Patient Protection in Research-Based Hospital Services
DOI:
https://doi.org/10.0805/p848hy97Kata Kunci:
patient protection; hospital services; clinical research; informed consent; health data; research ethicsAbstrak
This study examined patient protection when research is embedded in hospital services. Normative legal research used statutory, conceptual, and comparative approaches based on Indonesian health, clinical-trial, ethics, medical-record, and personal-data rules, international ethical standards, and recent scholarship. The study found fragmented protection at the boundary between individualized care and research, particularly concerning therapeutic misunderstanding, consent quality, secondary data use, injury, compensation, and continuity of care. It proposes a Research-Based Hospital Patient Protection Model comprising activity classification, proportional review, layered consent with comprehension assurance, integrated safety monitoring, transparent data governance, and no-fault-oriented compensation with independent complaints. The model assigns verifiable duties to hospitals, investigators, sponsors, ethics committees, and regulators. It recommends a national technical standard, hospital research ombuds functions, secured injury funding, and integrated safety and data reporting.
Unduhan
Referensi
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