About the IRB
Our Mission
The mission of the Institutional Review Board (IRB) Office is to ensure the protection of the safety, rights, and welfare of all human participants in research studies conducted by Johns Hopkins Bloomberg School of Public Health (BSPH) faculty, staff, and students in the U.S. and in countries around the world.
The BSPH IRB is authorized to interpret the federal human subjects research regulations and determine which activities require BSPH IRB oversight. To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty, staff, and students at BSPH must submit for IRB review any human subjects research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted. For more information on the federal guidelines that determine the kind of research the BSPH IRB is required to approve, please visit the Department of Health and Human Services website.
The BSPH IRB serves as the IRB of record for the following departments:
- JHU faculty and staff with primary appointments at BSPH
- JHU faculty and staff from other JHU Divisions (SOM, Homewood), with the approval of the Vice Dean for Research for BSPH and the other JHU Divisions
- Agora Institute PIs who are affiliated with BSPH or have approval to submit to the BSPH IRB because their topics are in our wheelhouse
- Jhpiego staff who conduct human subjects research
- CCP staff who conduct human subjects research
- External institutions with whom BSPH enters into a Reliance Agreement accepting review and oversight responsibility
Human Research Protection Program
The School’s human research protection program (HRPP) is registered with the U.S. Office of Human Research Protections (OHRP) as follows:
- IORG Number: 0000077
- Federal Wide Assurance (FWA): 00000287
- IRB X Registration #00000758
- IRB FC Registration #000000112
IRB Administration
| Name | Title |
| Katherine Frey | Director, IRB Office |
| Nino Miragliuolo | Sr. IRB Administrative Coordinator |
Department & Ancillary Reviews for IRB Submission + Subaward Concordance Review
Contact the Assistant Director for Institutional Coordination with questions to ensure smooth coordination of multiple review and compliance requirements. The Assistant Director for Institutional Coordination also serves as a liaison between JHURA and investigators to facilitate the review of concordance between stated roles of project partners and proposed sub-awards.
| Name | Title |
| Tariq Syed | Sr. IRB Analyst/Assistant Director for Institutional Coordination |
Review Teams and Staff
Not sure which IRB Review Team and IRB Analyst your application is with? Log in to PHIRST and open up the application. This will direct you to the application workspace page, and you will be able to see the IRB Team and Analyst your application has been assigned to.
PHIRST Help Issues and Guidance
For questions about the status of your application, PHIRST technical questions, or PHIRST training questions, contact the PHIRST Help Desk at BSPH.phirsthelp@jhu.edu. Emails that cannot be addressed directly with the Help Desk are routed to an appropriate IRB Office staff member.
| Name | Title |
| Susan Trabing | Sr. IRB Analyst/Operations Administrator |
| Robin Holland | IRB Administrative Specialist, IRB-FC |
| Nino Miragliuolo | Sr. IRB Administrative Coordinator |
| Shannon Owens | IRB Administrative Specialist, IRB-X |
Senior IRB Analysts
For regulatory support, questions about specific protocols, when your application will be scheduled for review, where to upload your documents, or questions about concerns returned to you in a PHIRST application, contact the IRB Analyst assigned to your application via Study Team Note in PHIRST.
| Name | Committee/Review Team |
| Thomas Bradsher | NE/NHSR/NR |
| Anne Fresia | IRB-FC |
| Tobey McGuiness | IRB-X |
| Tariq Syed | IRB-FC |
| Susan Trabing | IRB-X |
IRB Navigator
To assist faculty, staff, and students with their PHIRST submissions, and if you require a more comprehensive discussion and guidance to help streamline the IRB review process, including conducting pre-reviews and protocol planning.
| Name | Title |
| Tobey McGuiness | IRB Navigator/Sr. IRB Analyst |
Reliance Team
For questions about requesting a reliance agreement, single IRBs for a multi-center study, or relying on a commercial IRB please contact the IRB Reliance Program.
| Name | Title |
| Katherine Frey | Director, IRB Office |
| Thomas Bradsher | Sr. IRB Analyst/Reliance Specialist |
| Shirleen Harris | Reliance Analyst/Sr. Quality Improvement Specialist |
HIPAA
For guidance on HIPAA-related requirements and regulatory issues, including federal, state, and local policies and guidance.
