ResMed changes lives with award-winning medical devices and cutting-edge cloud-based software applications that diagnose, treat and manage sleep disordered breathing (SDB), chronic obstructive pulmonary disease (COPD) and other chronic diseases. ResMed is a global leader in connected care, with millions of patients remotely monitored every day. Our team is committed to creating the world's best tech-driven medical device company – improving quality of life, reducing the impact of chronic disease, and saving healthcare costs in more than 100 countries.
As part of our commitment to deliver innovative therapies to patients across the globe, ResMed believes in the need to support ethical, independent clinical research, conducted by qualified third-party investigators. Investigator-initiated research (IIR) serves as an important complement to ResMed-sponsored research, to help better understand the benefits and risks of our therapies, as well as to explore new opportunities to address unmet medical needs. Such clinical research must be aimed at addressing meaningful scientific and/or clinical objectives, supported by valid study designs in which the safety, welfare and privacy rights of patients are of paramount importance.
Like many other health care-focused companies, ResMed supports the funding of Investigator Initiated Research (IIR) through a well-defined process with robust governance measures. Preference will be given to programs that align with the ResMed mission of advancing innovative technologies in sleep and respiratory medicine. Support is typically provided in the manner of funding and/or devices, depending on the type of research.
Grants will be considered to support independent medical research with strong scientific merit, provided that the following guidelines are met:
- The research proposal addresses a legitimate scientific need that is identified and documented in advance (ResMed does not consider requests for unrestricted grants).
- The principal investigator must have the appropriate education, training and experience to successfully conduct and complete the proposed research, with the highest ethical standards.
- The research proposal must include a written study protocol that demonstrates sound scientific design and methodology.
- The research proposal must include a detailed, line-item budget that is based on fair market value.
- If a research proposal is accepted, a written agreement with well-defined goals, objectives and milestones must be executed by ResMed and the investigator(s) prior to commencement of the project.
SUBMITTING AN IIR PROPOSAL
ResMed accepts unsolicited concept proposals from potential investigators. If a concept proposal is of interest, ResMed will make a follow-up request for a full submission. A full submission must be received in order for a request to be considered for approval.
ResMed will acknowledge receipt of all concept and full submissions. The ResMed Clinical Review Board conducts the review process and decisions are based upon medical and scientific merit as well as the available resources and research priorities. ResMed will make every attempt for a speedy review process and communicate the process timelines along the way with the investigator and/or their representative. A formal notification on the status of the request will be sent once a decision is reached. While all requests will be reviewed, ResMed makes no promises that it will approve a request.
Key areas of interest include:
- Optimization of clinical pathways to improve accessibility and efficiency in the diagnosis and treatment of sleep apnea.
- Innovative strategies to enhance initial compliance and long term adherence to PAP therapy, especially through use of telemedicine.
- Evidence to show the economic value of treating sleep apnea and COPD.
- Association of clinical outcomes and quality of life with the use of portable oxygen concentrators (POCs).
- Contribution to scientific knowledge and patient pathways for the use of non-invasive ventilation.
- New insights into utilizing clinical data to improve patients' lives; for example, through reducing hospital admissions, reducing healthcare costs, enabling meaningful prediction of exacerbations, increasing quality of life, patient engagement.
A concept proposal checklist will be provided at your request, and is highly recommended, to ensure that proposals contain all the necessary documentation required for evaluation. A concept proposal should contain an adequate amount of information in order for ResMed to determine interest in receiving a full submission. You may also consider submitting a full submission alone. When submitting a concept proposal, the following information is requested:
- Project description including hypothesis and objectives, study title, phase of research, population, treatment regimen, enrollment and approximate study dates
- Clinical site information including principal investigator and detailed information for the contact person
- Draft itemized budget including other support not requested in the proposal to support the study
- Amount of product/devices required, if any
- Curriculum Vitae of the principal investigator
A full submission checklist will be provided at your request, and is highly recommended, to ensure that proposals contain all the necessary documentation required for evaluation. A full proposal submission must contain enough detail about the research study and the grant request to enable ResMed to make a final evaluation regarding support.
When submitting a full proposal, all of the information required for a concept proposal (as listed above), as well as the following information should be included:
- Detailed study protocol
- Draft informed consent form
- Total funding requested (itemized and detailed)
- Total amount of product requested (if applicable)
- Curriculum Vitae of any sub-investigators and other clinical staff expected to participate in the study
- Certification that no one to be involved in the investigation has ever been disqualified or otherwise under investigation by a regulatory or institutional body
Ownership of the Concept Proposal remains with the investigator.
If there is any material in the Concept 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 Concept Proposal confidential and only make it public if/when accepted. All personal information included in applications will be handled according to applicable privacy laws.
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 Grant Agreement.
Before submitting your budget, please ensure that all study-related expenses have been itemized and are appropriate with regards to 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 organization’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.
RESMED REQUIREMENTS FOR IIR COLLABORATION
Upon approval of the full 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
- Submission/approval of all applicable regulatory documents and written commitment to comply with all applicable regulatory requirements
- Fully executed Grant Agreement
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), projected publications and study completion dates. Additional requirements for the provision of safety information to ResMed are detailed below. 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 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.
The institution and/or investigator has the responsibility for reporting safety events to your 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 analyze 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.
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.
ResMed encourages investigators to publish the results of the study, whether or not the results are favorable to the ResMed product(s). The investigator will comply with recognized 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.
REGISTERING YOUR RESEARCH WITH PUBLIC WEBSITES
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.
ResMed requires that the institution indemnify ResMed. Details will be outlined in the Grant Agreement.
FINANCIAL DISCLOSURE BY RESMED
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.
For further information or to submit a concept proposal for an investigator-initiated research grant, please contact the ResMed Office of Medical Affairs via email, at IIR@resmed.com.
OPEN PAYMENTS REPORTING
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.