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Institutional Review Board

Institutional Review Board

FWA#0000287

The Johns Hopkins Bloomberg School of Public Health is committed to protecting the rights and welfare of all individuals who participate as subjects in research. The School has two on-site Institutional Review Boards (IRB X and IRB FC). It is the responsibility of all faculty and students to ensure that they obtain IRB approval or Exempt determination before initiating any human subjects research project.

IRB News

What’s New

 

March 27, 2020

Please see on our COVID 19 page new consent language for studies testing investigational drugs, devices and diagnostics, that limit a participant's ability to sue​ if harmed through a COVID 19 study.

We have also posted a new FAQ that provides COVID 19 information for participants and also lists mental health and other resources for U.S. based studies, focusing on the Baltimore area.  Studies conducted internationally and outside of Baltimore may use this FAQ as a guide to what resources to think about and look for.

March 25, 2020

The IRB is functioning remotely.  Please review the following updates:

 

1.   All new applications and amendments that involve remote data collection and/or secondary data analysis will be processed normally.  Remote contact with participants must be secure and be careful not to disclose confidential information or the nature of the study to other people who may have access to the participant's phone or computer.

 

2.  The IRB will review new applications that involve direct person-to-person contact and will issue approval letters but those letters will inform that direct enrollment and study activities may not proceed until restrictions are lifted.  The IRB will not release stamped consent forms and recruitment materials until that time.

 

3.  Investigators may submit one amendment in the PHIRST2.0 system at a time.  If they submit an amendment to add in person contact activities, the IRB may approve the amendment but will not finalize that approval by releasing stamped documents.  No additional amendments may be submitted until restrictions are lifted and documents are released.  Consider waiting to submit these amendments.

4.  The IRB is prioritizing COVID-related studies.  

March 20, 2020

The IRB website now has a page called "COVID 19 Information" which will update researchers on the JHU information related to human subjects research.  Please visit this page to look for updates and new resources.​

March 17, 2020

JHU leadership has been coordinating efforts to provide researchers with information about human subjects research and COVID 19.  They have created a Tier Plan which categorizes research studies into 3 Tiers, with the understanding that as COVID 19 conditions progress from Phase 0 through Phase 3, study activities will reduce or pause depending upon the Tier.  Please bookmark this link to the JHU Research Preparedness page, and check it frequently: https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/.  There is an additional guidance focusing on international research here: https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/human-subject-research-international-supplemental-guidance/.  Researchers may have to adapt their studies to adapt to the COVID 19 conditions and local requirements at their research sites.

 

What should researchers do now?

  1. Consider your protocol in light of the JHU Tier Plan published above and decided which Tier it falls into and how the COVID 19 Phase affects that study.  Today (March 16), the U.S. is considered to be in Phase 2.  If your study is outside the U.S., work with your local partners to determine how to proceed.
  2. JHU is directing all researchers to execute emergency changes in study activities, including pausing study activity and modifying direct interactions with participants, in response to the COVID 19 state of emergency and local health care directives.  If you abide by the JHU Tier Plan, you do not need to submit an Amendment for IRB approval prior to implementing these emergency changes.  Document the changes and report them on your next Continuing Review/Progress Report as Protocol Deviations required under the JHU Tier Plan in response to the COVID 19 emergency. 
  3. All changes to your research unrelated to the JHU Tier Plan must have IRB approval prior to implementation.
  4. You may use without submitting an Amendment  two Research Participant Communication documents to help explain the pausing of study activities and the risk of COVID 19: Changes to Research Participation due to COVID-19​, and Important Information about COVID-19 and Research Participation .
  5. If you have questions about your study, send an email to jhsph.irboffice@jhu.edu.

 

Please review materials on the one drive and consider sharing your COVID related study materials as well:  https://livejohnshopkins-my.sharepoint.com/:f:/g/personal/kparris1_jh_edu/Ek1V__sQqK1GtQc5x0pGokoBc7FWAjE5nc23_r5tuHUfwg?e=uuPmZ0

March 13, 2020


Dear colleagues,

As we confront the novel coronavirus pandemic, we have to balance continuing research with the risk to our students, staff and faculty and to our study participants. We are entering uncharted waters with personal and work disruptions only likely to increase. During recent days, this rapidly evolving environment has prompted numerous questions from research teams and generated frequent guidance (albeit with a short expiry date in terms of relevance). 

This communication is intended to provide key messages relevant to on-going research activity, and then provide linkages to the substantive resources that have been accumulated.

We provide annotated JHSPH Research Preparedness Resources to assist research teams in navigating these steps on a OneDrive folder.

