title: Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial.
abstract: BACKGROUND
  Privacy laws have recently created restrictions on how researchers can approach study participants.
  
  
  METHODS
  In a randomised trial of 152 patients, 50-74 years old, in a family practice, 60 were randomly selected to opt-out and 92 to opt-in methods. Patients were sent an introductory letter by their doctor in two phases, opt-out before and opt-in after introduction of the new Privacy Legislation in December 2001. Opt-out patients were contacted by researchers. Opt-in patients were contacted if patients responded by email, free telephone number or a reply-paid card.
  
  
  RESULTS
  Opt-in recruited fewer patients (47%; 43/92) after invitation compared with opt-out (67%; 40/60); (-20%; [-4% to -36%]). No proportional difference in recruitment was found between opt-in and opt-out groups varied by age, sex or socioeconomic status. The opt-in group had significantly more people in active decision-making roles (+30%; [10% to 50%]; p = 0.003). Non-significant trends were observed towards opt-in being less likely to include people with lower education (-11.8%; [-30% to 6.4%]; p = 0.13) and people who were not screened (-19.1%; [-40.1% to 1.9%]; p = 0.08). Opt-in was more likely to recruit people with a family history of colorectal cancer (+12.7%; [-2.8%, 28.2%]; p = 0.12).
  
  
  CONCLUSIONS
  The number of participants required to be approached was markedly increased in opt-in recruitment. Existing participants (eg, screening attendees) with a vested interest such as increased risk, and those preferring an active role in health decision making and with less education were likely to be recruited in opt-in. Research costs and generalisability are affected by implementing privacy legislation.
authors.affiliation: Room 322, Edward Ford Building (A27), The University of Sydney, Sydney, NSW 2006, Australia. lyndalt@health.usyd.edu.au
authors.forename: L
authors.initials: L
authors.lastname: Trevena
authors.forename: L
authors.initials: L
authors.lastname: Irwig
authors.forename: A
authors.initials: A
authors.lastname: Barratt
mesh_terms: D000367:Age Factors; D000368:Aged; D001294:Attitude to Health; D001315:Australia; D015179:Colorectal Neoplasms / Q000175:diagnosis; D005260:Female; D015438:Health Behavior; D006801:Humans; D008297:Male; D008875:Middle Aged; D009780:Occult Blood; D018579:Patient Selection; D018907:Privacy / Q000331:legislation & jurisprudence*; D012737:Sex Factors; D012959:Socioeconomic Factors