Division of Student Affairs

Are you or members of the WCU community on the study team?

• If yes, you may need to file an IRB application. See the next set of questions for further clarification.
• If no, the members of the study team are responsible for filing the IRB application.

Are you or members of the WCU community conducting an assessment or evaluation (e.g., examining the quality of programs, services, resources, learning, climate, etc. and with the intention of making improvements)?

• If yes and you will share the results only with members of the WCU community, an IRB application is not required.
• If you are conducting an assessment or evaluation you would like to share with individuals outside the WCU community, you must file an IRB application.
• If you are not conducting an assessment or evaluation project, it may fall under research.

Are you or members of the WCU community conducting research (e.g., projects related to grants, presentations to people outside of the intended constituent group, publications, benchmarking, comparison studies, dissertations, capstone projects, thesis studies, theories, research days)?

• If yes, you must file an IRB application.

Research Study Team Includes Only WCU Faculty, Staff or Students

If the research study team is made up of current WCU faculty, staff or students, the study team must file an IRB application. For employees in Student Affairs, please contact Amanda Thomas, Executive Director of Assessment and Planning for more information. For all other employees, please contact the IRB Committee directly if you have questions.

Research Study Team Includes Only Individuals or Organizations Outside of WCU

The external individual or organization must have an approved IRB application in place before the survey can be administered (by them or by a member of WCU). Members of WCU are not required to file a separate IRB application.

If an external individual or organization does not have an approved IRB application in place, they can become a guest of WCU, complete the training for filing an IRB application, and then file an IRB application with the WCU Institutional Review Board. In this instance, a member of WCU who has completed training would need to sponsor their application and be listed as the Principle Investigator.

Before the study can commence, the individual or organization needs to provide a data use agreement for the PASSHE Legal Counsel to review and sign stating that we agree to share WCU data with them.

Research Study Team with WCU Members and External Individuals or Organizations

If the research study team is made up of current members of WCU and external individuals or organizations, one of the groups must file an IRB application at their respective organizations. If data files with individual student responses are being shared across WCU and the external organization, the IRB must be approved by the WCU IRB Committee and the IRB committee for the external organization (if one exists). The IRB committees may work together to come to an agreement regarding the study design and details (e.g., consent form).

The following also needs to be included in the IRB application:

• A data use agreement from the organization or individual that has been reviewed and signed by the PASSHE Legal Counsel
• A letter of support from the Registrar stating that Academic and Enterprise Services will pull the data in the timeframe needed

Data files cannot include students who have said no to sharing their student directory information (FERPA column)

Invitation for Study Conducted by Anyone Outside WCU

• Sent by WCU via distribution list – data use agreement and letter of support recommended
• Sent by WCU to individual student email addresses – data use agreement and letter of support recommended
• Sent by member of a PASSHE University – data use agreement required, letter of support required from Registrar's Office
• Sent by external organization using a list WCU provides – data use agreement required, letter of support required from Registrar's Office

• Request data use agreement from external organization (the earlier the request, the better) and send it to the PASSHE Legal Counsel Office for review and signature. If there is a contract between the two organizations, there may be a data use agreement in place that PASSHE Legal Counsel may have already approved.
• External organization/individuals on study team - Send IRB application to WCU IRB committee for review. Ask the WCU IRB committee if a cede letter is needed.
• WCU member part of the study team - File IRB application with WCU IRB Committee
• If an external organization will send WCU a data file with individual student responses – file IRB application.

• Ask for the data use agreement ASAP. It may take a few weeks for the external organization to process and a few more weeks for the PASSHE legal counsel to review and sign the agreement (and leave time for potential changes that may need to be made).
• Once the data use agreement is approved by Legal Counsel, the Registrar's Office will process a letter of support for the study. The letter of support states that the Registrar's Office agrees to the project and the timeline for pulling the student email addresses for the researcher. A copy of the letter of support should be included in the IRB application. The letter of support should be in place and the IRB application should be approved before the Academic and Enterprise Services pulls a list of student names, email addresses, demographics, etc.
• The WCU IRB committee reserves 4-6 weeks for reviewing IRB applications and their reviews may come back with notes about changes that need to be made. Once the changes are completed (and highlighted in the document for the reviewer), the second review typically takes 1-2 weeks. This process continues until the application is in order and approved by the committee. Data collection cannot begin before the application is approved.