continue to include a memo highlighting the charge master total, amount of adjustment and reduced balance for payment from the study IO#.

Your continued support and cooperation are appreciated as we continue to improve administrative processes supporting clinical research. Study teams may contact the Clinical Research Support Services (CRSS) team to access pricing and develop budgets that ensure financial integrity of research projects. Please contact that group at crss@jhmi.edu or via phone at 410-361-8362.

Change in Federalwide Assurance [FWA] Numbers

Effective November 1, 2017 we are making changes to streamline the number of FWAs held by the institution and ensure that each legal entity has one FWA. This change will require closing out some existing FWAs assigned to organizations that are components under either the Johns Hopkins School of Medicine FWA number or The Johns Hopkins Health System FWA number. Functionally nothing else regarding IRB review or our human research protections program will change. However, organizational components should please take note of the new FWA that will be affiliated with each component and ensure only the two FWAs listed below are referenced moving forward.

FWA Numbers & Components:

The Johns Hopkins University School of Medicine [FWA00005752]
Includes the following components:

  • The Johns Hopkins School of Medicine
  • The Johns Hopkins University School of Nursing
  • The Johns Hopkins University Applied Physics Laboratory

The Johns Hopkins Hospital and Johns Hopkins Health Systems [FWA00006087]
Includes the following components:

  • All Children's Health System, Inc.
  • Howard County General Hospital
  • Johns Hopkins All Children's Hospital, Inc.
  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Community Physicians
  • Johns Hopkins Regional Physicians, LLC
  • Johns Hopkins Hospital
  • Sibley Memorial Hospital
  • Suburban Hospital and Health System

The following separate FWAs should no longer be referenced as of November 1, 2017:

  • All Children's Hlth System, Inc., FWA00000977 - expires10/17/18
  • The Johns Hopkins University School of Nursing, FWA00006088-expires 6/4/2019
  • Johns Hopkins Bayview Medical Center, FWA00006089-expires 3/6/2022
  • The Johns Hopkins University Applied Physics Laboratory, FWA00018613 - expires 3/6/2022
  • Johns Hopkins Community Physicians, FWA00002251-expires 3/13/2022
  • Howard County General Hospital, FWA00005743-expires 1/27/2020
  • Sibley Memorial Hospital, FWA00003508 - expires 8/13/18
  • Suburban Hospital and Health System - FWA00005924 - expires 3/6/2022

For additional questions about FWAs please visit: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/assurance-process/index.html

For questions regarding the changes to our existing FWAs, please contact Megan Kasimatis Singleton, Assistant Dean for Human Research Protection at msingl16@jhmi.edu or (443) 287-0204.

Changes to NIH-funded Human Subjects 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 you:

  • select the right NIH funding opportunity announcement
  • write the research strategy and human subjects sections of your application
  • comply with appropriate policies and regulations

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:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

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.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

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, including:

  • the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
  • Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
  • updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
  • new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
  • use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
  • expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

  • respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
  • facilitates design of clinical trials while reducing unnecessary duplication
  • promotes broad, timely, and responsible dissemination of research information and results
  • fosters responsible stewardship of the public's investment in biomedical research

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.

The NIH will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog.

Free Resources for Longitudinal Clinical Research Studies

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 website (http://www.improveLTO.com):

  1. Database of common patient-reported and performance-based outcome measures, and standardized information about these measures (includes physical, cognitive, mental health and quality of life outcomes);
  2. Adaptable tools, templates, and manuals to maximize cohort retention (including an interactive database with >600 retention strategies abstracted from a recent systematic review);
  3. A statistical tool to address the competing risk of mortality (i.e. truncation due to death) when evaluating functional outcomes.

NIH requirement for Single IRB (sIRB)

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 Planning Phase and New Applications that involve Hopkins as the reviewing sIRB must submit a "Reliance Request" through an on-line SOM IRB query portal available on this page: http://www.hopkinsmedicine.org/institutional_review_board/about/
    . Reviewers will evaluate and act on the request. SOM faculty will use the same portal for applications seeking to rely on an external sIRB.
  • JHSPH and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (jhsph.irboffice@jhu.edu) or Homewood IRB (hirb@jhu.edu) for further guidance.

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 Reliance Requests

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:

a) when studies are in their planning stages, and
b) when studies are ready to be submitted for IRB review

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

Sharing Partnership for Innovative Research in Translation

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 system.

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, University of Pennsylvania's Institute for Translational Medicine and Therapeutics, University of Pittsburgh's Clinical and Translational Science Institute, Washington University 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.

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/.

Return to top of Human Subjects Research

June 2018 articles:
Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Change in Federalwide Assurance [FWA] Numbers
Changes to NIH-funded Human Subjects Research
Free Resources for Longitudinal Clinical Research Studies
NIH requirement for Single IRB (sIRB)
JHM IRB Reliance Requests
Sharing Partnership for Innovative Research in Translation
Johns Hopkins Institute for Clinical and Translational Research
Johns Hopkins Research Network
Visit Animal Care and Use Committee Website
Current Classes
"Interinstitutional Assurance" Agreement
Health, Safety, and Environment (HSE) presents: Safety in Research Updates
WW Smith Charitable Trust Heart Disease, Cancer and AIDS Research Grants
Mallinckrodt Foundation Grants for Early-Career Faculty
Funding for Prostate Cancer Research
Michael J. Fox Foundation (MJFF) Challenge
Why Project Outcomes Matter in your Interim and Final Research Performance Progress Report (RPPR)
NIH Matchmaker, A Tool For Finding Similar NIH Projects
NIH Video Tutorials on How to Apply for Grants
NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization

This Month's Departmental Listings

Upcoming Deadlines for June and July

June Events at the Genetic Resources Core Facility


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