Internal JHSPH Ancillary Reviews
Ancillary review of a BSPH 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 BSPH 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 BSPH 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 BSPH 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 BSPH IRB Office with the research application. See BSPH 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 reviews, please check the references on the School of Medicine IRB website SOM Department and Ancillary Reviews.