There are many researchers who have interest in researching their own questions, and this is encouraged as it promotes innovative thinking with the potential expansion of medical knowledge! Investigator-initiated studies are managed in much the same way as sponsor-initiated studies in regards to compliance with state and federal laws, good clinical practice guidelines, and ultimately the safe and ethical conduct of a study.
Though our office does not have funding set aside to assist with these types of projects, we are available to assist as our time allows. Many considerations need to be made in regards to the type and phase of the study, budget, informed consent, resource constraints, IRB submission, etc. We are able to provide guidance with these steps.
If you have an interest in pursuing an investigator-initiated project, the following are some suggestions on how to begin:
- Choose your topic and your question
- Quantify what you want to measure and what would be considered a "difference"
- Formulate your question into a hypothesis
- Name your objectives for doing the study
- Perform a literature search on your own, or recruit the help of the health sciences library
- Consider discussing your research question with others in your field
- Consider the resources, time, budget needed to complete the study
- Draft a protocol, outlining exactly how this study will be conducted
At any point along the way, our office can be contacted for assistance at (515) 241-6727. In addition, the Institutional Review Board (IRB) process needs to be completed prior to beginning the study. The IRB office has information located on the following webpage www.unitypoint.org/irb.