THE SOURCES.
THE RECEIPTS.
A transparent reference catalogue so readers can examine the law, literature and data quality behind this initiative. References are source leads; inclusion does not imply endorsement by the publisher.
- F0121 CFR §312.2 — Applicability of IND regulationsFederal regulation
Core tests for IND applicability/exemptions; not a universal research exemption.
https://www.ecfr.gov/current/title-21/section-312.2 - F0221 CFR §312.3 — Definitions of sponsor and sponsor-investigatorFederal regulation
Expressly recognizes individual IND sponsors and sponsor-investigators.
https://www.ecfr.gov/current/title-21/section-312.3 - F0321 CFR §312.40 — General IND requirementsFederal regulation
General IND clock, authorization, and clinical hold boundaries.
https://www.ecfr.gov/current/title-21/section-312.40 - F0421 CFR §312.32 — IND safety reportingFederal regulation
Safety reporting obligations and evidence requirements.
https://www.ecfr.gov/current/title-21/section-312.32 - F0521 CFR §312.50 — Sponsor responsibilitiesFederal regulation
Sponsor selection, conduct, safety, and records.
https://www.ecfr.gov/current/title-21/section-312.50 - F0621 CFR §312.52 — Transfer of sponsor obligationsFederal regulation
Certain sponsor obligations may transfer by written agreement.
https://www.ecfr.gov/current/title-21/section-312.52 - F0721 CFR §50.20 — Informed consent general requirementsFederal regulation
Voluntary informed consent and exclusion of exculpatory negligence waivers.
https://www.ecfr.gov/current/title-21/section-50.20 - F0821 CFR §50.25 — Elements of informed consentFederal regulation
Disclosures about uncertainty, contacts, alternatives, injury/compensation.
https://www.ecfr.gov/current/title-21/section-50.25 - F0921 CFR §56.110 — Expedited IRB reviewFederal regulation
Existing expedited review for eligible categories; not a blanket exemption.
https://www.ecfr.gov/current/title-21/section-56.110 - F1045 CFR Part 46 — Human Subjects Protection / Common RuleFederal regulation
Application depends on institutional and federal involvement; distinct from FDA obligations.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html - F1121 USC §360bbb-0a — Right to TryFederal statute
A narrow congressional statutory example, distinct from general adult self-research.
https://www.law.cornell.edu/uscode/text/21/360bbb-0a - F1221 USC §355 — Drug approval and investigational exceptionsFederal statute
Drug approval framework underlying investigational pathways.
https://www.law.cornell.edu/uscode/text/21/355 - F1321 CFR §809.10 — Certain IVD labeling rulesFederal regulation
RUO language in an in vitro diagnostic context does not waive human drug study rules.
https://www.ecfr.gov/current/title-21/section-809.10 - F1445 CFR §164.514 — HIPAA de-identification/re-identificationFederal regulation
Codes and pseudonyms require actual regulatory analysis.
https://www.ecfr.gov/current/title-45/section-164.514 - F15HHS — De-identification guidanceFederal guidance
Expert Determination and Safe Harbor, quasi-identification, disclosure risks.
https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html - F1645 CFR §164.524 — HIPAA access rightsFederal regulation
Defined access rights for covered records, not universal ownership of all models/data.
https://www.ecfr.gov/current/title-45/section-164.524 - F17FTC Health Breach Notification Rule, 16 CFR Part 318Federal regulation
Relevant to certain health apps and personal health record service providers.
https://www.ftc.gov/legal-library/browse/rules/health-breach-notification-rule - F18FDA — Decentralized Trial Elements (Final, September 2024)Federal guidance
Remote research can be organized but does not waive IND/oversight obligations.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements - F19FDA — E6(R3) Good Clinical Practice (Final, September 2025)Federal guidance
Quality-by-design and proportionality in modern clinical trials.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp - F20FDA — Patient-Focused Drug Development (Final, October 2025)Federal guidance
Participant experience as evidence and appropriate outcomes.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome - F21FDA — Enhancing Trial Participation (Final, December 2025)Federal guidance
Inclusion and representativeness in investigational design.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial - F22FDA — Expanded Access OverviewFederal guidance
Patient access pathway distinct from trial enrollment and Right to Try.
https://www.fda.gov/drugs/investigational-new-drug-application-ind/ind-applications-clinical-treatment-expanded-access-overview - F23Congressional Research Service — Expanded Access and Right to Try, R45414Congressional analysis
Comparison of clinical trials, expanded access and Right to Try.
