Skip to main content
Institutional Review Board (IRB)

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 FreyDirector, 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
ReviewerDepartmentExpertise 

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 PFRHAdolescent 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
ReviewerDepartmentExpertise

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, MPHEPI 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, MPHMH 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