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.
- Student Projects
- The JHSPH Ethical Code for Student Activities that Involve Human Interactions
- IRB Office Determination Request Form for Secondary Data Analysis
- IRB Office Determination Request Form for Primary (New) Data Collection
- Student IRB Manual
- Student FAQs
- Submitting a new PHIRST (Public Health Institutional Review Submission Tracking) Application for human subjects research activities
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 firstname.lastname@example.org 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 email@example.com 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 firstname.lastname@example.org 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 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 (email@example.com) or Homewood IRB 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.
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 firstname.lastname@example.org 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 trials.gov 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 trials.gov NCT ID number to confirm that the study has been registered on clinical trials.gov. Please contact the IRB office if you have any questions.
January 20, 2017
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: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects. 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: https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.html.
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.
“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 http://intranet.insidehopkinsmedicine.org/data_trust/research-data-requests.html. Contact the JHSPH IRB office if you have questions.”
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.
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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html). 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.
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 email@example.com. Thank you!
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.
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. Check it out! See: https://humansubjects.nih.gov/. “
The JHU School of Public Health IRB is posting the PHIRST (Public Health Institutional Review System Tracking) User 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:
- The PHIRST registration process
- An overview of the submission and review process
- Basic methods and terms you need to know to create and submit electronic IRB applications