Welcome to the In-Vitro Diagnostics Research Program at the Indiana University School of Medicine. We are excited to work with you on all your research needs. This page will give you more information regarding the contract and IRB aspect of your research with us, including our group's contact information as well as an overview of what is needed, what department handles which task and how long approval takes.
Office of Research Administration
Contract Negotiations — Including NDA/ CTA/CSA/SOW agreements
If you are an individual, company, institution, organization, agency or other group supporting human subject’s research at Indiana University, the following information is provided for your convenience:
IU Indianapolis
Office of Research Administration
Lockefield
980 Indiana Avenue
Indianapolis, In 46202
Submittal is required for:
- New proposals (including projects transferring to IU) and resubmissions
- Pre-proposals requiring a detailed budget and/or a signature from an authorizing official
- Competing renewal/continuation proposals
- Budget revisions involving an increase in cost share (only if submitting to the agency)
- Change of project eirector or co-project director
Items required for contract submittal
- Finalized (agreed upon) budget
- Finalized protocol
- Sponsor provided CTA/CSA/SOW with finalized protocol and budget included in it.
How long does contract routing take?
Once we have all the required items form the sponsor needed for submittal, we will enter the information into the submittal system used by IU. The contract approval process takes generally two to four weeks for completion and final execution.
Indiana University Human Subjects and Institutional Review Boards
Sponsored human subjects research
If you are an individual, company, institution, organization, agency or other group supporting human subject’s research at Indiana University, the following information is provided for your convenience:
Institutional Review Boards
Indiana University Indianapolis
980 Indiana Avenue, LV 3315
Indianapolis, IN 46202
Submittal is required for:
- New protocols
- Protocol amendments including protocol updates and staff updates
- Continuing reviews
- Possible protocol deviations, adverse events, immediately reportable events.
IRB meetings
Indiana University relies on the work of seven IRBs — two social/behavioral/educational IRBs and five biomedical IRBs. The Human Subjects Office schedules protocols requiring review by the convened IRB for the next available meeting and not based on specific deadlines. Scheduling is dependent on receipt of the complete protocol, completion of pre-review, and expertise or focus of the particular IRB.
The IU Bloomington social/behavioral/educational IRB meets on the third Thursday of the month. The Indianapolis social/behavioral/educational IRB meets on the fourth Friday of the month. IU’s biomedical IRBs meet monthly in Indianapolis, as follows:
- IRB-02 — the second Tuesday of the month
- IRB-03 — the first Thursday of the month
- IRB-04 — the third Tuesday of the month
- IRB-05 — the fourth Wednesday of the month
- IRB-07 — on an ad hoc (convened as needed) basis
Items required for IRB submittal
- Finalized study protocol
- Sample informed consent if available
- Any data collection forms the study may require
- Any flyers/brochures/advertisements/verbal scripts the study may require
- No draft documents — we will need the FINAL documents. Incomplete documents will delay the approval process and start time of study within our group.
How long does IRB routing take?
Once we have all the required items needed for IRB submittal, we will enter the information into the submittal system used by IU. The IRB approval process takes generally three to six weeks for completion and final approval, depending on complexity of IRB study and the queue at the IRB.
Contact the In-Vitro Diagnostics Division at Indiana University School of Medicine
For more information or to answer any IRB or contract related questions, as well as when you are ready to proceed with a study with our program, please contact:
Del Warren — Business Manager
Indiana University School of Medicine
Department of Pathology and Laboratory Medicine
IU Health University Hospital
AOC Room 6029
550 University Blvd
Indianapolis, In 46202
deawarre@iu.edu
317-274-1734
Rebecca Buckner — Clinical Research Operations Manager
Indiana University School of Medicine
Department of Pathology and Laboratory Medicine
IU Health University Hospital
AOC Room 6029
550 University Blvd
Indianapolis, In 46202
rbuckner@iu.edu
317-274-3389