Investigator Initiated Research Program
Welcome to Vapotherm’s Investigator Initiated Research (IIR) Program.
To search this page use Control+F, or Command+F on a Mac, for a keyboard shortcut for the Find command.
As part of our commitment to improve patient lives, we are dedicated to supporting independent clinical research involving Vapotherm high velocity nasal insufflation (HVNI) and other devices in the Vapotherm family.
We are interested in collaborating with physicians and scientists committed to advancing respiratory care through research. If you have a research question or hypothesis involving HVNI or another product that you wish to evaluate, we invite you to apply or contact us for additional information.
If you are interested in submitting an IIR application, please review the steps and material needed to complete the application:
- Fill out and submit the IIR application. (Please note –you are unable to save and finish the application later)
- The following documents are needed for submission. (Please provide them in a PDF format):
- Draft or final protocol
- Current CV
- Detailed budget estimate
- Letter requesting resources (equipment, disposables, funding equipment, or additional support (if applicable)
Once submitted, the application will be reviewed for completeness, scientific review, significance, and available resources. You will be notified by email of the acceptance or denial of the project within 4 weeks.
IIR submissions will be reviewed with the following in mind:
- Scientific merit
- Alignment with Vapotherm’s areas of research interest
- Availability of resources.
Areas of Interest:
- Expanded treatment areas and patient populations
- Sleep disordered breathing
- Physical rehab
- Expanded use in critical care
Roles and Responsibilities:
Below are the definitions and responsibilities of all participating IIR members.
- International Organization for Standardization (ISO) (ISO 14155:2020) – a worldwide federation of national standards bodies.
- Good Clinical Practice (GCP) – the international ethical, scientific, and practical standard to which all clinical research is conducted.
- Principal Investigator (PI) (ISO 14155:2020) – qualified person responsible for conducting the clinical investigation at an investigation site.
- Sponsor-investigator (21 CFR 812.o)- an individual who both initiates and conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used.
Principal Investigator Responsibilities (ISO 14155:2020):
- The role of the principal investigator is to implement, oversee the management of the day-to-day conduct of the clinical investigation as well as ensure data integrity and the rights, safety, and well-being of the subjects involved in the clinical investigation, all while using GCP.
- Design the protocol and conduct the scientific investigation.
- Gain approval through Institutional Review Board (IRB)
- Control study protocol and manage the data generated during the study.
- Notify the company of significant study milestones as required in the study agreement
- Provide a draft manuscript and study data upon completion of the study.
- Report safety data to regulatory authorities, and the IRB
- Understand and comply with all requirements of institution(s) which are associated, or which research will occur.
What is the IIR application submission and review process?
Please see the Submission Process on top of the page
How long does the application review process take?
The review process will be complete within 4 weeks
What if my IIR request is denied?
All decisions are final, although anyone is welcome to reapply at any time. We will notify you of the reason for denial (scientific merit, not aligned with present company priorities, lack of available resources, etc.)
If my IIR request is approved, will I receive a contract template?
Will the study need approval from an independent ethics committee?
The PI is responsible for the study and all regulatory requirements including oversight by an IRB. If a study investigator needs IRB assistance, this can be address on a case-by-case basis.
Do you provide products if requested for IIR study?
Yes – machines are loaned for duration and exclusive use in trial – disposables are just that
Will any financial assistance be provided if needed?
No financial compensation will be provided as these are not sponsored studies. No admin overhead will be provided. Professional meeting registration costs for investigators who are presenting data may be provided.