Frequently Asked Questions

How long will it take to gain IRB approval?

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.

Does Solutions IRB review international studies

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.

What personnel documents do I need to include with my submission?

-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 de-identified. -HIPAA training certificate if a clinical study

What documentation should be included with my submission?

-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.

Who should be the PI listed on the study?

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

Who should be listed on my 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.

Does my study need IRB approval?

While clinical studies typically require IRB review, it might not be as clear for a social- behavioral study. The following checklist of questions can assist a researcher in deciding whether or not an IRB review might be appropriate. -Is the ultimate goal to publish the study findings? If the answer to this question is ‘Yes’, the researcher should consider obtaining IRB approval prior to beginning the study. Most peer-reviewed journals require that the study complies with ethical research guidelines. Obtaining IRB approval ensures this requirement is met. -Does the funding source require IRB approval? Many grants and sponsor-based sources will require as a condition of funding that the study be approved by an IRB. Researchers should check the funding agreement to determine whether or not this is a requirement. -Does the research involve human subjects? If direct interaction will occur between the researchers and human subjects, it should be assumed IRB review and approval will be required. Federal guidelines dictate specific protocols that must be followed when research involves human subjects. An IRB is the body designated by Federal guidelines to review study protocols to ensure the ethical rights of human subjects are protected. -Does the study involve a program evaluation? The answer to this question is dependent upon various factors. If the program evaluation is being conducted solely for internal quality assurance, an IRB review is not required. However, if the program evaluation is a requirement of the funding source or needed to substantiate to external sources the on-going existence of the program, an IRB review is required. -Does research involving secondary data analysis require IRB approval? Again, the answer is dependent upon various factors. In situations where the secondary data has been completely de-identified prior to receipt by the researchers, IRB approval may not be required. However, the researcher(s) might want to obtain an Exempt or Expedited category approval if the findings will be published. If the researcher(s) will be de-identifying the data after it is received from the original source, the study should be reviewed by an IRB.

What are the areas of expertise of Solutions IRB board and reviewers?

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.

Once I gain approval, do I continue to have a relationship with the IRB?

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.

What should be reported to the IRB?

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.