Single IRB Review

Main Content

Reliance Request Form

UMMC Investigator Request to Cede IRB Review

Name*

Email address*

UMMC Principle Investigator's name and email address (if different)

UMMC department

Scope of UMMC's engagement (select all that apply)*

Protocol development

Recruiting participants

Obtaining consent/assent from participants

Performing a research intervention or activities directly involving human subjects, identifiable information, and/or identifiable biospecimens

Deidentified data analysis

Other (specify below)

*
If other:

Attach study protocol

*.txt,*.doc,*.docx,*.xls,*.xlsx,*.pdf, *.gif,*.jpg,*.jpeg,*.bmp,*.png,*.tif,*.tiff

Name of the external IRB (institution) upon which you are asking to rely*

Title of the study*

A lay description of the study and study aims*

Funding source or sponsor of the study*

Method of agreeing to reliance*

Please work with the external IRB's administrative staff to answer the following questions:

External IRB's Federalwide Assurance Number*

Expiration date*

*Invalid Date

External IRB point of contact information*

Confirmation that the external IRB is in good standing with OHRP and FDA (no recent warning letters, no open investigations)*

Confirmation that the external IRB is located within the U.S.*

STOP HERE - Please contact the Human Research Office at umcirb@umc.edu before proceeding further.

Confirmation that the external IRB has applicable policies and procedures in place*

Whether the IRB has elected to extend its FWA to all research*

Confirmation that the external IRB is AAHRPP-accredited*

Statement of assurance from the proposed IRB that its review will be consistent with applicable ethical and regulatory standards, and that it will report any regulatory investigations, citations, or actions taken regarding the reviewing IRB, and, when applicable, to the organization’s FWA
An attestation about, or summary of, any quality assessment of the reviewing IRB such as evaluation by an external consultant or internal evaluation of compliance using the FDA’s self-evaluation checklist or AAHRPP’s self-evaluation instrument
Upload quality assurance evaluation if available	.txt,.doc,.docx,.xls,.xlsx,.pdf, .gif,.jpg,.jpeg,.bmp,.png,.tif,*.tiff
The willingness of the external IRB to accommodate requests for relevant minutes and other records of the proposed study
The willingness of the external IRB to accommodate a request for someone from the relying organization to observe the review of the proposed study; and/or perform an assessment of the external IRB’s policies and procedures

Human Research Office

Please attach study Informed Consent Form template (if applicable) so that UMMC’s institutional language requirements can be reviewed or inserted by the Human Research Office*

*
*.txt,*.doc,*.docx,*.xls,*.xlsx,*.pdf, *.gif,*.jpg,*.jpeg,*.bmp,*.png,*.tif,*.tiff

Please note: once permission to cede IRB review of the study has been granted, the study still needs to be submitted in Cayuse and receive a local administrative review prior to initiating conduct of the study.

For any questions regarding this form or IRB reliance, please reach out to the Human Research Office at umcirb@umc.edu.