What's New | Johns Hopkins | Bloomberg School of Public Health

What’s New

January 26, 2024

Johns Hopkins Libraries is hosting Love Data Week, a virtual series of events related to data collection and management running Feb 12-16. Please consider participating in this useful and important event!

December 18, 2023

Effective January 1, 2024 investigators with studies where the BSPH either relies on another IRB or requests that another institution rely on the BSPH must complete the CITI Single IRB training (https://publichealth.jhu.edu/offices-and-services/institutional-review-board-irb/training.) Requests for documentation of training will be processed at the time of an initial reliance request or when an amendment requesting entry into a reliance agreement is submitted. Please contact the IRB if you have any questions about this process.

November 8, 2023

Johns Hopkins ISCRO Policy and MyLearning Module Update

Join the Johns Hopkins Institutional Stem Cell Oversight (ISCRO) administrator and Interim ISCRO Co-Chairs for a discussion of the 2021 updated Stem Cell Research Guidelines published by the International Society for Stem Cell Research and the revisions made to JHU ISCRO policy and procedures to align with these new guidelines. An overview of the revised ISSCR guidelines will be presented and updates to the ISCRO policy, website, and training related to these new guidelines will be shared. Researchers who submit applications subject to ISCRO review or who may do so in the future are encouraged to attend. Each session will feature a live Q&A session.

All sessions will be held virtually and may attend either session.

Tuesday, November 28, 2023, 1:00 – 2:00 pm EST
Thursday, December 7, 2023, 9:00 – 10:00 am EST

https://jhjhm.zoom.us/j/3232936751?pwd=Z0FZREhtU2dEbGY1dWlxbTJSL0kvQT09

November 2, 2023

With the upcoming holiday season, please see the IRB's holiday meeting schedule and plan submissions accordingly. If you have a protocol expiring the week of Thanksgiving or the first week of January you must submit at least two weeks early and contact your IRB analyst to ensure that it is reviewed.

Week of Nov. 20: IRB X 11/21 meeting cancelled, IRB FC 11/22 meeting will be held to process urgent requests (e.g. expiring continuing renewals, problem events, etc). All submissions for this meeting must be received by 11/17.

Week of Dec. 18: IRB X 12/19 and IRB FC 12/20 meetings will be held to process urgent requests (e.g. expiring continuing renewals, problem events, etc). Submissions for these meetings must be received by 12/15

Week of Dec. 25: University holiday - No IRB meetings

Week of Jan. 1: IRB X meets 1/2, IRB FC meets 1/3. Because the University is closed the previous week, any submissions for these meetings must be received by 12/21 to be assigned and prepared.

Thank you, and have a safe and healthy holiday season!

August 23, 2023

Our website is having some issues which we are working on. If there is any document you may need please contact us at bsph.irboffice@jhu.edu. We appreciate your patience and apologize for any inconvenience this may cause.

June 22, 2023

IRB-X will not meet on Tuesday, July 4^th, 2023 due to the holiday.

March 16, 2023

IRB X will not meet on April 18, 2023, due to IRB Board training.

January 24, 2023

NIH now requires researchers to submit data management and sharing plans with their grant proposals, which Data Services offers expertise on.

Please visit Data Services at NIH Data Management and Sharing Plan Support page or contact dataservices@jhu.edu to schedule a consultation. Please also visit this link for more information about resources available for support.

January 23, 2023

The IRB has combined the student IRB Office Student Determination Request Forms into one form for both primary data collection and secondary data analysis. Please see the new form here: BSPH IRB Office Student Determination Request Form.

December 8, 2022

The IRB is posting three articles on its guidance page to help investigators think through ethical issues associated with working with Adolescents and in Emergency settings with diplaced people, The article on conducting research and programming wtih Adolescents (Ethics in Research and Programming with Adolescents: Caputre the Perspectives of International Organizations) was generated by the Global Early Adolescent Study (GEAS) under Bob Blum's leadership. The BSPH IRB worked with this report and collaborators at GEAS to produce the Ethical Social/Behavioral Research with Adolescent Participants. The Guide to Ethical Conduct of Research on Child Marriage in Emergencies, Robinson et. al, includes information about conducting research in settings where local IRBs may not exist. We hope this information will be useful.

