Studies Involving Drugs and/or Devices

Drugs, Biologics, Medical Devices, Tobacco and Generally Recognized as Safe (GRAS) Substances

What is a Sponsor-Investigator (SI)?
What are Brown’s Institutional Procedures related to Sponsor-Investigator studies?
What is the role of the IRB in Sponsor-Investigator research?
Sponsor-Investigator Training
Available FDA Resources
Protocol and Submission Writing Resources
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What is a Sponsor-Investigator?

A Sponsor-Investigator (SI) means a researcher who both initiates and conducts an investigation.  An SI not only is accountable to the roles and responsibilities on the project as the PI, but is also required by the Food and Drug Administration (FDA) to follow the FDA regulations that apply to sponsors.

Brown’s Institutional Procedures and Resources

SIs must include a completed Medical Device checklist and/or Investigational New Drug checklist with all initial IRB submissions for research that involves a drug or device.  These checklists provide guidance in determining if an application for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application must be submitted to the FDA. In addition, completing these checklists helps ensure that the required information is documented and submitted to the IRB.  Sponsor-investigators may also reference the Device/IDE chart and the Drug/IND chart.  If you need assistance with any of the checklists, have questions about FDA regulations, or would like a desk audit conducted of your FDA-regulated study prior to an FDA inspection, please contact our Quality Assurance / Quality Improvement Administrator @ christiana_provencal@brown.edu.

The Role of the Institutional Review Board

Some investigations require approval by the FDA and the IRB prior to commencing research, while others require only IRB approval.  For example, two types of studies are subject to IDE regulation - significant risk (SR) and non-significant risk (NSR) studies. Sponsor-Investigators are responsible for making the initial risk determination and presenting it to the IRB.  Unless the FDA has already made a risk determination for the study, the IRB must review the Sponsor- Investigator’s determination for every medical device study reviewed and modify the determination if the IRB disagrees with the Sponsor- Investigator’s.

Sponsor-Investigator Training

Brown University researchers are required to take CITI training prior to conducting human subject research. Please review the CITI Training requirements for additional information and to link to the CITI course. The FDA’s Clinical Investigator Training Courses can also be helpful.

FDA Resources

Drugs

Medical Devices

Biologics

Tobacco

Marijuana

Generally Recognized as Safe (GRAS)

Expanded Access (Compassionate Use)

Protocol and Submission Writing Resources

Links to the FDA website provided on this webpage were current as of the posting date, but may be moved or changed in the future. If you notice any broken or outdated links, please email us at irb@brown.edu.