Human Subjects Research Reviewed by the Institutional Biosafety Committee

The focus of the IBC review of human subjects research is for the local oversight of biosafety concerns, such as handling of the agent during preparation and administration of the agent, risk of shedding from the research participant and handling of samples collected from the research participant.

  • The IBC reviews the experimental administration of human gene transfer agents, infectious agents and biological toxins.  
  • The IBC also reviews research conducted with biospecimens collected from research participants that are known or suspected of being infected with an infectious agent.

What is a human gene transfer agent?

Human Gene Transfer or "HGT" is used to describe research involving the transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into human subjects. It is also sometimes referred to as "Gene Therapy." Nucleic acids (DNA or RNA) may be transferred as "naked" nucleic acid, encapsulated nucleic acid, or nucleic acid within another organism, such as a virus or within a cell. This includes mRNA based vaccines and cells that are modified with RNA or DNA ex vivo. 

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Section III-C-1 define human gene transfer agents as:   

Recombinant nucleic acid molecules, DNA or RNA derived from recombinant nucleic acid molecules, or Synthetic nucleic acid molecules, DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:

Contain more than 100 nucleotides; or

  • Possess biological properties that enable integration into the genome ( e.g. cis elements involved in integration); or 
  • Have the potential to replicate in a cell; or
  • Can be translated or transcribed

What are examples of infectious agents being administered to human research participants that would require review?

While most biological agents used as study drugs are recombinantly modified, there are some instances of testing replication competent infectious agents being administered in a highly controlled manner as therapeutics. The most common examples of an infectious agent being administered as a therapy are oncolytic viruses. The IBC reviews human subjects studies involving infectious agents or biological toxins in the same manner as human gene transfer studies.

What do investigators need to submit to the IBC for the initial review?

Via the eIBC System, Researchers will need to submit:

Please refer to the guide sheet on How to Submit a Human Gene Transfer Study to IBC for Review or contact ibc@ohsu.edu with questions.

What does IBC require for study modifications, continuing reviews and reportable new events?

Follow IRB instructions as usual. The IBC will review all materials in eIRB and approve prior to IRB approval. If any change is needed to your IBC-specific documentation, the IBC office will contact you to complete a modification in the eIBC, otherwise, no additional eIBC submissions will be required.

An IBC approval memo is not issued when reviewing modifications in the eIRB system. An approval memo for the continuing review is issued via the eIBC system.

IBC review requirements for certain categories of human subjects

The following types of studies require an IBC review associated with the initial IRB submission. The IBC will work with the study team to determine the appropriate paperwork for submission. Follow-on submissions in eIRB will not be reviewed by the IBC.

When is IBC review required for handling biospecimens collected from human subjects?

The IBC also reviews research involving the collection, processing and experimental use of biospecimens for research purposes from study participants that are known to be ill with an infectious agent (such as COVID-19, Tuberculosis, HIV, etc.). Note that this includes participants that are known to be infected with a virus even if not actively ill. The IBC uses a biospecimen triage form to identify the level of IBC review required. 

What is required for review of use of botulinum neurotoxin, aka Botox in human research participants?

The OHSU IBC reviews studies involving botulinum neurotoxin as a covered agent under the IBC review policy. Any research use of this toxin is also subject to review under the federal policy on Dual Use Research of Concern (DURC). This regulatory oversight includes human subjects studies administering botulinum neurotoxin as a study drug. The IBC office will guide researchers on submitting an abbreviated protocol via the eIBC system for the DURC review of the initial study.