November 14, 2022

Please see the IRB's holiday meeting schedule:

Week of Nov. 21: IRB X meets 11/22, IRB FC 11/23 meeting cancelled

Week of Dec. 26: No IRB meetings

Week of Jan. 2: IRB X 1/3 meeting cancelled, IRB FC meets 1/4

Thank you, and have a safe and healthy holiday season!

September 28, 2022

There is a change for the BSPH registration of clinical trials on clinicaltrials.gov. The School of Medicine group responsible for clinicaltrials.gov registration will also assume responsibility for BSPH clinical trials. Please see: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/clinical_trials.html for help in registering your clinical trial on clinicaltrials.gov.

August 29, 2022

BSPH investigators who will be involved in Animal Research may access the CITI course "Working with the IACUC" through the BSPH CITI account. Go to CITI to take courses

August 25, 2022

For JHU investigator-held INDs and IDEs, there is a new JHM website explaining how the new regulatory program operates. Please see: Investigational New Drug (IND)/ Investigational Device Exemption (IDE) Regulatory Program (hopkinsmedicine.org)

July 8, 2022

The IRB has posted a link to the new JHU Investigator-Held IND/IDE policy on its website for easy access. It describes the process for JHU investigators who wish to be the IND/IDE holder of FDA regulated products in investigational clinical trials.

June 21, 2022

The IRB has updated its sIRB and Reliance Agreement information on the website. Please visit this page and review our FAQs.

April 22, 2022

The IRB has created a new guidance to provide information on research that does not need IRB oversight. Please review the NHSR/NE for these details.

April 14, 2022

The Human Subjects Research Restart Committee volunteers responded to COVID by meeting weekly since July, 2020, to review plans designed to protect research staff and participants from COVID transmission. We celebrate the members of this group and their unselfish dedication and commitment. At this time, we have now decided to disband the Committee, as researchers are more aware of COVID risks and the variability of those risks across the world. To replace the HSRRC effort, the BSPH IRB will add a question to the Risk section of the Research Plan asking the Principal Investigator to consider the protections that need to be in place; investigators will no longer need to submit the separate Safe HSR Protocol Plan.

March 11, 2022

New Position in the BSPH IRB! Tobey McGuiness is your new IRB Navigator in the BSPH IRB. This is a new position, created by the Vice Dean for Research, and is a customer-focused position, with specific emphasis on helping students navigate the procedures, and assisting faculty with their first-time submissions or with particularly complicated protocols.

Reach out for help with your IRB submission: IRBNav@jh.edu.

December 7, 2021

IRB X will not meet on January 4 because of the JHU holiday schedule. The IRB staff and IRB members will not be working between Christmas and New Year's. Please be patient as new application processing will be delayed.

November 10, 2021

As the holidays approach, please note that the JHSPH IRBs will not meet the week of Thanksgiving (Nov. 22-) nor the week between Christmas and New Year's (Dec. 27-). Happy holidays to all JHSPH faculty, staff, and students from the JHSPH IRB!

October 22, 2021

The HSRRC has revised the Covid 19 Isolation Procedure for Staff to clarify procedures when vaccinated and unvaccinated staff have had an unprotected known exposure and are asymptomatic for Covid. Please refer to this guidance when writing your Safe HSR Protocol Plan."

October 15, 2021

New Data Protection Attestation Improves Access to JHM Limited Data Sets and Eliminates Data Use Agreements: The JHM Data Protection Attestation available here outlines expectations for the protection of patient data and serves as a data use agreement to enable the sharing of limited data sets among JHU researchers outside of JHM. Now, when a PI submits a New Application or Amendment in PHIRST, and when study team members “agree to participate”, researchers commit to follow the terms of the Data Protection Attestation. This new change eliminates the need to execute a DUA through JHURA for most transfers of a limited data set to JHU collaborators outside of JHM.

October 7, 2021

The IRB has updated its Instructional Research Plan Template to help investigators understand what the IRB looks for when reviewing submissions. Please use this tool as a guide.

