Overcoming barriers to recruitment in health research

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Abstract
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 to a third party. However, we believe that in most cases the adverse effects on the conduct of methodologically rigorous research more than outweigh any putative advantages. Credit: TONY SIMPSON Firstly, scientific losses must be considered as well as confidentiality gains. If scientific losses are real, patients and the public need to know about them, because they may prefer a carefully regulated opt-out system to an opt-in system that produces evidence—and care—of poorer quality. Such losses are likely to vary according to the type of study but could include: Failure to include participants who might benefit most from an intervention (such as those who have more severe disease or are socioeconomically disadvantaged) Underestimation (or overestimation) of the incidence or prevalence of a condition Biased assessment of the association between an exposure or risk factor and a health outcome Failure to detect differences in quality of care and outcome between socioeconomic or ethnic groups Failure to capture the full range of views and perceptions about a health issue. Secondly, for most patients the claimed confidentiality benefits may not be real. Patients may distinguish between different kinds of third parties and may not consider, for example, a brief telephone call after a letter explaining the proposed research to be an unjustifiable invasion of their privacy if there seems to be a good reason for the call and their privacy is in all other respects protected. If, as seems likely, many people who do not respond to a request would not object to being approached by a researcher, an opt-in system may deprive them of the opportunity to participate in research or allow their records to be used for such purposes. Indeed, some people might prefer an opt-out system because of the support and reassurance that personal contact can provide. This raises the possibility that the advantages and disadvantages of the two systems might be distributed differently across patient groups. All of these arguments point in the same direction: if some kind of trade-off between confidentiality costs and health benefits is unavoidable, the debate about what it means to protect patients' interests must be public.