Importantly, we provide linkages to the substantive guidance provided by our School and to Institutional and SOM guidance.  We also provide additional resources including study-specific examples of posters, signage, screening procedures etc. If you're willing to provide your resources in response to COVID-19 with our research community, please forward them to Katherine Frey (kparris1@jhu.edu). Many of these materials will be continually updated, so please check back frequently to get the most up-to-date information.

We remain confident that the BSPH response will be adept and appropriatel to deal with the COVID-19 disruptions. Thanks for your attention and dedication as we work together to ensure that our research activities remain well-positioned to respond to interruptions and bounce back as strong as ever.

Best, Greg​


March 11, 2020

The JHSPH IRB has worked with the other JHU IRBs to create a guidance for investigators.  Please see: Coronavirus and Johns Hopkins Human Subject Research.  ​We anticipate providing more information in the near future.  Please also see preparedness information on the JHURA website: https://research.jhu.edu/jhura/about-us/jhuranews-2/​.

February 28, 2020

Starting March 16, 2020, the IRB office will return email submissions of Administrative Amendments, and Continuing Review/Progress Reports; it will accept only email submissions of Final Study Reports. ​Please complete your "shell" applications in PHIRST2.0 following the instructions provided in our User Guide on Completing Study Shells  and submit them through the system for activation.  Once activated, all future submissions for your study will be through PHIRST2.0.  Contact jhsph.irboffice@jhu.edu.  

January 28, 2020

The JHU IRBs worked together on Guidance for International Research​ and an Investigator Checklist for Human Subjects Research in International Settings​.  These tools aim to help researchers anticipate and plan for the complex issues associated with research overseas.  We welcome your feedback

January 24, 2020

Cooperative Agreements and Single IRB -As of January 20, 2020, most  human subjects research involving more than one institution, and funded by federal cooperative agreements, must rely on the approval of a Single IRB for that portion of the research that is conducted in the U.S.  Please consider this requirement when formulating your grant proposals.

January 23, 2020

The Baltimore City School System has decided to limit research in its schools as follows:

The Baltimore City Schools IRB is not accepting:  

https://www.baltimorecityschools.org/research-and-data-requests

 

January 7, 2020

The new PHIRST system provides a mechanism for submitting Amendments and Administrative Amendments for studies that are active in that system.  Please follow the posted User Guide for Completing Study Shells ​to submit your currently approved study to the IRB for activation in the PHIRST2.0 system.  If you need to submit Amendments before your study is active in PHIRST2.0, the IRB will accept email submissions as it has been doing.  The IRB will stop accepting email submissions of all types in March, 2020. Principal Investigators must complete their study shells by then so that all future Amendments and Continuing Review/Progress Reports, etc., will be submitted electronically in the PHIRST2.0 system.

January 6, 2020

The IRB's launch of PHIRST2.0 is proceeding well, though we are finding a number of minor issues that we will address one by one.  All active studies approved before Dec. 10​ have "shell" applications that need to be made active before March 1, 2020We will not accept email submissions after that date.  Please refer to the Completing Study Shells User Guide posted on our website, and contact the IRB office at jhsph.irboffice@jhu.edu for assistance

December 13, 2019

This is a reminder that there is open training for PHIRST2.0 today, 3 – 5 pm in W3011.  It will also be available remotely with Zoom, using this link to join the training: https://jh.zoom.us/j/624815073.​  Hope to see you there!

December 10, 2019

The IRB Office is happy to announce that PHIRST2.0 is up and running!  We are working on populating the shell applications for existing, approved studies with study documents; then it will be your job to complete and submit to the IRB.  Please see our PHIRST User Guide for Completing Study Shells.  All New Applications may be submitted through PHIRST.  Please contact us at jhsph.phirsthelp@jhu.edu if you have any questions or concerns.  We welcome your feedback.

November 26, 2019

The JHSPH IRB has updated its IRB Policies to reflect changes to the Common Rule and Institutional Policies.  ​We have tried to present the policies in a way that will help investigators and students navigate the searchable policy document.  Please let us know if you have any questions

November 25, 2019

The OHRP has posted notice of an exception to the requirement that federally funded, cooperative research projects involving more than one institution meet the Single IRB requirement.​ (See: https://www.govinfo.gov/content/pkg/FR-2019-11-22/pdf/2019-25358.pdf).   The exception includes cooperative research approved by multiple IRBs prior to January 20, 2020, funded by NIH (and not governed by the NIH Single IRB Policy) or funded by other federal agencies.

November 20, 2019

The IRB Office has revised its guidance on "What Needs Submission to the IRB?".  Please review and let us know if you have any questions.

