Investigator Initiated Studies

Investigator initiated studies (IIS) are independent, innovative research studies conceived, designed, and supported by qualified researchers, involving both Investigational Use Only (IUO) / Research Use Only (RUO) and post-launch QIAGEN products. These differ from QIAGEN clinical trials which are designed and implemented entirely by QIAGEN with external collaborators.  Investigator initiated studies shall investigate areas of clinical and therapeutic interest to QIAGEN with the main goal of improving patient care and management of the disease state of interest. In addition to purely investigator owned studies, QIAGEN also supports Collaborative Research proposals which allow for QIAGEN input. 

Investigator initiated studies are important to QIAGEN to supplement our clinical trials to gain insights into additional intended uses or sample types (off label use) or addressing unmet medical needs.  QIAGEN can provide funding, reagents, instruments and/or training as support for IISs.

Protocol for submission

A study protocol shall be submitted to QIAGEN for review by the Medical Affairs staff. Proposals must be submitted in English, and with a detailed description of the study design, objectives, and workflow. 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 interest and research goals of evaluating the utility of QIAGEN products to provide additional insights into technical, medical, and/or economic value of our products to patients, clinicians, administrators, or laboratories.
2. Is conducted by experienced and qualified researchers.
3. The study protocol is well designed and scientifically valid, with the intention to result in publication in a peer-reviewed journal within 18 months of initiation.
4. Provides added value to the current body of knowledge regarding the QIAGEN product of interest.
5. Ethics committee (EC) or institutional review board (IRB) and/or health authority approval

If approved, a member of the QIAGEN medical affairs team will contact you with next steps.