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. Click here for 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 at IRB@wcupa.edu or Dr. Cheryl Monturo at cmonturo@wcupa.edu

1. Utilize the Health and Human Services Human Subject Regulation Decision Charts to determine if your activity is research that must be reviewed by an IRB.
2. If you have determined that your research must be reviewed by an IRB please follow the following steps:
   1. Review IRB Faculty Guidelines
   2. Submit the IRB Application Form via e-mail to IRB@wcupa.edu **This updated form is the only version of the application that the IRB will accept (Revised Date 6-2017).
   3. You must submit the application as one Word document. All attachments must be converted to Word and added at the end of the application. If you have documents that are native PDF's (often scanned documents, and CITI certificates), please utilize the "take a snapshot" option in Adobe PDF (found under Edit). This will allow you to drag over an area of the document in order to copy it. Once copied, the information can then be pasted at the end of the IRB application form.
   4. Within 3-4 business days of the submission of your application, you will be copied on an e-mail which confirms that your application has been forwarded to an IRB committee member for review. This gives you the contact information for your reviewer.
   5. Within three weeks, you will receive an e-mail regarding the status of your application. If your reviewer requests revisions to your application, these revisions must be made to your original application using the "track changes" feature in Word. If revisions are requested on a Technical Review form (TR), you will have two weeks to make the requested changes or request additional time and then the revised application can then be sent directly to your reviewer and copied to the IRB@wcupa.edu.
   6. Once your protocol is approved you will receive three PDF documents (Final Application, Final TR and Approval Document) and may begin your research. Your protocol approval is good for one year and you must request additional time to extend (see Exempt Protocols Only: Protocol Renewal Procedure OR Expedited & Full Board Review Protocols Only: Federal Requirements for Continuing Review and Closure Procedure.)

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**
12. Once you pass the training, you much attach your completion report to your IRB application, in order for the IRB to accept the certificate, the course name must read "Social & Behavioral Research - Basic/Refresher" or "Biomedical Research- Basic/Refresher"

• If you have any questions regarding which trainings to register for, please contact:
  • Catherine Spaur (610-436-3060), or
  • Laura Vassallo (610-430-5606)

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).

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 to irb@wcupa.edu for review and approval.  Please follow the following steps:

1. Complete the IRB application form:
1. Check off Yes to I.F. and provide the approximate date of review.
2. Check off Revision to I.G. and provide the Protocol ID# of the original submission.
3. Highlight the revisions in the body of the application. Unchanged portions of the application can be cut and pasted from your original application.
2. E-mail the completed form (in Word format only) to irb@wcupa.edu
1. In the subject line of the e-mail, should read revision application of approved protocol.
2. 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 return of your application and processing delays.

To extend the time of a previously approved exempt protocol (with or without revision), please complete and submit the regular IRB application form, in its entirety, to irb@wcupa.edu. In the application specify I.F. Application previously considered and I.G. Renewal (with Protocol ID#). If you have revisions to the protocol, follow the revision procedure above as well. Please allow 3 weeks for review.

Except for human research studies that have been granted Exempt registration, Department of Health and Human Service's Office for Human Research Protection (OHRP) regulations requires the IRB to continually review ongoing research at intervals appropriate to the potential risk to participants, but at least annually.

• OHRP Guidance on IRB continuing review of research
• WCU IRB Continuing Review Form

Continuing Review Process (not required for those protocols approved as "exempt". See Exempt Protocols Only-Protocol Renewal Procedure)

• Approximately two months prior to your approval end date, you will receive a Continuing Review form.
• Complete this form even if your project has been completed or is discontinued.
• Return the form, as one word document, to irb@wcupa.edu no later than two weeks after it is received.
• You will receive status of your continuing review within three weeks.

• Next workshop to be held in the Fall of 2016
• Slide Deck (PDF)

• 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

Meetings will be held in Philips Lower Level Conference Room at 1pm

• Friday, September 1st
• Friday, October 6th
• Tuesday, November 7th
• Tuesday, December 5th