Comply with Regulations

Consultations and Services

Orthopaedic Surgery Research Team
The Department of Orthopaedic Surgery has research staff that can help with all steps in clinical, preclinical, and educational research studies. Staff are available to help with study design, grant proposals, data collection and management, regulatory support, statistics, and publication of results. To get started, please contact Joan Bechtold.

CTSI Regulatory Support and Planning
Regulatory experts from the Clinical and Translational Science Institute (CTSI) can provide assistance navigating the regulatory requirements, such as FDA inspections, clinical trial monitoring, and more.

Resources

UMN Research Compliance Office
The Research Compliance Office supports the research community by facilitating the investigation of research compliance concerns, overseeing research ethics and compliance education, and assisting other ethics, regulatory, and financial compliance programs across the University.

FDA Investigational New Drug (IND) or Device Exemption (IDE) Resources
This FDA website has resources about administering an investigational drug or biological product to humans.

UMN Export Controls
The University of Minnesota Research Compliance Office is responsible for ensuring compliance with US export controls, the federal statutes and regulations that govern certain transactions having an international component. Export Controls Officers can help with technology transfers to non-US personnel, shipments abroad, and international transactions having certain foreign policy and national security implications.

Other Resources

Additional resources on complying with regulations can be found through the CTSI research toolkit.