Frequently Asked Questions

As per the Med Tech 2022 Guidelines when conducting IIS studies, the research is conceptualised, initiated, and conducted by an investigator whom has full responsibility over the research program. Either the investigator or the institution whom employs the investigator, becomes the Sponsor of the study- It is never Ambu. A breakdown of specific roles and responsibilities is included at the end of this document.

Within Ambu’s IIS program, the types of support which Ambu may provide can vary. Some examples of support may include;

- Medical device products
- Limited monetary assistance
- Equipment/ Supplies
- Data Management Expenses
- Study- related personnel costs (this could include a medical writer, statistical support or research personal)

Naturally, experienced researchers and clinicians who have completed previous research studies are encouraged to apply, however it is not just those with experience. Ambu values and wishes to support young, upcoming clinicians and researchers, thus PhD students, postdoctoral students and all healthcare professionals involved within clinical research are invited to submit their applications. Please be ready to submit a copy of your CV as part of your application.

In order to apply, all applications require some key information as a minimum. This includes, but is not limited to

• The sponsoring investigator or institutions information
• The overall objectives and outcomes measures of the research (including the proposed evalution methods)
• Information on the study design and anticipated duration
• Type of support/funding requested
• Relevnt study budget details
• Synopsis/summary of the protocol

Once you have this information, the application can be submitted at www.IIS.ambu.com. Any additonal queries can also be directed to CHECK EMAIL ADDRESS

Specifically, research studies that aim to improve the overall quality of patient care, by exploring clinical and health outcomes are encouraged. Please note, the studies must include one or more of Ambu’s products (on-label) and be aligned with the company defined areas of strategic interest. Examples include research which explores clinical benefits and complications, impact on workflow, burden of illness, sustainability, and resource utilisation.

Once you have lodged an application you can expect a response within 60 days. Applications are reviewed throughout the year when the IIS committee meets. Each proposal is evaluated, and support is awarded based on the study’s scientific merit, as well as research priorities, current scientific trends and available resources. In the event further information is required, we will contact you prior to making a finalised decision

Following approval, Ambu will need to receive the following in order to issue the requested support

• A fully executed IIS contract
• Institutional Review Board (IRB)/ Ethics Committee (EC) Letter of Approval/ Letter of     Exemption with Expiration Date
• A study protocol
• CV of the principal investigator

In the case of IIS, it is the investigator/ institutions responsbility to report any clinical research on humans to a clinical trials website such as ClinicalTrials.gov. Similiarly the responsibility is with the investigator to report any study related adverse events if and as required according to national and institutional reporting procredures.

Once the investigator notifies Ambu that the study is complete, a completion letter is generated, reminding the investigator of the obligaitons detailed within the agreement. In short, this includes providing a copy of the final study report, and review of the manuscript that is prepared and suitable for peer-reviewed journal submission.