November 13, 2019

The JHSPH IRB is posting new PHIRST FAQs to provide information about the transition from PHIRST 1.0 (old PHIRST) to PHIRST 2.0.  The launch of PHIRST 2.0 is scheduled for December 10, 2019.  PHIRST 1.0 will stop accepting new application at midnight, Thursday December. 5.  It will be "down" from Friday, December 6th until December 10th.  Keep in mind that because Christmas and New Year's Day are on Wednesday this year, the IRB will not meet the week of December 23 or the week of December 30. 

November 7, 2019

The IRB is posting a new research plan template with an updated data security section and study management section.  The changes in the data security section are in response to the School's change from JHBox to OneDrive.  Please let us know if you have questions.

November 5, 2019

The Revised Common Rule makes clear that "Public Health Surveillance" activities do not fall within the definition of "human subjects research".  The IRB has posted a Guidance on "Public Health Surveillance Activities"; if you think your project falls in this category, submit the Public Health Surveillance/Not Research Determination Form with your PHIRST submission instead of a Research Plan.  The IRB will review the submission and make the determination

October 31, 2019

JHSPH IT has developed two guidances to help investigators:  Data Lifecycle Protection and Storage and Computer Options. ​  We welcome your feedback.

October 23, 2019

As part of the regulatory requirements of the revised Common Rule that took effect on January 21, 2019, federally funded studies that were approved after January 20, 2019, must comply with all of the provisions of the revised Common Rule.  In particular, U.S. based multi-site studies must comply with the provision for single IRB review. The compliance date for the sIRB requirement is January 21, 2020.  If your study requires sIRB review by that date, please contact the JHSPH IRB office for assistance as soon as possible.​

October 23, 2019

The IRB is revising how it processes changes that involve instruments or consent forms.  Please use the Amendment Application, and not the Administrative Amendment Application, to submit those changes.  Thank you.

October 2, 2019

Please see our revised Unanticipated Problem/Event/Non-Compliance Report form.  We've added a separate "Non-Compliance" section for reporting any failure to follow the IRB approved protocol beyond minor protocol deviations that you report with the Continuing Review/Progress Report."​

October 1, 2019

Please see the revised "Guidance on Reliance Agreement"; it has a new flow chart that may help people know whether or not they need to comply with Single IRB requirements.

September 30, 2019

The news is out:  PHIRST2.0 will go live in December 2019.  All IRB submissions (New Applications, Amendments, Continuing Review/Progress Reports, etc.) will go through this updated electronic system.  Please close all active studies that ​involve only de-identified data; you may continue analyzing and publishing but do not need IRB oversight for those activities.  Please contact the IRB office at jhsph.irboffice@jhu.edu with questions.

September 25, 2019

Please see our new guidance on Recruitment Materials.

September 17, 2019

The Vice Dean for Research posted a new Guideline for retention and disposal of data that will be useful to investigators.  Please take a look.

August 30, 2019

JHU has revised its Payment to Participants guidance to clarify that payments under $200 do not require collection of social security numbers, and to outline the different permissible mechanisms for payments.  Please contact the IRB office if you have questions.

July 19, 2019

The JHU IRBs have defined "Publicly Available Data" through a new Guidance on Publicly Available Data​​​.​  We will use this definition when reviewing applications that may qualify as Exempt under Category 4i.  Please contact the JHSPH IRB office if you have any questions

July 2, 2019

The Revised Common Rule includes a new requirement that consent documents begin with Key Information.  The IRB has posted a new Guidance on "Key Information​ for Informed Consent"​ to help investigators draft that section of the consent document.

April 25, 2019

The JHSPH IRB, working with the JHM Privacy Office, has revised its HIPAA page, including all its applications, forms and tools.  We have also posted a new set of HIPAA FAQs to help researchers understand what is required when working with Protected Health Information (PHI).  We also have streamlined the procedure for ensuring that Data Use Agreements (DUA) are in place when using PHI for secondary data analysis.  Please contact the IRB if you have any HIPAA questions.​

April 5, 2019

JHU has revised its policies on Payments to Participants in research studies.​  It clarifies how participants may be paid (gift cards, petty cash) and when identifiers like names, addresses and SSNs must be collected

February 12, 2019

Please see the new JHU Guidance on Payments to Research Subjects that clarifies the elimination of the use of a VCN form.  The new guidance clarifies that investigators making payments (not reimbursements for expenses) to research subjects over $200 per year must collect Social Security Numbers (SSNs) in order to process those payments.  Research subjects are obligated to report those payments to the IRS as personal income. Payments to subjects of $200/year or less do not require collection of SSNs.  Currently approved VCNs are grandfathered and do not require amendment or renewal for the life of the study.