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 Training Requirements

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.

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 or Nicky Cattano, WCU IRB Co-Chair at NCattano@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 for irb@wcupa.edu

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 through irb.wcupa.edu, please follow these steps:

    • Complete the IRB application form :
      • Check off Yes to I.F. and provide the approximate date of review.
      • Check off Revision to I.G. and provide the Protocol ID# of the original submission.
      • Highlight the revisions in the body of the application. Unchanged portions of the application can be cut and pasted from your original application.
    • E-mail the completed form (in Word format only) to the Institutional Review Board
      • The subject line of the e-mail should read, revision application of approved protocol.
      • In the body of the e-mail, clearly list your revisions by application section (number/letter of section, or appendix documents)
    • Your application will be reviewed within three weeks. Failure to follow above instructions will result in the return of your application and processing delays.

Closures for irb@wcupa.edu

Upon completion of your project, WCU requires all investigators to close their research project. Investigators closing their research study should complete this closure form   in lieu of a Continuing Review Form.

Informed Consent Creator

  1. 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.
  2. Complete the form in its entirety
  3. You will be given the opportunity to review the form before submission
  4. After you preview the form, click submit
  5. Your consent form will be e-mailed to you as an editable Word Document

After you receive and review the document:

  1. Make any necessary changes, but avoid editing too much since you may increase the reading level
  2. Once you are finished with the document, please complete a spelling/grammar check on it including the reading level.
  3. Access the directions for Readability Set Up . The highest reading level should be at an 8th grade level.
  4. 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

or

contact Dr. Cheryl Monturo.

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

  1. Go to citiprogram.org and click on Register under Create an account.
  2. Enter West Chester University into the Select Your Organization Affiliation text box (choose WCUPA when it appears as you type)
  3. Select Continue to Step 2
  4. Follow on-screen instructions for step 2-4
  5. For step 5, regarding CEU credits, please select No
  6. For step 6, you only need to enter the information with an asterisk
  7. 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**
  8. Other courses can be selected as desired, but are not required for IRB applications
  9. After all courses have been chosen, click complete registration, and then click finalize registration.
  10. 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**
  11. 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:

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

Dr. Melissa Reed

WCU IRB co-chair

Spring 2021 – please email mreed3@wcupa.edu to schedule a phone call or Zoom conversation.

IRB Drop In/Open Sessions

WCU IRB Q&A Zoom Sessions: Questions & Answers when Applying

Topic Information
Dates/Times/Zoom Links
  • March 3rd, 10am-11am
    Dr. Geeta Shivde
  • March 10th, 12pm-1pm
    Dr. Stacie Metz
  • March 10th, 3pm-4pm
    Dr. Michelle Wade
  • March 11th, 12pm-1pm
    Dr. Seth Kahn
  • March 25th, 2pm-3pm
    Dr. Heather Leaman

Email irb@wcupa.edu for Zoom information. All may Zoom in at any time during the scheduled times listed!

Topics Discussed
  • Address any questions/concerns on applications being prepared or considered
  • Common errors when submitting
  • Opportunity to clarify any confusion
  • Q&A with IRB Committee members
Intended Audience
  • Anyone who is conducting research involving human subjects
  • If you have a question or two, we are available to discuss your concerns
Hosts IRB Members

**WCU IRB co-chair office hours for Spring 2021: Email Dr. Melissa Reed, mreed3@wcupa.edu, to schedule a phone call or Zoom conversation.

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

  
    • Nair, Julie
    • Nursing
    • 930 E. Lincoln Hwy 121
    • 610-436-2331
    • Park, Innhwa
    • Languages & Cultures
    • Mitchell Hall 232
    • 610-436-2640
    • Roman, Aaron
    • Communication Sciences & Disorders
    • 201 Carter Dr. 417
    • 610-436-3436 

Non-WCU Community Member

Sims, Christopher

IRB Monthly Meeting Schedule:

The Spring 2021 monthly meeting schedule is as follows:

Friday, February 19th, 3pm-5pm

Friday, March 26th, 3pm-5pm

Friday, April 23rd, 3pm-5pm


Questions?

  • Please contact the IRB co-chairs, Dr. Melissa Reed and Dr. Nicky Cattano, if you have any questions. You can call or setup a Zoom meeting about any IRB matters.
  • You may also contact the IRB staff with any questions/concerns/requests at irb@wcupa.edu.
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