Human Subjects

For Sponsors

Compliance Information

Recent Compliance Issues:

The IU IRBs underwent an FDA inspection April 22 – May 3, 2016. The inspection resulted in an FDA Form 483 with two observations; one observation regarding written procedures for conducting review of research, and a second observation regarding IRB meeting quorum. IU’s response, inclusive of a corrective and preventive action plan, was accepted by the FDA on January 4, 2017.

Investigator Brochure Updates

Since February 1, 2015, the IU IRBs no longer review Investigator Brochure (IB) updates unless the revisions result in changes to additional study documents. The IB is a technical document provided to the IRB for informational purposes only; as such, review of stand-alone IB updates does not offer additional protection to human subjects. The IB should still be submitted to the IRB at time of initial review, and the most updated version should be submitted by the study team with each renewal. If a change to the IB results in revisions to other study documents, such as a changed risk profile requiring updates to the informed consent, the revised IB should be included with the amendment as supporting documentation only.

Data Safety Monitoring Reports

In accordance with OHRP 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 DSMB/DMC), the IU IRB requires submission of the most current report from the monitoring entity with submission of each Renewal. The IRB relies on this information in order to make the required determinations regarding continuation of research. Absent this report, the IRB may not be able to adequately evaluate risk to subjects and approve continuation of the research.

At a minimum, such monitoring reports should include:

  • A statement indicating what information (e.g., project-wide adverse events, subject withdrawals, complaints about the research, interim findings, and any recent literature that may be relevant to the research) was reviewed by the monitoring entity;
  • The date of the review; and
  • The monitoring entity’s assessment of the information reviewed.

IRB Information

Indiana University Institutional Review Boards
980 Indiana Avenue, LV 3315
Indianapolis, IN 46202

IRB Registrations

IRB00000219 – Indianapolis IRB-04
IRB00000220 – Indianapolis IRB-01
IRB00000221 – Indianapolis IRB-02
IRB00000222 – Bloomington IUB
IRB00000228 – Indianapolis IRB-03
IRB00004960 – Indianapolis IRB-07
IRB00004961 – Indianapolis IRB-05

Contact the Human Subjects Office

  • Bloomington

Human Subjects Office
Office of Research Administration
Indiana University
Carmichael Center, Room 203
530 E. Kirkwood Avenue
Bloomington, Indiana 47408

Phone: 812-856-4242

  • Indianapolis

Human Subjects Office
Office of Research Administration
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202

Phone: 317-274-8289

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