The JHSPH has a contract in place with WIRB to permit review of Phase I, II, and III clinical trials, at the discretion of the JHSPH PI. The JHSPH IRB also reviews clinical trials. Although these studies may be reviewed by WIRB, the conduct of the studies must be compliant with JHSPH policies.
A WIRB submission must include the appropriate WIRB forms. See the submission instructions below for applications that involve conflict of interest, drugs, ionizing radiation, cancer treatment or biosafety materials, or are conducted at one of the General Clinical Research Centers (GCRCs). All WIRB protocols are to be submitted utilizing the electronic IRB submission system. Applications may not be submitted directly to WIRB.
The IRB Office will screen all WIRB applications to confirm their eligibility for review by WIRB and to ensure that any required JHU internal reviews are completed prior to submission to WIRB. See JHPSH IRB Policy 103.10 “Ancillary Reviews.” Please note that applications submitted directly to WIRB will be returned to the JHSPH IRB Office by WIRB.
Upon completion of the internal ancillary reviews, applications will be forwarded to WIRB by the IRB Office . WIRB will send via email a tracking number to the Principal Investigator and to the IRB Office.
Investigators who receive confirmation of WIRB review via a tracking number should submit all subsequent amendments, modifications, progress reports, adverse event reports, etc., for the study to WIRB with a copy to the JHSPH IRB Office.
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. To see PPM 4 click here.
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 & 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
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.”
The Johns Hopkins Cancer Center Clinical Research Office (CRO) has special requirements for all cancer treatment studies conducted at JHMI. Prior to submitting your application to the IRB, please contact the CRO at 410-955-8866 for CRO review instructions.
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.
Studies that will be conducted at one of the General Clinical Research Centers must be reviewed and approved by the GCRC prior to submission to the IRB.
- For Drugs Used in Clinical Investigation
- For Studies Involving Ionizing Radiation
- Report Form for Unanticipated Problems that are Adverse Events
- Report Form for Unanticipated Problems that are Not Adverse Events
AN ORIGINAL PLUS 3 COPIES OF EACH FORM MUST BE SUBMITTED. INCOMPLETE APPLICATIONS WILL BE RETURNED TO THE INVESTIGATOR AND WILL NOT BE PROCESSED.
The WIRB contact information is: firstname.lastname@example.org; website is www.wirb.com.