Sabai Answers
What is Sabai?
Independent IRB and IBC review for clinical research.
Sabai is an independent ethical review and biosafety organization. It provides Institutional Review Board (IRB) review through Sabai IRB Services and Institutional Biosafety Committee (IBC) review through Sabai IBC Services. Founded in 2017, Sabai is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and is based in Raleigh, North Carolina.
This page answers the questions sponsors, contract research organizations (CROs), sites and institutions ask most often. Each answer links to the page with more detail.
About Sabai
6 questions
What is Sabai?#
Sabai is an independent ethical review and biosafety organization for clinical research. It was founded in 2017. It began by providing biosafety services and oversight for institutions. That work led Sabai into Institutional Review Board (IRB) review. Sabai was built to support cell and gene therapy, infectious disease, rare disease and oncology research. Today it supports sponsors and sites across all phases of research and all therapeutic areas. Read more about Sabai.
What services does Sabai offer?#
Sabai has two service lines. Sabai IRB Services provides ethical review of human subjects research. Sabai IBC Services provides centralized Institutional Biosafety Committee (IBC) review and support for local IBCs. Sabai does not bundle review with technology or other research services.
Who does Sabai work with?#
Sabai works with sponsors, CROs, institutions and sites, research foundations and investigators. Many Sabai team members began their careers at academic medical centers and research institutions. See who we serve.
Is Sabai accredited?#
Yes. Sabai IRB holds Full Accreditation from AAHRPP. Sabai is registered with the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) as an IRB organization. Its IORG number is IORG0012659 and its IRB registration number is IRB00014968. Sabai runs internal quality assurance reviews twice a year and is audited by third parties. See Sabai compliance.
Where is Sabai located?#
Sabai's headquarters is at 421 Fayetteville Street, Suite 1100, Raleigh, North Carolina 27601. Before you send anything by mail, check the current Sabai mailing address. The main phone line is 1-888-442-2472.
Who leads Sabai?#
Sabai's executive team is Mike Keens, Chief Executive Officer; Dawn Pope, Chief Operating Officer; Chris Jenkins, Founder and Chief Scientific Officer; Melanie Gill, Chief Commercial Officer; and Austin Read, Chief Financial Officer. Service leaders include Melissa Fink, Senior Director, IRB and Jessica Poole, Director, IBC. Meet the Sabai team.
Independence and how Sabai compares
5 questions
What makes Sabai different from other IRBs?#
Independence. Many of the largest IRBs now sell site selection, feasibility, participant recruitment, technology integration or research staffing. Sabai does not. Its only business is ethical and regulatory review. Sabai's commitment is "100% Independent. 100% Ethical. 100% focused on IRB and IBC Review." Read about Sabai's zero conflicts of interest commitment.
Does Sabai have conflicts of interest?#
No. Sabai has zero conflicts of interest. Its review decisions are based on science, ethics and compliance. They are not based on business relationships. Sponsors, investigators and regulators can rely on reviews conducted without outside influence. See zero conflicts of interest.
Why does IRB independence matter?#
A conflict of interest can arise when an IRB is owned by or affiliated with a company that sells other research services. Federal regulations and accrediting bodies expect IRBs to operate free from conflicts of interest. ICH E6(R2) and E6(R3) Good Clinical Practice (GCP) guidance reinforces the need for independent IRB oversight. Participants may also find it harder to trust an IRB when the same company profits from other parts of the trial. Read why conflicts of interest belong in plain sight.
Does Sabai offer site selection, patient recruitment or staffing?#
No. Sabai does not offer site selection, feasibility, patient recruitment, research staffing or technology integration. Sabai provides IRB review and IBC review. That focus keeps its review independent. Sabai IRB does review recruitment materials. See IRB considerations for patient recruitment.
Is Sabai a CRO?#
No. Sabai is an independent ethical review and biosafety organization. CROs are among the clients Sabai serves. Sabai's process is designed to meet CRO quality management system requirements. See how Sabai works with CROs.
