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Welcome to Ethical Review Manager

The University of the Incarnate Word's Research Office uses this platform to manage the Human Subjects Research (HRPP) and Conflict of Interest (COI) Programs. For information about research, regulatory compliance, and the UIW IRB, please visit the Office of Research and Graduate Studies website.

Before You Apply to the HRPP

  1. Review the Guide to the UIW IRB Process and IRB Policies, Procedures and Guidance and familiarize yourself with the approval process, regulations for the conduct of human subjects research, and responsibilities of the principal investigator (PI), mentors, and other people working with you.
  2. Be sure everyone involved – including co-investigators and faculty supervisor (if applicable) – have current training. Those who need training should contact using the contact informaiton on our website. UIW uses CITI training.

Remember: The HRPP cannot review protocols for projects that are in-progress or already completed. Per federal regulations, human subjects research cannot be reviewed for approval after the study starts.

Creating a New User Account

In order to use this system, everyone on the study team will need to create a New User account.

Remember: If you are a student you must include your faculty supervisor. As an applicant, your faculty supervisor must also have an Ethics Review Manager account.

Follow these steps to register for an account:

  • Click on “Log in” at the top right corner or bottom of this page.
  • Click on “New User”
  • Fill in the applicable information
  • If you are a student at UIW, an employee, or an affiliate with UIW credentials, use your name@uiwtx.edu email address.
  • Agree to Terms and Conditions
  • Note: A password must be 10+ characters long, contain both upper and lowercase characters, and contain at least 1 special character (!@%)
  • Click “Register”
  • An activation email will be sent to the entered address
  • Open the activation email and click the activation link provided
  • Return to the login page and click “Log in”

Completing and Submitting the Applications

All applications must be submitted online via ERM. Guides can be found by clicking the “Help” tab at the top left of the screen above. The Help section also includes several templates.

A complete online IRB Application includes the following components:

  • Application Form
  • Research Protocol
  • Recruitment Materials (e.g., emails, flyers, scripts for in-person recruitment)
  • Consent Documents (e.g., formal, signed consent, emailed invitations to surveys)
  • Instruments for Data Collection (e.g., surveys, interview questions)

  • Visuals, timelines, recruitment materials, consent documents, instruments for data collection, and any additional supplementary documentation are uploaded to the Documents section of the online application.

  • Please note that the online Research Protocol form cannot accept tables or figures; any tables or figures you would like to include with your Research Protocol should be referenced in the Protocol and uploaded as Word files to the Documents section.

Read each section of the application carefully and provide all required information. Incomplete applications will be returned without review. Students must identify a Faculty Supervisor who is responsible for the conduct of their study and will review and sign before submission.

Notification of Approval

Applicants will be notified electronically of all decisions including requests for revision or clarification, conditional approval, disapproval, and approval. If you have applied for Human Subjects research approval, you may not initiate any activity without a letter of approval or a "Not Human Subjects Research" determination letter.

Continuing Review, Study Status Update, Amendment, Unanticipated Problem Reporting, and Closure

IRB approval is good for one year. Before a protocol's expiry, investigators must submit a request for a renewal or closure of the protocol. The Continuing Review form should be used to renew all protocols. A Closure form should be used to report the closure of all protocols. Submission is mandatory. Failure to inform the IRB of continued work or closure of a protocol will result in administrative closure and notification of Federal and University policy violations.

Courtesy notification of protocol expiry is given 60, 30, and 14 days prior to expiration.

Any change to the approved study (including research procedures, instruments, title, research sites, addition or removal of investigators, change of faculty supervisor, number of subjects, consent form, or recruitment materials) must be reported to the IRB before implementation using the Amendment Request form.

An unanticipated problem that may pose risks to participants or others or a protocol deviation must be reported to the IRB immediately according to federal regulations. The window for promptly reporting unanticipated problems to the UIW IRB is five working days (Monday-Friday).

To submit Continuing Review, Amendment, Unanticipated Problem/Protocol Deviation and Closure Request forms, return to your approved IRB protocol within the online system and choose "Create Sub­Form" from your protocol's Action menu.

Not Regulated Research

The IRB Office will consider requests for the determination of Not Human Subjects Research (Non-Regulated Research). Requests are submitted via this system and a determination letter is provided when appropriate.

An NRR project may be converted to regulated research through amendment or by copying it to a new project. 

 

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