Task force 1: The ACCF and AHA codes of conduct in human subjects research

Task force 1: The ACCF and AHA codes of conduct in human subjects research
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DOI:
10.1016/j.jacc.2004.08.038
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发表时间:
2004-10-19
影响因子:
24
通讯作者:
Ofili, E
Ofili, E
中科院分区:
医学1区
文献类型:
--
作者:
Alpert, JS;Shine, KI;Ofili, E

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Richard L. Popp,MD,MACC,FAHA,联合主席Sidney C.史密斯,JR,医学博士,FACC,FAHA,联合主席卫生保健专业一直享有特殊的信任和地位,在我们的社会。患者信任医疗保健专业人员(HCP)来保护他们的健康,告知他们,并将患者的利益置于任何其他考虑之上。这是“专业”的一个定义。当HCP在研究中处理人类受试者时,1979年经典的贝尔蒙特报告中阐述的基本伦理原则已被所有人接受(1)。根据我们的经验,我们相信美国心脏病学会基金会(ACCF)和美国心脏协会(AHA)的成员和工作人员努力为社会和患者做“好事”。在绝大多数情况下,他们把病人的利益放在第一位,高于自己的利益。在美国,几乎每天都有数十万例患者与HCP的接触。假设HCP正在尽最大努力使患者受益,即使结局不是最佳或疾病进展无法得到有效治疗。尽管有最好的意图,治疗的并发症还是会发生。临床科学家和医疗行业开发新的疗法来改善心血管疾病患者的生活,在过去的几年里,社会已经看到了这一努力的好处。该系统中的一切都运行良好,直到或除非HCP的利益与患者的利益之间的冲突导致伤害患者的行为。然后,假设已经违反了尊重的患者-HCP信任。在许多现代情况下,HCP的个人利益可能与患者的利益不一致。在这些情况下,HCP必须做出伦理选择。示例包括:
Richard L. Popp, MD, MACC, FAHA, Co-Chair Sidney C. Smith, JR, MD, FACC, FAHA, Co-ChairThe health care professions have always enjoyed special trust and position in our society. Patients trust health care professionals (HCPs) to guard their health, inform them, and put a patient’s interests above any other consideration. This is one definition of “professionalism.” When HCPs deal with human subjects in research there are basic ethical principles, articulated in the classic Belmont Report of 1979, that have been accepted by all (1). We believe from our experience that the members and staff of the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) strive to do “good” for society in general and for patients specifically. They put patients’ interests first, above their own, in an overwhelming majority of situations. There are virtually hundreds of thousands of patient-HCP encounters daily in the US It is assumed that HCPs are trying their utmost to benefit their patients even when the outcome is not optimal or when disease progression cannot be effectively treated. Complications of therapy occur despite the best of intentions. Clinician-scientists and the medical industry develop new therapies to improve the lives of patients living with cardiovascular disease, and society has seen the benefits of this effort over the past several years. Everything in this system works well until or unless a conflict between the HCP’s interests and those of the patient results in actions that harm the patient. Then it is assumed that there has been a breach of that respected patient-HCP trust. Many modern situations exist in which the personal interest of the HCP may not be aligned with that of the patient. Ethical choices must be made by the HCP in these situations. Examples include: