Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.
PLoS One. 2021 Sep 15;16(9):e0256689. doi: 10.1371/journal.pone.0256689. eCollection 2021.
Vulnerable groups, e.g. persons with mental illness, neurological deficits or dementia, are often excluded as participants from research projects because obtaining informed consent can be difficult and tedious. This may have the consequence that vulnerable groups benefit less from medical progress. Vulnerable persons are often supported by a legal guardian in one or more demands of their daily life. We examined the attitudes of legal guardians and legally supervised persons towards medical research and the conditions and motivations to participate in studies.
We conducted a cross-sectional study with standardized surveys of legal guardians and legally supervised persons. Two separate questionnaires were developed for the legal guardians and the supervised persons to asses previous experiences with research projects and the reasons for participation or non-participation. The legal guardians were recruited through various guardianship organizations. The supervised persons were recruited through their legal guardian and from a previous study among psychiatric patients. The data were analysed descriptively.
Alltogether, 82 legal guardians and 20 legally supervised persons could be recruited. Thereof 13 legal guardians (15.6%) and 13 legally supervised persons (65.0%) had previous experience with research projects. The majority of the guardians with experience in research projects had consented the participation of their supervised persons (n = 12 guardians, 60.0%; in total n = 16 approvals). The possible burden on the participating person was given as the most frequent reason not to participate both by the guardians (n = 44, 54.4%) and by the supervised persons (n = 3, 30.0%). The most frequent motivation to provide consent to participate in a research study was the desire to help other patients by gaining new scientific knowledge (guardians: n = 125, 78.1%; supervised persons: n = 10, 66.6%).
Overall, an open attitude towards medical research can be observed both among legal guardians and supervised persons. Perceived risks and no sense recognized in the study are reasons for not participating in medical research projects.
弱势群体，例如患有精神疾病、神经缺陷或痴呆症的人，通常被排除在研究项目参与者之外，因为获得知情同意可能既困难又繁琐。这可能导致弱势群体从医学进步中获益较少。弱势群体的日常生活需求通常由法定监护人提供支持。我们研究了法定监护人和受法律监管的人对医学研究的态度，以及参与研究的条件和动机。
我们进行了一项横断面研究，对法定监护人和受监管人进行了标准化调查。为法定监护人和受监管人分别制定了两份单独的问卷，以评估他们以前参与研究项目的经验，以及参与或不参与的原因。法定监护人通过各种监护组织招募。受监管人通过他们的法定监护人，以及之前一项精神科患者研究招募。数据采用描述性分析。
共招募到 82 名法定监护人和 20 名受法律监管的人。其中 13 名法定监护人（15.6%）和 13 名受法律监管的人（65.0%）有参与研究项目的经验。有研究经验的监护人中，大多数同意其被监管人的参与（n = 12 名监护人，60.0%；总计 n = 16 人同意）。参与人的潜在负担是监护人（n = 44，54.4%）和受监管人（n = 3，30.0%）都表示不参与的最常见原因。同意参与研究的最常见动机是通过获得新的科学知识来帮助其他患者（监护人：n = 125，78.1%；受监管人：n = 10，66.6%）。
总体而言，法定监护人和受监管人对医学研究都持开放态度。认为研究存在风险和没有从中受益是不参与医学研究项目的原因。
