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 |