https://www.congress.gov/crs_external_products/R/PDF/R45414/R45414.5.pdf - F24HHS — Single IRB for Cooperative ResearchFederal guidance
U.S. cooperative studies and state/local context; guidance is draft.
https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-use-single-institutional-review-board-for-cooperative-research/index.html - F25ClinicalTrials.gov — Learn About StudiesFederal research registry
Interventional versus observational studies and participant basics.
https://clinicaltrials.gov/study-basics/learn-about-studies - P01Methods used to conduct decentralised clinical trials — systematic review (2021), PMID 34961991Peer-reviewed synthesis
Forty-five trials in quantitative analysis; insufficient evidence to determine recruitment/cost superiority.
https://pubmed.ncbi.nlm.nih.gov/34961991/ - P02Participants as Partners in Decentralized Clinical Trials (2025), PMID 40633104Peer-reviewed perspective
Participant engagement and value design.
https://pubmed.ncbi.nlm.nih.gov/40633104/ - P03Trial characteristics and challenges of DCT — scoping review, PMID 41271425Peer-reviewed synthesis
Fifty-three papers, multiple retention and biased recruitment challenges.
https://pubmed.ncbi.nlm.nih.gov/41271425/ - P04Decentralized clinical trials and equity of access (2024), PMID 38358756Peer-reviewed perspective
Arguments for geographic access in oncology research.
https://pubmed.ncbi.nlm.nih.gov/38358756/ - P05Ethical Challenges in DCTs — scoping review (2026), PMID 41806287Peer-reviewed synthesis
Thirty-two included papers; consent, equity, privacy, safety, validity and oversight concerns.
https://pubmed.ncbi.nlm.nih.gov/41806287/ - P06Platform trials: design and methods systematic review (2025), PMID 40349734Peer-reviewed synthesis
189 platform trials; transparency of protocols/statistical simulation remains uneven.
https://pubmed.ncbi.nlm.nih.gov/40349734/ - P07N-of-1 medical studies evidence/reporting standards (2023), PMID 37463877Peer-reviewed synthesis
Only four of 115 reviewed articles met all analyzed evidence standards; reporting issues.
https://pubmed.ncbi.nlm.nih.gov/37463877/ - P08N-of-1 trial methodology and statistics (2025), PMID 41355573Peer-reviewed review
Methods, reporting, analysis and implementation obstacles.
https://pubmed.ncbi.nlm.nih.gov/41355573/ - P09N-of-1 trials in medical literature (2011), PMID 21478771Peer-reviewed synthesis
Reporting limitations and individual-treatment effect analysis.
https://pubmed.ncbi.nlm.nih.gov/21478771/ - P10Individualized therapy trials: care and research ethics (2021), PMID 34642487Peer-reviewed perspective
Care-research distinction, equipoise, reporting, funding, informed consent.
https://pubmed.ncbi.nlm.nih.gov/34642487/ - P11DCT-in-a-box framework (2023), PMID 38028335Peer-reviewed framework
Research participation distribution framework, not proof of lower costs.
https://pubmed.ncbi.nlm.nih.gov/38028335/ - P12Trial recruitment systems framework (2026), PMID 41694058Peer-reviewed synthesis
Literature-informed approach to geographic, technology and institutional barriers.
https://pubmed.ncbi.nlm.nih.gov/41694058/ - P13Characteristics of explicitly decentralized trials (2026), PMID 42934714Peer-reviewed synthesis
Twenty-eight unique trials; definitional and reporting heterogeneity.
https://pubmed.ncbi.nlm.nih.gov/42934714/ - P14DCT trends and global challenges (2026), PMID 41544140Peer-reviewed analysis
Digital equity, regulatory variability, methodological validation and implementation barriers.
https://pubmed.ncbi.nlm.nih.gov/41544140/ - L01Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc)Judicial precedent
Rejected an asserted fundamental due process right in specific investigational access circumstances, without blocking congressional legislation.
https://law.justia.com/cases/federal/appellate-courts/caDC/04-5350/04-5350b-2011-03-24.html - L02Wyeth v. Levine, 555 U.S. 555 (2009)Judicial precedent
Context for express/implied federal preemption; fact-specific.
https://supreme.justia.com/cases/federal/us/555/555/ - L03Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990)Judicial precedent
Refusal of treatment jurisprudence is not an automatic research-access entitlement.
https://supreme.justia.com/cases/federal/us/497/261/