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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 BoardsIndiana University Institutional Review Boards
980 Indiana Avenue, LV 3315
Indianapolis, IN 46202
Resources and compliance information
Most recent FDA inspection
Indiana University IRBs underwent an FDA inspection from April 22 to May 3, 2016. The inspection resulted in an FDA Form 483 with two observations. The FDA accepted IU’s response on January 4, 2017.
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.
Investigator Brochure updates
Indiana University IRBs do not accept a sponsor’s Investigator Brochure (IB) updates unless the revisions result in changes to additional IRB-approved documents, such as the informed consent or protocol. If this is the case, submit an amendment to change the IRB-approved document and include the IB as supporting documentation.
IU IRBs will accept the most recent IB as part of an initial submission and with each renewal.
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 Indiana University Human Subjects Office provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.
Indianapolis (Main):Human Subjects Office
Office of Research Compliance
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
- Phone: 317-274-8289
- Email: firstname.lastname@example.org
Bloomington:Human Subjects Office
Office of Research Compliance
2218 N. Dunn St.
Bloomington, Indiana 47408