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Institutional Review Board

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November 30, 2017

The SOM IRB and the JHSPH IRB have agreed on standard Certificate of Confidentiality language for the consent forms for NIH funded studies that collect personal identifiers from participants. This language is shorter than that posted by NIH and has been inserted into our consent templates. 

For NIH funded, U.S. based studies that will collect identifiable information, please include this language:

Your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means. 

 It does not protect information that we have to report by law, such as child abuse or some infectious diseases. The Certificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, or if you need medical help. 

 Disclosures that you consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that you make yourself are also not protected. 

For NIH funded, international studies that collect identifiers and may bring identifiable data to the U.S., include this language:

This study is protected by a Certificate of Confidentiality that helps keep your information private when stored in the U.S.

Please let us know if you have any questions.

November 2017

Under NIH’s new policy, all NIH funded studies started or ongoing on or after December 13, 2016, that collect personal identifiers, are deemed to have Certificate of Confidentiality protections. This protection goes with the grant, and investigators are responsible for explaining the extent and limitations of the protections to study participants. We have modified our consent form templates, both oral scripts and consent documents to be signed, to include language that meets NIH requirements. We have tried to make the language as concise as possible. Please be sure to include this language for all studies that fall under this policy.

March 2017

The IRB has disabled the HIPAA questions in the PHIRST application and will use exclusively the Application for the Disclosure of Protected Health Information available now via link in PHIRST, and on our HIPAA webpage. Please contact the IRB Office at jhsph.irboffice@jhu.edu if you have questions.”

December 2016

“Johns Hopkins Medicine has convened a Data Trust Council that is setting policies for the access and use of clinical data from JHH and its affiliates. The Research Data Subcouncil has posted FAQs for all researchers to help them navigate the new procedures for accessing clinical data: see the intranet for more information. Contact the JHSPH IRB office if you have questions.”

November 2016

Due to the upcoming holidays, IRB-X and IRB-FC will miss a few meeting days. IRB-X will not meet on November 24 and December 29. IRB-FC will not meet on December 28. Please keep this schedule in mind as you prepare your submissions.

October 2016

On September 16, 2016, NIH issued a requirement that “all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP)….” (See the intranet for more information.) The NIH definition of a clinical trial is, “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The JHSPH IRB offers access to GCP training through the JHSPH’s CITI training account, which you may access here: https://www.citiprogram.org/. When you log into the CITI site (selecting Johns Hopkins Bloomberg School of Public Health as your institution), select “Add a Course”, then under “Question 2”, select the first Learner Group which offers GCP training.

August 2016

The IRB office has revised its Research Plan for New Data Collection to include new questions on data confidentiality and security. The questions are more detailed and we hope that it will inform investigators of the high standards of security required for research data. The template also has more space and designated areas for responses; this is an effort to make the finished document easier for reviewers and staff to read. We welcome your comments - please send them to jpettit@jhu.edu. Thank you!

June 2016

Investigators working with JHH affiliates with studies that involve clinical services must be familiar with the PRA (“Prospective Reimbursement Analysis”) and CRMS (“Clinical Research Management System”) processes that help control the billing procedures for those study services. The SOM Vice Dean for Clinical Investigations has agreed to allow JHSPH investigators to submit these projects through the SOM’s eIRB2 system, which automates the PRA and CRMS processes. Contact the JHSPH IRB Office if you have any questions.

May 2016

NIH has created a new “human subjects” webpage that links investigators to training and to the Certificates of Confidentiality kiosks. It also helps investigators prepare their “human subjects” sections of their research proposals.   

March 2016

The JHU School of Public Health IRB is posting the PHIRST (Public Health Institutional Review System TrackingUser Guide developed specifically for investigators and study team members using the PHIRST system, our portal for all new human subjects research applications. This manual includes the following topics to get you started:

1.     The PHIRST registration process

2.     An overview of the submission and review process

3.     Basic methods and terms you need to know to create and submit electronic IRB applications

If you have any questions about the PHIRST User Guide, please contact the PHIRST Help Desk at jhsph.phirsthelp@jhu.edu or call 410-502-5780.

November 2015

Our Quality Improvement Specialist, in conjunction with her School of Medicine counterparts, has posted tools to help you set up your regulatory research binders: Regulatory Binder Tabs for Hard Copy Binders and Regulatory Documents Binder Tab Topics for Electronic Storage. We hope they will be useful for you.

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