Investigator Initiated Studies Medical Program

Investigator Initiated Studies (IIS) are independent, innovative research studies conceived, designed, and supported by qualified researchers, involving Investigational Use Only (IUO) / Research Use Only (RUO) and post-launch IVD QIAGEN products. These differ from our clinical trials which are QIAGEN developed, sponsored, and used or regulatory clearance. Investigator initiated studies shall examine areas of clinical, economic, lab efficiency and therapeutic interest to QIAGEN with the main goal of improving patient care, reducing healthcare costs and management of the disease state of interest.  To support such studies QIAGEN may provide funding, reagents, instruments and/or training.

Protocol for submission

A study protocol shall be submitted to QIAGEN for review by the Medical and Scientific Research Committee. Proposals must be submitted in English, and with a detailed description of the study design, objectives, and workflow. The QIAGEN standard IIS template is provided below to ensure completion of all required information.

A designated QIAGEN review committee composed of medical and scientific staff will evaluate your submission based on the following criteria:

1. Study is aligned with QIAGEN areas of clinical and economic outcomes of interest. 
2. The research goals will provide additional insights into technical, medical, and/or economic value of our products for patients, clinicians, administrators, or laboratories.
3. Experience and qualifications of the researchers and study staff.
4. Study protocol: must be original,  well designed and scientifically valid, with the intention to result in publication in a peer-reviewed journal within 18 months of initiation.
5. Provides added value to the current body of knowledge regarding the QIAGEN product of interest.
6. Applicability of the budget and resources requested to the proposed study and in accordance with compliance standards.
7. Compliance with all applicable local laws and regulations including ethics committee (EC) or institutional review board (IRB) and/or health authority approval.

Complete study protocols will be reviewed with 20 working days of submission. A member of the QIAGEN Medical Affairs team will contact you with next steps.