Investigator Initiated Studies
Indivior PLC and its subsidiaries (the “Company”) may provide research grants to fund legitimate, scientifically sound, clinical and pre-clinical studies and research where such research is (a) conducted by qualified grant recipients and (b) is intended to provide valuable scientific and clinical information, improve medical care, lead to promising new treatments, promote better delivery of healthcare, or provide other benefits to patients. Research grants may not be provided with the intent of, directly or indirectly, implicitly or explicitly, influencing or encouraging the recipient to prescribe, purchase, recommend, sell, or arrange for or recommend the prescribing, purchasing, or sale of any Company product or as a reward for any such behavior.
Research grant proposals shall be evaluated by the Investigator Initiated Trials Committee to ensure scientific merit and requests for research grant funding shall only be approved if:
- There is a legitimate scientific and clinical purpose to the research;
- The research protocol is valid and scientifically sound, and is designed to yield results of improving our treatment for patients;
- The amount of the grant is reasonable and justified; and
- The researcher(s) are qualified and have the necessary expertise to conduct the research.
Grant funds may not be provided to support research that has already occurred.
Grant funds shall be provided to offset the reasonable costs of specified and documented research conducted pursuant to a research grant proposal. Grant funds shall not be used in any way to defray a recipient’s ordinary operating expenses (i.e., expenses of activities that the recipient is already required to perform or customarily performs).
No research grant funding may be provided to any governmental institution without review and determination of consistency with the rules governing benefits to such entities.
All approved research grants must be documented in a written research grant agreement between the Company and the research grant recipient. The research agreement must specify:
- The objectives of the study and the research to be performed;
- That the investigator will be solely responsible for controlling the objectivity, balance, and outcome of any research funded by the Company;
- The time period during which the research is to be completed;
- The method of payment and detailed description of how funds will be used, including whether grant payments should be staggered based on milestone events or target dates, to the extent appropriate;
- An acknowledgement by the investigator that the results of the research will be collected, analyzed, and adequately reported to the Company, including, at a minimum, submission of annual progress reports and/or a written report, or equivalent documentation of the work that has been done, upon conclusion of the research;
- An acknowledgement by the investigator that he or she has properly notified and received all necessary consents and permissions from all required entities (g., regulatory authorities, independent review boards/ethics committees, hospital employer, etc.);
- An acknowledgment by the investigator that he or she will, in the conduct of the research, comply with all applicable legal and regulatory requirements; and
- An acknowledgement by the investigator that he or she will, in the conduct of the research, report to the Company all adverse events in accordance with applicable legal and regulatory requirements.
Each request for an IIT Grant must submit a fully completed study design and protocol.
Grant requests shall be evaluated by the IIT Committee which shall meet once a month, barring any unforeseen circumstances.
The Company is committed to compliance with all laws, regulations and guidance related to its obligations to report payments to healthcare professionals and institutions to any appropriate national authorities.
Investigator Initiated Trial requests should be submitted to email@example.com.