Unit 4D Leroy House, Genetic Alliance UK, London, UK.
BMJ Open. 2013 Aug 7;3(8):e003022. doi: 10.1136/bmjopen-2013-003022.
A mixed-methods study exploring the UK general public's views towards consent for the use of biosamples for biomedical research.
Cross-sectional population-based focus groups followed by an online survey.
12 focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.
(1) Views on the importance of consent when donating residual biosamples for medical research; (2) preferences for opt-in or opt-out consent approaches and (3) preferences for different consent models.
Participants believed obtaining consent for use of residual biosamples was important as it was 'morally correct' to ask, and enabled people to make an active choice and retain control over their biosamples. Survey responders preferred opt-in consent (55%); the strongest predictor was being from a low socioeconomic group (OR 2.22, 95% CI 1.41 to 3.57, p=0.001) and having a religious affiliation (OR 1.36, 95% CI 1.01 to 1.81, p=0.04). Focus group participants had a slight preference for opt-out consent because by using this approach more biosamples would be available and facilitate research. Concerning preferred models of consent for research use of biosamples, survey responders preferred specific consent with recontact for each study for which their biosamples are eligible. Focus group participants preferred generic consent as it provided 'flexibility for researchers' and reduced the likelihood that biosamples would be wasted. The strongest predictor for preferring specific consent was preferring opt-in consent (OR 4.58, 95% CI 3.30 to 6.35, p=0.015) followed by non-'White' ethnicity (OR 2.94, 95% CI 1.23 to 7.14, p<0.001).
There is a preference among the UK public for ongoing choice and control over donated biosamples; however, increased knowledge and opportunity for discussion is associated with acceptance of less restrictive consent models for some people.
一项混合方法研究，旨在探讨英国公众对同意使用生物样本进行生物医学研究的看法。
基于人群的横断面焦点小组研究，随后进行在线调查。
选择 12 个焦点小组（81 名参与者），以反映各种人群的多样性；通过分层抽样方法招募了 1110 名调查响应者，并对性别、年龄、地理位置、社会经济群体和种族进行了配额设置。
（1）对捐赠剩余生物样本用于医学研究时同意的重要性的看法；（2）对选择加入或选择退出同意方法的偏好；（3）对不同同意模式的偏好。
参与者认为获得剩余生物样本使用的同意很重要，因为这是“道德上正确的”，它使人们能够做出积极的选择，并保留对其生物样本的控制。调查响应者更喜欢选择加入的同意（55%）；最强的预测因素是来自低社会经济群体（OR 2.22，95%CI 1.41 至 3.57，p=0.001）和有宗教信仰（OR 1.36，95%CI 1.01 至 1.81，p=0.04）。焦点小组参与者对选择退出的同意有轻微的偏好，因为通过这种方法可以获得更多的生物样本，从而促进研究。关于生物样本研究使用的同意模式的偏好，调查响应者更喜欢在他们的生物样本有资格的情况下，为每一项研究进行特定的同意并重新联系。焦点小组参与者更喜欢通用的同意，因为它为“研究人员提供了灵活性”，并降低了生物样本浪费的可能性。偏好特定同意的最强预测因素是偏好选择加入的同意（OR 4.58，95%CI 3.30 至 6.35，p=0.015），其次是非“白种人”种族（OR 2.94，95%CI 1.23 至 7.14，p<0.001）。
英国公众对捐赠生物样本的持续选择和控制有偏好；然而，更多的知识和讨论机会与一些人对限制较少的同意模式的接受有关。
