Investigator-Initiated Research (IIR)

• IIR Research Areas of Interest

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  Switching Efficacy

  • Efficacy of JUUL products for helping adults switch from combustible cigarettes
  • Comparisons between JUUL and other nicotine products for helping adults switch from combustible cigarettes
  • The role of flavors for helping adults switch from combustible cigarettes
  • The role in nicotine concentrations/strengths for helping adults switch from combustible cigarettes

  Nicotine Science

  • Nicotine pharmacokinetic profiles of JUUL products – flavors/nicotine strengths
  • Effects of nicotine pharmacokinetics on use behaviors/perceptions

  Risk/safety analyses of JUUL (clinical or preclinical)

  • Harmful and potentially harmful constituent (HPHC) / toxicology profile analyses of JUUL
  • Cardiac effects of vaping
  • Pulmonary effects of vaping
  • Cardiac effects of second-hand exposure to vaping
  • Pulmonary effects of second-hand exposure to vaping

  Vaping Behaviors

  • JUUL vaping topography (including lower versus higher nicotine concentration pods)
  • JUUL use behaviors in adults (transitions to and from tobacco smoking, frequency of use, effects of flavors, etc.)
  • Abuse liability

• IIR Proposals

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  Investigator-Initiated Research (IIR) proposals are studies with significant scientific merit developed by an investigator or institution independent of and without the participation of Juul Labs for which the IIR investigator requests JUUL Labs to provide JUUL products.

  IIR studies will be limited to Material Transfer Agreements (MTA) where JUUL products will be provided to investigators pursuant to a written agreement. Juul Labs supports enacted legislation raising the minimum age to purchase tobacco products to 21 as well as FDA’s enforcement policy on unauthorized flavored cartridge-based ENDS. IIR submissions must comply with applicable federal and other laws and regulations.

  The investigator (not Juul Labs) will have responsibility for study conception, design, operational execution, data handling, data analysis, interpretation, reporting and publication, safety monitoring and ensuring compliance with all local laws and regulations. Juul Labs will not provide input on research concepts, design, execution, analysis or the dissemination of IIR studies.

• Evaluation of IIR Applications

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  While Juul Labs communicates its general areas of research interest above, it does not solicit IIR applications. Applications will be reviewed by a multi-disciplinary review board that includes representatives with applicable expertise who will evaluate the application’s scientific merit. Reviews will take place quarterly and will assess the merit of applications based on the following:

  • Scientific Merit will be evaluated based on the following six criteria:
    1. Significance of proposed research
    2. Qualifications of Investigator(s)
    3. Innovation
    4. Approach
    5. Environment
    6. Overall impact
  • The IIR must be ethical, and safeguard subject privacy, safety and welfare, and be robust in design.
  • All studies must be conducted using internationally approved methods (e.g., Coresta) and must have approval from an appropriate IRB.

  Robust scientific governance systems are in place at all levels of the Juul Labs organization. Under no circumstances will Juul Labs permit the involvement of its sales or marketing employees in any aspect of the IIR review and approval process.

• Roles and Responsibilities

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  Investigators will be required to acknowledge the Terms and Conditions which are found in the contractual agreement.

  Investigators have responsibility for all aspects of the study, including, but not limited to:

  • Initiating and conducting the study from concept to dissemination
  • Ensuring appropriate institutional, regulatory, and ethics compliance and approval
  • Ensuring appropriate and adequate record-keeping, medical monitoring, adverse event reporting and medical supervision
  • Analyzing, interpreting, and disseminating results (e.g., publications and submissions to conferences and journals)

  Investigators shall report any unexpected or serious adverse events related to the use of JUUL products in accordance with Juul Labs and regulatory requirements.

• Investigator Qualifications

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  Pre-requisites

  Investigators and institutions must be recognized for their expertise and scientific credentials to conduct the proposed research and have a proven track record in the subject matter of the proposal. Proof may be in the form of qualifications, publications, and certifications.

  Any misrepresentation of investigator credentials will result in the immediate withdrawal of our support.

  Facilities/Labs/Sites shall follow appropriate and recognized quality standards, e.g. ISO 17025, GLP, GCP OR minimally:

  • Have a detailed study plan/protocol
  • Use robust and reproducible methods/assays
  • Have adequate facilities for study and demonstrates data integrity

  Qualifications

  Juul Labs will only accept IIR proposals from investigators that are able to demonstrate high ethical and scientific standards as it relates to clinical research in human subjects.

  Before the contracting of an IIR with a potential principal investigator/sub-principal investigator or institution, Juul Labs will require documentation (i.e., an NIH Biosketch) that demonstrates the following:

  • Recent evidence (within the previous 3 years) of the investigator’s experience in undertaking tobacco control research.
  • Use robust and reproducible methods/assays
  • Previous publications in tobacco control research

• IIR Studies Outside the U.S.

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  International IIR studies will be limited to Material Transfer Agreements (MTA) where JUUL products will be provided to investigators pursuant to a written agreement. In some circumstances, grant funding will be considered on a case-by-case or country by country basis.

  MTA agreements are described in the above section ‘IIR Proposals’.

  For Grant Funding Agreements (GFA):

  • The progress and results of the GFA study will be collected, analyzed, and adequately reported to Juul Labs by the investigator, including, at a minimum, submission of periodic progress, final study report and safety information.
  • We expect scientists and institutions whose GFA proposals are accepted to make their research available through appropriate and recognized peer-reviewed journals, conferences and repositories independent of Juul Labs.

If you are interested in submitting an Investigator-Initiated Research proposal, please click here.