IRB Submission Instructions
Please review the following instructions before preparing a study for submission:
You can download this basic document checklist to assist in the required documentation for review.
The following is required for all study submissions:
- Completed application form – available once logged into the Axiom Mentor IRB system, instructions are attached. Note – all sections of the application must be completed. Do not reference sections of the protocol in response to a question. You must answer each question independently.
- Full Protocol or a summary of the study. This does not have to be lengthy and does not replace the IRB application.
- Consent documents (if applicable)
- Must have Solutions IRB contact information. A sample narrative frequently-used would be, “If you have any questions regarding your rights as a participant in the study, you may contact Solutions IRB (the body that oversees our protection of study participants) at (855) 226-4472 or email@example.com”
- How the participant can leave or withdraw from the research study. For example, “Email or call the CO-investigator or PI”. (both email and phone number are required). If at any point the participant can no longer withdraw, please provide the deadline for subject withdrawal and an explanation of why they will no longer be able to withdraw from the study. Such situations include but are not limited to, data becoming de-identified or after data analysis has begun.
- When appropriate (not required for all research) add to the informed consent the participant will be informed of new findings if developed during the research, which may relate to the participant’s willingness to continue in the research.
- The informed consent, you must explain the expected duration of the subject’s participation.
- When appropriate provide a statement that researchers retain the right to terminate subject participation without regard to participant consent at any time from the study should it be deemed necessary.
- Inclusion\exclusion criteria should be included in the consent form for all clinical\medical studies.
- Include a phone number and email contact information for the PI.
- Recruitment materials, including flyers, letters, brochures, or scripts if applicable.
- Documentation of human research protection training for all study personnel, completed within the past 3 years.
This is the one through the NIH. I believe this one takes approximately 3 hours and costs around $40.
Title: Ethics and Human Subjects Protection: A Comprehensive Introduction – No Contact Hours – Non-Member
This one takes approximately 2 hours to complete but is free. Please note that when you sign up for this one it takes a few minutes to show up within your profile and if you have trouble getting the certificate at the end the most likely culprit is a missing answered question within the survey.
- A CV (resume) for all personnel.
- For clinical studies, HIPAA training certificates are required for all personnel. You can obtain this by going to https://gcp.nidatraining.org/. This good clinical practice training covers the HIPAA training requirements, takes approximately 6 hours to complete, and is free to take.
- If there are data collection instruments, a copy of the data collection instruments, including but not limited to surveys and interview questions.
- If grant-funded, a copy of the grant is required.
- If there are non-English speaking participants, documents for the participants in all required languages. Documents include, but are not limited to consent forms, study questionnaires, and recruitment materials.
- If the study is Sponsored research the attached attestation must be completed. This does not include grant-funded studies.
- For medical devices, if your study involves a non-significant risk device a letter of determination by the Sponsor and/or Principle Investigator must be provided stating this determination. This determination must be stated and determined per FDA guidelines.
- For drug\supplement studies, an IND exemption letter of determination by the FDA OR Sponsor and/or the Principle Investigator must be provided stating this determination. This determination must be stated and determined per FDA guidelines.
You can submit the study in our online system, Axiom-Mentor Institutional Review Board Protocol Management system. Axiom Mentor is an online 24/7 submission system. To create an account contact us at firstname.lastname@example.org to set up an account. Our office hours are Monday-Friday 8 AM to 5 PM MST.
After submission, you can access your study, submit continuing reviews, amendments, modifications, adverse events or protocol deviations at https://www.axiommentor.com/login/axlogin.cfm?i=solutionsirb