Human Subjects

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General Information

InfoED Human Subjects Module

As of February 1, 2017, the WSU IRB will require all investigators to use its new paperless submission system (InfoED) to submit new human subject studies that may be exempt or qualify for expedited review.  The current paper forms will no longer be accepted for exempt and expedited studies.

The IRB has begun accepting voluntary submissions of full board studies via InfoED. The IRB will start reviewing InfoED full board submissions at its April 17, 2017 meeting.   Therefore, investigators who want to begin the submission and routing process (including HIRC review) can do so now – noting that any full board studies submitted via InfoED will not be placed on an agenda before the April meeting. 

Current full board submission deadlines apply regardless of whether the submission is in paper or via InfoED.  For example, a Premier study submitted via InfoED must be approved by the HIRC, then approved in InfoED by Premier, and then “received” by IRB Office in InfoED by April 4 (to be placed on April 17 agenda.  Please plan accordingly.

Future Implementation Deadlines

As of June 1, 2017, all new full board studies (along with expedited and exempt studies) will be required to be submitted via InfoED. 

PIs who have ongoing studies that need continuing review on or after July 1, 2017 will be required to either close their study via current paper form or transfer their ongoing study into InfoED so that it can receive continuing review before its annual expiration date.  Starting in May, investigators will receive instructions on how to transfer their study into InfoED as part of the continuing review reminder notification.

Please note that this website will provide the latest information about the implementation – please check it regularly.

Before you use the system, it is recommended that you attend an investigator training session.  Training sessions will be given each month.  Please contact the IRB Office if you would like to be placed on the list to receive training notifications.  

HS InfoED Training Schedule (PDF)

All new studies that are submitted using the new system must be done via the Initial Application Form.  It is important to understand that this one form replaces the current paper “petitions” below (e.g., Full, SEBR, Chart and Blood).   All forms within the HS Module are “smart” forms that add/remove questions based on your responses.  Therefore, it is important that you answer every available question to avoid submitting an incomplete form.

To facilitate your use of the system, we have posted new required forms and guidance documents below:

Human Subjects Module Instructions

HIPAA

Project Specific Disclosure

 

Setting Up Human Subjects Module Access

It is important to understand before you start an InfoED submission, that the PI, Faculty Advisor (if applicable), and WSU Department Chair (if not Premier or Dayton VA) must have an active W-number and relevant InfoED permissions to use the system.

If you have an active Wright State user account, contact Robyn Wilks at robyn.wilks@wright.edu to request InfoED IRB access.  Include your full name and w-number.  Please note that all notifications/approvals in InfoED are sent to your campus email so you must be able to receive your Wright State email to properly use the system.  If you would like InfoED notifications to be sent to a different email address, you may forward your campus email via instructions here.

If you do not have a Wright State account, fill out this account request form, sign, scan, secure and return it to Robyn Wilks at robyn.wilks@wright.edu.  Please plan appropriately as it takes approximately two weeks to obtain a W-number and set up access to the Human Subjects Module.

If you have not used your Wright State account in some time, you may reset your password via the instructions found here.

InfoED can be accessed from an on-campus machine or secured wireless connection.  If you need to access it remotely, you must first authenticate through Wright State VPN.

Forms

Required Human Subjects Training

WSU is pleased to offer on-line human subjects protection training for Principal Investigators and key personnel on projects involving human subjects, and IRB members. This training is available through the Collaborative Institutional Training Initiative (CITI). At the log-in page, either click on "New Users - Register Here" or, if you're already registered, enter your username and password. Identify yourself as affiliated with Wright State University. The succeeding forms to be filled out are fairly self-explanatory. Upon completion of the appropriate modules, a certificate will be generated. The IRB will confirm that all project participants have completed the appropriate training courses prior to the approval of any studies.

While not required, the IRB staff members offer in-person training sessions for classes and other groups, as well as one-on-one training. Please contact the IRB office to arrange for one of these sessions.

Other Guidelines

Contact Information

Jodi Blacklidge, Human Subjects Program Facilitator

Ms. Blacklidge may be contacted with general questions about the IRB, human subject training requirements, and about projects that may meet Exemption or Expedited Review criteria. (937) 775-3974 or Jodi.blacklidge@wright.edu

Robyn Wilks, Administrative Coordinator

Ms. Wilks may be contacted about IRB operations, the WSU IRB FWA, human subject protections regulations, WSU IRB requirements, collaborative research with other institutions and questions about projects that require full board review. (937) 775-4462 or robyn.wilks@wright.edu


Federal/External Regulations & Guidelines