ResMed Support for Investigator-Initiated Research

FAQ

• How does ResMed handle Confidentiality?

  Ownership of the IIR Proposal remains with the investigator.
  
  If there is any material in the IIR Proposal owned by a third party, the investigator warrants that all necessary licenses and consents have been granted for the use of those materials. ResMed will keep the IIR Proposal confidential and only make it public if/when accepted. All personal information included in applications will be handled according to applicable privacy laws.

• Who owns the Intellectual property of the research proposal?

  The research proposal remains the intellectual property of the investigator. Additional details around intellectual property of the technology or research results will be defined in the IIR Grant Agreement associated with accepted IIR proposals.

• What study activities may be supported by ResMed?

  Before submitting your IIR budget, please ensure that all study-related expenses have been itemised and reflect fair market value.

  ResMed will consider funding activities related to both direct (subject-related costs, study-related personnel costs, diagnostic fees/services and external data management expenses, etc.) and indirect study costs (IRB review fees, equipment and supply expenses).

  ResMed will not compensate for the following: general education, training activities not specific to the study, support for ongoing clinical programs that are part of an organisation's routine operations, start-up funds to establish new clinical or research programs or to expand existing programs, purchase of capital equipment unrelated to the study or that would generate revenue, construction funds or hiring of staff that are not dedicated to the study. Typically, we would expect that no government or commercial payor will be billed for patient therapy using devices that are provided by ResMed for use in the study.

• What budget information do I need to provide during my submission?
   

  The Clinical Review Board requires both the (1) total study budget (including costs for data management, study personnel, other funding sources, statistician, recruitment materials, IRB submission costs) and the (2) amount you are requesting ResMed to provide (in the form of either direct financial funding or ResMed equipment). This provides transparency to ResMed when determining the total study costs required for a successful study, as well as what the financial commitment from ResMed is being requested. 
  

• If I receive approval for my research study, is there anything else required before I begin my study?

  Upon approval of the IIR proposal, there are several documents that are required prior to initiating support (devices and/or funding). These include:

  • Final study protocol and informed consent form
  • IRB/ethics committee approval letter of final study protocol and informed consent
  • Fully executed IIR Grant Agreement with ResMed

• What are my responsibilities to ResMed after I receive an approval?

  ResMed requires at least one study status update per quarter, unless otherwise specified, to comply with ResMed's regulatory requirements. Updates should include information on enrollment, device-related adverse events (AEs), protocol deviations, projected publications and study completion dates. Additional requirements for the provision of safety information to ResMed are detailed in a subsequent section. ResMed also requires prompt notification of any amendments to the original protocol after the study has been initiated.

  An Investigator conducting an IIR is required to provide ResMed with a written report of the final study results. Any planned publications or presentations must be sent to ResMed in advance of submission, according to the IIR Grant Agreement. Upon study closure, the Investigator will be required to certify that the study was conducted, that the ResMed funds and/or device(s) were used solely to conduct or report the study, and that all safety and regulatory reporting obligations were met. Any unused funding and/or device(s) must be returned to ResMed within 90 days of study completion. 

• Who is responsible for reporting safety events observed during my research study?

  The institution and/or investigator has the responsibility for reporting safety events to their local regulatory authority (ex: FDA or other Competent Authority), or IRB/EC, as required per relevant local and federal regulations. 

  ResMed has the ethical and legal responsibilities to collect and analyse safety information on its investigational and marketed products so that the company can fully understand their risk-benefit profile and provide accurate safety information to regulatory authorities, physicians and patients. As an independent investigator-sponsor conducting research involving ResMed products, you play an important role in monitoring the study and reporting all relevant safety events to ResMed.

  A cumulative listing of adverse events related to ResMed-manufactured devices must be provided to ResMed on a quarterly basis or sooner to comply with ResMed-required regulatory submissions. This listing should include all relevant adverse events that have occurred from the start of the study. 

  In accordance with local legislation, Good Clinical Practice and overall Clinical Trial Safety Management principles, ResMed has the responsibility to evaluate device-related adverse events for reportability. The institution and/or investigator has the responsibility of providing all required information about the device-related adverse event to ResMed as soon as possible.

  Reporting an AE or SAE to ResMed does not relieve the institution and/or investigator of the responsibility for reporting the events to the FDA, other regulatory authorities, or IRB/EC, as required per relevant local and federal regulations. 

• What are my responsibilities as an Investigator?
   

  As the sponsor of a study, the investigator and/or institution must ensure that the study is conducted in accordance with the provision of appropriate Good Clinical Practice (GCP) guidelines and all applicable local and regulatory requirements. The Investigator must assume all regulatory responsibilities including, but not limited to, IRB/EC approvals, informed consent, regulatory approvals, and any and all reporting obligations to regulatory authorities and ResMed. 

• Can I publish the results of my research study funded by ResMed?
   

  ResMed encourages investigators to publish the results of the study, whether or not the results are favourable to the ResMed product(s). The investigator wil comply with recognised ethical standards concerning publications and authorship, such as those established by the International Committee of Medical Journal Editors. ResMed reserves the right to first review of any draft publications.

• Do I have to register my study with a public website?

  The investigator and/or institution must add the study to the FDA's clinicaltrials.gov database or a trial registry website in the country of study, if it meets the requirements for posting.

• What do I need to know about 'Indemnification'?

  ResMed requires that the institution indemnify ResMed. Details will be outlined in the IIR Grant Agreement. 

• Will ResMed disclose any financial support provided for my study?

  If applicable, as a publically traded company, ResMed is dedicated to transparency relating to its financial relationships with investigators and study sites; therefore ResMed may publically disclose funding associated with an IIR.

• What are the local and federal regulations on 'Open payments' reporting of funding to physicians and/or teaching hospitals?

  All payments or other transfers of value to physicians and/or teaching hospitals outside the US made in connection with a research activity that are subject to a written agreement, a research protocol, or both, must be reported per relevant local and federal regulations. 

  All payments or other transfers of value to US-based physicians and/or teaching hospitals made in connection with a research activity that are subject to a written agreement, a research protocol, or both, must be reported to the Center for Medicare and Medicaid Services ("CMS") under these special rules ("Sunshine Act"):

  • Research-related payments or other transfers of value to covered recipients (either physicians or teaching hospitals), including research-related payments or other transfers of value made indirectly to a covered recipient through a third party, must be reported to CMS separately from other payments or reportable transfers of value, and must include the name of the research institution, the individual or entity receiving the payment or other transfer of value, the total amount of the research payment, the name of the research study, the name of the related covered device, and information about each covered recipient principal investigator. 
  • ResMed employees reporting research-related payments or other transfers of value to physicians must also include the name as listed in the NPPES system (if applicable), National Provider Identifier ("NPI") number, state professional license number and the state in which the license is held, specialty, and the primary business address of the physician. For teaching hospitals, the name and primary business address of the teaching hospital must also be included. If paid to a non-covered recipient (such as a non-teaching hospital or clinic), list the name and primary business address of the entity.