Section 1–3: short title, findings and definitions
Section 1 — Short title. A bill to be cited as the 'Right to Research and Participant Choice Act.' Define the movement's purpose as facilitating lawful, rigorous, voluntary scientific investigation led or joined by competent adults, while making risk responsibility and research integrity traceable. A title does not itself confer investigational authorization.
Section 2 — Findings and objectives. Congress could find that interstate biomedical research depends on independent scientists and voluntary participants; that existing regulatory structures already recognize individual sponsors; that small projects face practical barriers to protocol development, ethics navigation and data governance; and that modern decentralized trial methods warrant evidence-based evaluation. Avoid claiming empirical reductions in cost or increases in recruitment without substantiation. F02F18P01
Section 3 — Definitions. Define 'independent investigator,' 'covered research activity,' 'participant,' 'research participant data,' 'qualified clinician,' 'sponsor-support service,' 'regulatory classification determination,' 'covered investigational article,' and 'research consent record.' The definition of 'covered research activity' should explicitly distinguish literature research, secondary data analysis, observational records and intervention assignment. Imported FDA terms must not silently acquire contradictory meanings. F01F02F25
Define 'participant-directed data' as identified, coded, or de-identified records subject to specific enforceable duties and exceptions rather than a declaration that health information is property for all purposes. Define a 'permitted secondary use' and a 'restricted AI training use' separately, including recipient obligations and withdrawal timing. Genomic identifiability, rights to derivative research, and contracts require explicit treatment. F14F15
Section 4–6: classification, guidance, and fair administrative procedure
Section 4 — Individual research classification request. Any qualifying applicant should be able to request a written FDA decision identifying whether a proposed activity is regulated under the cited investigational-drug provisions, qualifies for an existing exemption, requires a specific application, or falls outside that particular pathway. The application should summarize product, method, population, consent and safety plan. Define completeness and an administrative response clock distinct from clinical-study start authorization. F01F03
Section 5 — Technical assistance and interpretation. Require FDA, in coordination with HHS/OHRP and NIH, to publish a small-sponsor pathway map and maintain staffed assistance. Include plain-language templates, referral to independent review bodies, record standards and educational resources. Agency participation must not be framed as individualized medical clearance or guaranteed financial support without appropriation.
Section 6 — Reasons, review and data reporting. A classification determination should provide specific cited reasons, the scope of the decision, information needed for reconsideration, and an administrative review process. Congress must decide whether judicial review follows existing administrative law or is expressly created. Published aggregate metrics should include response time, common grounds for denial and changes in completeness rates, subject to legitimate confidential information restrictions.
Section 7–10: independent research infrastructure and clinician roles
Section 7 — Research-support commons. Authorize an independently governed competitive-grant program to provide protocol-design support, scientific consultation, clinical-trial operations training, statistical review, privacy engineering and research-data management. Procurement and board rules should disclose conflicts with manufacturers or marketers of investigational products. The support network should not act as a regulatory substitute for IND sponsorship.
Section 8 — Review access. Establish a directory of accredited or appropriately registered review services and a model set of written reliance, payment and independence terms. Where existing expedited IRB review or HHS single-IRB rules apply, maintain their defined coverage. Any proposal for a new review category requires identifying which regulatory standard changes, which risk criteria determine eligibility and how participant safety will be protected. F09F24
Section 9 — Voluntary qualified clinician participation. Create optional templates clarifying medical scope, licensed jurisdiction, adverse-event escalation, sponsor delegation, and investigator duties. Consider a statutory federal defense only for narrowly defined good-faith participation within a lawfully authorized program, with explicit survival of negligence, fraud, misconduct and state licensing obligations absent specifically identified preemption. F05F06
Section 10 — Research supply and quality. An investigational product may enter a protected research route only under a specified lawful supply channel with verifiable identity, manufacturing and storage controls appropriate to the product and procedure. Tailored access should not be a blanket waiver of adulteration, misbranding or prohibited promotion. Congress may direct FDA to clarify standards for small sponsors and publicly report the costs of obtaining required quality documentation. F01F05F12
Section 11–14: consent, harm, privacy, independent oversight
Section 11 — Informed participation. Require context-appropriate consent identifying the nature of an investigation, expected uncertainty, foreseeable risk, alternatives, privacy terms, withdrawal, contacts and incident escalation. Provide optional separate disclosure for experimental uncertainty. Preserve civil accountability for negligence and intentional wrongdoing unless Congress deliberately specifies a different narrow rule after public deliberation. F07F08
Section 12 — Study-associated injury. Request a feasibility report on three models: existing responsibility with clear disclosure; mandatory proof of sponsor financial capacity or insurance; or a limited no-fault compensation fund supported by defined contributions and appropriations. The final Act should state eligibility, proof of injury, compensation caps if any, appeal, coordination with tort rights and how claims avoid insolvency.
