SCIENTIFIC & REGULATORY ARCHITECTURE
PILLAR (d) & PILLAR (e) RESEARCH GOVERNANCE
VALOR FOUNDATION INC. is organized and operated for charitable, educational, and scientific purposes within the meaning of IRC § 501(c)(3). Our Articles of Incorporation establish strict statutory and clinical guardrails separating educational programming from IRB-regulated clinical research.
PILLAR (d) • INSTITUTIONAL RESEARCH COLLABORATION
IRB-Approved Studies, SBIR, VA & NIH Collaborations
Under Program Pillar `(d)`, Valor Foundation supports and collaborates with academic medical centers, independent research institutes, Small Business Innovation Research (SBIR) grant investigators, the U.S. Department of Veterans Affairs (VA), and the National Institutes of Health (NIH).
- IRB Protocol Review: Every collaborative clinical study requires prior review and ongoing oversight by a duly constituted Institutional Review Board (IRB).
- Ethical Veteran Study Recruitment: Facilitating voluntary, non-coercive recruitment of OIF/OEF and post-9/11 veterans into approved clinical trials investigating TBI, burn-pit pulmonary disease, HPA-axis dysfunction, and metabolic restoration.
- Public-Benefit Scientific Dissemination: Publishing aggregate, de-identified findings in the public interest in accordance with IRS Revenue Ruling 76-296 scientific organization standards.
PILLAR (e) • INVESTIGATIONAL HEALTH OPTIMIZATION RESEARCH
45 CFR Part 46 & 21 CFR Parts 50 & 56 Protections
Under Program Pillar `(e)`, Valor Foundation facilitates voluntary veteran participation in structured investigational health optimization research examining peptides, hormonal optimization, and targeted nutritional supplementation.
- Licensed Clinical Oversight: All medical evaluations, laboratory interpretations, and investigational or prescription protocols are ordered and supervised exclusively by appropriately licensed clinicians.
- 45 CFR Part 46 (The Federal Common Rule): Full adherence to federal regulations for the Protection of Human Subjects, including risk minimization, equitable selection, and independent IRB oversight.
- 21 CFR Parts 50 & 56 (FDA Human Subjects & IRBs): Documented written informed consent (`21 CFR Part 50`) and continuous Institutional Review Board supervision (`21 CFR Part 56`) for any FDA-regulated clinical investigation.
MANDATORY DISTINCTION — NO COMMERCIAL PRODUCT SALES OR UNAPPROVED DRUG CLAIMS: Valor Foundation Inc. (`1947 A1A S, Suite B, Saint Augustine, FL 32080`) does not manufacture, compound, distribute, or sell commercial peptides, research chemicals, pharmaceuticals, or dietary supplements on this website. Discussions of peptides, hormonal optimization, or nutritional compounds under Pillar `(e)` refer strictly to clinically supervised, IRB-governed research participation and evidence-tier education—never a promise of treatment, cure, or commercial sale.
