New to Human Subjects Research
If you are new to human subjects research, the IRB process can be overwhelming. This checklist will help you get started.
Please reach out to the IRB Office if you need additional assistance:
- IRB Chat: Chat live with a member of the HRPP staff. Simply click below to begin your chat session via Teams.
- Virtual Office Hours: Every Wednesday from 11 a.m.–12:00 p.m. EST
- Login directly to our WebEx meeting (Meeting Number: 2302 494 3505) to speak to an HRPP Staff Member.
- E-Mail: Please e-mail irb-rsp@wright.edu to set up a consultation. Please note: consultations are scheduled in 30-minute blocks and are first come-first served.
- Phone: IRB Help Line: The IRB Office can be contacted at 937-775-4462. If not answered, please leave a message, and your call will be returned as soon as possible.
- SharePoint site: Review Checklist & Worksheets, IRB Workshop Series recordings and slides. This site can only be accessed with your Campus Username and Password.
If you are a student or resident, find a faculty adviser/mentor.
Faculty advisers/mentors are responsible for monitoring all aspects of student research; student research cannot be submitted without a faculty adviser/mentor. This individual will need to satisfy all investigator credentialing requirements.
Request an account. For more information, please see the Cayuse Information page.
How to Obtain Cayuse Human Ethics Module Access
Before you start a Cayuse Human Ethics submission, all investigators, as well as organizational approvers (e.g., Wright State department chairs) must have an active profile and relevant Cayuse permissions in the system.
Wright State Employees and Students
Fill out the Cayuse Access Request Form. Please note that all notifications/approvals in Cayuse 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 Cayuse notifications to be sent to a different email address, you may forward your campus email.
Non-Wright State Employees and Students
If you are requesting access to Cayuse, but NOT REDCap, please fill out the Cayuse Access Request Form. Provide your work email when prompted for a Wright State email.
If you need access to Cayuse AND REDCap, fill out the New Account Request Form, Please plan appropriately as it can take up to one week to obtain a Wright State account and set up access to REDCap.
If you have not used your Wright State account in some time, you may reset your password via these instructions.
Complete Investigator Credentialing: CITI Training, Annual COI, Upload CV
Wright State University requires all individuals who act as investigators to complete training and credentialing requirements prior to conducting research which involves human subjects. Investigator credentialing involves three components: completion of training in human subjects research, verification of qualifications to conduct the proposed project by providing a CV, and completion of appropriate conflicts of interest disclosures and/or training.
Develop your study documents: local protocol, consent forms, recruitment scripts, and any other documents needed for your study.
Submission Requirements
The initial submission should include, but is not limited to the following:
- Initial Review Form (only accessible via Cayuse Human Ethics)
- Human Research Scientific Merit & Feasibility Attestation Form (WSU Campus Expedited & Full Board studies only)
- Local Protocol (Created by PI even when sponsor protocol exists. Specialized templates are available.)
- Sponsor Protocol, when applicable
- Informed Consent Document(s) (Specialized templates are available.)
- Recruitment materials (flyers, print/radio ads, social media ads, phone scripts, etc.)
- Data collection and/or assessment tools
- Letter of support and/or permission for non-Wright State University locations, database access permissions, and/or rights to use certain measures.
- Any other related study documents
Templates and check lists for the local protocol and informed consent are available on the Templates & Check Lists page.
Complete & submit the initial IRB application in Cayuse Human Ethics.
Wright State University investigators are required to use the Cayuse Human Ethics module to submit applications to the Wright State IRB. All new human subject research studies must be submitted using the Initial Application Form. All forms within the HE 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. The initial application form is also utilized by the IRB to make non-human subject and/or non-research determinations, as well as process external reliance registrations, delayed onset determinations, and emergency research reports.
Wait for IRB response. The IRB review process takes time. Please allow two weeks before contacting our office for follow up. You can monitor your study progress in Cayuse Human Ethics.
If minor stipulations or revisions are requested, respond to requested changes in a timely manner. Many applications will require at least one round of changes, especially if this is your first time submitting. The IRB requests all changes be submitted within 60 days.
Receive IRB approval. Once your study receives IRB approval, you need to download the official stamped version of consent documents to use in your study.
Manage your study. Please review the information located on the website on filing modifications, renewals/continuations, incidents/reportable events, study closure, and responsible record keeping.
