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Institutional Review Board

Institutional Review Board


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) and an external IRB (the Western IRB) that reviews certain studies on our behalf. It is the responsibility of faculty and students to ensure that formal IRB approval is obtained before initiating contact with human subjects in any research project.

IRB News

What’s New


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 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:   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 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.

December 11, 2018

The JHSPH IRB is posting new consent form templates to comply with the Revised Common Rule (RCR) requirements.  All New Applications may use the new templates.  New Applications under IRB review with current Common Rule (CR) consent templates that are not approved before January 21, 2019, must submit consent forms on the new RCR templates before final approval.

December 6, 2018

The NIH recently announced changes in the NIH Management of Genomic Summary Results Access Policy (available at: , which will permit unrestricted download of genomic summary results data by third parties from the NIH Database of Genotypes and Phenotypes “dbGaP”).  Please note these changes apply to the sharing of summary results only and do not impact requirements for sharing of individual-level data.

For new NIH funded studies that will collect genomic data that is subject to the NIH Genomic Data Sharing Policies, all JHU Institutional Review Boards (“IRBs”) have developed new template language for informed consent documents to inform research participants about the further dissemination of genomic summary results data.  Investigators should make certain that they are using the current template language for new or on-going studies subject to the data-sharing requirements.

For studies that have already deposited data into dbGaP, the NIH has acknowledged that this change in policy may heighten the privacy risks to subjects for studies that are particularly sensitive; including studies involving populations from isolated geographic areas, populations with rare traits, or populations with stigmatizing traits.  The NIH has given institutions until May 1, 2019, to designate, through the Institutional Certification process under dbGaP, whether any studies previously submitted will be designated as “sensitive” by the institution and which therefore should be maintained as controlled access only.  Johns Hopkins University IRBs have convened a small group of internal experts to develop a consistent rubric to review already deposited studies and will be communicating with impacted investigators directly about any further action required.  Investigators who have been contacted by their program officers, or who have questions about an existing study, may contact the relevant IRB office with questions about their particular study.

December 6, 2018

On January 21, 2019, new consent form requirements go into effect.  The JHSPH IRB will soon post new consent templates that include those new requirements.  While the Office of Human Research Protections (OHRP) has not yet issued guidance on these new requirements, the OHRP Director has permitted the circulation of his Dec. 5, 2019 slide presentation on New Informed Consent Requirements.

November 12, 2018

On January 21, 2019, the DHHS regulations governing human subjects research will change.  Research applications Approved or Approved with Administrative Changes after that date must follow the Revised Common Rule.  To help investigators understand the changes, the JHU IRBs have worked together on a common guidance called “What You Need to Know about the Revised Common Rule”.  Please contact the IRB if you have any questions or concerns.

November 5, 2018

Effective November 1, 2018 the IRB will no longer send an administrative amendment approval memo for changes to funding, study personnel, or previously approved instruments that do not require stamping. (As a reminder, changes to the PI require submission of an Amendment Application.)

Instead of an approval memo, the IRB will send an email approval to the study PI/study contact. This email serves as the official IRB approval notice of the administrative amendment and must be retained by the study team for their records.

August 29, 2018

JHU has developed a guidance about the European Union's new General Data Protection Regulation (GDPR) and how it may affect research.  Please review it if you are collecting information about a person who is physically located in the EU.

August 13, 2018

The IRB is changing its terminology with respect to continuing review to be consistent with other IRBs.  Our “Progress Report” will be referred to as a “Continuing Review Form” going forward.  Please use the updated Continuing Review Form going forward.  Please contact the IRB if you have any questions

July 26, 2018

The JHSPH IRB’s “Self-Assessment Modules” are available for anyone to use – find them on our Quality Improvement Program webpage.  Please let us know if you have any questions.

July 23, 2018

The IRB has updated its consent forms to include new, shorter HIPAA language generated in collaboration with the SOM IRB and the JHH Privacy Office.  The instruction templates for each form have also been revised.  Please let us know if you have any questions or comments.

June 29, 2018

The JHSPH IRB has posted new guidance and forms to guide investigators through the requirements for Reliance Agreement arrangements between the JHSPH and external IRBs.  Not all of these arrangements involve NIH mandated “Single IRBs”, or sIRB, so we have separated those two topics.  We are integrating our reliance agreement process into our PHIRST submission system so that we can have a file and IRB number for each study that involves one of these arrangements.  Please review these materials and let us know if you have any questions. 

