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R
Randomised clinical trial (RCT)
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Regulatory intelligence
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Re-identification risk (motivated intruder test)
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Schrems II
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Scientific research purposes (Art. 89 GDPR)
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W
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World Health Organization (WHO)
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XAI (explainable artificial intelligence)
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Zero-knowledge proof
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Zero trust architecture
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

C

Common Rule (45 CFR 46)

The Common Rule is the US Federal Policy for the Protection of Human Subjects, codified for HHS at 45 CFR 46 Subpart A. It establishes protections for covered human-subject research, including institutional review board review and informed consent requirements. It is not the name for every provision of Part 46.

Key takeaways

  • The Common Rule is Subpart A, not all of 45 CFR 46.
  • Applicability depends on the research and relevant federal framework.
  • Research consent and HIPAA authorisation are separate concepts.

When the Common Rule Applies

The HHS regulations overview distinguishes the Common Rule from additional subparts. Its 2018 requirements text covers relevant federally conducted or supported research, with exemptions and other scope conditions. Do not assume that every privately funded US study is covered solely because it takes place in the United States. FDA-regulated research can have separate human-subject protection requirements.

FrameworkMain question
Common RuleAre covered research participants appropriately protected?
HIPAA Privacy RuleMay a covered entity use or disclose protected health information?
GDPRIs personal data processing lawful within its applicable scope?

Why It Matters for Data Protection

The HHS research guidance explains that HIPAA permissions for research are separate from Common Rule and FDA protections. As an operational recommendation, document the applicable ethics framework, privacy permissions and data flows rather than using one signed form as a universal answer. IRB approval does not, by itself, establish the appropriate mechanism for an international transfer.

Hypothetical example: A US research institution joins a study with European sites. The project team recommends a matrix distinguishing Common Rule applicability, any HIPAA authorisation or waiver, and the European data protection assessment. This makes gaps visible without pretending that the frameworks have identical terminology.

Frequently Asked Questions

Is IRB review always required?

Not every activity is covered non-exempt research; assess the rules and any available exemption.

Does research consent automatically satisfy HIPAA?

No. HIPAA authorisation or a permitted alternative needs separate consideration.

Does the Common Rule replace GDPR?

No. They have different purposes and scopes and may both matter to one project.

Related reading: institutional review board, informed consent.

For practical implementation, explore HIPAA support.

Updated: 27 October 2026