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Institutional Review Board

Internal JHSPH Ancillary Reviews

Ancillary review of a JHSPH research application occurs when prior permissions are required from research sites, or when the research itself involves certain activities that require specialized review. In the latter case, the IRB Office will notify specialized reviewers when review is required. For example, when a study involves radiation or FDA regulated food or drug products, the IRB Office will alert the JHSPH radiation reviewer or Pharmacy and Therapeutics to obtain an ancillary review. If an investigator seeks access to patients or patient information at JHH, the department in question must provide permission. Other ancillary reviews, such as review of financial disclosures by the Committee on Conflict of Interest, must be initiated by the Principal Investigator. The chart below identifies the required pre- and post- department or other ancillary reviews that must occur before the research activity may begin.

Conflict of Interest

Principal investigators, co-investigators, and study staff must disclose all financial conflicts of interest in accordance with institutional policy. Conflicts of interest that involve a human subject research application will be reviewed by the Committee on Conflict of Interest prior to submission to WIRB. Conflict management requirements developed by the Committee will be provided to WIRB as part of its review.
See PPM 4.
 
Drugs Used in Clinical Investigation
All applications involving a drug used in a clinical investigation must be reviewed by the Pharmacy and Therapeutics Committee. See JHSPH Policy No. 103.19a “Drug Use and Control in Clinical Investigation (DUCI) and Policy No. 103.19 “Pharmacy and Therapeutics Review”. A completed Investigational Drug Data Sheet must be submitted to the JHSPH IRB Office with the research application.
 
A drug used in a clinical investigation is defined as any drug, biological, botanical or other substance used specifically for a clinical investigation as described in the protocol. The Pharmacy and Therapeutics Committee will specifically address issues related to:
  • drug safety
  • drug management
  • study design
  • IND status
  • drug data sheet (DDS) review for investigational new drugs (INDs)
  • informed consent document(s)
  • any other relevant material
Studies Involving Ionizing Radiation
The Clinical Radiation Research Committee must review all applications for human subjects research that involve ionizing radiation. Completed radiation form(s) must be submitted to JHSPH IRB Office with the research application. See JHSPH IRB Policy No. 103.21, “Review of Radiation Procedures.”
 
Cancer Treatment Studies
The Johns Hopkins Cancer Center Clinical Research Office (CRO) has special requirements for all cancer treatment studies conducted at JHM. Prior to submitting your application to the IRB, please contact the CRO at 410-955-8866 for CRO review instructions.
 
Studies Involving Biosafety Materials
Research involving the use of human and human-derived tissue, infectious agents/pathogens, recombinant DNA, or toxins must be registered with the Biosafety Office in order to maintain compliance with institutional and federal regulations. This must be done prior to submission to IRB. Please contact the Biosafety Office at 5-5918.
For all other ancillary review, please see the information below.

Department/Ancillary Committee

Contact Information

Timing of Review

Ann Arundel Medical Center (AAMC)

Celeste Dove
Margaret Matula

Concurrent with IRB Review

Baltimore City Health Department (BCHD)

Paul Overly

Post IRB Approval

Biosafety Office

Stephen Dahl

Concurrent with IRB Review

Cell Therapy

Jeffrey Bitzan
Janice Davis Sproul
Juliana Edwards
Susan Fiorino
Josephine Logan
Michelle Muth
Angela Ondo

Notification Only

Clinical Engineering

Roy Shipley
Andrew Currie
Charles Bacon

Concurrent with IRB Review

Radiation

Clinical Radiation Research Committee (CRRC)

Jon Links

Stan Wadsworth

Concurrent with IRB Review

Committee on Conflict of Interest (COI)

Elizabeth Peterson

Concurrent with IRB Review

Emergency Department Patients (ED)

Gabor Kelen
Judy Shahan

Concurrent with IRB Review

FM Kirby Center

Jim Pekar

Pre IRB review

General Clinical Research Center (GCRC)

Matthew Courtemanche
Shernice Madison
Gerald Stacy

Acknowledge Anytime

Howard County General Hospital

Judith Moss
Robert Sheff

Post IRB Approval

JHU Emergency Medicine

Gabor Kelen
Judy Shahan
Lauren Sauer

Pre IRB Review

JHU Genetic Medicine

David Valle

Pre IRB Review

JHU Gynecology and Obstetrics

Harold Fox

Pre IRB Review

JHU History of Medicine

Randall Packard

Pre IRB Review

JHU Ophthalmology

Peter McDonnell
Sharon Solomon

Pre IRB Review

JHU Physical Medicine and Rehabilitation

Rebecca German

Pre IRB Review

JHU Physiology

William Guggino

Pre IRB Review

JHU Surgery

Dana Andersen
Steven Leach
Martha Zeiger

Pre IRB Review

Johns Hopkins Community Physicians Review (JHCP)

Wendy Greenberg

Post IRB Approval

Johns Hopkins Health Care (JHHC)

Peter Fagan
Martha Sylvia

Notification Only

KKI Review

Pre IRB Review

Maternal and Fetal Research Committee (MFRC)

Frank Witter

Concurrent with IRB Review

Office of Research Administration (ORA)

Alex McKeown

Post IRB Approval

P&T

Vivian Rexroad

Brent Petty

Concurrent with IRB Review

Pathology Department Review

J. Jackson
Frederic Askin

Notification Only

Prospective Reimbursement Analysis (PRA)

Karen Roz

New Oncology and Radiation Studies until further roll out.

Concurrent with IRB Review

 

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