Introduction to Investigator Initiated Studies (IIS)
Mölnlycke’s IIS program aims to support clinical research initiatives with the intent to generate new knowledge within the areas of wound management, prevention of pressure injuries and customised surgical solutions.
We support high quality projects that always put patient safety first. For this reason, approvals (or waivers) from an applicable Research Ethics Committee (REC) / Institutional Review Board (IRB) are part of our process when we review requests for IIS support.
How to submit your research proposal
We’ll review your research proposal in detail before we decide whether to support it.
If your idea is in an early stage, please submit a concept proposal here.
If you already have a protocol or clinical investigation plan in place, please submit a full proposal here.
We can’t promise to support every proposal that is submitted.
After you’ve submitted your proposal
Supporting a research proposal is a big step for us and for you. So we want you to know how we make decisions and what to expect after you submit your proposal.
1. We’ll confirm when we’ve received your proposal. And if we need more information, we’ll ask you for it.
2. Once we’ve received the information we need, we’ll review your proposal, looking at: safety of the participating subjects, alignment with Mölnlycke clinical and health economic evidence strategy, study design, statistics, possibility that the study will lead to a meaningful publication in a peer review journal, your qualifications and scientific merits and if your budget request is within fair market value.
3. You may be asked additional questions before we can make a decision about supporting your proposal.
4. After about a month, you’ll receive a written response with a rationale for our decision. We may decide to reject your proposal, offer a conditional approval or give you final approval. We only give final approval after receiving a copy of the REC / IRB favourable opinion/approval for the study.
5. Once the approval is in place, we’ll prepare our Support Agreement, describing the responsibilities of everyone involved.
N.B.: Kindly sumbit your proposal in English by using the following formats: PDF, jpeg and png.