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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?
The types of clinical studies we accept is dependent upon the expertise of our board. Solutions IRB does not provide review of animal research. Please feel free to have us conduct a free no obligation pre-review on your study and we will be happy to advise if we can accept the study. You may email us your protocol or our completed IRB application form (download from the “forms” area) for our no obligation pre-review and we will be happy to let you know if your clinical study is within our expertise to review.
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: Services and prices page.
How often does the full committee meet?
Unlike other commercial and private IRBs we understand independent researchers need a quick review. The full committee of Solutions IRB is available to meet within 48 hours after the initial screening and submission of appropriate documentation. The initial screening will determine the level of risk and any additional supporting documents needed for the full IRB to review the study.
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:
- Protocol or summary of the study (this does not have to be lengthy)
- Consent documents (if applicable)
- The consent forms must have Solutions IRB contact information. i.e. 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.
- Add to the informed consent how the participant can leave or withdraw from the research study. Ex: email the CO-investigator or PI, call the CO-investigator or PI, etc.. If at any point the participant can no longer withdraw (i.e. data becomes de-identified) please provide the dates the subject can no longer withdraw with an explanation of why they will no longer be able to withdraw.
- Add to the informed consent that: The participant will be informed of new findings if developed during the course of the research, which may relate to the participant’s willingness to continue in the research.
- In your informed consent you must provide an explanation of the expected duration of the subject’s participation.
- Provide a statement that researchers retain the right to terminate subject participation without regard to participant consent any time from the study should it be deemed necessary.
- Recruitment materials (flyers, letters, brochures or scripts if applicable)
- Documentation of human research protection training for all study personnel that has been completed within the past 4 years.
- CV(resume) for Principle Investigators, Co-Principle Investigators, and Research Coordinators. (Any key personnel)
- A copy of the data collection instruments (survey, interview questions, etc.)
- Completed application form – an online version is available once you log into the system or has been attached as well. Note – all sections of the application must be completed. Place NA in those areas which are not applicable. The benefits and risks sections cannot contain NA. Do not reference to sections of the protocol instead of completing sections.
- A copy of the grant if the project is DHHS grant funded
- If there are non-English speaking participants please provide documents for the participants in all required languages i.e. consent forms, questionnaires, etc.
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.