Clinical Trials

IBC Requirements for Clinical Trials

Some clinical trials require Institutional Biosafety Committee approval before enrollment of study subjects. Clinical trials being performed by Indiana University employees or receiving Indiana University funding that meet any of the following criteria must be reviewed by the IBC:

  • Trials that involve human blood, fluids, or tissue that will be analyzed or handled in an IU laboratory.
  • Trials that meet the definition of Human Gene Transfer (HGT), as stipulated by the NIH Guidelines:
    • The NIH defines HGT as “the deliberate transfer into human research participants of either:
      • Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
      • Synthetic nucleic acid molecules, or 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.”

If you are unsure whether a trial will require IBC approval, please send the Sponsor Protocol to the Office for Research Compliance, Research Safety Office at IBC@iu.edu for guidance.

Required Training

IBC training requirements for investigators participating in a clinical trial are the same as any IBC involving biological research.

Clinical trials involving an investigational product that requires IBC coverage that utilize IU Health Services or Groups (e.g., BMT Nurses, Clinical Research Center (CRC), Cellular Therapy Lab (CTL), Investigational Drug Services (IDS), or CTSL) must ensure that all staff members handling the investigational product are appropriately trained. Staff members from these groups/services are not required to take individual trainings (i.e., NIH Recombinant DNA Guidelines Training, Biological Safety Training, Bloodborne Pathogens Training), but should review the Biosafety Considerations for Clinical Studies Involving an Investigational Product, found below.

 

Biosafety Considerations for Clinical Studies Involving an Investigational Product

What is an Investigational Product?

NIH definition

  • A preventative (vaccine), a therape​utic (drug or biologic), device, diagnostic, or palliative used in a clinical trial
  • May be an unlicensed product or a licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use

Regulatory Compliance and Investigational Products

NIH requires IBC approval for any clinical trial involving:

  • Deliberate transfer of the following into one or more humans
    • Recombinant nucleic acid molecules or DNA/RNA derived from recombinant nucleic acid molecules
    • Synthetic nucleic acid molecules or DNA/RNA derived from synthetic nucleic acid molecules or those that meet any of the following:
      • Contain more than 100 nucleotides
      • Possess biological properties that enable integration into the genome
      • Have the potential to replicate in a cell
      • Can be translated or transcribed

NIH Training Requirements

  • Principal Investigator is responsible for training all personnel involved directly or indirectly in experiments
  • The IBC considers anyone involved in the experiment to be any personnel handling/administering the investigational product
  • Required training for personnel involved in experiments:
    • Information regarding the potential biohazards involved in experiments
    • Emergency procedures for accidental release of product or exposure to product
    • Reporting procedure for accidental exposure or spill/release of product

Risks Associated with Investigational Products

  • Every investigational product is unique and has its own risks associated with it
  • The Principal Investigator (PI) must be able to provide anyone involved with handling/administering an investigational product information about the risks associated with the product
  • Any investigational product containing human blood, cells, tissues, or fluids is considered to have the potential of transmitting unknown human pathogens
  • Investigational products must be handled using the proper PPE, engineering controls, and work practices as required by the study’s IBC protocol
  • Please contact the PI of the IBC protocol for the specific instructions for handling and working with the investigational product

Accidental Exposure to an Investigational Product

Exposures include any of the following:

  • Cutting, puncturing, piercing of the skin with a contaminated sharp (i.e., needle, broken glass, etc.)
  • Product coming into contact with an existing cuts, rashes, or abrasions
  • Product coming into contact mucous membranes: splash to the eyes, nose, or mouth
  • Accidental ingestion
  • Accidental inhalation of a product that can be transmitted via the respiratory route (e.g., lentiviral vector)

Steps to Take If An Exposure Occurs

  • Wash exposed area for 15 minutes with soap and water
  • Use an eyewash for 15 minutes if contact to the eyes occurs
  • Follow steps for reporting an injury to your employer
  • As soon as possible, report exposure to the protocol’s Principal Investigator, the IU Environmental Health and Safety Office, Biological Safety Program (ehsbio@iu.edu (Indianapolis) or biosafe@iu.edu (Bloomington)), and the IU Research Safety Office, using the Reportable Events section of your IBC protocol in Kuali Protocols.
  • Exposed individuals on the Indianapolis campus may be requested to be seen by the IU Occupational Health Physician located in Coleman Hall

Steps to Take for a Spill or Release of an Investigational Product

  • Any spill or release of an investigational product (no matter the quantity) must be reported immediately to the protocol’s Principal Investigator, the IU Research Safety Office (IBC@iu.edu), and the IU Environmental Health and Safety Office, Biological Safety Program (ehsbio@iu.edu (Indianapolis) or biosafe@iu.edu (Bloomington).

  • Follow any additional spill procedures and reporting required by IU Health
  • Cover the spill with an absorbent material and apply an appropriate disinfectant
  • Once an appropriate contact time for the disinfectant has been achieved (consult IBC protocol or manufacturer’s instructions), discard the material into the appropriate waste container

Important Contact Information

  • Please contact the Principal Investigator for information about an investigational product including risks and safety requirements

  • Contact the IU Environmental Health and Safety Office, Biological Safety Program (ehsbio@iu.edu (Indianapolis) or biosafe@iu.edu (Bloomington)) with any additional questions regarding the safety of an investigational product

  • Report all exposures and spills involving an investigational agent to the PI, IU Research Safety Office (IBC@iu.edu) and the IU Environmental Health and Safety Office, Biological Safety Program (ehsbio@iu.edu (Indianapolis) or biosafe@iu.edu (Bloomington))