Institutional Review Board (IRB)
WCU is guided by the ethical principles regarding all research involving human subjects as set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report".
In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations will be followed for all applicable Department of Health and Human Services (HHS) funded research and for all other research without regard to source of funding.
Frequently Viewed/Helpful Documents
IRB Processing Time and Procedures for Submitting to the WCU IRB:
Initial review of your application will take place within three weeks of when the IRB reviewer receives your application. Your IRB reviewer may request edits and changes to your application, this can take an additional two to three weeks to complete. Please plan ahead and allow at least one month for the entire review, revision, and approval process to be completed. The IRB cannot honor requests for a "quick turnaround" or reviews completed by a certain date.
CITI Program COVID-19 Training
Revised Common Rule Now in Effect
Revisions to the Common Rule (federal human participant research regulations) went into full effect on January 21, 2019.
In accordance with this revision, WCU requires all PIs to submit an updated IRB Application
Form. The Office of Research and Sponsored Programs recommends that all PIs watch
this brief video, which provides an overview of the impact these changes may have
on your IRB application process and complete the CITI IRB training for the Revised
Common Rule.
NEW!! Cayuse Electronic IRB Submission (required as of 02/05/2021)
We are excited to introduce our NEW IRB electronic application submission process through Cayuse IRB! Please click here to access Cayuse IRB with your WCU Single Sign On information: https://wcupa.cayuse424.com/. After 02/05/2021, all new IRB applications must be submitted through Cayuse IRB.
INFORMATION FOR FACULTY & STAFF: Some faculty and staff have been pre-loaded into the system based on previous IRB use. If you get an error or an alert that your account has been disabled, please make a request to ADD yourself (or any co-investigators) that are not found in the current system. Please submit the request(s) here: CAYUSE IRB NEW USER REQUEST. Once the IRB Office receives the information, this will be uploaded into Cayuse IRB. Please allow up to 2 business days for your request to be granted.
INFORMATION FOR STUDENTS: If you have never used the Cayuse IRB system, please make a request to ADD yourself here: CAYUSE IRB NEW USER REQUEST. Once the IRB Office receives the information, this will be uploaded into Cayuse IRB. Please allow up to 2 business days for your request to be granted.
Here is a link for the Cayuse IRB Training Manual: Cayuse IRB Training Manual
Here is a link for the Cayuse IRB Training Video: Cayuse IRB Training Video
If you have questions about Cayuse or training opportunities, please email the IRB
office at IRB@wcupa.edu.
Revision Request and Closures for Protocols Approved in Cayuse IRB
Revision Requests for Cayuse IRB
ALL revisions to WCU IRB approved protocols (even minor revisions such as adding a new student assistant’s CITI Human Subjects Research training completion report) must be submitted as a formal revision. If you submitted your initial protocol through Cayuse IRB, click here to submit your revision for review and approval.
Closures for Cayuse IRB
Upon completion of your project, WCU requires all investigators to close their research project. Please click here to access Cayuse IRB with your WCU Single Sign On information to submit a closure request for your research project.
Revision Request and Closures for Protocols Approved through irb@wcupa.edu
Revision Requests
ALL revisions to WCU IRB approved protocols (even minor revisions such as adding a new student assistant's CITI Human Subjects Research training completion report) must be submitted as a formal revision. If your protocol was approved via email submission through irb.wcupa.edu, please follow these steps:
Create a NEW application in our online Cayuse system by copying and pasting the information
from your approved protocol. This will transition your project to the new system and
assist with compliance, modifications, and automated reminders.
If you have not created an account with Cayuse, complete the Qualtrics survey: CAYUSE IRB NEW USER REQUEST. Submission of the Qualtrics survey must be completed before you will be able to input the protocol information into Cayuse.
This submission will not go through a complete review. Once you copy and paste the components from your previously approved application and submit it, it will be assigned to an IRB reviewer who will approve the submission expeditiously. Once you receive the approval, submit a MODIFICATION application with the revisions you are seeking to get approved. Once submitted, send an email to irb@wcupa.edu to inform a new transition submission has been submitted to Cayuse for approval.
Closure Requests
Upon completion of your project, WCU requires all investigators to close their research project via the Cayuse system.
Informed Consent Creator
- Please click on this link, informed consent creator, to start your consent form. This is a new form to help you easily create a consent at the proper reading level.
- Complete the form in its entirety
- You will be given the opportunity to review the form before submission
- After you preview the form, click submit
- Your consent form will be e-mailed to you as an editable Word Document
After you receive and review the document:
- Make any necessary changes, but avoid editing too much since you may increase the reading level
- Once you are finished with the document, please complete a spelling/grammar check on it including the reading level.
