Let’s say the researchers have reviewed all of the EHRs and have limited their list to people who definitely have diabetes and could participate in the research study. These are the people who the researchers want to invite to participate in the study. This study has been approved by the Institutional Review Board. There will be an informed consent process for the study, so people who are invited to participate can learn all about it and then decide whether they want to participate or not.
a. Method of contact: There are two general ways that researchers could contact patients to invite them to participate in the study.
• Direct contact: One way is to contact patients directly, for example by letter, phone, or email. The patient could then decide whether to be in the study.
• Through physician: The other way would be to contact patients’ physicians, and ask them to let their patients know about the study. In this approach, it would be up to the physician to decide whether to let patients know about the study and, if so, which patients. If a patients’ physician agrees to allow the patient to hear about the study, it would still be up to the patient to make a final decision about whether to participate.
b. Response requested: Let’s say that the way researchers plan to contact patients about the study is by letter. After describing a little bit about the study, there are two different things the letter could say:
• Opt in: One thing the letter could say is: “If you would like to learn more about this study, please call the study’s 1–800 number.” In other words, you would need to take the step of calling if you wanted to find out more about the study – otherwise, researchers would not contact you further.
• Opt out: The other thing the letter could say is: “We will give you a call next week to see if you would like to learn more about this study. If you would rather not hear from us, please call the study’s 1–800 number to let us know and we will take you off the list.” In other words, you would need to take the step of calling only if you want no further contact – otherwise, researchers would call to see if you wanted to find out more about the study.