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About the WIRB/RCA Process

	WIRB Standard    Operating Procedures
	.rtf    .doc

    Forms:

	WIRB Eligibility    Checklist
	.rtf    .doc

	IU Application for    Protocol Review by    WIRB (v05/01/09)
	.rtf    .doc

	HIPAA Authorization    Template for the    Release of Health    Information    (v05/01/09)
	.rtf    .doc

	IU WIRB Informed    Consent Template
	.rtf    .doc

   Tech Tip!Each Forms is available in two different formats, .rtf and .doc.

MAC and Linux-based operating system users should use the .doc (Microsoft Word) format only as we have experienced problems upon receiving .rtf forms from those users.

When you have completed all applicable forms, please submit them to the email address listed under 'Contact us' to the left.

	WIRB Initial Review    Submission Form, see:
	WIRB Website

Investigator    Submission Form for    Multi-Center Protocols,    see:  WIRB Website

    Resources:

IU WIRB Fee         Information

WIRB Guide for         Researchers

Training Materials         (August 08)

The RCA/WIRB         Process

WIRB is an independent IRB which provides IRB services to institutions and individuals across the country. IUPUI/Clarian has partnered with WIRB to provide an alternative method of IRB review for protocols which meet certain criteria. 

Submissions may now be made to WIRB. Please follow the instructions below and contact the Clinical Trials Office with any questions. All submissions should be sent to the email listed under 'Submit WIRB forms to' on the lower left.

Eligibility

Studies which meet the following criteria are eligible for submission to WIRB:

• Meets the NIH definition of a clinical trial: “a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”
• Phase II/III/IV multicenter clinical trial
• Designed and written by the sponsor
• Sponsor is a for-profit entity/company
• Sponsor holds all INDs/IDEs
• Not previously submitted to a Clarian or IU IRB

Studies which involve any of the following are NOT eligible for submission to WIRB:

• Planned emergency research
• Xenotransplantation
• Gene transfer
• Embryonic stem cells
• VA hospital
• Research funds from a federal or non-profit funding agency
• Medical devices
• Children
• Waivers of informed consent or authorization

1. Use the eligibility checklist found below or on the IU Application for Protocol Review by WIRB to determine whether the protocol is eligible for submission to WIRB.  If not, please submit the protocol through the normal IUPUI/Clarian IRB process.

2. If you determine that the protocol is eligible for submission to WIRB, fill out and collect all required documents (see below).  All documents should be in electronic form.    

3. Submit your documents to the email listed under 'Submit WIRB forms to' on
the left.   

4. The Clinical Trials Office will verify eligibility and, if eligible, will submit the documents to WIRB within three (3) business days.

5. WIRB will contact the PI regarding the submission and all further communication will take place directly between the PI and/or study contact and WIRB. 

The following documents should accompany your initial submission:

• IU Application for Protocol Review by WIRB
• WIRB Initial Submission Form (available at the WIRB website. See link in the Tool Kit to the upper right)
• CVs for all investigators listed on the WIRB Initial Submission Form (question 37) or the WIRB Investigator Submission Form for Multi-Center Protocols (question 27) 
• Protocol, drug brochure, advertisements, solicitation scripts
• Proposed informed consent and HIPAA authorization forms  

As WIRB-eligible studies are multi-center trials, WIRB may already be reviewing your study at another site. Please take a moment to contact WIRB to determine if they have already reviewed your study. If so, you may submit the Investigator Submission Form for Multi-Center Protocols (available at the WIRB website. See link in the Tool Kit to the upper right) instead of the WIRB Initial Submission Form. Using this form requires less time to complete and may result in lesser fees from WIRB.

Additional fees will apply for use of the WIRB review process. ORA will charge $500 processing and local review of each protocol. For information about fees charged by WIRB, see 'WIRB Fees' listed under 'Resources' in the Tool Kit to the upper right.