Changes in HSR Recertification

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/

Research Billing Buzz eNewsletter - October 2019

Clinical Research Billing Compliance's (CRBC) eNewsletter helps the research community understand research billing and the importance of Epic and CRMS use. To read the October issue click here.

If you would like to subscribe to get Research Billing Buzz in your inbox, please do so here.

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required

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.

Change in JHM IRB Review Fees for Commercially-Funded Studies
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:

• Inclusion of IRB review fees for study closures for commercially-funded studies
  
• Inclusion of fees for select studies that require monitoring by the Office of Human Subjects Research Compliance Monitoring Program.
  

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 https://www.hopkinsmedicine.org/institutional_review_board/news/letters_dean/archive/
2018_fee_change.html

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

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/
resources/offices-policies/CRBC/resources.html.

The Executive Committee for Clinical Research Billing, consisting of senior research, legal, compliance and finance executives for Johns Hopkins Medicine met in December 2018 to review and update the research charge adjustment percentages.

For statements generated after March 1, 2019 Hospital Billing (HB) charges will be reduced to 36.5% of the facility charge master for Government/Not for Profit organizations and 59.7% for Pharmaceutical/For Profit sponsors. These reductions maintain parity with our target guideline of 100% of CMS Medicare rates for Government/Not for Profit sponsors and 150% of CMS Medicare rates for Pharmaceutical/For Profit companies. For comparison, 2018 guidance provided for reductions of 35.7% and 53.6% respectively.
Monthly Single Billing Office (SBO) account statements for research accounts with HB charges will continue to include a memo highlighting the charge master total, research rate adjustment, and reduced balance for payment from the study IO#.

Your support and cooperation is appreciated as we continue to improve administrative processes supporting clinical research. Study teams should 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.

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.

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.

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