Pre-submission Investigator Requirements
As of March 1, 2017, IRB oversight of human subjects research conducted at IU Health Bloomington Hospital will be provided by the Indiana University IRBs. The IU IRBs are administered and supported by the IU Human Subjects Office (HSO), which currently serves all eight IU campuses and IU Health locations in the Indianapolis area and around the state, among others.
Beginning March 1, 2017, all new human subjects research applications, including requests to utilize commercial or other external IRBs, should be submitted to the IU IRBs for review. Studies previously approved by the IU Health Bloomington Hospital IRB will be transitioned to the IU IRBs by July 31, 2017.
To redirect to the HSO website, click http://researchcompliance.iu.edu/hso/index.html.
The HSO website includes Information about IRB submission, policies and procedures. All investigators are encouraged to review the website prior to submission and are required to conduct research in accordance with the IU Standard Operating Procedures for Research Involving Human Subjects, found under Policies & Guidance. The HSO website also provides instructions for submission, guidance for investigators on several topics, and information for sponsors and subjects, among other things.
For questions about the IRB process or submissions, contact HSO at 317-278-8289 or firstname.lastname@example.org.
For help with the electronic IRB system, KC IRB, contact our KC IRB experts at 812-856-4242.
Human Subjects Office Website: http://researchcompliance.iu.edu/hso/index.html
KC IRB Training Guides: http://researchcompliance.iu.edu/hso/hs_elearning.html
HSO utilizes a web-based system called KC IRB for entry and management of IRB submissions. All IRB submissions are submitted to the HSO via KC IRB. HSO uses KC IRB for all aspects of the submission and review process, including communication of revision requests and approvals.
All Principal Investigators any individuals accessing KC IRB must have an IU computing account. To request an IU computing account, complete this form.
Beginning March 1, 2017, you will use KC IRB to:
- Make all submissions to the HSO
- Complete the IRB application
- Review comments and requested revisions from HSO staff and IRB members, and submit responses and revisions during the pre-review process
- Receive notification of approval
- Retrieve approval information and view approved study documents
The KC IRB Questionnaire Tab utilizes ‘smart-form’ functionality which allows you to complete IRB applications almost solely within the KC IRB system. As you work from the top of the Questionnaire Tab to the bottom, additional questions are displayed based on previous responses, ensuring that only the questions the IRB needs to review in the application are answered.
Notifications, including approvals and renewal notices, are emailed to investigators’ IU-provided email addresses affiliated with their IU computing account. IU email can be automatically forwarded to a preferred email address. More information about KC IRB notifications and retrieving your study documents is available on the HSO website at http://researchcompliance.iu.edu/hso/hs_post_approval.html.
Step-by-step instructions for using KC IRB (accessing, submitting, retrieving documents, etc.) are available online at http://researchcompliance.iu.edu/hso/hs_elearning.html. You are encouraged to download the relevant training guide and contact our KC IRB experts for help at 812-856-4242.