Methoden vergleichen

	Registrierung klinischer Studien	Forschung mit vulnerablen Populationen
Fachgebiet	Forschungsethik	Forschungsethik
Familie	Process / pipeline	Process / pipeline
Entstehungsjahr	2005	1979
Urheber	World Health Organization; International Committee of Medical Journal Editors	U.S. Department of Health and Human Services; World Health Organization; International research ethics community
Typ	Requirement	Guideline
Wegweisende Quelle	World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement.	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Subparts B, C, D.
Aliasnamen	trial registration, prospective registration, ClinicalTrials.gov, trial registry	vulnerable subjects, special populations, vulnerable groups, additional protections
Verwandt	5	5
Zusammenfassung	Clinical trial registration is the prospective documentation of a trial's key information (hypothesis, design, population, outcomes) in a public registry before enrollment begins or results are known. In 2005, the World Health Organization established the requirement that all clinical trials be registered in an internationally recognized registry before participant enrollment. The International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in major medical journals in 2005, updated in 2015. Primary registries include ClinicalTrials.gov (U.S.), ISRCTN (UK), EudraCT (EU), and others operating under WHO oversight. Registration serves to prevent selective outcome reporting, reduce publication bias, and enhance research transparency.	Vulnerable populations are groups with limited capacity to protect themselves due to age, cognitive ability, institutional dependency, or social circumstances. Regulatory frameworks in the U.S. (45 CFR 46 Subparts B, C, D) and internationally identify specific vulnerable populations—children, prisoners, pregnant women, cognitively impaired individuals—and mandate additional ethical protections beyond standard informed consent. These protections include obtaining informed consent from surrogate decision-makers (parents, guardians), additional assurances of minimal risk, and enhanced monitoring for safety. Research ethics committees apply heightened scrutiny to studies involving vulnerable populations and may deny approval if special protections are inadequate.