Opting in and out

Before the changes, properly vetted and approved researchers were allowed to contact potential participants directly after NHS staff had identified and sent information to them about the research. The initial letter from NHS providers stated clearly that if people did not want to be contacted by researchers they should let NHS staff know, so that their contact details would not be passed to the research team—that is, they could opt out. By contrast, many ethics committees now require that researchers approach only people who respond positively to a letter from their general practitioner or hospital clinician informing them about an opportunity to take part in research—that is, potential participants must opt in to being contacted by a researcher.3 4 Under both systems, the researcher then seeks informed consent for participation.

An opt-in system for approaching potential participants is claimed to benefit patients because it ensures that only healthcare providers have access to the information that, say, someone has diabetes unless that individual has explicitly agreed to the information being given …