September 30, 2021

Please see the updated Instructional Template for the Research Plan for New Data Collection to help you draft your research plan.

September 17, 2021

The IRB has updated its Research Plan for New Data Collection and Research Plan for Secondary Data Analysis, and the principal change is in the Data Security section. Please use these new templates for all new submissions.

August 16, 2021

The IRB Office is working remotely. Please send general questions to: jhsph.irboffice@jhu.edu and PHIRST questions to: jhsph.phirsthelp@jhu.edu.

May 28, 2021

Please note that the IRBs will not be meeting the week of May 31, 2021. They will resume their weekly meetings the week of June 7. Thank you.

March 24, 2021

The IRB has added information about CLIA to its guidance page. Please review and send any questions to jhsph.irboffice@jhu.edu.

March 17, 2021

The JHSPH IRB has updated its FAQs. The document is hyper-linked, so you can search for your topic and then click right to it. Please send questions to jhsph.irboffice@jhu.edu if there are topics that you would like us to add.

March 3, 2021

The Human Subjects Research Restart Committee (HSRRC) is posting an algorithm to help study teams. COVID-19 Isolation Procedures for Research Staff outlines what isolation procedures study team members who are symptomatic or asymptomatic should follow depending whether there is a known COVID exposure or not. Please review and use when drafting/revising your Safe HSR Protocol Plan.

February 16, 2021

The JHU IRBs have worked together to clarify what formative/pre-clinical/pilot work requires IRB approval prior to beginning. We have updated our flowchart, called “What Needs Submission to the JHSPH IRB?” and are posting more information under the Guidance, “Submitting Formative/Pre-Clinical/Pilot Work to the JHU IRBs”. Please review and send any questions or concerns to jhsph.irboffice@jhu.edu.

November 16, 2020

Thanksgiving week is a “no meeting" week at JHSPH. IRB X, IRB FC, and the HSRRC will not meet. Please take that into account when planning your human subjects research submissions. Additionally, these committees will not meet the last week in December. We hope everyone benefits from this no meeting break and has a safe and relaxing Thanksgiving weekend.

November 6, 2020

The JHSPH IRB and HSRRC are working closely together to better coordinate reviews of New Applications and Amendments that involve in person research activities. PIs should upload the Safe HSR Protocol Plan with the New Application/Amendment documents and ensure that the research plan is consistent with the proposed activities outlined in the plan. The IRB Staff will send the Plan to the HSRRC for review, and once approved by the IRB and the HSRRC, both approval letters will be uploaded into the submission when final. Ongoing studies that need HSRRC review should continue to use the "Other Administrative Submission" vehicle in PHIRST to submit their Safe HSR Protocol Plan for HSRRC review. Please consult the information on the COVID 19 & HSRRC page for more information.

October 26, 2020

The JHU IRBs worked with JHSPH IT and JHU IT on a Guidance Regarding Security of Custom Developed Mobile and Web Applications to make clear the standards required for such tools. All research that involve the use of mobile or web apps for data collection will undergo JHSPH IT review in accordance with these standards. Please let us know if you have any questions.

October 23, 2020

The CITI Training platform offers a course called “COVID-19: Back to Campus 2020-2021 and Remote Contact Tracing". This course is available to JHSPH investigators through the JHSPH institutional account. Feel free to use it for staff training. Use this “How to Access the COVID-19: Back to Campus" course guide to help you choose this CITI offering.

October 7, 2020

The IRB Office is removing the old Common Rule consent templates from its website, leaving only the Revised Common Rule templates.

September 30, 2020

JHSPH Office of Facilities Management has developed a process for ordering PPE to help faculty obtain the PPE stock (hand sanitizer, faceshields, etc.) needed for research activities. Please see the letter of September 24 from the Office of Facilites Management describing the steps for ordering PPE stock from the Facilities Service Request Center and the PPE Order Form titled "CSC JHU Research Managed Stock Order Form".

September 22, 2020

The HSRRC is posting two excellent Safe HSR Protocol Plans for faculty to use as models for other faculty. Please see them on the COVID-19 Information & HSRRC page.

