关键词: Ethics Ethics- Medical Informed Consent Policy Tissue and Organ Procurement

来  源:   DOI:10.1136/jme-2023-109033

Abstract:
The sensitivity of human tissue and previous instances of misuse have, rightfully, led to the introduction of far-reaching oversight and regulatory mechanisms for accessing, storing and sharing samples. However, these restrictions, in tandem with more broad-based privacy regulations, have had the unintended consequence of obstructing legitimate requests for medical materials. This is of real detriment to ambitions for biomedical research, most notably the precision medicine agenda. As such, this paper makes the case for facilitating authorised researcher access to human tissue and associated data along practical medical ethics lines, detailing how liberating samples from unfit regulations, re-evaluating biobanks, diversifying considerations for donor benefit-risk, future proofing donor consent and flattening hierarchies of donation acceptability equate to a more cohesive and respectful means of managing biological samples and information than is achieved at present.
摘要:
人体组织的敏感性和以前的误用情况,理所当然,导致引入了影响深远的监督和监管机制,存储和共享样品。然而,这些限制,与更广泛的隐私法规相结合,产生了阻碍合法医疗材料请求的意外后果。这确实不利于生物医学研究的雄心,最引人注目的是精准医学议程。因此,本文为促进授权研究人员沿着实际的医学伦理路线访问人体组织和相关数据提供了理由,详细说明如何将样本从不合适的法规中解放出来,重新评估生物银行,多样化考虑捐助者的利益-风险,与目前相比,未来证明捐赠者的同意和扁平化的捐赠可接受性等级等同于管理生物样本和信息的更有凝聚力和尊重的手段。
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