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, Bologna, Italy, and Nanjing, China), Carey Business School, Peabody Institute, and School of Government and Policy.
Medical and clinical research should be reviewed by either the JHU School of Medicine IRB or the Bloomberg School of Public Health IRB.
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. Please visit the HIRB’s Training & Education page for information 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.
Documents & Resources for Investigators
Ancillary Reviews
In some cases, HIRB requires studies to undergo ancillary reviews to assure that research activities are conducted in compliance with institutional and/or regulatory requirements.
Ancillary reviews take place concurrently with IRB review, after HIRB staff members have completed the administrative Pre-Review process. Ancillary reviews may be triggered by certain selections within the study application in eHIRB; they may also be triggered manually by HIRB staff based on information a study team provides in the application.
Ancillary review teams are provided with a dedicated workspace in eHIRB where they can review and record outcomes related to their respective review processes. HIRB provides training and guidance to ancillary reviewers as needed to aid in review completion. If an ancillary reviewer reaches out to a study team via email or through the eHIRB platform with questions about a study or requested alterations to a specific aspect of the protocol, the study team should communicate directly with the relevant ancillary reviewer as needed to provide additional information and/or resolve outstanding concerns.
Ancillary reviewers aim to complete reviews and work with study teams to resolve questions and concerns related to their specific areas of focus within two weeks of receiving notice of the application. However, the review timeline may vary based on the complexity of the study and the specific issues relevant to the project.
HIRB Ancillary Reviews
| Review | When is this review required? | Review focus areas/goals |
|---|---|---|
| Homewood Conflict of Interest and Commitment (HCOI) | Required when a research application indicates that any member of the study team has a financial or economic interest (e.g., royalty, equity, consulting, employment) or fiduciary relationship (e.g., board service, office role, director role) with the sponsor and/or manufacturer of products used in the research or with an outside entity whose financial interests could reasonably appear to be affected by the research. | Review focuses on management of conflicts of interest/conflicts of commitment and compliance with relevant federal regulations and institutional policies. |
| International (or I-Team) Responsible Parties: Offices of General Counsel, Export Control, and University Tax | Required when the research proposes recruiting participants internationally, and/or when the research will take place at an international site. | Review focuses on legal, tax, and export control/sanctions issues when research is proposed in an international setting. |
| Laboratory Safety Responsible Party: Johns Hopkins Medicine & UniversityHealth, Safety & Environment | Required when the research will take place in a lab at the Krieger School of Arts & Sciences (KSAS) or the Whiting School of Engineering (WSE). | Review focuses on health and safety hazards relevant to the subjects of the research (beyond the review conducted by HIRB); and laboratory and other experimentally-related hazards related to the conduct of the research by researchers (i.e., threats to the experimenter). Hazards addressed are those relevant to the entire experimental lifecycle, from conception and acquisition of materials and equipment; through setup, conduct, and teardown of experimental apparatus; and disposal of equipment, chemicals, cultures, etc. |
| Provost’s Office Responsible Party: Institutional Risk Management (IRM) | Required when the research proposes recruiting JHU affiliates (students, faculty, or staff) as participants, and/or when the research proposes using institutional data. | Review focuses on specific risks, notably: recruitment of employees or students; topics that would benefit from coordination with certain university or school offices; and factors that could inadvertently pose legal, financial, and/or reputational risks. The review goal is to set up processes that manage risk, not restrict the research itself. |
| Office of the University Registrar (OUR) | Required when the research will utilize JHU student education records. | Review focuses on compliance with the Family Educational Rights and Privacy Act (FERPA) and adherence to institutional policies and procedures related to the use of student education records. More information is available on the OUR website’s FERPA Information for Researchers page. |
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 (DUAs). Compliance with FERPA (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) .
Student-led research: DUAs are subject to JHURA 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.
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 Expectations for Sharing Individual Level Research Data
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 Fraud Prevention Regarding Use of Survey Instruments
Investigators planning to use survey instruments in Johns Hopkins research should familiarize themselves on preventing fraud in data collection. The purpose of this guidance is to assist research teams by offering recommended strategies to preserve data integrity and mitigate the risk of financial loss or fraudulent submissions / data contamination while using survey instruments to collect data from research subjects.
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.
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
Last Updated: September 2025
Payment Options <$200 Per Individual in a Given Year:
Payments to participants in research studies may be paid without collection of SSNs/ITINs for some of the options below if they do not exceed $200 per individual per year. The exceptions is ClinCard that always requires SSN or the payment is subject to 30% tax withholding.
- ClinCard (Greenphire): ClinCard is a Study Participant specialized management and payment solution providing a virtual, single use or reloadable card as payment options. The study must first obtain IRB approval to use ClinCard and also obtain verification from the appropriate Departmental/Divisional financial approver that there is a valid IO and Fund# to support the use of the program. Once IRB approval is obtained, the Study can be set up within the ClinCard solution and administered locally by the department. ClinCard always requires a SSN from the payee even for amounts less than $200 otherwise the payment amount is subject to 30% IRS tax withholdings. ClinCard is subject to card and load fees.
- Study teams seeking to use the ClinCard as a participant payment option must first obtain IRB approval using the instructions available here.
- For studies that use the ClinCard all participants must be provided with a Greenphire ClinCard Information Sheet.
- Gift Cards: Requests for gift cards in amounts under $200 from retail outlets will be handled in accordance with the Petty Cash Policy. Note: gift cards normally have an acquisition cost in addition to the face value of the card.
- Petty Cash: With the rollout of Greenphire’s prepaid card program, the University is migrating away from opening new petty cash bank accounts. Requests for new petty cash bank accounts will be evaluated on a case-by-case basis by the JHU Treasury Office. Petty Cash Tills, for study program reimbursements less than $500, may still be created by submitting a request to the Treasury Office at [email protected].
Payment Options >$200 Per Individual in a Given Year:
Payments to participants in research studies that exceed $200 must collect SSNs/ITINs for the options below and report annually all payments made to each individual. ClinCard which always requires SSN for payment is subject to 30% withholding; reporting requirements are all automated to reduce the burden on the study team.
- ClinCard (Greenphire): See description above for ClinCard.
- Study teams seeking to use the ClinCard as a participant payment option must first obtain IRB approval using the instructions available here.
- For studies that use the ClinCard all participants must be provided with a Greenphire ClinCard Information Sheet.
- Direct Payment from APSSC: Studies can choose to have their participants set up as vendors via the vendor management portal, PaymentWorks. Once created, the study will submit online payment requests (FV60) through SAP with all necessary supporting documentation. After the transaction is reviewed and approved by APSSC, the payment will be issued to the participant via check or electronic funds transfer, per their vendor record setup. See the Vendors page on the Accounts Payable website for details regarding PaymentWorks:
https://ap.ssc.jhu.edu/vendor-mgmt/vendors/
Contact Information
Prepaid cards/Gift Cards:
Procurement – https://jhuprocureprod.service-now.com/
Petty Cash:
Treasury – [email protected], [email protected]. or [email protected]
Reliance Agreements
Please see HIRB’s Reliance Agreements page for information and guidance. (Link Coming Soon)