Guide to the UIW IRB Process

Human subjects researchers not affiliated with UIW, who would like to access the UIW community to conduct their IRB-approved research, must complete the UIW Population Access for Research Request form.

Submission of this form does not mean you have permission to conduct your study with the UIW community. If you are approved to conduct your study here, you will receive a signed approval letter sent to the PI's email address provided in the form, and you must seek the appropriate UIW departmental approval before directly soliciting participation.

In order to assess your request you will be asked to provide your IRB protocol, consent forms/information sheets, and your IRB approval letter if you have one.

Any project undertaken by University of the Incarnate Word faculty, staff or students that meets the federal definition of “human subjects research” must be submitted to the IRB for review and approval prior to initiation.

The document What Needs Review – Determination of Human Subjects Research (pdf) includes a detailed discussion of the types of projects that meet the definition of “human subjects research.” If, after reviewing this document, you are still not sure if your project meets this definition, follow the submission instructions in the Protocol Submission > Submit Application section below, or contact the Office of Research and Graduate Studies for further assistance.

A letter of Not Human Subjects Research (or Non-regulated Research) will be issued if the appropriate determination is made.

All investigators who will be collecting data from human subjects, obtaining the informed consent of human subjects, or accessing identifiable human subjects data, as well as faculty supervisors of student protocols, must complete human subjects training prior to receiving IRB approval. UIW provides access to online human subjects training through the CITI program.

An overall score of 85% is required. Initial CITI human subjects training is good for three years. Once initial training has been completed, renewal training is also good for three years. For those investigators that have previously met IRB human subjects training requirements by taking courses offered elsewhere, that training is also good for three years. When training needs to be renewed, investigators may take the CITI refresher course. For training requirements and registration instructions, see the Research Compliance training section.

Studies submitted to the IRB undergo one of three types of review: exempt, expedited or full Board. Applicants should determine the level of review their study will require early in the planning process.

Exempt Status Review

Research qualifies for exempt status only if it involves no more than minimal risk or no risk to participants and falls within one or more of the exemption categories listed in the Exempt Status Review (pdf) policy. Although the category is called “exempt,” this type of research does still require submission of an IRB application and review to confirm exempt status. Exempt protocols undergo administrative review by the Office of Research and Sponsored Projects Operations and can usually be approved within one week or less.

Expedited Review

Research qualifies for expedited review only if it involves no more than minimal risk to subjects and falls within one or more of the minimally invasive procedures listed in the Expedited Review (pdf) policy. Expedited protocols are reviewed by a subset of the IRB (usually no more than two members, including the chair) and can usually be approved within two to four weeks, or longer, depending on the need for revisions and the current workload of the IRB.

Full Board Review

Research that is not eligible for exempt or expedited review must be submitted for full Board review at a convened meeting of the IRB. The IRB meets monthly during the spring and fall semesters and as needed during the summer. If you plan to submit a full Board application, please refer to the meeting dates on the IRB website and plan to submit your protocol two weeks before the meeting date to ensure a spot on the agenda.

• Click on “Log in” at the top right corner of the landing page.
• Click on “New User.”
• Fill in the applicable information (Note: you can skip fields that aren’t relevant to you), and agree to Terms and Conditions.
• Note: Password must be 10 to 64 characters long, contain at least one lowercase, uppercase and special character.
• Must use your UIW email address as primary email.
• Click “Register” and an activation email will be sent to the entered address.
• Access email and click the activation link provided.
• Return to the Log in page and click “Log in.”

Note to student applicants: Students must include a faculty supervisor on all IRB applications. The faculty supervisor must review and sign the application before submission, so be sure your faculty supervisor has an Ethical Review Manager account set up.

All applications must be submitted online via the Ethical Review Manager (ERM) system. Guides for submitting IRB applications, study status updates, continuing review requests, amendments and closures can be found by clicking “Help” tab at the ERM website. The Help section also includes templates for the Research Protocol and consent forms.

