Investigator Initiated Research
Investigator Initiated Studies (IIS) Program Overview and Mission:
The Acelity Investigator Initiated Studies (IIS) Program evaluates and provides support for investigator initiated research which is designed and conducted by the Investigator or Institution.
The IIS Program mission is to support research that forwards Acelity scientific goals while promoting better patient outcomes and providing valuable information to the health care community through peer-reviewed publications.
Proposals submitted to Acelity are evaluated for scientific and technical merit by the IIS Committee through a systematic, two-phase formal review process. First, a study proposal including a protocol synopsis and budget outline are evaluated in alignment with our criteria for support. Following this initial review, Investigators with proposals meeting the goals and criteria of the IIS Program will be contacted by the IIS project manager. The IIS project manager will assist the Investigator with the submission of additional documents required for a comprehensive evaluation and final determination of support.
The IIS Committee considers the review criteria below in the determination of scientific and technical merit:
- Innovation/Clinical Significance
Does the application challenge clinical practice paradigms by utilizing novel concepts, approaches or methodologies? Does it address a critical barrier to progress in advanced would therapy or regenerative medicine? Does it demonstrate an evidence-based approach in pursuit of knowledge to advance the scientific goals of Acelity? How will the scientific knowledge and clinical practice be improved?
- Study Design and Approach
Will the proposed design likely result in acceptable publication? Are the overall strategy, methodology and analyses appropriate to accomplish the specific aims of the project? Are the study endpoints realistic?
- Investigator Research Capabilities
Are the researchers well suited to the project and do they have appropriate credentials training and resources? Do they have an ongoing record of accomplishments that have advanced their field?
- Environment and Budget
Will the scientific environment in which the work will be done contribute to the probability of success? Is the requested budget suitable for the proposed research and within the parameters of fair market value?
If the project involves clinical research, are the plans for protection of human subjects from research risks part of the strategy proposed? Does the research plan include provisions for compliant safety reporting and methods of reporting study product related Serious Adverse Events back to Acelity? In all cases, IRB/EC or IACUC approval is required prior to the grant being awarded.
Is the proposed study consistent with the labeled indications for use ( i.e. “on label”)? If it is determined by Regulatory Affairs that the proposed study falls outside the labeled indications for use (i.e. “off label”), the grant recipient is fully responsible for obtaining an Investigational Device Exemption (IDE) prior to the implementation of the proposed research.
Some examples of Grant Requests that the Acelity IIS Committee does not support:
- Grant requests not affiliated with an investigator initiated research protocol.
- Requests for educational grants, fellowships and charitable contributions. The application process for these types of grants is through Professional.Affairs@Acelity.com
- Requests directly or indirectly conditioned on the requesting organization’s agreement to purchase, lease, recommend, use or arrange for the purchase or lease of Acelity products.
- Requests where there is evidence of unduly influencing the decision of whether a particular institution will receive a grant or the amount of such grant by a member of Acelity.
- Requests from organizations listed on the Office of Inspector General’s List of Excluded Individual/Entities (OIG LEIE) or the General Services Administration Excluded Parties List System (GSA EPLS)
PLEASE REFRAIN FROM CONTACTING AN ACELITY COMMERCIAL REPRESENTATIVE AS THEY SHOULD NOT BE INVOLVED IN THE IIS GRANT PROCESS.
Please contact us directly at AcelityIIS@Acelity.com for more detailed information about how to apply, including documentation requirements, submission guidelines and the review process.
Acelity is aware of the growing need for support in Investigator Initiated Research. A higher volume of requests are received than can be funded. Nonetheless, every request will receive a fair and thorough review, based on our criteria for support.