September 15, 2020

JHSPH has posted a new school in-person restart guidance called "Safe Research & Practice Restart Resource" on an internal Sharepoint site. The guidance covers laboratory research, human subjects research, practice activities, and on-campus activities in general. It describes a review process for in-person public health practice activities. Please look it over.

September 14, 2020

The IRB is posting the CDC guidelines on "Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19" to assist investigators with their Safe HSR Protocol Plans.

September 9, 2020

The HSRRC has reviewed a number of Safe HSR Protocol Plans over the past 6 weeks and notes that some investigators include guidance following the WHO social distancing recommendation of 1 meter. Recent data shows that 2 meters is better than 1 meter: see https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931142-9.

In addition, sourcing face coverings does not seem problematic in most parts of the world. However in those regions where it is difficult, creating a face covering is much safer than having none. See the CDC guidance on making a face covering: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-to-make-cloth-face-covering.html.

August 20, 2020

As the JHU Return to Research Guidance is implemented, the IRB wants to clarify and distinguish JHSPH requirements. Please go to the COVID 19 Information page for FAQs and other information.

JHSPH Requirements

1. Recording and Reporting Changes and Decisions During Emergency Response Period

For all studies approved for active data collection between March, 2020, and June, 2020, the JHSPH IRB did not require investigators to submit amendments reporting changes in data collection from in person to remote data collection. It is important to record and report the actions taken during this time and when. The IRB requires investigators submitting PHIRST2.0 Continuing Review/Progress Report for studies actively collecting data from human subjects to upload a Research Record for Changes in Response to COVID19 as part of their response to Question 8.

All studies that made changes without submitting an amendment, and which will go forward with procedures not currently described in the research plan, should be formally amended in PHIRST 2.0 so that the research plan reflects current data collection activities.

2. Human Subjects Research Restart Committee (HSRRC)

The Bloomberg School has established a Human Subjects Research Restart Committee (HSRRC) which is responsible for overseeing plans for all research studies that involve in-person research activity. HSRRC started reviewing submitted Safe HSR Protocol Plan Forms in mid-July. The details about this process are described in the Safe HSR Resumption FAQs on our COVID 19 Information page.

August 4, 2020

JHU leadership has approved a revised JHU Return to Research Guidance on July 22, 2020. The guidance has expanded the research activities permitted in Phase 1 to include "Observational or other minimal risk studies where ALL in-person procedures occur during routine standard of care clinical visits and have minimal participant interaction in terms of duration or activity (e.g., collection of blood or other biospecimens, research quality vital signs).

Greater than minimal risk studies of limited or no direct benefit to study participants may resume in this phase, but excluded from this phase are studies that involve: 1)high-risk, aerosol- generating procedures (such as Sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise test) or 2) research participant group activities (greater than one research participant plus a parent or LAR not sharing the same household seen at one time)."

Investigators seeking to resume Phase 1 in-person activities must submit a SAFE HUMAN SUBJECT RESEARCH (HSR): PROTOCOL PLAN FOR IN-PERSON RESEARCH ACTIVITY for HSRRC review and approval prior to initiating those activities.

July 21, 2020

JHU has updated its Return to Research Guidance (July 14, 2020). Please review Part V, pages 15-17, which address human subjects research activities.

July 16, 2020

The Safe Human Subjects Research Resumption Committee (HSRRC) is posting Safe HSR Resumption FAQs on the IRB's COVID 19 Information page. Investigators wishing to resume in person data collection activities must check the JHU Return to Research Guidance to identify activities that are allowed to proceed, and submit their Safe HSR Protocol Plan form as directed. Only studies that are active in the PHIRST system may submit the plan as an "Other Administrative Submission". Please review the FAQs and send questions to the jhsph.irboffice@jhu.edu email box.

July 8, 2020

Dear faculty, staff, postdocs and students involved in human subjects research,

With the relaxation of COVID-19-related restrictions at the state and local levels, JHU has proceeded with a relatively smooth restart to on-campus laboratory research over the last few weeks. Although some human subjects research (HSR) may be conducted remotely, many studies need to perform in-person assessments in order to collect biological samples or perform clinical measurements. University guidance delineates a phased approach to restarting human subjects research with the safety of study participants and of research team members as a guiding principle. Currently, besides COVID-19-related studies, only therapeutic or interventional HSR studies of direct benefit to study participants conducted at Johns Hopkins facilities are allowed under current phased guidance (See pg. 16). However, we continue to work with the University to advance re-engagement in the safe conduct of human subjects research both locally and globally, and anticipate broader resumption of HSR activity shortly.

Safe HSR Restart

In anticipation of broader HSR activity restarting soon, the Bloomberg School has developed a process for research teams to describe their plans for safely restarting direct, in-person interactions as part of their study protocols. PIs and research teams will need to develop a specific restart plan which systematically addresses issues of safety, including:

· Providing a safe and supportive research experience for our research participants

· Screening for COVID-19 symptoms of staff and participants

· Adapting study work flow to allow physical distancing and reduced density in the work environment

· Assuring the availability and appropriate use of personal protective equipment (PPE)

· Adhering to appropriate cleaning and disinfecting standards

This process, which we have termed Safe HSR Restart, will have all protocol plans undergo a timely review at the school-level. The Human Subjects Research Restart Committee (HS-RRC), comprised of faculty representatives with HSR expertise and from both administration and facilities management, is responsible for review and approval of all protocol plans for HSR studies that involve in-person research activities. PIs should not resume in-person activities until their protocol is approved by this committee.

Protocol Approval Process

· Each HSR study protocol must obtain specific approval for resumption of in-person data collection. The PI must submit a Safe HSR Protocol Plan form through PHIRST2.0. While the submission, review and notification process will be administratively handled through PHIRST 2.0, the review will be performed by the HS-RRC.

· PIs must complete the Safe HSR Protocol Plan and upload the form along with any other required documents to PHIRST2.0 as an “Other Administrative Submission”.

· IRB staff will triage submissions to assigned HS-RRC reviewers, whom may send questions or concerns to PIs through the PHIRST2.0 system. Convened meetings of the HS-RRC will occur twice weekly with rolling approval of protocol plans.

· Once the plan is approved, PIs will be notified through the PHIRST2.0 system.

· PIs may begin in-person study activities as soon as they receive approval.

· PIs do not need to submit an IRB amendment to revise research plans to incorporate the COVID-19 mitigation procedures included in their Safe HSR Restart plan.

· However, some studies may also need to substantively change the data collection or other study procedures described in their currently approved research plan in response to the ongoing pandemic situation. For example, if PIs research plan includes only in-person data collection activities (which were paused during the Emergency period) and now would like to collect data both in-person and using remote procedures, a separate IRB Amendment Application is required. Amendments will undergo typical IRB review and approval. Please note that these review processes are separate and PIs will receive separate approval notification for each.

International HSR studies

· JHSPH faculty lead research studies on countless topics with study participants around the world. While COVID-19 represents a global pandemic, the intensity of transmission and risk mitigation procedures vary widely. Approval of international studies will not be tied to the stage of the pandemic and return to on-campus activities in Baltimore, but instead will consider the local context of the study site.

· Each study protocol regardless of location must complete the Safe HSR Restart plan. The HS-RRC includes faculty with long-standing expertise in global research.

· In collaboration with local partners, PIs of international studies will need to describe the local context of the pandemic and how their study will ensure safety of staff and participants, including reference to any mitigation procedures recommended by local IRB’s or other authorities.

· Basic PPE, including cloth face coverings and in some cases clear face shields which can be readily constructed from widely available materials, will be required for Hopkins HSR studies irrespective of location.

We are working to update the JHSPH IRB website with resources to assist investigators in developing their Safe HSR Restart plans, including providing answers to Frequently Asked Questions regarding the process. Please check the site regularly for these materials and for updated guidance.

I would like to thank Joan Pettit and the IRB team for their support of this process. We also are extremely appreciative of those faculty whom provided vital input on the Safe HSR Restart planning process and for their participation and commitment to reviewing protocol plans as part of HS-RRC. Finally, thanks for the substantial patience and flexibility of our HSR research teams over these difficult past few months. We look forward to partnering with you all to ensure a Safe HSR Restart and productive return to in-person research activities with our study participants.

Best,

Greg

Gregory D. Kirk, MD, MPH, PhD

Vice Dean for Research

Professor of Epidemiology, Medicine & Oncology

Johns Hopkins Bloomberg School of Public Health

June 29, 2020

The IRB is changing the frequency of annual review for studies that involve data analysis only. We hope this change will reduce burden on investigators. Unless there are other factors involved, such as the sensitivity of the data or concerns about security, the following studies will have a 3-year interval between Progress Reports:

Exempt Cat. 4 and Expedited Cat. 5 studies may have a 3-year period between Progress Reports. Exception: Repositories
All studies, from IRB X and IRB FC, that reach “data analysis only" status may have a 3-year continuing review period. Note: Data Coordinating Centers require annual review.

June 17, 2020

The IRB is posting a new guidance, FAQs for Remote Data Collection. It provides information about tools and data security practices for safe data collection and storage. Please review and send any questions to jhsph.irboffice@jhu.edu.

June 3, 2020

As investigators revise studies to include remote data collection as a study procedure beyond the "emergency" phase of the COVID 19 response, please address the privacy and security protections you will provide to study participants. This guidance will help you consider those issues: https://livejohnshopkins-my.sharepoint.com/:w:/g/personal/kparris1_jh_edu/ERuQfp34BztPnt43etb2QcEBvFbiwMTlt9H9GkA_ztT86A?rtime=uj0gcxwH2Eg.

May 21, 2020

The JHU IRBs have developed consent language for studies that involve payment to participants using Venmo while we are under COVID restrictions. Please add the following to the payment information in your consent forms:

"The use of Venmo as a payment option allows remote payment to help protect the safety of participants and the research staff. Venmo may collect personal information (first and last name, email address, phone numbers, bank account information) that is needed to pay you for participating in the study. There are some security protections needed to make sure your personal information is protected. "

2. Under "Paying Research Participants Using Venmo", add a 4th item:

Please use the following consent language for the Payment section of your consent form:

May 5, 2020

Investigators who use research Mobile Apps to collect data must make sure that participants understand that the App is not a clinical tool or otherwise publicly available. The IRB is revising its research plan to ask investigators if:

o Use of the app is restricted to people in the research, with access limited to those who have consented to the study.

o The consent information for participants clarifies that the app is not for clinical or public use but is restricted to this research study.

April 21, 2020

JHU has approved the use of Venmo as a temporary measure to allow remote payment for research participants during the COVID Phase restrictions. Please review both Guidelines and the Acknowledgement form we are posting on our COVID-19 Information page.

April 16, 2020

Clarifications to investigators from the JHSPH IRB regarding changing study procedures from in-person to remote contact:

1. Although the IRB is not requiring PIs to submit an Amendment for changing procedures from in person to remote data collection, if you need to revise your consent form or your recruitment and enrollment materials (and need watermarking), please submit an Amendment for these changes. All changes not approved by the IRB must be reported with your Continuing Review/Progress Report.

2. Be sure to document all changes you make in response to COVID19. To assist investigators in that effort, the IRB is posting a brief Guidance for Investigators on Recording Protocol Changes Made in Response to COVID 19 on our COVID19 webpage. Please document your changes and upload this form with your next Continuing Review/Progress Report.

3. If you introduce Zoom as a tool for data collection, be sure to use the password-protected mechanism now available as it is more secure. Also, do not record your Zoom sessions (audio or video) without specific IRB approval.

Please send any questions to jhsph.irboffice@jhu.edu. Thanks, and keep up the good work!

April 2, 2020

The JHU Hub COVID Preparedness Human Subjects Research Page (https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/) has new updates about how Tier 1 and Tier 2 studies will be handled. Please check regularly to keep informed.

March 27, 2020

Please see on our COVID 19 page new consent language for studies testing investigational drugs, devices and diagnostics, that limit a participant's ability to sue if harmed through a COVID 19 study.