Sabai IRB Services
8 questions
What studies does Sabai IRB review?#
Sabai IRB reviews multisite and single site studies across pharmaceutical, device and human factors, biotech, social behavioral, natural history, registry and investigator-initiated research. It also reviews single patient expanded access (compassionate use) requests. See Sabai IRB Services.
What types of IRB review does Sabai provide?#
Sabai provides exempt determinations, initial review, continuing review and ongoing review. Ongoing review covers amendments and safety reporting. Sabai also determines whether an activity is research that needs IRB review. Guidance on exempt categories and expedited review is on the IRB guidance page.
What is the difference between expedited and full board review?#
Expedited review applies to minimal risk research that fits categories set by federal regulations. The IRB chair or an experienced member designated by the chair conducts it. Full board review takes place at a convened IRB meeting with a quorum present. It applies to research that does not qualify for exempt or expedited review. Read expedited vs full board review.
Can Sabai serve as the single IRB for a multisite study?#
Yes. Sabai reviews multisite studies. The sponsor or CRO submits a multisite initial protocol application. Each site then joins the approved protocol through a site application. Read the role of a single IRB in multisite research and find the application guides on Sabai IRB resources.
Does Sabai help with informed consent forms?#
Yes. Sabai offers informed consent form (ICF) pre-review, consultation and development. It also offers translation services. Sabai publishes short form consents and the California Experimental Subject's Bill of Rights in 15 languages, each with a certificate of translation. See short form consents and read the role of informed consent in ethical clinical trials.
Which regulations does Sabai IRB follow?#
Sabai IRB operates under 45 CFR 46 (the Common Rule), 21 CFR Parts 50 and 56, the National Institutes of Health (NIH) Guidelines and ICH E6 GCP as applicable. Its review also follows the Belmont Report and local and state laws. Read exploring ethical standards in clinical research and Good Clinical Practice basics.
Does IRB oversight stop after approval?#
No. After approval the IRB reviews amendments, reportable events and continuing review until the study closes. Sites report events through the reportable events form in MySabai. See the reportable events guide, read why IRB oversight does not stop after approval and read about protocol deviations.
Does Sabai review single patient expanded access requests?#
Yes. Sabai reviews single patient expanded access, also called compassionate use. Submit a single patient expanded access application through MySabai. The resource guide is on the IRB guidance page.
Sabai IBC Services
7 questions
What is an Institutional Biosafety Committee?#
An Institutional Biosafety Committee (IBC) reviews research involving recombinant or synthetic nucleic acid molecules. The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules set out its role. In clinical research, IBCs review human gene transfer (HGT) trials such as gene and cell therapy studies. Read IBC basics.
When does a clinical trial need IBC review?#
The NIH Guidelines require IBC review when the investigational product contains recombinant or synthetic nucleic acids that meet Section III-C criteria and one of these applies. The trial is at an institution that receives NIH funding for this type of research. The trial is sponsored by such an institution. Or the product was developed with NIH funds and the developing institution sponsors or takes part in the trial. See NIH Guidelines and clinical trials.
What does Sabai IBC Services provide?#
Sabai IBC Services can act as a centralized IBC. It can also work with an institution to create an additional HGT-specific IBC. Support covers IBC setup, NIH registration, administration and staffing. Sabai coordinates concurrent IBC and IRB reviews for participating sites and supports IBC review outside the United States. See Sabai IBC Services.
What is IBC Concierge?#
IBC Concierge speeds study startup by managing submission to and approval by a site's local IBC. It serves study teams, CROs and sponsors. Each submission includes a customized supplemental risk assessment. Sabai identifies the people responsible for submission, works with key personnel on IBC requirements and stays in contact through review. See IBC Concierge.
What is IBC Concierge Plus?#
IBC Concierge Plus adds continuing review support for the life of the trial. That includes annual or periodic IBC review under the institution's charter. It also includes updated risk assessments when sponsor documents change, such as the protocol, Investigator's Brochure or pharmacy manual. See Sabai IBC Services.
What does a site need for IBC review?#
Sabai publishes IBC site requirements, the documents required for IBC review and the documents required for annual review. The biosafety levels guide and the initial study cycle guide explain what to expect. All are on Sabai IBC resources.
