Definition of Exempt Research

Instructions for Submitting an Exempt Protocol

Human Subjects Research Determination (Is your project Not Human Subject Research?)

Request for Exemption Application

Reminder:
Request for Exempt review can be submitted at any time.

Definition of Expedited Research

Instructions for Submitting an Expedited Protocol

Forms to Include with your Submission:

Protocol Template
Protocol Template Instructions
Application for Protocol Review
Instructions for using Application for Protocol Review
Attachment F - Expedited Review
Consent Template (If Applicable)(This format required after Feb 1, 2008)
Assent Template (If Applicable)

Reminder:
Request for Expedited review can be submitted at any time

Instructions for Submitting for Full Board Review

Reminder:
Protocols requiring full board review can be submitted at any time and will be assigned to the first available board meeting after the initial screening of the submitted materials..

Continuing Review Procedure

Continuing Review Policy

View Procedure

View Procedure

All unanticipated problems should be reported electronically to COMIRB within 5 days by using Protocol Manager the Unanticipated Problem Report Form.

Unantcipated Problem Report Form

Unanticpated Problem Policy

When to use the Safety Form:
The Safety Form is to be used only to submit any of the following documents:

• Medwatch reports
• IND reports
• DSMB or other safety review reports
• Investigational Brochures
• Changes to Package Inserts
• Audit reports

Safety Update Report Form

Assent Form Template
Assent Form Guidelines for Children

Consent Template (required after Feb 1, 2008)
Standard Consent Statements
Consent Example for Blood and Tissue
Consent Instructions
Guide for Clinical Researcher
Tips for Writing a Consent Form

The completion or termination of the study is a change in activity and must be reported to the COMIRB. Although subjects will no longer be "at risk" under the study,  COMIRB is required to ensure that there are no safety concerns that have led to the closure of a study or ensure that any safety concerns have been appropriately managed. The COMIRB is also required to conduct a continuing review for the period since the last continuing review.

A final report to the COMIRB also allows it to close its files as well as providing information that may be used by the COMIRB in the evaluation and approval of related studies.

Full board studies
If the last continuing review for the study was reviewed at full board then the closure will be reviewed at full board.

Documents to be submitted:
               18 copies of closure letter and
               18 copies of all documents required for continuing review - See link to “How to submit for continuing review”

Expedited studies
Studies previously determined to meet criteria for expedited review or studies previously submitted for continuing review with a status of data analysis can be closed by expedited process.

Documents to be submitted:
               1 copy of closure letter and
               1 copy of all documents required for continuing review - See link to Continuing Review Procedure

Re-Opening a Study

Submit a brief cover letter requesting that the study be re-opened and the following:

Studies that have been administratively closed
Due to failure of the investigator to provide proper closure with a continuing review form it will require both an initial and continuing review.  All required documents must be submitted for an initial review, and in addition all documents for continuing review must be provided. Submit all required documents for Initial Expedited or Full Board Review and Continuing Review.

Studies appropriately closed
If the study was properly closed with a completed and approved continuing review form then it will require an initial review only. Submit all required documents for Initial Expedited or Full Board Review.

Protocols that have been closed for 3 years or longer will require a new protocol to be submitted

Humanitarian Use Device Application Instructions

HDE Consent Form