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Table 1 Experimental design of the survey (Modified from Nayak et al. [8])

From: Patients’ beliefs regarding informed consent for low-risk pragmatic trials

Research conducted at the time to providing health care

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

High blood pressure

Affects millions of persons in Spain

Can lead to stroke, heart attack, and/or kidney disease if untreated

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

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

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 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 done

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

  1. Shows the 2 × 2 factorial design and information presented to respondents. Half received a drug RCT scenario comparing 2 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