In our continued commitment to help adult smokers worldwide move away from combustible cigarettes, JUUL Labs believes in supporting ethical, independent research conducted by qualified third-party investigators. Independent research is key to advancing the science of electronic nicotine delivery systems (ENDS).
The goal of JUUL Labs’ IIR Program is to encourage independent, investigator-initiated research studies that validate or advance the science of ENDS.
This program is open to researchers and institutions who are interested in receiving authentic JUUL products for conducting research and who have the relevant expertise and scientific credentials to conduct the proposed study in compliance with local regulations.
JUUL Labs provides product support for IIR pursuant to a written agreement (contract for sale of product (CSP)), which requires that third-party investigators comply with applicable local laws and regulations. The research must set out to address meaningful scientific objectives supported by robust study designs where the protection of privacy rights, safety, and welfare of research subjects are paramount.
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 contract for sale of product (CSP) 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.
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:
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.
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:
Investigators shall report any unexpected or serious adverse events related to the use of JUUL products in accordance with JUUL Labs and regulatory requirements.
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:
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:
International IIR studies will be limited to contract for sale of product (CSP) 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.
CSP agreements are described in the above section ‘IIR Proposals’.
For Grant Funding Agreements (GFA):