Initiate Required Regulatory Tasks

Regulatory Resources

IRB (Institutional Review Board)
The University of Minnesota IRB reviews research projects involving human participants, working with investigators to ensure adequate protection and informed, uncoerced consent. The IRB’s online Determination Assessment Tool can be used to determine whether or not an IRB is needed for a particular study. Orthopaedic surgery research staff can help with IRB submissions. To get started, contact Kristin Mathson.

Ancillary Reviews
The IRB requires various ancillary reviews depending on the type of project. Ancillary reviews can include a scientific review, review by Fairview Research Administration, and HIPPA review, among others. These reviews can now be completed and tracked in ETHOS, the IRB’s study management platform.

ClinicalTrials.gov
The IRB requires that biomedical research studies be registered with ClinicalTrials.gov.

Investigational New Drug (IND) or Device Exemption (IDE)
This FDA page describes the IND and IDE application process and houses related resources. For assistance with this process, please contact Kristin Mathson or CTSI’s regulatory support staff.

Intellectual Property

Material Transfer Agreements (MTAs)
Material Transfer Agreements (MTAs) govern the transfer of tangible research materials from one institution to another. They are legal contracts used to protect intellectual property rights, limit liability, and ensure that researchers are properly credited for their work. Additional information on requesting an MTA can be found on the Office for Technology Commercialization (OTC) website, or on this Sharing Research Materials handout.

Non-Disclosure Agreements (NDAs)
Non-disclosure agreements (NDAs), also called confidentiality agreements, protect intellectual property when you share information about confidential research and ideas. For more information on NDAs and when you might need them, please see this handout on Confidentiality Agreements.

Intellectual Property Disclosure Form
University policy requires researchers to report inventions to the Office for Technology Commercialization (OTC) that they believe may have commercial or public value. More details on carrying this out can be found on the OTC website.

License Agreement Definitions and Documents
This Office for Technology Commercialization (OTC) website has downloadable templates of standard licensing agreements including a Confidential Disclosure Agreement (CDA), Material Transfer Agreement (MTA), and license application.

Regulatory Services and Support

Orthopaedic Surgery Research Team
The Department of Orthopaedic Surgery has research staff that can help with IRB submissions, continuing reviews, and other regulatory requirements. To get started, please contact Joan Bechtold or Kristin Mathson.

Clinical and Translational Science Institute (CTSI)
CTSI offers support for IRB submissions, project planning, IND and IDE applications, FDA inspections, clinical trial monitoring, and more. Request services via the CTR portal.

Fairview Research Administration
Fairview Research Administration facilitates the use of investigational devices within the Fairview system, including arranging billing to insurance. This site includes information on how to get started.

Regulatory Committees
Depending on the nature of the project, research may require approval from other committees. 
Examples of such groups include: