April 2016

The Organization requires that certain human subjects research studies be reviewed and approved by the Institutional Biosafety Committee (IBC).  These studies include those in which investigators wish to introduce recombinant or synthetic nucleic acid molecules (DNA/RNA), potentially infectious agents or pathogens, or biological toxins into human subjects.  IBC approval of such research must precede approval for conduct by a JHM IRB.

Additionally, the Organization requires that individuals who collect and/or ship biological specimens register with the Biosafety Office.  For the purposes of human subjects research, this requirement extends to studies conducted at all Hopkins/Affiliates sites.  Investigators must document satisfaction of this requirement in the eIRB application prior to final approval by a JHM IRB.