Studying a Drug or Device?

Please contact the Human Subjects Office by phone at (317) 274-8289 or send an email to irb@iu.edu if you need accessibility help with the protocol decision tree.

Review the following questions and select the best option by answering either "Yes" or "No" as it applies to your new study submission. Your selections on each proceeding page will help identify the most likely level of review.

Will your research involve the study of a drug or device

for which an IND¹ or IDE² has been obtained, or will be obtained prior to initiation of the study?
to support a new indication?
which will be administered through randomization?
which will be administered to a subject within a vulnerable population³?

Start Over

¹Investigational New Drug

²Investigational Device Exemption

³Vulnerable populations include the following: children, pregnant women, neonates and fetuses, prisoners, and the individuals lacking consent capacity.

Questions?

Contact the Human Subjects Office:

Phone: 317-274-8289
Email: irb@iu.edu

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
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202

Bloomington:

Human Subjects Office
Office of Research Compliance
Indiana University
2218 N. Dunn St.
Bloomington, Indiana 47408