HeartWare will accept applications for consideration of funding of educational grants. HeartWare will only provide educational grants in order to further legitimize educational or scientific purposes.
Educational grants include funding requests in the following areas:
- Accredited Continuing Education: Educational programs for healthcare providers such as physicians and nurses. Attendees of such programs receive continuing education credits.
- Non-Accredited Professional Educational Activities: Educational programs for healthcare providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. HeartWare requires that all presentation material in such programs related to HeartWare products be consistent with the FDA-approved or notified-body approved labeling. If the presentation material does not meet that standard, HeartWare will not fund the program.
- Patient Education: Printed or online educational materials targeted to those with a particular disease or condition.
- Fellowships: HeartWare will consider proposals for the support of fellowship programs at teaching institutions and medical centers with an academic or charitable affiliation. HeartWare may also elect to provide support for travel scholarships for fellows, residents or healthcare providers in training so that they may attend relevant major medical or scientific conferences for education purposes.
- Third-party educational congresses: HeartWare may provide the following types of support:
- Grants to allow attendance by medical students, fellows, residents or other healthcare providers in training when: the gathering is primarily dedicated to promoting objective scientific and educational activities and discourse and the training institution or the conference sponsor selects the attending healthcare professionals who are in training. HeartWare will only fund such a grant to an organization with a genuine educational function. The grant recipient may only use the grant funds to reimburse legitimate expenses for bona fide educational activities. Such grants also should be consistent with applicable standards established by the conference sponsor and anybody accrediting the educational activity. The conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods, and materials.
- Funding to the conference sponsor to support the provision of meals and refreshments to conference attendees. Such meals and refreshments should be of modest value.
- Grants to cover reasonable honoraria, travel, lodging and modest meals for health care professionals who are conference faculty members.
- Purchase advertisement and booth space for displays at conferences.
An applicant for grant funding is required to complete the Educational Grant Request Form and also submit the following materials to HeartWare for consideration:
- W-9 Form (Tax ID) (U.S. submissions only)
- Program objectives / course agenda and target audience (when applicable)
- Detailed proposed budget
- Accreditation statement (if any), including approved hours (when applicable)
All applications must be received at least 8 weeks prior to the activity for which funding is sought in order to allow sufficient time for consideration and approval.
If a funding request is approved, a Letter of Agreement will be coordinated between HeartWare and the requesting organization.
All applications should be forwarded to: email@example.com
Note: HeartWare will review all requests for support and provide assistance in accordance with the following guidelines:
- AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry
- Policies of the FDA’s Guidance on Industry-Supported Scientific and Educational Activities
- Accreditation Council for Continuing Medical Education Standards for Commercial Support
- American Medical Association Ethical Guidelines for Gifts to Physicians from Industry
- AdvaMed Code of Ethics for Interactions with Healthcare Professionals
- Eucomed Code of Ethical Business practices
- Disclosure laws
- Additional relevant regulatory and industry standards
Investigator-Sponsored Research Grants
HeartWare recognizes that Investigator-Sponsored Research (ISR) represents a valuable tool in the advancement of medical and scientific knowledge. We believe in partnering with academic and medical organizations to promote independent research that facilitates scientific and clinical discovery, improves clinical care or leads to promising new treatments.
In furtherance of these objectives, HeartWare will provide research grants to support independent medical research with scientific merit. HeartWare is interested in supporting research in the general area of mechanical circulatory support, ranging from preclinical through clinical and including retrospective and prospective research. Proposals will be reviewed by HeartWare’s internal research grant committee, and will be evaluated based on patient safety, scientific merit, feasibility, alignment with the company’s research interests, and funding availability. Researchers may request monetary support or equipment/supplies. HeartWare’s global program of support is open to all researchers who are interested in conducting their own independent, innovative research.
A researcher who would like to apply for support is required to complete the Investigator-Sponsored Research Form and include the following:
- Relevant financial disclosures
- Summary/Synopsis of the proposed research
- Detailed proposal/protocol that includes:
- Methods (data collection and analysis, including sample-size justification and applicable power analysis)
- Expected duration, and safety reporting and publication plans
- Detailed budget (costs must be at fair market value in keeping with local laws and regulations)
- Summary of the plan for meeting applicable regulatory requirements
The investigator fulfills the obligations of both a study sponsor (an individual or institution) and an investigator (individual/physician). The sponsor oversees the conduct of the study, including data collection, ethics review, publication, FDA reporting, and trial registration. The investigator conducts the day-to-day activities and medical supervision according to the protocol. The sponsor-investigator of an ISR assumes responsibility for all aspects of the trial, including trial design, ensuring appropriate institutional and regulatory approval, study conduct (including responsibility for ensuring appropriate medical safeguards, medical monitoring, and medical supervision), analysis and interpretation of the results, and communication of the results (i.e., publication). If the research proposal involves off-label use, the sponsor-investigator will be required to obtain an Investigative Device Exemption (or international equivalent) in advance.
If a research proposal is approved for funding, HeartWare and the sponsor-investigator will enter into a research agreement. The research agreement will define the study, identify the parties’ duties and expectations, specify milestones, allocate intellectual property ownership, and clarify publication responsibilities.
All Investigator-Sponsored Research Proposals should be forwarded to: firstname.lastname@example.org.
Note: Funding can only be awarded for legitimate scientific endeavors that follow Good Clinical Practices and ICH guidelines. All grants will comply with HeartWare policies, as well as HHS Office of Inspector General (OIG) compliance guidance, Food and Drug Administration (FDA) guidance, the AdvaMed Code of Ethics for Interactions with Healthcare Professionals, the Eucomed Code of Ethical Business practices, and all applicable laws and regulations.