Intended for healthcare professionals

Analysis And Comment Confidentiality and consent in medical research

Overcoming barriers to recruitment in health research

BMJ 2006; 333 doi: (Published 03 August 2006) Cite this as: BMJ 2006;333:300
  1. Jenny Hewison (, professor1,
  2. Andy Haines, director2
  1. 1 University of Leeds, Institute of Health Sciences and Public Health Research, Leeds LS2 9LT,
  2. 2 London School of Hygiene and Tropical Medicine, London
  1. Correspondence to: J Hewison

    The public needs to be included in debates about what is, and isn't, in its best interests. Until then, ethics committees should suspend their preference for “opt-in” recruitment to research projects

    The burden and expense of implementing current research ethics and governance requirements are beginning to be recognised.1 2 However, the ethical requirements may also affect the quality of the primary research. Ethics committees are now insisting that researchers can approach only people who respond positively to letters from their general practitioner or hospital clinician, informing them about an opportunity to take part in research—that is, people who have opted in.3 4 However, the ethical benefits of this approach are not proved and it can lead to low response rates, wasted resources, and research of limited validity.

    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 …

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