June 28, 2018

Due to an IRB error, the June “reminder letters” notifying investigators to submit their Progress Reports were sent out late.  We apologize for any inconvenience this may have caused.  Please contact the IRB if you have any concerns.

June 28, 2018

IRB X and IRB FC will not meet the week of July 2 because of the July 4 holiday.  The normal meeting schedule will resume the week of July 9.

June 22, 2018

UPDATE: Changes to the Federal Policy on Protection of Human Subjects (the Common Rule) Delayed to January 21, 2019.

A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) was originally scheduled to go into effect on January 19, 2018 and was subsequently delayed to July 19, 2018 by an interim final rule. On June 19, 2018 a new final rule was published which delays the general compliance date of the revisions to January 21, 2019.  

The new Final Rule can be accessed at the following link:

Until the Final Rule becomes fully effective on January 21, 2019, all human subjects research must continue to comply with the existing Common Rule. The JHSPH IRB will keep study teams apprised of any changes to the federal requirements for human subjects protections and will offer training sessions jointly with the other JHU IRBs this Fall to help study teams prepare for the changes. Please check the JHSPH IRB website frequently for any updates.

March 9, 2018

The IRB has updated the Data Security section of its two research plan templates, "Research Plan for New Data Collection" and "Research Plan for Secondary Analysis of Existing Data".  Please use these new versions when you submit research applications.

March 7, 2018

The IRB is streamlining processes to improve efficiency in three ways: 1) Administrative Amendments changing study personnel will be acknowledged and confirmed via email rather than by letter; 2) IRB Progress Report reminder letters will be sent via email only, not by hard copy/interoffice mail; and 3) Consent and recruitment documents associated with Exempt Studies will no longer be stamped as “IRB Approved”. The documents associated with studies that the IRB determines to be exempt will continue to be listed in the IRB Exempt Determination letter, and no other consent documents or recruitment materials should be used. Please let us know ( if you have questions about any of these changes.

March 7, 2018

For those investigators who need more information about submitting NIH grants that involve Single IRB, and the broader definition of “Clinical Trial”, this presentation by the ICTR team is very informative.  See:

March 6, 2018

The Hopkins ICTR group held a training session on March 5 that covered NIH’s  Single IRB (“sIRB”) and reviewed the new NIH definition of “Clinical Trial”, and its impact on registration requirements.  It’s a very informative session, and we recommend it for investigators and their study teams:

January 23, 2018

The JHU IRBs are all posting a new guidance to help investigators and IRB members understand the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA), and what is required when performing research that involves access to/use of student education records.  Please contact the IRB if you have any questions.

January 18, 2018

UPDATE: Delay in Changes to the Federal Policy on Protection of Human Subjects (the Common Rule): The Federal government issued a notice on January 17, 2018, informing the public of a delay of the effective date of a revised version of the Common Rule  from January 19, 2018 until at least July 19, 2018.

There is the possibility of a longer delay.  You may access the Interim Final Rule at the following link:

Until the revised version of the Common Rule becomes effective, all human subjects research must continue to comply with the existing Common Rule. We will keep study teams apprised of any changes to the federal requirements for human subjects protections. Please check this website frequently for any updates. Training sessions outlining the planned rule changes and the status of the rule will still be held in January 2018. Please click here to register:

December 13, 2017

As you may have heard, OHRP has undertaken a revision of the existing rules governing Human Subjects Research (i.e., the Common Rule), effective on January 19, 2018.  All studies approved on or after that date must comply with the new rule. Some of the changes will be welcome, others may not.  For example, minimal risk studies submitted after that date may have reduced or no annual reporting requirements.  On the other hand, the new rule includes new consent form requirements.  As a result, we encourage investigators with current submissions who do not want to revise consent forms to respond promptly to IRB communications, as all submissions Approved, or Approved with Administrative Changes on or before January 18, 2018, will be reviewed under the current rule.  More information about the changes generated by the new rule will be posted and circulated in early January.

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.

October 23, 2017

As we approach the holiday season, please note the following dates that the Boards will deviate from their weekly Wednesday (IRB FC) and Thursday (IRB X) meetings.

