Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT
| Autor: | Caryn J. Rogers, Joel Press |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Risk
medicine.medical_specialty Standard of care 0603 philosophy ethics and religion Blindness 03 medical and health sciences 0302 clinical medicine Informed consent Political science Positive airway pressure Multiple treatments medicine Humans Multicenter Studies as Topic Parental Consent 030212 general & internal medicine Intensive care medicine Human resources Confusion Randomized Controlled Trials as Topic business.industry Research Infant Newborn Standard of Care 06 humanities and the arts General Medicine Oxygen Philosophy Issues ethics and legal aspects Risk analysis (engineering) 060301 applied ethics medicine.symptom business Infant Premature |
| Zdroj: | The Journal of medicine and philosophy. 42(2) |
| ISSN: | 1744-5019 |
| Popis: | Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) and the Office for Human Resource Protection's (OHRP) judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP's definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a standard-of-care treatment should instead be considered risks of treatment. However, analysis of OHRP's definition demonstrates that some risks in such trials can be research risks. |
| Databáze: | OpenAIRE |
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