/**
 * FDA 21 CFR Part 56 (IRB Regulations) Compliance Pack
 *
 * 21 CFR Part 56 -- Institutional Review Boards.
 * FDA authority (not OHRP) for IRBs reviewing FDA-regulated research
 * under the Federal Food, Drug, and Cosmetic Act and the Public Health
 * Service Act. Parallel framework to 45 CFR 46 (Common Rule) but
 * distinct legal authority, distinct enforcement body, and distinct
 * regulatory scope.
 *
 * Scope: Any clinical investigation regulated by FDA under:
 *   - 21 CFR Part 50  (protection of human subjects -- informed consent)
 *   - 21 CFR Part 312 (IND -- drugs / biologics)
 *   - 21 CFR Part 812 (IDE -- devices)
 *   - 21 CFR Part 820 (QMSR -- SaMD quality management)
 *
 * Key subparts:
 *   Subpart A -- General provisions (purpose, applicability, definitions)
 *   Subpart B -- Organization and personnel (56.107 composition requirements)
 *   Subpart C -- IRB functions and operations (56.108-56.110)
 *   Subpart D -- Records and reports (56.115)
 *   Subpart E -- Administrative actions (56.120-56.124)
 *
 * Distinction from Common Rule (45 CFR 46):
 *   - Authority: FDA (FD&C Act / PHS Act) vs HHS/OHRP (45 CFR 46)
 *   - Scope: FDA-regulated clinical investigations vs federally-funded research
 *   - Enforcement: FDA Office of Good Clinical Practice (OGCP) vs OHRP
 *   - Reporting: FDA district offices + OGCP vs OHRP
 *   - Both packs may be active simultaneously for dual-covered research
 *     (e.g., NIH-funded IND study). In that case, more restrictive control
 *     applies per each dimension.
 *
 * Out of scope here:
 *   - 21 CFR Part 50 (informed consent) -- separate future pack
 *   - 21 CFR Part 11 (electronic records) -- see part11.ts pack
 *   - 21 CFR Part 820 (QMSR) -- see fda-samd.ts pack
 *
 * Key obligations for AI systems:
 *   - AI tools used in FDA-regulated clinical investigations must be
 *     documented in the IRB-approved protocol.
 *   - IRB review is required for any change in protocol affecting AI
 *     tools used in data collection or analysis.
 *   - Prompt reporting of unanticipated problems involving risk to
 *     subjects must include any AI-generated outputs contributing to
 *     the problem.
 *   - IRB records including AI tool documentation must be retained
 *     >= 3 years after clinical investigation completion (56.115(b)).
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * FDA 21 CFR 56 IRB category classifiers.
 * Clinical investigation data and IRB-specific markers are
 * high-sensitivity; BLOCK on identifiable subject data.
 */
export declare const US_FDA_21CFR56_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const US_FDA_21CFR56_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
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