The proposal submission process involves the following steps:
The online submission process includes concept submission as well as full proposal submissions. The online forms guide you through the process, using a series of questions to help the ISR committee understand the:
This information will enable the committee to make an informed decision and provide you a timely response.
For more information, please visit our online Frequently Asked Questions (FAQ) page.
On a monthly basis, the ISR committee will perform a multi-functional review to evaluate proposals in terms of scientific merit, regulatory compliance and market impact. You can log-on to the CARE website to review status at any time. An e-mail will alert you to status changes and new on-line correspondence. In this way, the committee will communicate questions, comments, suggested modifications and ultimately the ISR committee’s determination of scientific interest in participating in the project.
On a quarterly basis, the ISR committee meets to review projects determined to have relevance to the health and quality of life of Boston Scientific patient populations. The expected impact of each study is weighed in relation to the timeframe and cost of the project. Based on this evaluation, the proposals are prioritized and the top projects will receive support. For cases in which a project is very interesting, but funding is not available, CARE will keep the proposal in the queue for future consideration. Once funding is approved, a research agreement is coordinated between Boston Scientific and the physician.
The research agreement protects physicians, patients and Boston Scientific by defining roles and expectations. It addresses issues such as level of patient/study risk, understanding the requirements of a sponsor-investigator, intellectual property ownership and publication. The research agreement documents the final protocol and milestones so support funding can be provided when it is needed as the steps are completed.
The entire ISR program process is tracked through the CARE website (www.guidantcare.com), from submission to study completion. On the website, you can: