title: A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice.
abstract: BACKGROUND
  Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.
  
  
  METHODS
  We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.
  
  
  RESULTS
  We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients' tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus.
  
  
  CONCLUSIONS
  We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals.
  
  
  BACKGROUND
  Dutch Trial Register NTR2982.
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Rebers
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Vermeulen
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: A P
authors.initials: AP
authors.lastname: Brandenburg
authors.affiliation: Department of Dermatology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: T J
authors.initials: TJ
authors.lastname: Stoof
authors.affiliation: Department of Dermatology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Zupan-Kajcovski
authors.affiliation: Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: W J W
authors.initials: WJ
authors.lastname: Bos
authors.affiliation: Department of Dermatology, Spaarne Gasthuis location Haarlem Zuid, Haarlem, The Netherlands.
authors.forename: M J
authors.initials: MJ
authors.lastname: Jonker
authors.affiliation: Department of Obstetrics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: C J
authors.initials: CJ
authors.lastname: Bax
authors.affiliation: Department of Gynaecology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: W J
authors.initials: WJ
authors.lastname: van Driel
authors.affiliation: Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: V J
authors.initials: VJ
authors.lastname: Verwaal
authors.affiliation: Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: M W
authors.initials: MW
authors.lastname: van den Brekel
authors.affiliation: Department Pulmonology, St. Antonius Hospital, Nieuwegein, The Netherlands.|Division of Heart and Lungs, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: J C
authors.initials: JC
authors.lastname: Grutters
authors.affiliation: Department of Dermatology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: R A
authors.initials: RA
authors.lastname: Tupker
authors.affiliation: Department of Dermatology, Rode Kruis Hospital, Beverwijk, The Netherlands.
authors.forename: L
authors.initials: L
authors.lastname: Plusjé
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: de Bree
authors.affiliation: Department of Gynaecology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: J H
authors.initials: JH
authors.lastname: Schagen van Leeuwen
authors.affiliation: Department of Surgery, Spaarne Gasthuis location Haarlem Zuid, Haarlem, The Netherlands.
authors.forename: E G J
authors.initials: EG
authors.lastname: Vermeulen
authors.affiliation: Athena Institute for transdisciplinary research, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: R A
authors.initials: RA
authors.lastname: de Leeuw
authors.affiliation: Research Center Linnaeus Institute, Scientific Department, Spaarne Gasthuis, Hoofddorp, The Netherlands.
authors.forename: R M
authors.initials: RM
authors.lastname: Brohet
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: N K
authors.initials: NK
authors.lastname: Aaronson
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: F E
authors.initials: FE
authors.lastname: Van Leeuwen
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.|Division of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: M K
authors.initials: MK
authors.lastname: Schmidt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011795:Surveys and Questionnaires