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
(2016) In PLoS ONE 11(3).- 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.... (More)
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.
CONCLUSION: 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.
TRIAL REGISTRATION: Dutch Trial Register NTR2982.
(Less)
- author
- publishing date
- 2016
- type
- Contribution to journal
- publication status
- published
- keywords
- Adolescent, Adult, Aged, Aged, 80 and over, Biomedical Research, Female, Humans, Male, Middle Aged, Netherlands, Surveys and Questionnaires
- in
- PLoS ONE
- volume
- 11
- issue
- 3
- article number
- e0152509
- publisher
- Public Library of Science (PLoS)
- external identifiers
-
- pmid:27028128
- scopus:84962713412
- ISSN
- 1932-6203
- DOI
- 10.1371/journal.pone.0152509
- language
- English
- LU publication?
- no
- id
- 5268a8bc-d41e-42e0-b10d-521120417eb4
- date added to LUP
- 2022-04-05 09:37:41
- date last changed
- 2024-04-18 07:00:16
@article{5268a8bc-d41e-42e0-b10d-521120417eb4,
abstract = {{<p>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.</p><p>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.</p><p>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.</p><p>CONCLUSION: 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.</p><p>TRIAL REGISTRATION: Dutch Trial Register NTR2982.</p>}},
author = {{Rebers, S and Vermeulen, E and Brandenburg, A P and Stoof, T J and Zupan-Kajcovski, B and Bos, W J W and Jonker, M J and Bax, C J and van Driel, W J and Verwaal, V J and van den Brekel, M W and Grutters, J C and Tupker, R A and Plusjé, L and de Bree, R and Schagen van Leeuwen, J H and Vermeulen, E G J and de Leeuw, R A and Brohet, R M and Aaronson, N K and Van Leeuwen, F E and Schmidt, M K}},
issn = {{1932-6203}},
keywords = {{Adolescent; Adult; Aged; Aged, 80 and over; Biomedical Research; Female; Humans; Male; Middle Aged; Netherlands; Surveys and Questionnaires}},
language = {{eng}},
number = {{3}},
publisher = {{Public Library of Science (PLoS)}},
series = {{PLoS ONE}},
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}},
url = {{http://dx.doi.org/10.1371/journal.pone.0152509}},
doi = {{10.1371/journal.pone.0152509}},
volume = {{11}},
year = {{2016}},
}