Investigator Role

How do I become an investigator for a research study you may be asking? It is quite easy! And the Office of Research is here to assist you.

An investigator by definition is an individual who conducts a clinical investigation. This could be a physician, nurse, pharmacist, anyone who is using a test article with a human subject and is helping to contribute to generalizable knowledge. You can serve as either a Principal Investigator (the lead investigator at the site) or a Sub-Investigator.

How does a research study idea get started? It may happen in a variety of ways.

1. You hear about an exciting new drug being studied
2. A drug or device company contacts you to see if you want to participate in a study
3. Our office contacts you about an exciting new study
4. You develop your own research question

How exactly do you become an investigator?

1. Tell us what drug or what study you are interested in participating
2. We will contact the company and obtain the study protocol after signing a confidentiality agreement
3. Submit a signed and dated copy of your current CV to our office (fax (515) 241-6776)
4. Requirements of the Institutional Review Board (email to IRBsubmissions@unitypoint.org):

• Receive certification through the NIH online tutorial for human subjects protection training www.phrp.nihtraining.com
• Submit Conflict of Interest Form found at the IRB website.

We will be in close contact with you about the next steps in getting your study up and going. Our experienced staff is knowledgeable and able to assist with every step along the way of the study process, helping ease the burden on the investigator.

The investigator will be responsible for the following, with the assistance of the Office of Research:

• Help identify potential subjects
• Approach subjects to assess interest
• Sign study-required documents, including adverse event reports, as they occur
• Attend study-required monitoring visits

In addition, those serving as Principal Investigators (PI) may sign an FDA-required document called a 1572 (Statement of Investigator). This document outlines the responsibilities of the PI, and can be found on the FDA website by entering "1572" into a search engine (such as Google). The responsibilities are listed on section 9 of this form.