Research Toolkit

Initiate Required Regulatory Tasks

Regulatory resources

IRB (Institutional Review Board)
The IRB reviews research projects that involve human subjects to protect the rights and safety of human research subjectsDoes your project need IRB review? 

Scientific Assessment
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.

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, contact CTSI's regulatory support staff.

Intellectual property 

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 to 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
Downloadable templates of standard licensing documents and forms can be found on this Office for Technology Commercialization (OTC) 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.  

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

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