Research conducted at the time of providing healthcare |
Hospitals that integrate research as part of care provision Patients informed that studies are conducted through letters, posters and brochures All studies are reviewed and approved by a REC, which comprises researchers, clinicians, ethicists, patient representatives and community members |
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High blood pressure |
Affects millions of persons in Spain Can lead to stroke, heart attack and/or kidney disease if untreated |
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Pragmatic RCT scenario |
Scenario 1: Drug ‘CTD’ or ‘TRT’?
Two health authorities‐approved medicines Both effective in lowering high blood pressure; similar adverse effects Unknown which is more effective |
Scenario 2: Dose timing, ‘morning’ or ‘night’?
Patients told to take medicine at same time each day Unknown whether morning or night more effective |
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Trial proposal |
Random assignment to CTD or TRT Patient's medicine can be changed at any time by patient or physician |
Random assignment of whether told to take medicine at morning or night Patient's medicine can be changed at any time by patient or physician |
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Debate | REC is debating the best way to get consent for this study | |||
Consent options |
Written consent
vs. verbal consent |
Written consent
vs. general notification |
Written consent
vs. verbal consent |
Written consent
vs. general notification |
Written consent | • Some members argue that patients should give study‐specific written consent | |||
• Consent form would include purpose, risks and benefits, alternatives, method of maintaining privacy, and contact information; participation would be voluntary | ||||
• Written consent would require extra time and effort | ||||
• In some cases, if written consent is required, studies may not be conducted | ||||
Alternative option | General notification | |||
• Other members argue that because the risks are low, general notification through posters, brochures and letters is enough | ||||
• Eligible patients would be automatically enrolled without being informed | ||||
Verbal consent | ||||
• Other members argue that because the risks are low, verbal consent is enough | ||||
• Patient's physician would briefly explain the study |
Shows the 2 × 2 factorial design and information presented to respondents. Half received a drug RCT scenario comparing two first‐line drugs; the others received a dose‐timing RCT scenario comparing morning vs. night dosing. Half of participants in each group chose between written consent and general notification; the rest chose between written consent and verbal consent. CTD, chlorthalidone; RCT, randomized, controlled trial; REC, research ethics committee; TRT = hydrochlorothiazide.