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Institutional Review Board

Institutional Review Board

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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 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: https://humansubjects.nih.gov/coc/NIH-funded.

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 jhsph.irboffice@jhu.edu 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:  http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/upcoming_training.html.

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 jhsph.irboffice@jhu.edu 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 jhsph.irboffice@jhu.edu 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 jhsph.irboffice@jhu.edu 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 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 jhsph.irboffice@jhu.edu 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

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: 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.

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.