How are biosafety incidents reported?#
Sites follow Sabai's incident reporting guidelines. Sabai also publishes guidance on HGT hazards for clinical staff and on closing out IBC oversight. Federal agency resources from the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA) and NIH are linked on IBC external resources.
Working with Sabai
6 questions
How do I submit a study to Sabai IRB?#
Submit through the MySabai IRB Portal. Applications include exempt, single site, multisite initial protocol, site and single patient expanded access. Each has a step-by-step guide on Sabai IRB resources. New to the portal? Start with MySabai IRB portal access.
What is MySabai?#
MySabai is Sabai's online portal for IRB and IBC submissions. You can submit documents at any time, track a submission through review and copy past submissions to save time. You can also retrieve approval letters and download documents as a zip file. See IRB portal access and IBC portal access.
What human research protections training do investigators need?#
Principal investigators and research team members need human research protections training completed within the past four years. Sabai offers Collaborative Institutional Training Initiative (CITI Program) IRB Basic and Refresher training at no cost when you register through Sabai. Sabai also accepts several other options, including GCP training and training or certification from the Drug Information Association (DIA), the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA). See investigator training.
Does Sabai accept SMART IRB reliance?#
Yes. Sabai IRB is part of the SMART IRB reliance initiative. Institutions can use the SMART IRB Letter of Acknowledgement or Sabai's reliance agreement template. Sabai will also review an institution's own agreement when needed. See resources for institutions.
When does the Sabai IRB meet?#
Sabai publishes its IRB meeting calendar on the Sabai IRB Services page. Check the calendar when you plan submissions that need full board review.
How do I contact Sabai?#
New clients can reach the team through contact Sabai. Existing clients can use client services or email ClientServices@sabaiglobal.com. The main phone line is 1-888-442-2472.
Sabai IRB merger and legacy names
5 questions
What happened to Castle IRB and Alpha IRB?#
Castle IRB and Alpha IRB merged into Sabai IRB in February 2026. Sabai IRB operates under the legal name Sabai, LLC. Most existing contracts transferred to Sabai through a notice of assignment. Continuing review anniversary dates did not change. See Sabai IRB merger.
Does the merger require a new Form FDA 1572 or reconsent?#
No. A new Form FDA 1572 is not required for this administrative change. Participants do not need to reconsent because of the name change alone. Existing ICFs keep the legacy IRB name until the next submission that changes the ICF. See Sabai IRB merger.
What are Sabai IRB's registration numbers?#
Sabai IRB is IORG0012659 and IRB00014968. Legacy Alpha IRB was IORG0005158 and IRB00006205. Legacy Castle IRB was IORG0010151 and IRB00012054. As an independent IRB, Sabai does not hold a Federalwide Assurance (FWA). See Sabai compliance.
Do I need to update my institution's FWA?#
Only if the legacy IRB was the sole IRB on your FWA or reviewed the largest share of your institution's research. Otherwise no update is needed. Sponsors can report the change through an Investigational New Drug (IND) information amendment or an Investigational Device Exemption (IDE) annual report or supplement. See Sabai IRB merger.
Why do older records show other company names?#
Sabai grew by acquisition. Older records may show legacy names such as CBS, Castle IRB or Alpha IRB. These brands are now part of Sabai. Read more about Sabai.
For research participants
3 questions
I am in a study reviewed by Sabai. When should I call?#
Call Sabai at 1-888-442-2472 if you have a problem the study team could not solve, if you are concerned about your experience in the study or if you do not understand something about research. You can also email info@sabaiglobal.com. See information for research participants.
How do I report a concern about Sabai?#
Anyone with a concern about Sabai's conduct can call 888-442-2472. You can also use the compliance hotline or call toll free at 833-370-0002 (English) or 800-216-1288 (Spanish).
Can I serve on an IRB?#
Sabai welcomes community members who want to help review research studies. Call 1-888-442-2472 to learn more. See information for research participants.
Independent review for your next study
Sabai is 100% Independent. 100% Ethical. 100% focused on IRB and IBC Review.
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