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听with a member of the HRPP staff. Simply click below to begin your chat session via Teams.听
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- Virtual Office Hours: Every Wednesday from 11 a.m.鈥�12:00 p.m.听EST听
- Login directly to our听听to speak to an HRPP Staff Member.听
- E-Mail: Please e-mail听irb-rsp@wright.edu听to set up a consultation. Please note: consultations are scheduled in 30-minute blocks and are first come-first served.
- Phone:听IRB Help Line: The IRB Office can be contacted at 937-775-5171. If not answered, please leave a message, and your call will be returned as soon as possible.听
- SharePoint site: Review Checklist & Worksheets,听IRB Workshop Series recordings听and slides.听This site can only be accessed with your Campus Username and Password.听
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听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., 糖心原创 department chairs)听must have an active profile and relevant Cayuse permissions in the system.
糖心原创 Employees and Students
Fill out the听Cayuse Access Request Form. Please note that all notifications/approvals in Cayuse听are sent to your campus email so you must be able to receive your 糖心原创 email to properly use the system. If you would like Cayuse听notifications to be sent to a different email address, you may听forward your campus email.
Non-糖心原创 Employees and Students
If you are requesting access to Cayuse, but听NOT听REDCap,听please fill out the听Cayuse Access Request Form. Provide your work email when prompted for a 糖心原创 email.
If you need access to Cayuse听AND听REDCap, fill out the听New Account Request Form,听Please plan appropriately as it can take up to听one week to obtain a 糖心原创 account and set up access to REDCap.
If you have not used your 糖心原创 account in some time, you may reset your password via听these instructions.
Complete Investigator Credentialing: CITI Training, Annual COI, Upload CV
糖心原创 requires all听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听)
- Human Research Scientific Merit & Feasibility Attestation Form听(WSU Campus Expedited & Full Board studies only)
- Local Protocol (Created by PI even when sponsor protocol exists. Specialized听templates听are available.)
- Sponsor Protocol, when applicable
- Informed Consent Document(s) (Specialized听templates听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-糖心原创 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 .
糖心原创 investigators are required to use the Cayuse听Human Ethics听module to submit applications to the 糖心原创听IRB. All new human subject research studies must be submitted using the Initial Application Form.听All forms within the HE module are 鈥渟mart鈥� 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听non-research determinations, as well as process external reliance registrations, delayed onset determinations, and emergency research reports.听
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.听听
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