Link: University of Iowa

Regulatory Knowledge and Support

The goal of the Regulatory Knowledge and Support Key Function is to help investigators and trainees using the CRU comply with institutional and federal regulations by:

  • providing expertise and education in clinical research regulation
  • assisting with the Investigational New Drug (IND) application process
  • assisting with issues related to Food and Drug Administration (FDA) regulations


We can help investigators and trainees prepare:

  • research protocols
  • safety plans
  • Internal Review Board applications and informed consent documents


We enhance the safety of research participants by:

  • reviewing safety plans for all CRU protocols prior to approval by the Clinical Research Protocol Review Committee
  • monitoring safety issues for research subjects on the CRU


Currently this key function primarily serves investigators and trainees whose protocols utilize the outpatient resources of the CRU


Contact Us


Please direct any inquiries or questions regarding research protocols and research safety to Janet Schlechte, M.D., Director of Research Safety and Investigator Support. She may be reached via email
janet-schlechte@uiowa.edu or by phone at (319) 384-8305.

Questions or inquiries regarding IND processes and/or FDA regulations should be directed to Larry Fleckenstein, Pharm.D., Associate Director of Investigator Support. He may be reached via email l-fleckenstein@uiowa.edu or by phone at (319) 335-8804.


Resource Links


Frequently Asked Questions (FAQ)

We invite you to read the following FAQ list and hope to hear from you with any questions, comments, or concerns you might have.


Q: What type of protocol needs a safety plan?


A: All protocols involving research on human subjects are required to have a safety plan. Each safety plan is reviewed by the Research Safety Committee and forwarded for final approval to the CRU protocol review committee.


Q: Are there different types of safety plans?


A: The safety plan must include a clear description of the risks to subjects ALONG WITH plans to reduce or eliminate the risk. A protocol involving only minimal risk may be short while a complicated protocol with substantial risk to subjects will require a detailed discussion of potential risks and plans to reduce risks. Some protocols will also require a data and safety monitoring committee.


Q: Where do I find the safety plan template?


A: You may access the safety plan template by clicking on the following link: Safety Plan


Q: How do I write a safety plan?


A: The form is self explanatory but if you have questions you may contact Janet Schlechte, M.D., via email (janet-schlechte@uiowa.edu) or by phone at (319) 384-8305.


Q:Who do I call if I can't download the research safety plan template?


A: Please call the CRU administrator at (319) 384-8319.