Study teams and IRBs need to pay close attention to the consent process when preparing (or reviewing) a study that may enroll people whose capacity to consent is impaired. Study team members may also encounter potential subjects whose ability to provide consent is questionable, for whatever reason. What are some of the things IRBs and investigators need to consider in this kind of research?
Public Responsibility in Medicine And Research (PRIM&R)’s blog, Ampersand, recently devoted an item to this issue. Of particular interest are the three scenarios at the bottom, all of which seem realistic to us here at IRB Blog Central, and the discussion following each. Please click on the link, take a look at the item, and consider how you would approach each of these situations.