DSCKTN Tribal Food and Drug Authority & Institutional Review

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The Deep South Keetoowah Cherokee Tribal Nations Tribal FDA is a sovereign regulatory authority established under Tribal jurisdiction to provide ethical oversight, structured review, and governance for research, integrative health initiatives, and product development operating within its framework. Ultimately, a Tribal FDA regulates research governance within its sovereign or private framework. 

Rooted in the inherent sovereignty of the Tribe, the Tribal FDA was revised in 2020 to ensure that research conducted under its authority upholds the highest standards of participant protection, ethical integrity, and cultural respect. The Authority oversees Principal Investigator certification, protocol review, product research evaluation, and compliance monitoring for affiliated research centers and investigators.

The Tribal FDA integrates scientific methodology with interfaith and spiritual sciences principles, recognizing the importance of dignity, cultural sensitivity, and traditional medicine and holistic care within research environments. Its review process emphasizes informed consent, data integrity, risk assessment, and ongoing compliance.

As a living regulatory framework, the Tribal FDA continues to evolve to reflect best practices, responsible innovation, and improvements in research governance. Through structured oversight and sovereign stewardship, it seeks to advance ethical research while preserving the mission, values, and traditions of the Deep South Keetoowah Cherokee Tribal Nations.

The Deep South Keetoowah Cherokee Tribal Nations TFDA and its tribal nation partners, maintains a structured and ethical review process to ensure research integrity, participant protection, and mission alignment.

Applicants seeking recognition as a Principal Investigator or research center must submit a formal application including academic credentials, research experience, ethical training certifications, and a statement of research intent.

The DSCKTN TFDA Regulatory Council and Medical Board conducts a comprehensive review of submitted materials, verifying education, training, and ethical qualifications. Background and conflict-of-interest disclosures are evaluated at this stage.

All proposed research protocols are reviewed for:

• Participant safety
   
• Informed consent clarity
   
• Scientific rationale
   
• Ethical integrity
   
• Data protection safeguards
   

Protocols may receive full approval, conditional approval, or require revisions prior to authorization.

Approved investigators may enter a provisional period during which compliance monitoring and documentation review occur to ensure adherence to TFDA standards.

Upon successful completion of the provisional phase, the investigator or research center is formally recognized and listed within the TFDA registry.