Research
& Sponsored Programs |
As a result of the re-accreditation process, some of the IRB application forms were revised.
The revised forms are easily distinguishable by the “(v03.01.08)” that appears at the end of the document name. We recognize that some of you
have already begun completing previous versions of application forms; thus, we are allowing a brief grace period.
However, beginning May 5 2008, it will be mandatory that applications be submitted on the new versions of the forms.
Older versions of the forms received in the RCA office after this date will be returned and could delay processing the application.
Please note that you will not be required to update the summary safeguard statement at the time of continuing review as long as the current version is dated 06/05 or later. Any questions, concerns, or comments should be directed to resrisk@iupui.edu
Downloading Instructions
Left click on the form you want and the document should open in your word processing program. |
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IRB Instruction Packet (v03/01/08)
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The same
application forms are used for all IUPUI & Clarian Health Partners for all
IRBs.
Submission Forms:
Application Form for Non-Research Student Projects - 02/05
Application Form for Non-Human Subjects Research (v03/01/08)
This form should be used for research that does not meet the definition of “human subjects research” according to the Common Rule and FDA definitions, but still requires review by the IRB (e.g. research with coded, private information, research involving data on deceased individuals, de-identified data and data within a limited data set).Assent Templates:
Authorization Templates:
Authorization Template - 10/04
Authorization Template - Spanish - 09/03
Authorization - Healthy Subjects Template - 09/03
Authorization - Healthy Subjects Template - Spanish - 09/03
Checklist for Determining Whether an Activity Requires IRB Reviews (v03/01/08)
Covered Entity Checklist (v03/01/08)
Use this checklist to determine if you are a covered entity or are involving a covered entity in your research (vxx/xx/xx)Documentation of Review and Approval (DRA) (v03/01/08)
Exempt Research Checklist (v03/01/08)
Expedited Research Checklist (v03/01/08)
Informed Consent:
Form for Delegation of Authority to Consent
If necessary, this form may be used to delegate authority to consent for a research study per IC 16-36-1-6 of Indiana State Code Title 16 regarding medical consent; however, it is not required by the IRB.NCI CIRB Facilitated Review Form - 5/07
Noncompliance Reporting Form (v03/01/08)
Prompt Reporting Form (v03/01/08)
Recruitment Checklist (v03/01/08)
Request Form for Waiver of Informed Consent for Planned Emergency Research (v03/01/08)
Summary Safeguard Statement (SSS) (v03/01/08)
VA Waivers for Recruitment (v03/01/08)
Vulnerable Population Request Forms:
Request Form for the Inclusion of Children in Research (v03/01/08)
Request Form for the Inclusion of Cognitively Impaired Individuals in Research (v03/01/08)
Request Form for the Inclusion of Pregnant Women, Human Fetuses and Neonates in Research (v03/01/08)
Request Form for the Inclusion of Prisoners in Research (v03/01/08)
IRB Continuing Review and Closeout Forms
IBC
Protocol Submission Form (includes instructions and forms for new protocol
submissions involving rDNA)
Submission Form - 11/07 - Word format
Submission Form - 11/07 - PDF format
IBC Safety Procedures Information Sheets
IBC Continuing Review
BHC
(BioHazard Committee) Forms
Submission Form -1/5/05 - RTF format
Submission Form - 1/5/05 - PDF formatHuman/Primate Cell Culture Registration Form - 8/03 - RTF format
Human/Primate Cell Culture Registration Form - 8/03 - PDF format