Submission Process
Investigators can submit study ideas as a concept or full proposal.
A Concept or study idea includes a short, high-level summary of the study’s Main Scientific Question including therapeutic area, application of product or protocol, an estimated budget and research design setting details. A full proposal submission will still be required if the concept is approved.
A full Proposal submission details the study including a line item budget, a curriculum vitae of the principal investigator, and a fully developed protocol with objective, design, procedures, analysis plan, adverse event reporting, and safety plan as needed.
With this information, the Research Committee will determine whether or not Boston Scientific would like to explore the proposed study idea.
To submit a proposal or concept, please log in to the Global ISR System Website.
The benefit of the portal is that it:
- Allows investigators to submit research proposals
- Provides a web-enabled database
- Tracks project progress
- Enables open communication between investigators and the Boston Scientific ISR team at each step, including:
- study submission, review, and approval/rejection
- study progress (milestone based)
- study completion
- publication
- Helps maintain “arms-length” from investigators and BSC’s (commercial) field personnel
Step 1. Log in or register
Step 2: Submit Proposal
Submission of Concepts
Concept or study idea includes:
- Short Study Title
- Therapeutic Area
- Primary Product
- Institution Payee
- BSC Support requested
- Estimated Budget
- Main Scientific Question
- Primary Country/Geography
Full Proposal
A full proposal includes:
- The project title
- Expected duration of study
- Project objectives or hypothesis
- An explanation of the rationale and scientific novelty
- The methods of study/study design and justification
- A statistical analysis plan, including sample size justification and, where appropriate, a power analysis
- A plan for handling adverse events and a risk/benefit analysis
- Detailed budget breakdown
- A list of products involved (if specific)
- References
- Detailed publication plans
Documents required for full proposal evaluation and funding review:
- The sponsor-investigator's curriculum vitae
- Line item budget
- Detailed Study Protocol
With this information, the Research Committee will determine whether or not Boston Scientific would like to explore the proposed study idea. If so, the additional information required for a proposal submission will be necessary before funding can be considered.
Please note: Approval of a Concept submission by the Research Committee is an invitation to submit a full proposal for your research and does not guarantee Boston Scientific support for the research.
Step 3: Proposal Review
Each Divisional Research Committee performs multi-functional reviews as requests are submitted to evaluate proposals in terms of scientific merit, regulatory compliance and the ability to advance knowledge of our devices.
You will receive an e-mail alert when the status changes or if the committee has questions or comments, including its decision whether to support your research.
Step 4: Funding Determination
The Divisional Research Committees meet at least quarterly to review projects determined to be of interest to Boston Scientific and the medical community.
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.
If funding is approved, a research agreement is coordinated between Boston Scientific and the Investigator’s Institution.
Step 5: Mutual Agreement Executed
Research Agreement
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.
It documents the final protocol and milestones so that support can be provided when it is needed as the steps are completed.
In the event there are submissions that may need additional regulatory approvals, it will be the Sponsor's or researcher's responsibility to obtain approval from appropriate regulatory bodies.
Step 6: Follow-up Through Project Completion and Publication
The entire ISR program process is tracked through the Global ISR System Website from initial submission to study completion. On the website, you can:
- Review your proposal and project history
- Notify the Committee or submit documentation of the completion of a milestone
- Ask questions
- Report results
- View the research agreement
- Submit essential documents (i.e. publications, IDE approval letter, IRB approval)