Studying a Drug/Biological Product or Device?

Please contact the Human Research Protection Program (HRPP) 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/biological product 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 individuals lacking consent capacity.

Questions?

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: irb@iu.edu

Bloomington:

Human Research Protection Program (HRPP)
Office for Research Compliance
Indiana University
509 E. Third St.
Bloomington, Indiana 47401

Phone: (812) 856-4242
Email: irb@iu.edu

Studying a Drug/Biological Product or Device?

Questions?

Indianapolis (Main):

Bloomington:

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TOOLS

FORMS & POLICIES

DATA & REPORTS

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