The Johns Hopkins University (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 addition to IRB review, JHU requires ancillary reviews for studies that meet specific criteria to ensure compliance with other institutional and regulatory requirements. These reviews are separate from the IRB review process but, when required, occur concurrently with IRB member review.
Ancillary reviews are triggered automatically based on information provided in the eHIRB application. If an ancillary reviewer contacts a study team with questions, clarifications, or changes, the study team should communicate directly with that reviewer to provide additional information or resolve outstanding issues.
Ancillary reviewers aim to complete their review within two weeks of receiving notice of the application; however, timelines vary based on study complexity and the specific issues involved. As a result, ancillary reviews and their timelines are not within HIRB’s control.
Please note that if a study requires ancillary review(s), HIRB staff must ensure that ancillary approvals are recorded in eHIRB before the study can be fully approved by the IRB.
HIRB Ancillary Reviews
| Review | When is this review required? | Review focus areas |
|---|---|---|
| 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 | 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 | Legal, tax, and export control/sanctions issues when research is proposed in an international setting |
| JHHS Nursing Responsible Party: Heather Watson ([email protected]) | Required when the research proposes involvement of JHHS nursing staff | Issues related to intersections of JHHS nursing practice and human subjects research, including the following: – Involvement of JHHS nursing staff in assisting with any procedures that are part of an IRB-reviewed study – IRB-reviewed studies that are focused on relevant topics including the study of nursing processes and the study of potential effects of research participation on nursing staff workload and patient care/safety |
| Laboratory Safety Responsible Party: Johns Hopkins Medicine & University Health, 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) | 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 | 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 |
| Office of the University Registrar (OUR) | Required when the research will utilize JHU student education records | 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 |
Chart: What Needs to be Submitted to an IRB
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 on our Guidance and Procedures page.