Information for Sponsors

Sponsoring human subjects research

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 Institutional Review Boards 
986 Indiana Avenue, 5th Floor
Indianapolis, IN 46202

In lieu of providing IRB rosters, IU offers a Statement of Compliance (Accessible 06/22/21).

Most recent FDA inspection

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.

Stamping of IRB-Approved Study Documents

Effective January 19, 2021, the IU IRB no longer issues stamped copies of IRB-approved study documents, such as Informed Consent Statements.  The IRB reviews and approves the study documents submitted with the IRB application.  The IRB Approval Letter notes the study documents, including file names, and document descriptions approved with each submission.  Any questions regarding approved documents can be directed to the IRB at

Data safety monitoring reports

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.

The IRB publishes quarterly turnaround times


The Indiana University Human Research Protection Program (HRPP) provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.

Indianapolis (Main):

Human Research Protection Program (HRPP)
Office for Research Compliance
Indiana University
986 Indiana Avenue, 5th Floor
Indianapolis, Indiana 46202
  • Phone: (317) 274-8289
  • Email:


Human Research Protection Program (HRPP)
Office for Research Compliance
Indiana University
509 E. Third St.
Bloomington, Indiana 47401
  • Phone: (812) 856-4242
  • Email: