IRB News Archives - 2019
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 firstname.lastname@example.org 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
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 email@example.com with questions.
September 25, 2019
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.