- Access the directions for Readability Set Up . The highest reading level should be at an 8th grade level.
- Attach the consent form to your IRB application and follow instructions under “Procedure for IRB Application Approval”
Should you have any difficulties or questions, you can
contact the Institutional Review Board.
Mandatory Human Subjects Training (CITI Training)
WCU is a subscribing institution with The Collaborative Institutional Training Initiative (CITI Program). CITI provides comprehensive online training in Human Subjects Research.
All PI’s, co-PI’s, and faculty sponsors submitting a new application to the IRB are required to create an Account with CITI and complete Human Subject Research Training. You will have two modules to choose from: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). Please choose the module that is most closely related to your research.
Please follow the instructions below in order to create your account with CITI and begin your training: (please note, if you already have created a CITI account, please log-in and start at #10 below
- Go to citiprogram.org and click on Register under Create an account.
- Enter West Chester University into the Select Your Organization Affiliation text box (choose WCUPA when it appears as you type)
- Select Continue to Step 2
- Follow on-screen instructions for step 2-4
- For step 5, regarding CEU credits, please select No
- For step 6, you only need to enter the information with an asterisk
- For step #7, under Human Subject Research Courses, choose either the Biomedical or the Social-Behavioral-Educational training module. Choose the module that most closely relates to your research **do not select the IRB members or IRB administration module**
- Other courses can be selected as desired, but are not required for IRB applications
- After all courses have been chosen, click complete registration, and then click finalize registration.
- To begin the training, please select "Social & Behavioral Research - Basic/Refresher" or "Biomedical Research- Basic/Refresher" from your course list. **Do not select any Responsible Conduct of Research Module**
- If you do not see "Social & Behavioral Research - Basic/Refresher" or "Biomedical Research- Basic/Refresher" on your course list, please select "add a course or update learner groups" and under Human Subject Research Courses, choose either the Biomedical or the Social-Behavioral-Educational training module. Choose the module that most closely relates to your research**do not select the IRB members or IRB administration module**
- If you have any questions regarding which trainings to register for, please contact:
- Catherine Spaur (610-436-3060), or
- Andrea Smith (610-436-3064)
NOTE: NIH Protecting Human Subject Research Participants’ training certificates are no longer being accepted with new applications. However, NIH training will still be accepted for revision and renewal applications (as long as the training has been completed within three years).
IRB Office Hours
Please email the WCU IRB co-chairs to schedule a phone call or Zoom conversation.
Dr. Melissa Reed or Dr. Heather Leaman
WCU IRB co-chairs
IRB Drop In/Open Sessions
Fall 2022 drop in/open session dates and times will be posted once a schedule has been established.
IRB Coordination across Pennsylvania’s State System Universities
- If there is a need to coordinate multiple IRB reviews of research that uses human subjects from more than one State System university, please follow the PASSHE State System Policy
Institutional Review Board Members
-
- Co-Chair: Reed, Melissa A.
- Kinesiology
- Sturzebecker Health Science Center 320
- 610-436-2141
- Co-Chair: Leaman, Heather
- Early & Middle Grades Education
- Recitation Hall 203D
- 610-436-3323
- Craig, John
- Interdisciplinary Studies and Academic Support Programs
- Lawrence Center, Room 232
- 610-436-3133
- Di Giovine, Michael
- Anthropology & Sociology
- Old Library 204
- 610-436-2247
- Grugan, Shannon
- Criminal Justice
- BPMC 515
- 610-436-2659
- Kahn, Seth
-
English
Main Hall 537
610-436-2822
-
- Katirai, Matin
- Geography & Planning
- BPMC 528
- 610-436-2393
- Metz, Stacie
- Health
- SEC 228
- 610-436-2101
- Nair, Julie I
- Nursing
- 930 E. Lincoln HWY 121
- 610-436-2331
- Park, Innhwa
- Languages & Cultures
- Mitchell Hall 232
- 610-436-2640
- Roman, Aaron
- Communication Sciences and Disorders
- 201 Carter Dr 417
- 610-436-3436
- Shivde, Geeta
- Psychology
- Peoples BLDG 043
- 610-436-3207
Non-WCU Community Member
Sims, ChristopherIRB Monthly Meeting Schedule for Fall 2022
Questions?
- Please contact the IRB co-chairs, Dr. Melissa Reed and Dr. Heather Leaman, if you have any questions. A Zoom meeting can be scheduled to discuss any IRB matter.
- You may also contact the IRB staff with any questions/concerns/requests at irb@wcupa.edu.