Need Additional Information? If you need additional information on our services or would like to schedule a consultation, please complete the following information.
How quickly can we conduct a review?
Screening of your application will take place within 24 hours (business days) of submission of a complete* application. You will receive notification of the determination of the level of risk and any additional documentation needed. If the study is determined to be more than minimal risk, we will schedule a review by the full IRB within 48 hours. NOTE – review does not mean approval. Revisions may be required to ensure participant protection.
*For details on a complete application please see “What forms do I need to submit with the study”.
What types of studies do we review?
Solutions IRB reviews a wide range of studies including Phase I-IV biomedical, single and multi-site studies, medical devices, social-behavioral studies, educational evaluations, humanitarian use devices, nutraceuticals, and NIH\federally funded and Department of Defense funded studies. We also provide human subjects protections consultations and protocol writing assistance.
How do I submit a study for IRB review?
What are the costs associated with a review?
The costs associated with a review depend on the level of review required. Please refer to: Fees page.
How often does the full committee meet?
Solutions IRB has rapid turnaround times. Most often we begin your review immediately but promise 24 business hours upon receipt. Once our initial review is completed we notify you of any missing documentation or discrepancies. Once all required documentation is received, most exempt and expedited studies require 24 hours for completion. For full board studies, once all required documentation is received most full board reviews occur within 72 business hours. NOTE – review does not mean approval. Revisions may be required to ensure study participant protection.
What are the deadlines for submission?
There are no standard deadlines for initial submissions. We will complete the initial review of your study within 24 hours of submission
What forms do I need to submit with the study?
The forms you need to submit for IRB review depends on the study. The forms needed are based on the recruitment, level of risk, presence of a vulnerable population, type of intervention data collection strategies and data source. Some of the general documents we would need in the formal submission are:
- Completed application form – available once logged into the Axiom Mentor IRB system. 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 firstname.lastname@example.org.”
- 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.
- https://phrptraining.com/#!/ 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-MemberThis 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.
Do you have example forms?
Yes! You can download all of our Forms.
I need an FWA, what is it?
The FWA is assigned by OHRP to the institution conducting the research, not the IRB. The last time one of our clients applied for the FWA the number was assigned very quickly (within minutes). You can apply for a FWA at http://ohrp.cit.nih.gov/efile/FwaStart.aspx The instructions for completion of the form can be found here: http://www.hhs.gov/ohrp/assurances/forms/fwainstructions.html
When you complete the form, you will designate Solutions IRB as the IRB (item 6 of the form). Our IRB registration number is 00008523, and our IORG # is IORG0007116.
There is also another form some grants require. This is the IRB Authorization Agreement. You will need the FWA number prior to completing the Authorization Agreement. The template for the agreement is located here: http://www.hhs.gov/ohrp/assurances/forms/iprotsup.rtf.