Initiate Required Regulatory Tasks
Scientific assessment is required by the IRB for medical research involving human subjects deemed to be greater than minimal risk. One source for a scientific assessment is the Human Research Protection Program (HRPP). Consult the HRPP job aid for details on how to submit materials for scientific assessment by HRPP.
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, contact CTSI's regulatory support staff.
Data and Safety Monitoring Board (DSMB) Training Manual
Training manual for investigator-initiated studies with information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs
Material Transfer Agreements (MTAs)
Material Transfer Agreements (MTAs) govern the transfer of tangible research materials—such as chemicals, plant- or animal-derived material or software—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. More information on requesting a MTA can be found on this Office for Technology Commercialization (OTC) website, plus an overview is provided in the Sharing Research Materials handout.
Intellectual Property Disclosure Form
University policy requires researchers report inventions that they believe may have commercial or public value to Technology Commercialization. More details on carrying this out can be found on the OTC website.
License Agreement Definitions and Documents
Downloadable templates of standard licensing documents and forms can be found on this Technology Commercialization website. These include a Confidential Disclosure Agreement (CDA), Material Transfer Agreement (MTA), and License Application.
Regulatory services and support
Clinical and Translational Science Institute
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.
Research may require approval from other committees, depending on the nature of the project. Examples of such groups include:
- Institutional Animal Care and Use Committee (IACUC): Reviews all projects involving animals
- Cancer Protocol Review Committee (CPRC): Evaluation and monitoring of all University clinical cancer research protocols
- All University Radiation Protection Committee: Reviews radiation protection policies governing the use of ionizing radiation throughout the University
- Institutional Biosafety Committee (IBC): Approves practices and procedures for research involving rDNA, infectious agents, and biological toxins