October 9, 2017

Effective October 1, 2017, all ongoing or new research funded wholly or in part by NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information is automatically issued a Certificate of Confidentiality (Certificate) as a term and condition of NIH grant awards. Identifiable, sensitive information is information about an individual, gathered or used during the course of biomedical, behavioral, clinical or other research, through which the individual is identified, or there is at least a very small risk that the identity of an individual could be identified.

Under the new Policy:

The NIH has provided useful FAQs and information about the new Policy at:

Should you ever receive a subpoena or other legal process seeking disclosure of research records, please contact the Johns Hopkins University Office of the Vice President and General Counsel (OGC) immediately, and prior to disclosing any records or information. OGC will assist researchers with responding to the legal request for records, and with enforcing the privacy protections of Certificates of Confidentiality. OGC contact information may be found on the OGC website at: {link to OGC website}.

August 23, 2017

The IRB has updated several of our website pages; in some cases to improve clarity and currency, and in others to introduce new information.  Please see the following changes:

Please contact the IRB Office at if you have any questions.

July 20, 2017

The SOM IRB is sponsoring training sessions on the Single IRB (sIRB), and one session will be at the JHSPH on Wednesday, 8/16, at 11-12 in Room W4013.  To register and to find information about other sessions, more information is provided here:

July 17, 2017

To help investigators with developing data management plans, the IRB has posted some slides that we titled ‘Tips on Data Management Plans’ presented at the ICTR Data Managers Interest Group Meeting on Friday, July 14.

June 21, 2017

On June 16, 2017, NIH pushed back the implementation date of its Single IRB mandate from September 25, 2017 to January 25, 2018.  Information about the sIRB requirement and JHSPH is available on the sIRB FAQ page.

June 9, 2017

As part of the JHSPH IRB’s effort to implement NIH’s mandatory Single IRB (sIRB) requirement for multi-site non-exempt studies, we have modified our PHIRST application. When you use the “Create Application” activity, the first screen will instruct investigators who seek to have JHU serve as an sIRB to go to the School of Medicine’s Reliance Request page. All other JHSPH investigators should complete a PHIRST application. Those investigators who seek to have JHSPH IRB rely on an external (non-Hopkins) IRB should answer “YES” to the new Question 13. The information you provide in Question 13 will allow us to complete our local review prior to providing a Letter of Support. The application will abbreviate so you will not have to complete all the usual pages. Please contact the IRB office at with any questions.

May 22, 2017

The IRB has posted FAQs explaining NIH’s new Single IRB (sIRB) mandate for U.S. based, multi-center, non-exempt human subjects research studies, and how we will handle this new requirement. Please review and contact the IRB office at if you have questions.

April 18, 2017

The IRB is posting a New Application IRB Operations Flow Chart to help explain what happens to new applications once submitted to the JHSPH IRB PHIRST System. We hope that this flow chart will be useful. Please contact with any questions or comments.

April 6, 2017

Effective January 25, 2018 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 other reliance requests will be managed by the IRB associated with the PI’s division.

Please contact with questions about the SOM IRB sIRB process.

March 8, 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 if you have questions.

January 26, 2017

The IRB has revised its Progress Report to help investigators comply with NIH requirements for GCP training (clinical trials), HIPAA training and clinical registration. We will ask the PI to confirm that the appropriate study team members have taken the required courses, and will ask that investigators who are registered in the PHIRST system upload their certificates of completion into their Profile pages. We will also ask the PI to provide the clinical NCT ID number to confirm that the study has been registered on clinical Please contact the IRB office if you have any questions.

January 20, 2017

Common Rule

The U.S. government has published its changes to the regulation known as “The Common Rule” governing Human Subjects Research. The IRB office is reviewing the new rule (all 543 pages) and will communicate information about the changes in the new few months. The rule goes into effect in 2018. The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at: It is expected that the final rule will be published in the Federal Register on January 19, 2017.

January 10, 2017

The U.S. Office of Human Research Protections has a new public outreach website that provides resources for potential volunteers, including some short videos. Study investigators and coordinators may find them useful for recruitment and consent processes. See:

January 2017

The IRB has been working to facilitate JHSPH investigator compliance with the new NIH requirement that all clinical trials staff and investigators, for both drug/device trials and social behavioral trials, complete GCP training. We are posting a new GCP page under “Training” that will provide FAQs and direct people to the appropriate training courses.