| Research
& Sponsored Programs |
Although there is currently no automated system to be used for submission of IRB documents, the IUPUI IRBs (IRB-01, IRB-02, IRB-04, IRB-05, and IRB-06) now require that all study documents be submitted electronically to the IRB effective January 17, 2006. Such submissions must be made via email from the links below. In addition, please note that the principal investigator is not necessarily required to send the email message him/herself; rather, another member of the principal investigator’s research staff may submit, provided that the principal investigator is copied on the message. Copying the principal investigator on the message serves as his/her signature. Refer to Sponsor Letter Regarding the Electronic IRB Submission Process for more information.
To submit a particular type of item to the IRB for review, click on the appropriate link below to generate an email message to a Research Compliance Administration (RCA) inbox. In the text of the message, note what is being submitted and attach the relevant forms/supporting documents to the message.
Once the message and appropriate forms/supporting documents are received in an RCA inbox, our staff will ensure that any necessary paper copies are made and proceed with routing the items for IRB review as usual.
For those items which must be submitted per deadline, please note that deadlines will still be followed and whether deadlines have been met will be evaluated by receipt time noted in the inbox.
| If you have a... | Directions |
NEW STUDY |
Click here to submit a new full-board study |
| Click here to submit a response to a provisionally-approved new full-board study | |
| Click here to submit a response to a tabled new full-board study | |
| Click here to submit a new Exempt Application / Expedited Application / Application for Research Not Subject to FDA or Common Rule Definitions of Human Subjects Research / Application for Non-Research Student Projects | |
| Click here to submit a response to provisions generated per previous submission of Exempt Application / Expedited Application / Application for Research Not Subject to FDA or Common Rule Definitions of Human Subjects Research / Application for Non-Research Student Projects | |
| Click here to submit a new study to be reviewed via the NCI CIRB facilitated review process. | |
If
you have an... |
Directions |
AMENDMENT |
Click here to submit a new amendment |
| Click here to submit a response to a provisionally-approved amendment | |
| Click here to submit a response to a tabled amendment | |
| Click here to submit notification of a change to be taken on an approved Exempt study (no Amendment form needed) | |
| If you have a... | Directions |
CONTINUING REVIEW |
Click here to submit a new continuing review |
| Click here to submit a response to a provisionally-approved continuing review | |
| Click here to submit a response to a tabled continuing review | |
| Click here to request a continuing review form in order to notify the IRB of the closure of an approved study. | |
| Click here to submit notification of the completion of an approved exempt study (memo only needed) | |
| If you have a... | Directions |
| GENERAL
INFORMATION ITEM |
Click here
to submit a new general information item (e.g., Reporting Form for Events that Require Prompt Reporting to the IRB, Report of Non-compliance, memo regarding information not reportable via another form listed above, etc.) |
| Click here to submit a response to a provisionally-approved general information item | |
| Click here to submit a response to a tabled general information item | |
| If you need to UPDATE CO-INVESTIGATORS | Click here to update co-investigators listed on your study |
| If you need to request INVESTIGATOR 101 CD AND/OR TEST | Click here to request the Investigator 101 CD and/or test |
| If you have a QUESTION | Click here to ask a question of RCA staff |
| If you need to ACCESS THE READ ONLY HUMAN SUBJECTS SUBMISSION TRACKING SYSTEM | Click here to access the tracking system |
