In our continued commitment to smokers worldwide, JUUL Labs believes in supporting ethical independent research conducted by qualified third-party investigators. Independent research is key to understanding our product’s benefit/risk profile, as well as addressing any unmet needs.
JUUL Labs provides financial and/or product support for ISR pursuant to a written agreement, which requires that third-party sponsors comply with applicable local laws, rules, guidelines and regulations. The research must set out to address meaningful scientific and/or clinical objectives supported by robust study designs where the protection of privacy rights, safety, and welfare of research subjects are paramount.
Studies with scientific and medical merit developed and sponsored by an independent investigator or institution. An ISR proposal may be a scientific or clinical investigation conducted without the participation of JUUL Labs, for which the ISR sponsor requests JUUL Labs to provide either funding, product or both.
ISR studies are conducted independent of JUUL Labs. The investigator or affiliated study sponsor 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.
Rigorous ethical and scientific standards when engaging and reviewing study proposals from third-party independent sponsors, including investigator qualification and institutional site credibility. In study sites where JUUL Labs is not satisfied that Good Clinical Practice (GCP) standards exist, we will not support ISR. However, JUUL Labs will consider, on a case-by-case basis, helping to develop local sponsor capabilities in GCP, if local policy and regulations permit.
Robust medical and scientific governance systems in place at all levels of the JUUL Labs organization (globally, regionally, locally) with no commercial funding or influence on any aspect of the ISR process. Under no circumstances will JUUL Labs permit the involvement of sales or marketing associates in any aspect of ISR design, review and approval, operational execution, funding or transfer of value to a sponsor/investigator undertaking an ISR.
The review/approval process focuses specific attention on ensuring that patient safety is of paramount importance to the proposed ISR.
Worldwide training at JUUL Labs on the policies and practices required for successful ISR support, including the rules of independence of the third-party investigators/sponsor and no undue influence from JUUL Labs, when engaging in all aspect of the ISR process (conception, design, operational execution, and data management, including data handling and interpretation).
Financial transparency on amount of monies and transfer of value provided to any investigator or institution worldwide undertaking an ISR as part of a contractual agreement with JUUL Labs.
Communication and enforcement with all third-party sponsors, their contractual commitment to publish their research findings in a timely manner, as well as the need to report safety information findings during the conduct of the ISR in accordance with JUUL Labs and local regulatory requirements and timings.
Tracking and monitoring in an ongoing and transparent manner our ISR-contracted obligations and practices and sharing appropriate data with key stakeholders.
Holding ourselves accountable to the highest ethical standards, we will monitor and audit JUUL Labs associate’s adherence to our policies, standards, and effectiveness of training on ISR as part of our global risk assurance program and compliance framework.
JUUL Labs will monitor the investigator’s compliance and adherence to their contractual obligations related to disclosure of ISR findings, agreed upon milestones, and safety information reporting.
JUUL Labs is committed to complete data and financial transparency. We believe that sharing information in all areas of clinical research, without compromising patient data or confidentiality, supports sustainable innovation and accountability. Therefore, when JUUL Labs provides direct or indirect financial support, including JUUL Labs products, to a third-party sponsor (e.g., investigators or research institutions) we believe that the scientific community and patients have a right to access information about the following:
This means that at JUUL Labs we track all value transfers provided to an investigator or an institution and ensure that our interactions are properly documented in a written contract. We also encourage institutions and investigators that benefit from JUUL Labs research support to publicly share appropriate research results. All worldwide ISR agreements are filed in the centralized JUUL Labs Global ISR Repository.
JUUL Labs is committed to ensuring our ISR policies are followed throughout the organization. Accordingly, JUUL Labs is committed to communicating and enforcing the aforementioned principles and procedures for ISR to all relevant associates.
JUUL Labs mandates training to sales and marketing associates to ensure that they understand that under no circumstances may they be involved in soliciting, planning, approving, or executing ISR. Furthermore, JUUL Labs medical, clinical and field associates will be trained on the appropriate steps to take if they receive an unsolicited request from an HCP to conduct ISR, or support the conduct of ISR.
Furthermore, JUUL Labs will ensure that associates involved in the ISR processes across the globe (e.g., medical affairs associates, ISR cross-functional review team members) receive in-depth training on these policies and processes.
All training will be documented and associates must certify that they have completed and understood the training. JUUL Labs will regularly review this training to assess and, if necessary, improve its effectiveness.
JUUL Labs Medical Affairs associates may be involved in non-promotional interactions with both investigators and healthcare professionals (HCPs). In certain instances, a HCP may also be an investigator. The purpose of these interactions is to exchange scientific and educational information with HCPs and/or investigators who are experts in research, patient care, or both. These scientific and educational interactions will not interfere with either the manner in which a research study may be conducted or influence the independent medical judgment regarding patient care. Medical Affairs associates will maintain a relationship and discussions with the investigator or investigator/HCP prior to, during, and post study.
JUUL Labs will consider supporting studies independently conceived, designed and planned by investigators or third-party sponsors. While JUUL Labs may communicate its general areas of research interest, individual ISR requests must be unsolicited. These unsolicited requests may be derived and submitted by an investigator independently following a scientific discussion or meeting with the investigator or institution. JUUL Labs medical colleagues may respond to investigator-expressed interests with a science-based discussion intended to:
JUUL Labs will only accept ISR proposals from sponsors/investigators that are able to demonstrate high ethical and scientific standards as it relates to clinical research in human subjects as stipulated by the International Conference of Harmonization (ICH) Efficacy Guidelines E6 – GCP.
Before the contracting of an ISR with a potential sponsor/principal investigator/sub-principal investigator or institution, JUUL Labs will require documentation that demonstrates the following: