/**
 * Common Rule (45 CFR 46) Compliance Pack
 *
 * HHS Protection of Human Subjects regulations (45 CFR Part 46).
 * 2018 Revised Common Rule effective January 21, 2019. Subparts:
 *   A: Basic HHS Policy (all federally funded research on human subjects).
 *   B: Additional protections for pregnant women, human fetuses, neonates
 *      (45 CFR 46.201-207).
 *   C: Additional protections for prisoners (45 CFR 46.301-306).
 *   D: Additional protections for children (45 CFR 46.401-409).
 *
 * NIH overlay: NIH Grants Policy Statement Section 3.1; NIH Single IRB
 * Policy (effective January 25, 2018); NIH 2023 Data Management and
 * Sharing Policy (intersects when research data is shared -- see NIH
 * DMS pack).
 *
 * AI systems that process, analyze, summarize, or generate outputs
 * from identifiable human subjects research data operate as instruments
 * of research and are subject to Common Rule through the covered
 * institution's Federalwide Assurance (FWA).
 *
 * Key obligations for AI systems:
 *
 *   - 45 CFR 46.109: IRB review and approval required before research
 *     commences. AI systems used in research must be within scope of
 *     an approved IRB protocol.
 *   - 45 CFR 46.116: Informed consent required from each subject or
 *     legally authorized representative. AI must not process subject
 *     data without evidence that consent was obtained.
 *   - 45 CFR 46.116(b)(8): Right to withdraw consent without penalty.
 *     Data from withdrawn-consent subjects must not be processed by AI.
 *   - 45 CFR 46.116(d): Broad consent option for secondary research.
 *     AI use of broad-consent data requires scope confirmation.
 *   - 45 CFR 46.408 (Subpart D): Parental permission + child assent
 *     for pediatric research. Dual gate required.
 *   - 45 CFR 46.305 (Subpart C): Prisoner research requires IRB
 *     Prisoner Advocate review. Restricted permissible categories.
 *   - 42 USC 241(d); NOT-OD-17-109: NIH Certificate of Confidentiality
 *     prohibits disclosure of identifiable research data in any
 *     federal, state, or local proceeding. AI vendors receiving CoC-
 *     protected data must acknowledge this obligation.
 *   - 45 CFR 46.116; HHS DUA guidance (2004): Data use agreements
 *     required for sharing limited datasets with AI vendors.
 *   - 45 CFR 46.115(b): IRB and consent records retained 3 years
 *     after research ends; NIH may require longer per grant terms
 *     (citation to verify current NIH GPS section).
 *
 * Cross-pack interactions:
 *   - Common Rule + HIPAA: When research data contains PHI, both
 *     packs are active. HIPAA Privacy Rule 45 CFR 164.512(i) provides
 *     a research exception requiring authorization or IRB waiver.
 *     Common Rule IRB approval does not automatically satisfy HIPAA
 *     authorization. Both packs run; HIPAA governs breach notification
 *     clock; Common Rule governs OHRP reporting.
 *   - Common Rule + FERPA: Student records in education research are
 *     simultaneously FERPA-protected and potentially Common Rule-
 *     covered. FERPA 34 CFR 99.35 requires DUA; Common Rule requires
 *     IRB approval. More restrictive controls apply; cross-check DUA.
 *   - Common Rule + NIH DMS: Research data from Common Rule studies
 *     subject to 2023 NIH Data Management and Sharing Policy. Both
 *     packs active for NIH-funded human subjects research. Common Rule
 *     consent terms determine whether AI can access data for DMS-
 *     required sharing. Consent scope limits override DMS obligations.
 *   - Common Rule + COPPA: Pediatric research subjects covered by
 *     both Subpart D (parental permission) and COPPA (parental consent
 *     for online collection). Both packs must be active. In combination
 *     with HIPAA on pediatric clinical research, triggers
 *     TRIPLE_COVERAGE_ALERT.
 *
 * UF Health exposure: Loss of NIH funding (historically exceeding
 * $200M annually at UF; citation to verify current year total) is
 * the primary institutional risk. Even a temporary restriction during
 * OHRP investigation would constitute existential risk.
 *
 * Sovereignty: US Federal (HHS/NIH). FWA-covered institutions are
 * subject to Common Rule regardless of funding source for activities
 * covered by the assurance.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * Common Rule category classifiers for the pack-driven classifier (W1).
 */
export declare const COMMON_RULE_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const COMMON_RULE_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
//# sourceMappingURL=common-rule.d.ts.map