Investigator Initiated Studies application process

The IIS admission process consists of two steps: first you will need to submit a concept proposal, if the concept is approved then this is followed by submission of a full proposal that will be submitted for final approval and funding. Read below about the specific steps.

    • We have continuous admissions for concept proposals.
    • All proposals are reviewed by our Evidence Strategy Board (ESB).
    • If the project is of interest to Mölnlycke and is feasible, we will progress the submission to the next stage.
    • We aim to give an answer with in approximately eight weeks if the proposal meets with our research focus.

    Submit concept IIS proposal

    • We have continuous admissions for full proposals.
    • We ask you to submit budget details following our budget template along with your proposal.
    • Full proposals are reviewed internally to ensure they fully align with the product strategy, including product indications for use, and are validated from a financial and statistical perspective.
    • We aim to give an answer within two months of receiving the proposal. 

    Submit full IIS proposal

How to submit your proposal

Your proposal will of course be treated with confidentiality. For more information on how we process your data see our privacy notice. 

Please note
We always put patient safety first. For this reason, approvals (or waivers) from an applicable Research Ethics Committee (REC)/Institutional Review Board are part of our IIS review. 
 
Our research grant provides financial support for all or a portion of study‐ or product investigation-related costs. Since this type of project is sponsored and owned by the investigator, the financial support excludes overhead.

What happens after submission

We aim to make the process as open and straightforward as possible. Here’s a summary of how we assess your proposal and when you can expect to hear from us.

    1. We confirm receipt of your proposal and ask for more information if we need it.
    2. Once we’ve received the information we need, we review your proposal, looking at: safety of the participating subjects, alignment with Mölnlycke clinical and health economic evidence strategy, study design, statistics, probability that the study will lead to a meaningful publication in a peer reviewed journal, your qualifications, the project’s overall scientific merit and whether your budget request is within fair market value. We may ask additional questions before we can make a decision.
    3. Within eight weeks, you receive a written response with a rationale for our decision to approve or reject your proposal. If we accept your proposal, you can move on to STEP II by submitting a full IIS proposal.
    1. We confirm receipt of your proposal and ask for more information if we need it. 
    2. Once we’ve received the information we need, we review your proposal, looking at: safety of the participating subjects, alignment with Mölnlycke clinical and health economic evidence strategy, study design, statistics, probability that the study will lead to a meaningful publication in a peer reviewed journal, your qualifications, the project’s overall scientific merits and whether your budget request is within fair market value. We may ask additional questions before we can make a decision.
    3. At the end of the review period, you receive a written response with a rationale for our decision to either give you final approval, offer conditional approval or reject your proposal.
    4. Once the approval is in place, we prepare our IIS Financial Support Agreement, describing the responsibilities of everyone involved.
    5. We will insist on regular updates regarding the status of the study. We also aim to visit the study site at some point during the project if this is acceptable.
    6. The final and very important step is reporting and publication. At this stage we ask you to share your results, abstract/manuscript, including the final version for submission. 

Questions?

If you have any questions, please feel free to contact us by email at investigatorinitiatedstudies@molnlycke.com. 

If your IIS full proposal application is successful, you can also apply for Mölnlycke’s IIS dissemination grant. This is intended to help with, for example: 

  • medical writing and statistical analysis fees 
  • travel fees for presenting IIS study at conferences 
  • publication fees
IIS dissemination grant

Apply now

If you have already completed your project and you only need help with medical writing and/or preparation of a conference poster submission, please apply for a dissemination grant. Download the form and e-mail to investigatorinitiatedstudies@molnlycke.com.

Download IIS dissemination grant form

Please note
We only support proposals after receiving a copy of the Ethics Committee/IRB favourable opinion/approval for the study. 
For further information about regulatory requirements we adhere to, please see our IIS governance references.