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)

The Application Form and Research Protocol are submitted via online forms. It is recommended that you prepare the Research Protocol ahead of time in Microsoft Word, then copy and paste it into the online form. Recruitment Materials, Consent Documents, Instruments for Data Collection and any additional supplementary documents 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 uploaded as Word files to the Documents section.

Follow these instructions to submit a new IRB application: How to Submit a New Application. (pdf) These instructions, and other guidance documents, are located in the “Help” section of the ERM website.

Read each section of the application carefully and provide all required information. Incomplete applications will be returned without review. If the principal investigator (PI) is a student, the faculty supervisor’s contact information must be provided, and the application will be forwarded to the faculty supervisor for review and signature before submission. Applications will be automatically submitted after it has been signed by the PI and faculty supervisor (if applicable).

The Office of Research and Sponsored Projects Operations will review submissions for completion and assign an internal tracking number for each protocol received. A copy of the complete IRB application is sent for the appropriate review. The review process may involve communication between the applicant and reviewers. This may include requests for revision or clarification of submitted materials and protocol language. Comments and suggestions for revision made by the IRB should be considered by the applicant and are made in the spirit of improving protections for the proposed human subjects. Applicants are, however, the subject matter expert of their own research and are welcome to provide justification contrary to IRB recommendations.

Written notification of the results of IRB review are emailed to the investigator and faculty supervisor (if applicable). On average, applications will be approved within the time frames indicated below. This is an estimate and meant to serve only as assistance for project planning.

Estimated Duration of Reviews by the IRB

There are many reasons a review may take longer:

• Incomplete documents (e.g., missing documents, incomplete sections)
• Writing quality (e.g., incomplete sentences, grammatical errors)
• Clarifications needed (e.g., protocol uses undefined jargon)
• Insufficient protection for human subjects (e.g., inadequate consent procedures)
• Interactions with other institutions
• Involvement of personnel who do not work at UIW

Upon approval, the application is assigned an approval number, and a letter of approval is issued. Research cannot begin until the investigator has received IRB approval to conduct the protocol activities.

Principal investigators (PIs) are responsible for submitting any changes to the protocol or consent documents to the IRB for review and approval prior to the implementation of the change(s). Such changes include but are not limited to: the addition or elimination of an investigator, changes in consent form, supportive materials, flyers, questionnaires, surveys, script for person-to person or telephone interviews, etc. This is done with the submission of an IRB Amendment Request. After approval, the principal investigator will receive an amendment approval letter listing the approved changes. The changes cannot be implemented until the approval letter is received.

To submit an IRB Amendment Request, follow these instructions:

How to Submit an IRB Amendment Request (pdf).

Protocols determined to be Exempt do not require continuing review unless the need to do so is identified during review. For qualifying Exempt protocols, an end date 3 years after approval is assigned. PIs may request continuation before the end date. Exempt protocols that are still active at the end date will be administratively closed.

Expedited and Full Board protocols are approved for a one year period. Prior to the protocol’s expiry, PIs must submit either a request for renewal or a notification that the project has been completed.

Reminders are sent to PIs 60, 30, and 14 days before the protocol’s expiry / end date.

There are two forms used to renew protocols: the Study Status Update and the Continuing Review Request form. Exempt protocols require only a brief status update; Expedited and Full Board protocols require annual IRB review.

• The Study Status Update form should be used for Exempt protocols.
• The Continuing Review Request form should be used for all Expedited and Full Board protocols.

To submit a Study Status Update or Continuing Review Request, follow these instructions:

How to Submit a Study Status Update or Continuing Review Request (pdf).

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 a Unanticipated Problem or Protocol Deviation form, follow these instructions:

How to submit an unanticipated problem or protocol deviation (pdf).

PIs are responsible for promptly notifying the IRB of a project’s completion. This should be done by submission of an IRB Closure form.

To submit an IRB Closure form, follow these instructions:

How to Submit an IRB Closure (pdf).