November has no doubt been a month of interesting discussions and debates surrounding research and bioethics, as showcased recently at the 2015 PRIM&R Conference in Boston. (Editor’s note: for an in-depth look at our coverage from PRIM&R 2015, we welcome you to view our blog posts on PRIM&R Pre-Conference Highlights: From IRB 101 to Biobanking, […]
We all know how challenging drafting an effective informed consent form for research can be. As a researcher, you have the dual duty to disclose all the information considered to be legally and ethically necessary to make an informed decision in a manner that will be understandable to the prospective research participant. Many efforts have […]
When do you think this process begins? Take a moment to think about it before reading on… Does the informed consent process begin with the informed consent discussion? It may surprise you, but the “FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process”. This means […]
Comments on two articles recently published in NEJM In our last blog we referred to a recent edition of the New England Journal of Medicine (NEJM) in which prominent bioethicists argued that some comparative trials involving approved therapeutic or diagnostic interventions (also known as comparative effectiveness research (CER)) could be conducted without research participants’ consent […]
Comments on articles recently published in NEJM In a recent edition of the New England Journal of Medicine, prominent bioethicists argued that “some studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all”. The authors also propose to streamline the oversight of some studies that fall “below […]
Before someone asks you to ‘consent’ – or agree – to be in a research study, they have to tell you what the research is about. The people doing the study will also ask you to sign a form saying that you’re agreeing to be in the study. This form is called an ‘informed consent […]