| Name | Title |
| Tony Whaley | Compliance Associate |
Compliance-Monitoring Program
An ongoing support and service program to examine IRB approved protocols from two approaches: the Routine Monitoring Visit or the Direct Audit, and to provide tools that research teams may use to promote regulatory compliance in the conduct of research.
| Name | Title |
| Shirleen Harris | Reliance Analyst/Sr. Quality Improvement Specialist |
NE/NHSR/NR (Not Engaged/Not Human Subjects Research/Not Research) Review Team
Reviews and determines which activities do not require BSPH IRB oversight and provides documentation that no IRB oversight is needed for those activities.
| Name | Title |
| Thomas Bradsher | Sr. IRB Analyst/Reliance Specialist |
Student Research
Provides guidance for students or post-docs and their Advisors who are initiating projects as part of their degree or training requirements, and processes review of student determination forms.
| Name | Title |
| Thomas Bradsher | Sr. IRB Analyst/Reliance Specialist |
| Shirleen Harris | Reliance Analyst/Sr. Quality Improvement Specialist |
The IRB Boards
The IRB Office oversees two IRBs registered with the U.S. Office of Human Research Protections, IRB X and IRB FC, which meet weekly to review human subjects research applications for Bloomberg School faculty and students.
OHRP IRB FC Registration #00000112 - Meets every Wednesday morning
OHRP IRB-X Registration #00000758 - Meets every Tuesday afternoon
Both IRB Boards apply the requirements of the U.S. Common Rule, 45 CFR 46, to all non-exempt human subjects research. IRB-FC reviews studies involving FDA-regulated products in accordance with 21 CFR Parts 50 and 56.
To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty, staff, and students at the Bloomberg School must submit for IRB review any human subject research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted.
IRB X Members
| Reviewer | Department | Expertise |
|---|---|---|
Laura E. Caulfield, PhD Chair | IH | Maternal and child health; nutrition; nutrition and child growth and development; U.S. and international studies. |
| Stella Babalola, PhD | HBS | Strategic communication; gender issues; adolescent reproductive health; audience analysis. |
| Precious Davis | Unaffiliated / Community Member | |
| Stephan Ehrhardt, MD | EPI | Clinical trials; prevention and treatment of infectious disease. |
| Vanya Jones, PhD, MPH | HBS | Program evaluation; injury prevention; violence; health education; youth fighting; health behavior; urban youth; mentoring; parents; school health; older adults; older drivers. |
| Tamar Mendelson, PhD | MH and PFRH | Adolescent mental health; school-based interventions; prevention trials; community-based participatory research. |
| Ann Skinner, MSW | HPM | Survey research methods; patient-reported outcomes; mental health services research; health services research; mental illness; plder adults. |
IRB FC Members
| Reviewer | Department | Expertise |
|---|---|---|
Joanne Katz, ScD Chair | IH | Epidemiology; biostatistics; community trials; maternal, neonatal, and child mortality and morbidity; intrauterine growth restriction; prematurity; micronutrients; eye disease. |
| Sherry Adeyemi | Unaffiliated / Non-Scientific Member | BCHD – Operations Officer: Fiscal operations; School health; men’s health; aging services. Council of State Governments Justice Center – Deputy Division Director: corrections & reentry.
|
| Joseph Ali, JD | IH | Bioethics; research ethics; global health ethics; digital health; capacity strengthening; Consent; health policy and systems research; disease surveillance.
|
| Aruna Chandran, MD, MPH | EPI | Household and neighborhood factors that affect health outcomes; how resiliency factors can be leveraged to improve well-being. |
| Anna Durbin, MD | IH | Phase 1, 2, and 3 clinical trials; vaccine trials and safety; flaviviruses, malaria; infectious diseases. |
| Joseph J. Gallo, MD, MPH | MH | Depression in older adults; medical comorbidity; mixed methods in health services research. |
| Margaret Himelfarb, MPH | Unaffiliated / Community Member | |
| Jill Owczarzak, PhD | HBS | Qualitative research methods; medical anthropology; influence of cultural, social, and political forces on health disparities. |
| Vivian Rexroad, PharmD | IH | Drugs; herbals; biologicals; vitamins. |
| Tiffany Roundtree | Unaffiliated / Community Member |