The Review Process…in General

Submission

• All required documentation and project materials must be submitted via Submittable, the WOU IRB’s online application and form submission system.
• If this is your first submission, you will need to create a profile with Submittable. Importantly, you will need to use the “@mail.wou.edu” version of your email address when providing contact information for your profile.
• The submitting PI will receive a confirmation email and copy of their submission.
• WOU IRB staff reviews documents and materials for completeness and submission requirements.

Pre-Review

• WOU IRB staff reviews protocol materials to prepare for IRB review.
• If staff identify changes necessary before further review can be conducted, an email is sent to the researcher outlining the requested changes.
• If needed, the researcher provides revised materials to the WOU IRB via Submittable.
• WOU IRB staff verifies review readiness, assesses level of review, and sends protocol for review.

Review

• Exempt Review – Protocols are routed to one IRB member for review and verification of exemption. If an exemption is warranted, the PI will be notified and provided with documentation of the exemption.
• Expedited Review – Protocols are routed to two IRB members for review to determine all regulatory approval criteria are satisfied.
• Full Board Review – Protocols are routed to all IRB members and scheduled for review at the next available fully convened IRB committee meeting (see Levels of Review section above for more information).

Post-Review Actions, Communications, & Revisions

• WOU IRB staff communicates review outcome.
• If changes and/or clarification are necessary to secure approval or an exempt determination, WOU IRB staff will contact the PI and provide a comprehensive description of the required clarifications and/or modifications.
• The researcher provides a response to the review and any revised materials (with changes noted/outlined) to the WOU IRB.
• WOU IRB staff verify the changes satisfy the reviewer’s requests.  Once satisfied, approval or exempt determination documentation is issued.[endsection]

Initial Submissions

Where to Start

• Ensure that your project does in fact require IRB review. Note that projects that do not meet federal regulatory definition of research do not require IRB review. See the General Information page for more information.
• Prepare all required documentation for your application. Note that the WOU IRB will require a completed application, copies of project materials and documents (e.g., informed consent forms, surveys, etc.), confirmation of CITI training (if not already on file), and potentially additional documentation.
• If you are a student, confirm with your faculty sponsor that they approve of the project and submission to the WOU IRB. Please note that all student projects must be approved by the faculty sponsor. During the application process, the student will be required to submit the faculty sponsor’s email. The faculty sponsor will then be contacted and need to supply verification of approval before the student application will be reviewed.
  • Faculty Verification of Student Application Form
• Determine your level of review (Exempt, Expedited, or Full Board).
• Contact the WOU IRB with any remaining questions.

Application Process

• All applications should be submitted via Submittable, the WOU IRB’s online application and document management system.
• If it is your first time using Submittable, you will be prompted to create a profile, and all of your submissions to the WOU IRB (past, current, and future) will be linked to your profile.
• After creating your profile, select “IRB Application – New Submission.”
• Complete the application, upload any required documentation, and submit.
• Once you have submitted your application, you will receive confirmation that it has been received.

After Applying

• WOU IRB staff will provide an initial pre-review of the application to ensure that all required documentation has been received, to determine/confirm the level of review, and to determine the appropriate review process.
• If during the pre-review WOU IRB staff identifies an issue with the application (e.g., missing documentation), the application will be sent back to the researcher for correction.
• Following the pre-review, the application will be routed to the WOU IRB for formal review. Please note that timelines for review vary and are determined by a number of different factors. See the General Information page for more information regarding timelines, and please plan accordingly.
• Following formal review, WOU IRB Staff will contact the submitting researcher to communicate any requested clarifications and/or required modifications to the application/project.
• Upon approval, the submitting researcher will receive notification, as well as official documentation of the approval including the WOU IRB Approval Number. Please keep this documentation for your records.

Exempt Research

Application Process

• Projects that are determined to be Exempt by the PIs still need to be submitted to the WOU IRB for review.
• Please prepare your application following the guidelines provided above and indicate in the application that the project should undergo review at the Exempt level.
• Projects reviewed at this level will be sent to the WOU IRB Chair or designee for a determination of exemption.
• If an exemption is granted, the PIs will be provided with official documentation of the exemption.
• For additional information regarding WOU IRB procedures for granting exemptions, please see WOU IRB Procedures for Exemption.

Amendments & Modifications

Where to Start

• Confirm that your proposed amendment/modification does need to be approved by the WOU IRB. Only those modifications that have the potential to impact human research participants in some way must be approved.
• Prepare all required documentation for the amendment/modification request.
• Contact the WOU IRB with any remaining questions.

 Request for Modifications Submission Process

• Request for modifications are submitted via Submittable, the WOU IRB application and document management system.
• On Submittable, select “Modification Request for an Approved Project.”
• To complete the request, you will be asked to provide:
  • The title of your project
  • The IRB Approval Number for your project
  • A cover letter providing a complete description of the proposed modifications
  • Any additional documentation/paperwork that is relevant to the proposed modifications (e.g., modified survey instruments)
• Submit your request.

