Regulatory & Compliance

To comply with law and UMN policy, specific trainings for research faculty must be completed before grant submission and throughout the research process. Detailed information can be found here. 

Key Required Trainings:

• REPA (Report of External Professional Activities): Discloses relationships between University employees and business entities.

• Conflict of Interest (COI) Education: Must be completed before REPA submission and renewed every four years.

• Research Security Training: Required for senior/key personnel within one year of a federal proposal submission. Access the course via the Research Integrity and Compliance site or directly through CITI. 

• Responsible Conduct of Research (RCR) Core Training: The RCR Core Training must be completed no later than 90 days from the date of a PI’s initial appointment. Personnel anticipating a research award within the 90 day window should meet the RCR requirement as early as possible. Awarded funds cannot be released until all RCR requirements are met. 

Principal Investigators and study personnel must complete human subjects training prior to conducting human subjects research. Instructions for logging-in and additional guidance can be found here.

Not sure which training you need? 

• Biomedical human research study must complete "Good Clinical Practice and Human Research Protections for Biomedical Study Teams".

• Social Behavioral human research study must complete “Social / Behavioral or Humanist Research Investigators and Key Personnel”.

Responsible Conduct of Research (RCR): Required for Faculty, postdoctoral fellows, and Principal Investigators (PIs).

• • Deadline: Must be completed within 90 days of a PI's initial appointment.

  • Funding Note: Awarded funds will not be released until all RCR requirements are met.

CITI trainings are typically required for all people involved in a study, and must be renewed every 3 years. The triennial refresher only takes about 30 minutes to complete! 

Ownership, responsibilities and retention: 

Here's a distilled version of the University policy. 

Brush up on the University Policy for Transferring Research Data. This applies to the process of moving data to and from another organization in cases where a PI leaves or joins the University or the PI responsibility of a project is moved to or from another institution.

Different rules apply for a variety of scenarios. Check out different scenarios for sharing data and how to handle them correctly.

Can this UMN data be shared with another party? We love a decision tree!

Process for obtaining an agreement is outlined on SPA's UFRA webpage

For additional assistance, contact Amy Ash.

Unsure if your project needs IRB approval? Complete the Human determination Form

Use the Medical Template Protocol (HRP-590) for biomedical research. Think FDA-regulated items, radiation, human materials, controlled substances... If your study is primarily "social" but includes medical procedures (blood draws, MRI, etc., use the medical template.

Use the Social Template Protocol (580) for research focusing on human behavior - surveys & interviews, observational studies, educational research)

Data &/or Specimen Only Protocol (HRP-595) should be used for research that uses existing information or biological samples without any direct interaction with living participants.

♦️For more templates and forms, go to the IRB Toolkit library

First step is to set up an account in the Research Services Portal. Find directions here!

Click here to find out more information on: 

• How do to submit a New Proposal? 

• What happens after I submit a proposal?

*ALL IRB submissions require department approval with the exception of a determination form!

OnCore is a clinical trial management system and access is required for CPRC submission. CTSI offers free OnCore services! Just email oncore@umn.edu to get started.