Information for Sponsors

If you are an individual, company, institution, organization, agency or other group supporting human subjects research at Indiana University, the following information is provided for your convenience:

Institutional Review Boards

Indiana University IRBs underwent an FDA inspection from February 6 to 14, 2020. The inspection resulted in an FDA Form 483 with one observations. The FDA accepted IU's response on November 23, 2020.

Indiana University will not release Clinical Investigator related inspectional information.  IU investigators may release such information for their own prior inspections (those for which he/she was the Clinical Investigator under inspection).    Prior to releasing such information, IU investigators should ensure appropriate redaction of these materials to comply with executed institutional contracts and confidentiality agreements.  Outside of this scope, sponsors may request the inspectional information through the Freedom of Information Act.

In accordance with Office of Human Research Protection’s Guidance on Continuing Review (2010), when research is subject to oversight by an entity responsible for safety monitoring (e.g., the research sponsor, a coordinating or statistical center, or a Data and Safety Monitoring Board/Data Monitoring Committee), IU's IRBs require submission of the most current report from the monitoring entity with submission of each renewal. The IRB relies on this information to make the required determinations regarding continuation of research. Without this report, the IRB may not be able to adequately evaluate risk to subjects and approve continuation of the research.

At minimum, data safety monitoring reports must include:

• a statement indicating what information (e.g., project-wide adverse events, subject withdrawals, complaints about the research, interim findings) was reviewed by the monitoring entity,
• the date of the review, and
• the monitoring entity’s assessment of the information reviewed.