After Submission

• Request for modifications are routed directly to the WOU IRB Chair or designee for immediate review.
• Any clarifications will be communicated to the submitting PI.
• Upon approval of the request, the submitting PI will be notified and provided with official documentation of the approval.

Request for Continuation/Renewal

Where to Start

• Determine the appropriate timeline for continuation. Ongoing studies classified as posing “minimal risk” to participants (i.e., those under Exempt, Expedited, or Limited Review) require continuing review every five years. Full Board research requires annual continuing review.
• Please note that the WOU IRB does not prompt requests for continuation nor send reminders to PIs regarding when project approval will lapse. It is the PI’s responsibility to be aware of the timeline for continuation and to initiate the submission of the request for continuation without prompting from the IRB.
• Prepare all required documentation for the request.
• Contact the WOU IRB with any remaining questions.

Request for Continuation Submission Process

• Requests for continuation are submitted via Submittable, the WOU IRB application and document management system.
• On Submittable, select “Renewal Request for an Approved Project.”
• To complete the request, you will be asked to provide:
  • The title of your project
  • The IRB Approval Number for your project
  • A cover letter addressing your request for continuation, including the rationale for continuation
  • Additional documents relevant to your request for continuation, which should include but are not limited to:
    • A summary of the project protocol (i.e., a description of your study design)
    • A brief status report on the project
    • Copies of informed consent documents
• Submit your request.

After Submission

• Request for continuation are routed directly to the WOU IRB Chair or designee for immediate review.
• Any required clarifications will be communicated to the submitting PI.
• Upon approval of the request, the submitting PI will be notified and provided with official documentation of the approval.

Research Conducted by Non-WOU-Affiliated Investigators

Where to Start

• The WOU IRB regularly and frequently entertains inquiries from outside institutions and non-WOU affiliated individuals who wish to conduct research and collect some or all of their data at WOU. While we wish to encourage and facilitate such research, the following requirements must be met prior to initiating any projects in order to ensure effective communication between participants, project staff, and WOU, as well as to ensure that WOU IRB policies are being followed during the conduct said research.
• The IRB process for reviewing, approving, and providing oversight for human subjects research conducted by a non-WOU-affiliated investigator depends on whether the project (1) has been reviewed and approved by another institution’s IRB or (2) has not yet been reviewed and approval will be sought from the WOU IRB (described below).
• In either case, PIs should take care to prepare all required documentation prior to submission to the WOU IRB.
• All non-WOU-affiliated PIs are required to complete and submit a WOU IRB Individual Investigator Agreement (IIA) form with their application (see Forms, Guidance, and Other Resources page for more information).
• PIs should contact the IRB with any remaining questions.
• Note that although every attempt will be made to accommodate the review and conduct of non-affiliated research at WOU, the WOU IRB reserves the right to deny both review and approval of any such research without specified cause.

Application Process – Project Approved by Other IRB

• If research initiated by a third-party already has IRB approval from an outside institution, the  WOU IRB will maintain reciprocity with that approval, provided that the following are submitted to the WOU IRB:
  • A cover letter requesting that the WOU IRB maintain reciprocity with the other IRB
  • An IRB Authorization Agreement (IAA) form (WOU to cede review) identifying the other institution’s IRB as the IRB-of-record
  • IIA forms for all non-WOU-affiliated PIs on the project
  • Copies of all project materials (e.g., informed consent forms, surveys, etc.)
  • A copy of the official approval letter from the other institution’s IRB
• All of the above should be submitted to the WOU IRB via Submittable, the WOU IRB’s online application and document management system. For these submissions, select “Non-Affiliated Investigators – WOU IRB to cede Review.”
• All investigators on the project, regardless of affiliation, are required to meet all WOU IRB requirements for the conduct of human subjects research at WOU (e.g., holding a valid CITI certification) and should submit documents verifying this, as needed.
• Submissions are routed directly to the WOU IRB Chair or designee for immediate review.
• Any clarifications will be communicated to the submitting PI.
• If no clarifications or modifications are required, the submitting PI will be notified and provided with official documentation of approval.

Application Process – WOU IRB to Review Non-Affiliated Research

• If research initiated by a non-WOU-affiliated investigator has not already received IRB approval elsewhere, that party may submit an application to the WOU IRB for consideration for approval provided that the following conditions are met:
  • The non-affliated investigator(s) completes in full and submits a WOU IRB application and any associated project documentation (e.g., informed consent documents, project materials, etc.) following the process described above.
  • The investigator clearly indicates either in the IRB application or in a letter to the WOU IRB that at least one PI is not formally affiliated with WOU.
  • All investigators listed on the project, regardless of affiliation, have met (and can provide documentation of meeting) all IRB requirements for the conduct of human subjects research at WOU (e.g., holding a valid CITI certification).
  • The non-affliated investigator(s) complete and submit IIA forms along with their IRB application, as well as any other documents requested by the IRB prior to initiating research at WOU.
• Following the completion and submission of all required forms, the WOU IRB will initiate its review following the procedures outlined above.