Section 13 — Participant research-data charter. Establish defined access, portability, consent ledger, purpose-specific controls, downstream recipient obligations and administrative enforcement. The statute should distinguish records held by HIPAA covered entities from records held by independent research intermediaries. De-identification status should require actual accepted methods, and rights should not be implied to operate through tokenization alone. F14F15F16F17
Section 14 — Independent advisory and audit body. Require a governance body whose participants include scientific methodologists, privacy specialists, practicing clinicians, research volunteers and people with experience in independent studies. Publish conflicts of interest and recommendations, hold open evidence sessions, protect confidential submissions and periodically audit the impact on participant safety and research integrity.
Section 15–19: reporting, review, appropriations and boundaries
Section 15 — Registry and results transparency. For specifically defined covered studies, require a minimal prospective registration package: scientific question, design, primary outcome, sponsor identity, analysis plan, adverse-event contact and anticipated reporting date. Scope must consider existing ClinicalTrials.gov law, privacy and proprietary data. Reporting of unfavorable findings should be included because disappearing negative results can distort research. F25P06P07
Section 16 — Data-security and breach duties. Direct implementing agencies to define proportionate security requirements for research custodians and downstream recipients while recognizing HIPAA, FTC health-information duties and relevant state law. Specify breach notice, audit logs, protected records, independent complaints and documented deletion or retention exceptions. Do not promise technical elimination of all prior model training effects. F14F15F17
Section 17 — Rules of construction and federal-state relationship. State that the Act does not authorize deception, unlicensed medical practice, unauthorized manufacture or sales, or conduct outside specifically defined program eligibility. If a narrow federal preemption provision is adopted, include express text naming its subject and saving unaffected state remedies. Counsel should examine conflict preemption case law and the insurance regulatory context. L02
Section 18 — Administration, funding and reports. Assign agency heads, regulatory deadlines, appropriations, audit intervals, and congressional reporting content. A phased program might launch a guidance and support pilot first, then a separate interventional demonstration only after published eligibility and product quality standards. Agency reports should distinguish verified participant outcomes from project counts or website engagement.
Section 19 — Severability, effective dates and sunset. Supply effective dates separated by provision, so data rights, classification services and research piloting do not assume the same readiness. Specify any pilot sunset and evaluation. Severability is a drafting choice, not a cure for undefined rights; use it while keeping the operative mechanisms individually coherent.
The legislative-counsel issue list
Before filing, request a clause-by-clause authority review: which FD&C Act provisions must change; which regulations can be modified under present statutory authority; what is a new private right of action; how ordinary APA review is affected; where nonfederal review bodies fit; what appropriation and Congressional Budget Office analysis may be needed; and whether state practice and insurance rules would preclude intended clinical participation.
Ask counsel to produce two comparison drafts. Option A: procedural-access reform, focused on classification, guidance, infrastructure, consent/data rights and accountable reporting without a new general drug exception. Option B: a tailored investigational-access route, adding precisely defined eligibility and product-quality duties. Compare constitutional risk, measurable benefit, fiscal cost and operational feasibility instead of choosing by rhetoric.