Interventional Urology Investigator Initiated Study Program
Please use the Interventional Urology Investigator Initiated Study Proposal and Research Grant Request Form to submit Investigator Initiated Research projects.
Mission Statement
The mission of the Interventional Urology Investigator Initiated Study Program (IISP) is to provide support for research that advances medical and scientific knowledge relating to urology, urogynecology, endourology, patients treated in these areas, associated caregivers, and the health care providers who work in these areas. Through the support of ethical and scientifically sound research we hope to improve the overall quality of patient care. This program is open to all qualified researchers who are interested in designing, conducting, and analyzing their own research projects, and who desire funding and/or other assistance from Coloplast.
Process
The Investigator Initiated Study process begins with the submission of a Study Proposal and Research Grant Request Form. This form serves as a request for assistance and collects information needed to assess the scientific merit of the proposed study.
Complete and qualified submissions will be reviewed by the IISP Review Committee to determine alignment with Coloplast’s areas of clinical interest, mission, budget, and compliance with applicable laws/regulations and Coloplast policies. The submission of a study proposal does not imply approval, and any support is contingent upon obtaining a fully-signed IISP research agreement.
For human subject studies, any Coloplast or other medical device use must align with current approved labeling for the geographical location in which the study will be conducted, unless an Investigational Device Exemption (IDE) has been approved by the U.S. Food and Drug Administration or a similar process is followed for applicable geography. Ethics approval (e.g., Institutional Review Board, Ethics Committee, Institutional Animal Care and Use Committee), where relevant, is required.
Financial and product/materials/services support is subject to fair market value assessment. In the U.S., Coloplast will report the value of all funds, products, data, materials and services provided under any grant as may be required by state and/or federal disclosure laws, including the Federal Physician Payment “Sunshine Act” or applicable geographical transparency rules for any country outside the U.S.
Click here to download the IISP Study Proposal and Research Grant Request Form