1 General Approval |
• Patients are provided information through published institutional policies, newsletters, posters, and information sheets that their clinicians and care settings routinely conduct certain types of lower risk research that the institution thinks will not adversely impact patients' care, in order to ultimately learn which care is most effective. |
• Doctors will not routinely explain the study to patients during patients' appointments |
• There is no study‐specific opportunity to opt‐out of participation. |
2 Opt‐Out |
• Doctors will give patients a brief description of the study right before they are given their first blood pressure medicine |
• Patients are told that they will be part of the research study unless they say that they do not want to be part of it. |
3 Opt‐In |
• Doctors will give patients written and oral information about the objectives, risks, burdens, benefits, and alternatives of the study before they are given their first blood pressure medicine. |
• Patients are then asked if they are willing to participate and a patient is not enrolled in research without the patient's express, voluntary, and written agreement. Patients can only be part of the research study if they give their written permission. |