Clinical Trials

IBC Requirements for Clinical Trials

In addition to IRB approval, some clinical trials require Institutional Biosafety Committee (IBC) approval before enrollment of study subjects. Clinical trials 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 participant samples including blood, fluids, or tissue that will be analyzed or handled in an IU laboratory.
    • If human samples are collected in a clinical setting and sent directly back to the trial sponsor for analysis, and the Investigational Product does not meet the definition of Human Gene Transfer (HGT), no IBC protocol is required.
  • 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 and the Investigator Brochure to the Research Safety Compliance Office (RSCO) at IBC@iu.edu for guidance.

IBC Protocol Guide for Clinical Trial Submissions

The below guide is intended as guidance for completing a new IBC protocol form for clinical trials. The guide covers the basics for each section of the IBC protocol form in Kuali Protocols. When filling out a new IBC protocol, RSCO suggests reviewing the guide and filling out as much as you can in Kuali. If you need assistance after reviewing the guide, book an appointment with a member of RSCO.

Expand All

  • Principal Investigator (PI)
  • Department Name – This will populate automatically
  • Title of the study

  • Protocol Type: Research
  • Review Type:
    • Select Non-Exempt when a trial involves an investigational product that falls under the NIH Guidelines sections III-A – III-E.
    • Select Exempt when a trial involves only the collection of human participant samples (e.g., blood, cells, fluids) and analysis of those samples in an IU lab.
      • If samples are sent back to the sponsor for analysis, and there is no non-exempt IP, an IBC protocol is not required.
  • Will rDNA or synthetic rDNA be used: Generally, you will select Yes if the trial is non-exempt and No if the trial is Exempt.
  • Vector Systems: Generally, this will be answered Yes
    • Vector Type: dependent on IP
  • Will this research involve the deliberate transfer of rDNA or synthetic rDNA into humans: Generally, you will select Yes if the trial is non-exempt and No if the trial is Exempt.
  • Will animals be used: Generally, no animals are used in clinical trials
  • Will plants be used: Generally, no plants are used in clinical trials

  • Personnel List: List anyone directly responsible for the study or handling/administering the IP. Groups such as nurses may be listed.
  • IU Health Services and/or Groups: List any groups responsible for receiving, storing, preparing, or administering the IP. Examples of Groups and Services Provided include:
    • Investigational Drug Services (IDS) - Storing and dispensing investigational product
    • Cellular Therapy Lab (CTL) - Receipt, preparation, and infusion of investigational product
    • Nurses – Administration of investigational product to trial participants; Sample collection
    • Clinical and Translational Support Laboratory (CTSL) - Processing and shipment of participant samples to sponsor

  • List the associated IRB protocol even if it is pending

  • List the Sponsor in the Agency field.
  • List N/A in the Grant Number field.

  • Where will the IP be received, stored, and prepared?
  • Where will the IP be administered?
  • If human samples are analyzed in an IU lab, list the lab space.
  • If samples are imaged after administering a non-exempt IP, list the imaging location

  • Focus on the IP, safety practices for handling and administering the IP.
  • Most of these details can be found in the Investigator Brochure (IB) and sponsor protocol, though not always. If you’re having trouble finding the details, we can help.
  • Provide a clear statement of study objectives, including a brief summary of project’s purpose, goals, and anticipated outcomes. Remember that this is not the IRB so details about the number of participants, participant eligibility, etc., are not needed.
  • Include location where the IPs are made (i.e., by the Sponsor or at at IU or IU Health).
  • What is the rationale for gene transfer intervention?
  • Provide a detailed description of therapeutic agents including:
    • Type of therapy (e.g., CAR-T cell therapy, RNA therapy)
    • Source of gene(s) being transferred
      • This is often difficult to find and may need to be asked of the sponsor
    • Type of Vector system (e.g., viral, plasmid-based), if applicable
    • Manufacturing techniques, if provided by sponsor
      • In-vivo: therapy delivered directly to participant’s body
      • Ex-vivo: cells removed from participant, modified, and returned to participant
    • Preparation instructions and safe handling techniques
    • IP delivery methods
  • Participant Protection Measures
    • Administration methods (e.g., injection, infusion, etc.)
    • Dosage details and monitoring plans
    • Procedures to prevent environmental release
    • Participant follow-up for adverse effects or unexpected outcomes
  • Protection Measures for Medical Staff and Family of Participants
    • What special measures need to be taken by medical staff handling and administering the IP to participants?
    • What special precautions need to be taken by individuals involved in participant care after administration of a non-exempt IP?
  • Biosafety Information
    • Storage, handling, and disposal procedures
    • Decontamination protocols, including any special decontamination measures of subject waste after administration of a non-exempt IP
    • Procedures for accidental exposure or spill response
    • Reporting timelines for safety concerns or protocol deviations
  • Risk Assessment
    • Potential risks to participants, researchers, and the environment (including family and/or caretakers who may be exposed to the IP injection site)
    • Measures to mitigate identified risks
    • Justification for risk-benefit balance
  • Facility Information
    • Description of laboratory spaces for storage, preparation, and administration
    • Engineering controls and equipment used for containment 

