Clinical Research Standards
These standards define how our clinical research is conducted and how research participants are protected at every stage. Our work is governed by established federal guidelines, ethical research frameworks, and regulatory oversight to ensure safety, transparency, and scientific integrity.
CITI-Certified Investigators
All investigators involved in our research are certified through the Collaborative Institutional Training Initiative (CITI). This certification is required for individuals conducting research involving human subjects in the United States.
CITI training ensures that investigators are properly educated in:
• Human subjects protection
• Research ethics
• Informed consent requirements
• Participant safety and data integrity
This certification confirms that our research team is qualified to conduct clinical research involving human participants in a legal, ethical, and responsible manner.
FDA Good Clinical Practice (GCP)–Aligned
All research is conducted in alignment with FDA Good Clinical Practice (GCP) standards. GCP is an internationally recognized framework that governs how clinical research is designed, conducted, monitored, and documented.
GCP alignment ensures that:
• Research participants are protected
• Study protocols are followed consistently
• Safety events are monitored and addressed appropriately
• Research data are accurate, reliable, and verifiable
These standards exist to safeguard participants and to ensure that research findings are credible and responsibly generated.
FDA Investigational New Drug (IND) Oversight
Where required, research is conducted under FDA Investigational New Drug (IND) oversight. An IND is the regulatory framework that allows investigational biologic products to be studied in human subjects under defined conditions.
Under IND oversight:
• Investigational products meet FDA requirements for manufacturing controls
• Product handling and administration follow approved protocol conditions
• Safety monitoring and adverse event reporting comply with FDA regulations
• Clinical research is conducted under defined regulatory supervision
The Institute does not manufacture, market, or sell investigational products. All products used in research are manufactured by FDA-registered laboratories and are utilized solely within approved clinical research protocols.
Depending on the study, IND authorization may be held by the Institute or by the FDA-registered manufacturing entity supplying the investigational product. In all cases, the IND governs the approved protocol and provides regulatory oversight of investigational use.
IRB-Approved Clinical Research Only
All research is reviewed and approved by an Institutional Review Board (IRB), an independent committee responsible for protecting the rights, safety, and welfare of research participants.
IRB oversight includes:
• Review and approval of study protocols before research begins
• Evaluation of potential risks and participant safeguards
• Verification that informed consent is clear, complete, and appropriate
• Ongoing monitoring of research activities throughout the study
No research begins, is modified, or continues without IRB approval.
Research — Not Treatment
The Institute conducts clinical research only. Investigational approaches referenced on this page are not FDA-approved and are used solely within approved research protocols.
Participation in research is voluntary, and studies are designed to collect data — not to provide approved medical treatment.
The Institute does not market or represent investigational products as approved therapies.
Commitment to Compliance
Our commitment to FDA compliance ensures that all research activities are conducted responsibly, ethically, and in accordance with applicable regulations. Through strict adherence to federal guidelines and oversight processes, we prioritize participant safety, scientific integrity, and transparency in all aspects of our work.