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.

Address Ethical Issues

Research Ethics

Core Commitments 
The Office of the Vice President for Research has developed a set of Core Commitments for research conducted at the University of Minnesota. These Core Commitments represent our shared responsibility to protect research participants, uphold the highest ethical standards, and improve our practice at every step.

Education

Center for Bioethics
The University of Minnesota Center for Bioethics offers courses and seminars in bioethics, as well as two programs to suit the aspirations of graduate and professional students as well as working professionals. These include the Master of Arts in Bioethics and Graduate Minor in Bioethics programs. The Center for Bioethics may also be able to assist researchers with conducting literature reviews on any ethics matter pertaining to innovative or unusual research designs that use human subjects.

UMN IRB Required Training
The University of Minnesota Institutional Review Board (IRB) has training requirements for researchers and research personnel involved in the conduct of human research. These trainings include the Collaborative Institutional Training Initiative (CITI)Responsible Conduct of ResearchAssessing Capacity to Consent, and HIPAA training.

Human Research Training Website
This new CTSI tool helps users identify and maintain the appropriate training, certification, credentials, and immunizations needed to perform research with human participants at UMN. This tool creates a roadmap for each individual, which prescribes a curriculum of required and optional human research training courses customized to their specific research role, tasks, and studies assigned.