We have also posted a new FAQ that provides COVID 19 information for participants and also lists mental health and other resources for U.S. based studies, focusing on the Baltimore area. Studies conducted internationally and outside of Baltimore may use this FAQ as a guide to what resources to think about and look for.

March 25, 2020

The IRB is functioning remotely. Please review the following updates:

1. All new applications and amendments that involve remote data collection and/or secondary data analysis will be processed normally. Remote contact with participants must be secure and be careful not to disclose confidential information or the nature of the study to other people who may have access to the participant's phone or computer.

2. The IRB will review new applications that involve direct person-to-person contact and will issue approval letters but those letters will inform that direct enrollment and study activities may not proceed until restrictions are lifted. The IRB will not release stamped consent forms and recruitment materials until that time.

3. No additional amendments may be submitted until restrictions are lifted and documents are released. Consider waiting to submit these amendments.

4. The IRB is prioritizing COVID-related studies.

March 20, 2020

The IRB website now has a page called "COVID 19 Information" which will update researchers on the JHU information related to human subjects research. Please visit this page to look for updates and new resources.

March 17, 2020

JHU leadership has been coordinating efforts to provide researchers with information about human subjects research and COVID 19. They have created a Tier Plan which categorizes research studies into 3 Tiers, with the understanding that as COVID 19 conditions progress from Phase 0 through Phase 3, study activities will reduce or pause depending upon the Tier. Please bookmark this link to the JHU Research Preparedness page, and check it frequently: https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/. There is an additional guidance focusing on international research here: https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/human-subject-research-international-supplemental-guidance/. Researchers may have to adapt their studies to adapt to the COVID 19 conditions and local requirements at their research sites.

What should researchers do now?

Consider your protocol in light of the JHU Tier Plan published above and decided which Tier it falls into and how the COVID 19 Phase affects that study. Today (March 16), the U.S. is considered to be in Phase 2. If your study is outside the U.S., work with your local partners to determine how to proceed.
JHU is directing all researchers to execute emergency changes in study activities, including pausing study activity and modifying direct interactions with participants, in response to the COVID 19 state of emergency and local health care directives. If you abide by the JHU Tier Plan, you do not need to submit an Amendment for IRB approval prior to implementing these emergency changes. Document the changes and report them on your next Continuing Review/Progress Report as Protocol Deviations required under the JHU Tier Plan in response to the COVID 19 emergency.
All changes to your research unrelated to the JHU Tier Plan must have IRB approval prior to implementation.
You may use without submitting an Amendment two Research Participant Communication documents to help explain the pausing of study activities and the risk of COVID 19: Changes to Research Participation due to COVID-19, and Important Information about COVID-19 and Research Participation .
If you have questions about your study, send an email to jhsph.irboffice@jhu.edu.

Please review materials on the one drive and consider sharing your COVID related study materials as well: https://livejohnshopkins-my.sharepoint.com/:f:/g/personal/kparris1_jh_edu/Ek1V__sQqK1GtQc5x0pGokoBc7FWAjE5nc23_r5tuHUfwg?e=uuPmZ0

March 13, 2020

Dear colleagues,

As we confront the novel coronavirus pandemic, we have to balance continuing research with the risk to our students, staff and faculty and to our study participants. We are entering uncharted waters with personal and work disruptions only likely to increase. During recent days, this rapidly evolving environment has prompted numerous questions from research teams and generated frequent guidance (albeit with a short expiry date in terms of relevance).

This communication is intended to provide key messages relevant to on-going research activity, and then provide linkages to the substantive resources that have been accumulated.

