Beattie B Lynn
Department of Medicine, Division of Geriatric Medicine, University of British Columbia, Vancouver, BC, Canada.
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S27-31. doi: 10.1017/s0317167100005527.
In the era of chronic disease, we are challenged to find therapies that provide symptomatic relief and ideally, alter the course of the underlying disease. In Alzheimer's disease (AD), these issues are complicated by the disease itself, which affects the subject's decision-making capacity for participation in the research. According to established ethical guidelines it is clear that individuals with impaired capacity may participate in research and their risk should be no greater than that which the individual would have in day to day activities with anticipation of benefits within that realm. Decision making processes are complex and involve proxies who themselves have biases about their loved one and the potential for participating in the research. Newer disease-modifying approaches such as immunotherapy have potential for affecting the course of the underlying disease but with greater risk of more significant side effects. Ideally the health care of the subjects is not disadvantaged by research participation. At the same time, trials of potentially riskier therapy are relevant in subjects with the disease. Research for subjects with AD must have appropriate safeguards in place to enable effective progress in innovative therapy for a vulnerable, often elderly population. Recommendations are made which could further our capacity to undertake ethical research in the AD population.
在慢性病时代，我们面临着寻找能够缓解症状并理想地改变潜在疾病进程的治疗方法的挑战。在阿尔茨海默病（AD）中，这些问题因疾病本身而变得复杂，因为该疾病会影响受试者参与研究的决策能力。根据既定的伦理准则，显然能力受损的个体可以参与研究，并且他们所面临的风险不应高于该个体在日常活动中预期会遇到的风险，同时要预期在该领域能获得益处。决策过程很复杂，涉及代理人，而代理人本身对其亲人以及参与研究的可能性存在偏见。诸如免疫疗法等新型疾病修正方法有可能影响潜在疾病的进程，但出现更严重副作用的风险更大。理想情况下，受试者的医疗保健不会因参与研究而处于不利地位。与此同时，对患有该疾病的受试者进行潜在风险更高的治疗试验是有意义的。针对AD患者的研究必须有适当的保障措施，以便在针对脆弱且往往是老年人群体的创新疗法方面取得有效进展。本文提出了一些建议，这些建议可以进一步提升我们在AD人群中开展伦理研究的能力。
