The JHU Homewood Institutional Review Board (HIRB) is charged with assuring that human participant research studies conducted at JHU Homewood, by JHU affiliated individuals, or studies specifically recruiting individuals affiliated with JHU comply with JHU policies and federal regulations designed to protect human participants. This charge extends to social and behavioral research conducted at certain institutions affiliated with JHU or research conducted by personnel of those institutions working elsewhere, specifically the School of Advanced International Studies (SAIS) Washington, DC, Bolonga, Italy, and Nanjing, China, and Peabody. Medical research should be reviewed by either the JHU School of Medicine IRB or the Bloomberg School of Public Health IRB on the East Baltimore campus.
Please note: Undergraduate students conducting research without “on the ground” oversight by the PI are only permitted to conduct research that meets one of the exempt categories that does not require a Limited IRB Review. See “For Student Researchers” below for further details.
All investigators and research team members must complete training in the protection of human research participants prior to submission of applications for HIRB approval. The Collaborative Institutional Training Initiative (CITI) offers a training module that can be completed online. Investigators should select the human subjects training that is most applicable to their research project, or, if unsure, should complete the Social/Behavioral Training module or call the HIRB to ask which training is the most appropriate. You do not need to complete the Responsible Conduct of Research Training for IRB purposes. Training is valid for five years. Please read the Homewood IRB CITI Training Instructions.
Documents & Resources for Investigators
Approval Process for Research Involving Institutional Data Sets
Johns Hopkins maintains data sets for its own institutional and compliance purposes in a number of domains that may be of interest to researchers. These data sets are often subject to laws or policies that are distinct from the Common Rule or HIPAA, or may be information that Johns Hopkins considers proprietary. In recognition of our role as a research institution, access to these data sets may be permitted for JHU researchers under protocols approved by a JHU Institutional Review Board (“IRB”), and with the additional review and approval of the offices outlined below for the various data categories. Access to these data sets is conditioned on researchers demonstrating appropriate data security practices, removing identifiers to the maximum extent practicable and requiring any collaborators outside of Johns Hopkins to enter into appropriate Data Use Agreements. Compliance with FERPA policies (if applicable), and the JHU Policy on Personally Identifiable Information must be demonstrated by the researcher requesting data access.
Please click here to identify the institutional party responsible for different data types.
APPs in the Research Setting: A Checklist for Researchers
Chart: What Needs to be Submitted to an IRB
Compliance with JHU’s Policy on Safety of Children in University Programs
When a human subjects research study produces knowledge or suspicion of reportable child abuse or neglect, JHU policy requires reporting to the local authorities and to the JHU General Counsel’s Office. If the report is about a Baltimore resident or occurs within the Baltimore jurisdiction, the PI should report the incident to Baltimore CPS and to the jurisdiction where the abuse alleged occurred (if different than Baltimore City). The full policy is located on the University Policies website.
Here are the standard instructions for reporting.
Data Use Agreements (DUA)
Where faculty are receiving or sharing human subject data as part of a research collaboration, they will need to ensure that an appropriate Data Use Agreement or other form of research collaboration or confidentiality agreement is in place.
Faculty-led research: All DUAs should be reviewed and signed by Johns Hopkins University Research Administration (JHURA) or Business and Research Administration Office (BARA).
Student-led research: DUAs are subject to JHURA or BARA signature when the research is sponsored through JHU or is intended to be submitted in satisfaction of a JHU degree requirement. Faculty PI mentors of the student’s protocol must also review these agreements as part of their mentor responsibilities, and they must also be reviewed and signed by JHURA or BARA.
Electronic Homewood Institutional Review Board (eHIRB)
eHIRB is a paperless, electronic method to submit, track, and review the scientific, regulatory, and compliance information required for the safe conduct of human subjects research at Homewood. The system provides a platform for the IRB and other research compliance committees to share critical information regarding the submission and review of new applications, amendments, continuing reviews, reportable events, and study closures.
Read Additional Electronic Homewood Institutional Review Board (eHIRB) Information
For Student Researchers
Undergraduate students conducting research without “on-the-ground” oversight by the PI are only permitted to conduct research that meets one of the Exempt categories that does not require a Limited IRB Review.
Note: A Limited IRB Review is required for certain types of Exempt Research if information obtained is recorded by the investigator in such a manner that the identity of research participants can be readily ascertained directly or though identifiers linked to the participants and disclosure of information outside of the research would be potentially harmful (risk of criminal or civil liability, damaging to financial standing, employability, educational advancement, and/or reputation) to participants.
All students conducting research without “on-the-ground” oversight of the PI are highly encouraged to contact the HIRB as soon as they start seriously considering their research topic. At this point, the HIRB can guide the student on the type of research that will fall into one of the exempt categories and will also guide the student on how to minimize risks to participants.
IRB applications involving student-initiated international research must be submitted to the HIRB at least 12 weeks in advance of the planned start date, although students are highly encouraged to contact the IRB well in advance of the 12-week period. Student-initiated international work submitted less than 12 weeks in advance of the proposed start date will likely not be approved by the IRB in time. Students should not make travel arrangements or purchase airline tickets until their IRB protocol is approved.
Please contact the Global Education Office if you are an undergraduate student who is thinking of studying abroad and conducting human subjects research.
See also the HIRB Guidance on International Research below.
Guidance on Class Projects
Guidance on Formative Research Activities
Guidance on International Research
Investigators conducting research in foreign countries may find the following resources useful when planning their IRB applications. Please submit applications for international research 12 weeks in advance of planned study implementation.
In addition, the following resources may also be helpful:
Guidance on Planning Phase Approval
Some research projects that will eventually involve human subjects research include an initial planning phase which will not involve human subjects. This document provides Homewood IRB investigators with guidance, compliant with 45 CFR 690.118, regarding the process for obtaining administrative approval for projects that immediate plans for involvement of human subjects, their data, or their specimens.
Guidance on Social Media
Please see attached for social media research.
Guidance Regarding Security of Custom Developed Mobile and Web Applications
Please see attached for social media research.
HIRB Glossary
This is a glossary of IRB-related terminology.
HIRB Standard Operating Policies & Procedures
The Homewood Institutional Review Board (HIRB) Standard Operating Policies & Procedures manual contains guidelines for the operation of HIRB. HIRB is the central component of the Human Research Protection Program (HRPP) for those divisions within Johns Hopkins served by HIRB. The manual is an important resource for HIRB and HRPP members, investigators, and HIRB staff.
Please note that the Policies and Procedures manual is currently under revision, but a previous version is below.
Homewood IRB CITI Training Instructions
All faculty, staff, and students who conduct human subjects research must complete the CITI training. In addition, Homewood IRB members must also complete CITI Training. Please read the instructions so you take the correct CITI training.
Privacy Law Basics (2021)
Please review the attached slidedeck for training information about privacy law basics for research access to identifiable data.
Procedures for Paying Research Participants
This document outlines the procedures for paying research participants.