Collaborative Research

Where to Start

• Collaborative research typically involves a WOU-affiliated researcher engaging in human subjects research with an investigator from another institution of higher education, research institute, and/or organization. The WOU IRB encourages and will support collaborative research. However, appropriate steps must be taken to ensure that each institution associated with the conduct of the research is responsible for safeguarding the rights and welfare of human participants and for complying with applicable federal regulations.
• The PIs for the project must first decide whether they wish to submit applications to all associated IRBs or to identify a single IRB (i.e., sIRB; the IRB-of-Record). Note that as per 45 CFR 46, Subpart A (i.e., the Federal Policy for the Protection of Human Research Subjects), identification of a sIRB is required for federally-funded research, and PIs may not elect to undergo IRB review at multiple institutions for federally-funded projects.
• If intending to submit applications to all associated IRBs (i.e., the IRB for each PI’s affiliated institution), the WOU-affliated PI would need to complete the submission process described above, list all PIs on the project (regardless of institutional affiliation) on the WOU IRB application, and have all non-WOU-affiliated PIs complete and submit a WOU IRB Individual Investigator Agreement (IIA) form with the application (see Forms, Guidance, and Other Resources page for more information).
• If intending to identify and use a sIRB, the PIs must decide which institution’s IRB will serve in this role.

Application Process – WOU IRB identified as IRB of Record

The following applies to situations in which the WOU IRB will serve as the IRB of record for a collaborative research project involving multiple institutions.

• The WOU-affiliated PIs must complete and submit all documentation required of a typical IRB application (e.g., application form, project materials, etc.) following the procedures outlined above.
• The WOU-affiliated PIs must request in writing on the application form or in an application letter that the WOU IRB serve as the sIRB of a multi-site study.
• The WOU-affiliated PIs must identify on the application form or in an application letter each collaborating institution and provide the names of all PIs on the project, regardless of institutional affiliation.
• Each non-WOU-affiliated PI must complete an IIA form, to be submitted with the initial IRB application.
• The PIs must submit an IRB Authorization Agreement (IAA) form that identifies WOU as the coordinating institution and as providing the sIRB for the study. Each collaborating institution will need to submit a separate IAA form for their institution.
• Note that both the IIA and IAA forms must be completed, with the requisite information provided and appropriate signatures obtained, before the WOU IRB will agree to serve as the sIRB and initiate its review.
• Following the completion and submission of all required forms, the WOU IRB will initiate its review following the procedures outlined above.

Application Process – WOU IRB to cede Review

The following applies to situations in which the WOU IRB will cede review to another institution’s IRB and rely upon that IRB’s determinations regarding initial and continuing review of a collaborative research project.

• The PIs should first submit to the sIRB at the collaborating institution, following that institution’s typical policies and procedures for IRB review.
• After approval from the collaborating IRB but prior to engaging in the collaborative research project, the WOU-affiliated PIs must submit:
  • A cover letter requesting that the WOU IRB maintain reciprocity with the collaborating IRB
  • An IAA form (WOU to cede review) identifying the collaborating institution
  • IIA forms for all non-WOU-affiliated PIs on the project
  • Copies of all project materials (e.g., informed consent forms, surveys, etc.) that will be administered by the WOU-affiliated PIs and/or to WOU-affiliated participants
  • A copy of the official approval letter from the collaborating IRB
• All of the above should be submitted to the WOU IRB via Submittable, the WOU IRB’s online application and document management system. For these submissions, select “Collaborative Research – WOU IRB to cede Review.”
• These submissions are routed directly to the WOU IRB Chair or designee for immediate review.
• Any clarifications will be communicated to the submitting PI.
• If no clarifications or modifications are required, the submitting PI will be notified and provided with official documentation of approval.[endsection]

Incident Reporting

Filing an incident report involves notifying the WOU IRB of any unanticipated problems and/or adverse events involving risks to participants or others during the course of human subjects research. Unanticipated problems and events should be reported no later than 7 days of the investigator becoming aware of the occurrence. However, investigators should contact the WOU IRB via email immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.

• Incident reports may be filed by PIs or any other party who is aware of an incident occurring during the course of research.
• Incident reports are submitted via Submittable, the WOU IRB’s online application and document management system. For these submissions, select “Incident Report Form.”
• For the report, respondents will be asked to provide the following:
  • The complete title of the project (if known)
  • Name and contact information
  • The IRB Approval Number of the project (if known)
  • A brief description of the incident
• Following the report, respondents will be contacted by a member of the WOU IRB for more information.

For additional information on unanticipated problems, please see the Federal guidance which can be found at the Office for Human Research Protections (OHRP) website.