Research activity has not been halted, but pro-active preparations for substantive interruption should be underway. Plan NOW to do as much as possible remotely!
Lab-based research teams should defer longer-term experiments, make preparations to ensure stability of equipment and resources, and plan for performing staggered experiments to limit personal contact
Research Animal Resources (RAR) is in direct contact with labs doing animal research; Contingency Plan Phase 2 will be implemented on Monday, March 16 which among other recommendations involves the identification of critical animals to be maintained
All human subjects research studies should actively screen study participants for the presence of exposure to or symptoms of novel coronavirus; Implementation of screening does not require prior IRB approval
Protection of research subjects, especially those vulnerable older or comorbid patients, should be strongly considered when deciding whether to defer study visits
Research teams should develop alternative data collection methods (phone, video-conferencing, web-based surveys) as appropriate for capturing critical data from participants; Protocol changes such as these DO require prior IRB approval
IRB functioning is transitioning to fully remote work with no anticipated reductions in productivity; Protocol changes in response to COVID-19 will be reviewed as expeditiously as possible

We provide annotated JHSPH Research Preparedness Resources to assist research teams in navigating these steps on a OneDrive folder.

Importantly, we provide linkages to the substantive guidance provided by our School and to Institutional and SOM guidance. We also provide additional resources including study-specific examples of posters, signage, screening procedures etc. If you're willing to provide your resources in response to COVID-19 with our research community, please forward them to Katherine Frey (kparris1@jhu.edu). Many of these materials will be continually updated, so please check back frequently to get the most up-to-date information.

We remain confident that the BSPH response will be adept and appropriatel to deal with the COVID-19 disruptions. Thanks for your attention and dedication as we work together to ensure that our research activities remain well-positioned to respond to interruptions and bounce back as strong as ever.

Best, Greg

March 11, 2020

The JHSPH IRB has worked with the other JHU IRBs to create a guidance for investigators. Please see: Coronavirus and Johns Hopkins Human Subject Research. We anticipate providing more information in the near future. Please also see preparedness information on the JHURA website: https://research.jhu.edu/jhura/about-us/jhuranews-2/.

February 28, 2020

Starting March 16, 2020, the IRB office will return email submissions of Administrative Amendments, and Continuing Review/Progress Reports; it will accept only email submissions of Final Study Reports. Please complete your "shell" applications in PHIRST2.0 following the instructions provided in our User Guide on Completing Study Shells and submit them through the system for activation. Once activated, all future submissions for your study will be through PHIRST2.0. Contact jhsph.irboffice@jhu.edu.

January 28, 2020

The JHU IRBs worked together on Guidance for International Research and an Investigator Checklist for Human Subjects Research in International Settings. These tools aim to help researchers anticipate and plan for the complex issues associated with research overseas. We welcome your feedback

January 24, 2020

Cooperative Agreements and Single IRB -As of January 20, 2020, most human subjects research involving more than one institution, and funded by federal cooperative agreements, must rely on the approval of a Single IRB for that portion of the research that is conducted in the U.S. Please consider this requirement when formulating your grant proposals.

January 23, 2020

The Baltimore City School System has decided to limit research in its schools as follows:

The Baltimore City Schools IRB is not accepting:

Case studies and qualitative studies that utilize a single method of data collection (e.g., survey or interview)
Studies that do not address student or staff outcomes beyond satisfaction or opinion
Graduate theses, projects, or dissertations for non-City Schools employees

https://www.baltimorecityschools.org/research-and-data-requests

January 7, 2020

The new PHIRST system provides a mechanism for submitting Amendments and Administrative Amendments for studies that are active in that system. Please follow the posted User Guide for Completing Study Shells to submit your currently approved study to the IRB for activation in the PHIRST2.0 system. If you need to submit Amendments before your study is active in PHIRST2.0, the IRB will accept email submissions as it has been doing. The IRB will stop accepting email submissions of all types in March, 2020. Principal Investigators must complete their study shells by then so that all future Amendments and Continuing Review/Progress Reports, etc., will be submitted electronically in the PHIRST2.0 system.

January 6, 2020

The IRB's launch of PHIRST2.0 is proceeding well, though we are finding a number of minor issues that we will address one by one. All active studies approved before Dec. 10 have "shell" applications that need to be made active before March 1, 2020. We will not accept email submissions after that date. Please refer to the Completing Study Shells User Guide posted on our website, and contact the IRB office at jhsph.irboffice@jhu.edu for assistance

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 jhsph.phirsthelp@jhu.edu 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

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 jhsph.irboffice@jhu.edu 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.