FAQs

Exempt, Expedited, Full Board, and International Expedited studies- Our turnaround time is 24 to 48 hours once the entire study package and has been submitted. We first conduct a pre-review to ensure all documents are present, complete, and acceptable. The pre-review is completed within 24-48 hours and many times sooner. Once the pre-review is complete the reviewer will review your study withing 24-48 hours. We adhere to strict reviewer turnaround times and often the timeline will depend on how quickly the PI submits requested revisions. Board meetings are scheduled for your full board study once the study has been fully vetted by the primary and secondary reviewer and all revisions have been completed.

Yes! We have years of experience reviewing international studies. When you create the application in the online system, you can select the option for international research and specific application questions will appear for you to answer.

Begin by reaching out to our administrative team at correspondence@solutionsirb.com for study submission instructions. For more detailed information, please click here!

• Resume for each person listed on the study
• Copy of medical license for those who hold a medical degree
• Human subjects training certificate completed within the last three years should also be provided for all PI’s, Co-PIs and any persons that will be working with human subjects or human subject’s data that has not been deidentified.
• HIPAA training certificate if a clinical study

• Full protocol
• Consent forms
• Recruitment materials, including flyers, letters, brochures, or scripts if applicable
• Data collection instruments including surveys, interview questions or focus group scripts
• Copy of the grant or funding contract
• If there are non-English speaking participants, documents for the participants in all required languages must be included. Documents include, but are not limited to consent forms, study questionnaires, and recruitment materials. A translation attestation or translation certificate must also be provided
• 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.

The PI is the person who takes full responsibility of the study. The PI must be qualified to conduct the study.

Those who will be having contact with participants or identifiable data should be listed on the study, as well as anyone who will be named on any publications. 

The IRB’s involvement with the researcher depends on the study’s level of review. Exempt studies are not required to have annual check-ins, but are able to come back to the IRB for any changes that need to be made or if guidance is needed. Expedited, Full Board and International studies require annual check-ins that include a report updating the IRB on what happened with the study over the year. The IRB is also there for any changes that need to be made to the study.

• Amendments 
  • Changes in research activities must be reported to the IRB for review and approval prior to implementation,
• Annual Check-Ins 
  • All expedited, international and full board studies are subject to continuing review. This happens annually after the approval date until the closure of the study for all expedited studies. The same is true for full board studies, unless it is voted on by the board to have a more frequent check-in.
• Adverse Events
  • Investigators are required to report any adverse events that involve human subjects enrolled in the study that are determined to be unexpected and probably, possibly, or definitely related to the test article or research procedures
• Protocol Deviations 
  • Investigators must notify the IRB of any unapproved protocol deviations (accidental or unintentional change to the protocol approved by the IRB) that could potentially cause harm to participants and others within 2 weeks of discovering the deviation.
• Unanticipated Problems
  • Any incident, experience or outcome that is unexpected, related or possibly related to participation in the research, and suggests that the research places participants at a greater risk of harm than was previously known.
• Final Reports/Closures
  • If each of the below is true a study can be closed by submitting the proper report
    • The research is permanently closed to enrollment
    • All subjects have completed all research-related interventions.
    • Collection of private identifiable information is complete.
    • Analysis of private identifiable information is completed.
• Participant Complaints
  • Must be submitted if the it meets any of the following
    • The complaint is an unanticipated problem
    • The complaint involves possible non-compliance or research misconduct
    • The investigator is unable to resolve the complaint satisfactorily with the research participant in a timely manner.
    • If the investigator and research team were able to resolve the complaint formally it can be reported to the IRB at time of continuing review.

Solutions IRB, LLC is a private commercial AAHRPP fully accredited Institutional Review Board. We are a team of experienced reviewers readily supporting researchers with IRB services including the review of all levels of studies including Exempt, Expedited, Full Board and International, minimal and greater than minimal risk studies. We are committed to protecting research participants (including vulnerable populations), monitoring approved protocols and providing outstanding IRB services to researchers. Our team provides quality and timely IRB review for all levels and all types of studies including clinical trials, social-behavioral, medical device, non-significant risk and non-investigational new drug studies.

Please check out our checklist on “Defining Research for IRB Review” to help you understand if IRB review is needed for your specific study. If you’d like to schedule a time to discuss your study with our administrative team to hear their professional opinion please check here!