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Submit a Study

An organization requesting IBC review of a new study protocol and site credentials must submit:

Study-Specific Materials

  • IBC Study Submission Form (available via IBC portal)
  • Clinical protocol
  • Informed consent (draft acceptable)
  • Scientific abstract
  • Non-technical abstract


And, if available:

  • Investigator Brochure
  • Pharmacy manual
  • Safety data sheet for investigational product
  • Any prior correspondence with the NIH RAC

 

Note: Documents must address the requirements set forth in Appendix M of NIH Guidelines Requirements for Protocol Submission.

Site-Specific Materials

  • IBC Authorization Agreement (if Schulman will serve as the IBC of record for the site)
  • Principal investigator’s full CV with publications
  • Blood borne pathogen exposure control plan
  • Biohazardous waste/regulated medical waste disposal policy, procedures or permits
  • Standard Operating Procedures (SOPs) for use of the study agent or any associated supplemental documentation (if available)
  • Floorplan, diagram or pictures of the locations where the study agent will be stored, manipulated or disposed

Login to Schulman’s IBC portal to submit these materials.

Need access to the IBC portal? Contact IBC@sairb.com for assistance.

Join IBC Services

If you’re as passionate about biosafety as we are, let’s talk! Schulman is seeking IBC committee members, community members, site inspectors and consultants across the US to assist on a part-time basis with the IBC review process and biosafety-related projects.

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