  • Section III-C/III-C-1: Almost always checked since most IP that requires an IBC protocol is recombinant material going in to a human participant.
  • If other sections are needed, we can help you select them. This will depend on the IP, what it’s made with (viral, bacterial, cell therapy), risk groups, and how it needs to be handled/contained.
    • Cell therapy: Often III-D-1 and III-D-3 should be checked

  • This will always vary based on the IP.
  • Cell therapy protocols:
    • Source species: Human
    • Plasmid and/or Vector: This is usually the name of the IP
    • Host to be used: Human Cells
  • Other vector-based therapies will vary

  • This will vary depending on the IP
  • Cell therapy protocols: List information about the system used to modify the participant’s cells outside of their body.
  • Other vector-based therapies information will vary

  • Add an entry for each sample type you will take from participants (e.g., Human blood and/or blood derivatives, Human body fluid, Human tissue)
    • Source: Clinical Samples
    • Import permit: No
    • >10 L of culture: No
    • Zoonotic: No
    • Containment: BSL-2
    • Risk Group: RG2
    • Infectious Host Range: Humans
    • Potential Routes of Transmission: Injection, Ingestion, Direct Contact
    • Potential Risks Associated with Exposure: Unknown bloodborne pathogens
    • High risk aerosol-generating procedure: Generally, No.
    • Will you deviate from standard containment: Generally, No.
    • Sharps restricted: Generally, No.
    • Specialized spill procedures: Generally, No.
  • Add an entry for Investigational Drug Product (Clinical Trial)
    • Source: Vendor, then list sponsor name
    • Import permit: Generally, No.
    • >10 L of culture: Generally, No.
    • Zoonotic: Generally, No.
    • Containment: Dependent on IP
    • Risk Group: Dependent on IP
    • Infectious Host Range: Humans and warm-blooded animals
    • Potential Routes of Transmission: Dependent on IP, but generally Injection, Ingestion, Direct Contact
    • Potential Risks Associated with Exposure: Dependent on IP
    • High risk aerosol-generating procedure: Dependent on IP administration
    • Will you deviate from standard containment: Generally, No.
    • Sharps restricted: Dependent on IP
    • Specialized spill procedures: Dependent on IP

  • Most of the time this will be dependent on the IP and the samples you will gather from the participants. However, there are some basics you can almost always check.
    • BSL-2 (nearly always)
    • General Practices:
      • Generally, you should always check all boxes except specialized spill procedures (unless indicated in the biological materials section), and that the lab will deviate from above practices.
    • Non-Animal Research PPE:
      • Generally, you can always check the following:
        • Closed toe shoes
        • Long pants or skirts that cover legs
        • Gloves
        • Laboratory Coat
        • Eye Protection
        • Surgical Mask
      • Other PPE may be required depending on IP and preparation and administration practices.
    • Engineering Devices: This refers to the devices required for preparation of the IP. Generally, a Biosafety Cabinet is required.
    • Health Surveillance/Immunization: If human materials are being handled, check Hepatitis B vaccine offered. Other requirements will be dependent on the IP.
    • Laboratory Practices:
      • Generally, you can always check the following:
        • Lab will transport materials outside of a laboratory
          • Transported in a closed, rigid, leakproof container with biohazard symbol (for the IP moving from pharmacy to administration location and or samples moving from clinical setting to lab)
          • Materials that are infectious to humans and/or animals will be shipped (for human samples being sent back to the sponsor)
        • Needles and syringes are not recapped or reused
        • Sharps containers are only 2/3 full before disposal
        • Vortexing/mixing/centrifugation performed in tightly capped tubes
        • Centrifugation performed in aerosol containment capsules
        • Pipetting in Biosafety Cabinet for work requiring BSL-2 or higher containment
    • Laboratory Access
      • Generally, you can check the following:
        • Locked laboratories with limited public access
        • Limited to personnel trained for specific procedure
    • Lab and Surface Disinfectant
      • Generally, you can check 70% ethanol with 10 minutes contact time, but this may depend on the SOP of the trial location (e.g., IU Hospital SOP, CTL SOP)
    • Equipment Disinfectant:
      • This is likely dependent on the SOP of the trial location (e.g., IU Hospital SOP, CTL SOP)
    • Solid Waste:
      • Generally, you can check the following:
        • Materials will be appropriately autoclaved
        • Puncture resistant container with biohazard symbol: autoclaved prior to disposal
    • Liquid Waste:
      • This is likely dependent on the SOP of the trial location (e.g., IU Hospital SOP, CTL SOP)

  • Read and Check

  • Include all of the following:
    • Informed Consent (required)
      • If there are multiple, include all
    • Investigator Brochure (required)
    • Sponsor Protocol (required)
    • Pharmacy Manual (required)
    • Lab Manual (required)
    • Investigational Medicinal Product Manual (if available)
    • Vector maps (if available)
    • Any other manual the sponsor references in the protocol, IB, or other documents.

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

NIH definition

  • A preventative (vaccine), a therapeutic (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

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

  • The 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

  • 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

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 with mucous membranes (e.g., 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)

  • 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 Compliance 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

  • 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 Compliance 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

  • 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 Compliance Office (IBC@iu.edu) and the IU Environmental Health and Safety Office, Biological Safety Program (ehsbio@iu.edu (Indianapolis) or biosafe@iu.edu (Bloomington))