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July 2017
HUMAN SUBJECTS RESEARCH - Back

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

Session dates/times:

Tuesday 7/18, 10a.m. - 11 a.m.
Phipps (East Baltimore), Rm. 140

Thursday 7/27, 1 p.m. - 2 p.m.
Bayview Campus, Asthma Center, Grossi Auditorium

Tuesday 8/8, 1 p.m. - 2 p.m.
Phipps ((East Baltimore), Rm. 360

Wednesday 8/16, 11 a.m. - 12 p.m.
School of Public Health Building, Rm. W4013

Thursday 9/7, 10 a.m. - 11 a.m.
Phipps (East Baltimore), Rm. 140

Tuesday 9/12, 1 p.m. - 2p.m.
Homewood - Great Hall

*January 25, 2018 is the currently proposed implementation deadline for NIH's Policy on single IRB review.


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.


New Fee Schedule for Commercially Funded Studies

Effective July 1, 2017, there will be a change in the JHM IRB review fees for any commercially funded study with financial support in excess of $10,000. This change affects studies submitted on or after the July 1, 2017 date. To help cover the costs of IRB review for complex changes in research and the institutional review required when JHM IRB relies on an external IRB, the IRB review fees will be modified as of July 1, 2017. The JHM IRB review fees will be charged against the study internal order number or to the designated departmental/divisional internal order at the time of IRB approval.

The changes in IRB review fees include the following:

a. Inclusion of IRB review fees for changes in research for commercially-funded studies requiring convened review*
b. Inclusion of an administrative fee for processing the local JHM application for commercially-funded studies when JHM is relying on an external IRB

*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.

Type of Review
Initial Review
Continuing Review Changes in Research [with consent form changes] Changes in Research [without consent form changes]
Convened $2500 $1250 $800 $700
Expedited $2000 $1000 N/A N/A
Exempt $100 N/A N/A N/A
Local Context Review Fee [When Relying on an External IRB] $1800 N/A N/A N/A

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 contact information:
Aaron Coleman - phone: (443) 287-8329
FAX: (410) 955-4367 (This is the same fax number used by the JHM IRBs so specify if documents need to be directed to Aaron Coleman)


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/
    reliance_agreement.html
    . 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


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

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?

  • For Principal Investigators (PIs), recertification will include 4 required online modules and 1 in-person activity. 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?

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 tracker.

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July 2017 articles:
Training Sessions: Preparing for NIH's Single IRB Review Requirement
Free Resources for Longitudinal Clinical Research Studies
New Fee Schedule for Commercially Funded Studies
NIH requirement for Single IRB (sIRB)
JHM IRB Reliance Requests
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
NIH Directors' Early Independence Awards (DP5)
Searle Scholar Fund - Searle Scholars Program
Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP)
AHA Institute for Precision Cardiovascular Medicine
Sol Goldman Pancreatic Cancer Research Center Funding
Under Armour Women's Health & Breast Cancer Innovation Grant
Michael J. Fox Foundation (MJFF) Challenge
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 July, August and September

July Events at the Genetic Resources Core Facility
       

 

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