Where to Start
Use this checklist as a one-stop-shop to navigate from your research question all the way to publishing your work.
Step 1: Education and Certifications
You must have human subjects research training to participate in research activities at Woman’s.
If you are a Woman’s employee or affiliate, you must have completed the CITI Human Subjects Research certification. CITI HSR certifications last for 3 years, can be renewed as needed, and are available at no cost to you. If you are conducting a clinical trial, you must also have the CITI Good Clinical Practice certification. If you are affiliated with an outside organization, you may provide the respective human subjects protections training certificates required by your organization.
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Step 2: Documents for your project
What you will do in your project must be written in comprehensive detail into a protocol.
Woman’s has protocol templates to help guide your protocol writing. These are resources and not required. If you will be enrolling people into a study, you may need a consent form. Again, you may use the Woman’s consent template, but it's not required.
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Step 3: Research and Development Committee Feedback
If you're seeking preliminary feedback on a project idea (e.g., design, feasibility, etc.), you should submit your idea to the Research and Development (R&D) Committee.
If you are an external investigator seeking permission to conduct a study or project at Woman’s, you must submit this form to begin feasibility evaluations and the approval process. This is a collaborative resource- you don’t need to have all the details figured out to submit a project for review, we can help you with that!
Once submitted, the R&D Committee will meet to discuss your project and provide guidance and determine feasibility. You may be asked to attend the committee meeting to discuss your submission (options for in person at Woman’s or virtual).
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Step 4: Submitting for approval
The R&D Committee and Woman’s IRB must review and approve projects/studies before you can start any activities if you're conducting it at Woman’s (meaning on Woman’s campus, involving patients of Woman’s, or involving data from Woman’s).
The R&D Committee and Woman's IRB must review and approve projects/studies before you can start any activities if you are conducting a project/study at Woman's (meaning on Woman's campus, involving patients of Woman's, or involving data from Woman's)."
Submit your project/study at womans.my.irbmanager.com. The most important document for submission is the protocol (and consent form if applicable), however other documents may also be required. Once you are logged into IRB Manager, the submission form will walk you through prompts to answer about your project/study and may request additional attachments, such as an Investigator Agreement if you have never done a study at Woman’s before.
Once submitted, your project/study will be routed to the R&D Committee for scientific merit, feasibility, and conflict of interest review. Once approved, it will then be automatically routed for IRB review.
Resources:
- IRB Manager Login
- Investigator Agreement
- Protocol Template
- Consent Form Template
- Department Approval Form
- Financial Interest Disclosure Form
Frequently Asked Questions:
Questions?
Contact the Research Department for questions or concerns.