Recommendations for implementation of community consultation and public disclosure under the food and drug administration's "Exception from informed consent requirements for emergency research" - A special report from the American heart association emergency cardiovascular care committee and council on cardiopulmonary, perioperative and critical care
Recommendations for implementation of community consultation and public disclosure under the food and drug administration's "Exception from informed consent requirements for emergency research" - A special report from the American heart association emergency cardiovascular care committee and council on cardiopulmonary, perioperative and critical care
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DOI：
10.1161/circulationaha.107.186661
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发表时间：
2007-10-16
期刊：
影响因子：
37.8
通讯作者：
Peberdy, Mary Ann
中科院分区：
文献类型：
--
作者：
Halperin, Henry;Paradis, Norman;Peberdy, Mary Ann
研究的进行：尊重人，慈善和正义。该报告还提供了IRB用于评估个别研究提案的伦理标准的要素。贝尔蒙特报告和赫尔辛基宣言中提出的伦理原则在国际医学组织理事会最近出版的准则中得到了扩展和澄清，8特别是在提供在当地情况下适用伦理标准的准则方面。在对危及生命的紧急情况进行干预的研究中出现了一个困境，如心脏骤停、包括中风在内的神经系统紧急情况以及一些重大创伤的情况。在这些情况下，潜在受试者可能有资格参加研究，但由于意识受损、认知严重改变或失语症而无法提供前瞻性知情同意。通常，在这种研究方案中，受试者必须立即登记，以便在不可逆的器官损伤发生之前，实验干预的潜在生理效应可以最大化。9，10 FDA将“治疗窗”定义为“基于现有科学证据的时间段，在此期间，供试品的给药可能合理地产生可证实的临床效应”。11，12对于危及生命的紧急情况的研究来说，这个治疗窗口是有限的或实际上不存在的。通常没有时间寻求合法授权的患者代表进行披露和同意。此外，在这种紧急情况下的同意可能不符合知情同意的标准，因为研究者几乎没有时间解释研究，患者代表也几乎没有时间评估各种可用的治疗方案。13.此外，病人代表的情绪状态可能会消除客观反映情况的可能性。在儿科人群中获得知情同意尤其困难，研究表明，“诊断带来的情感创伤降低了母亲吸收和理解重要信息的能力，而儿童病情的紧急性和紧急性也降低了母亲吸收和理解重要信息的能力。”开始治疗进一步损害了知情同意。”14
conduct of studies: respect for persons, beneficence, and justice. The report also provides elements used by IRBs to evaluate the ethical standards for individual research proposals. The ethical principles presented in both the Belmont Report and the Declaration of Helsinki have been expanded and clarified in the most recent guidelines published by the Council for International Organizations of Medical Sciences, 8 especially with regard to the provision of guidelines for the application of ethical standards in local circumstances. A dilemma arises in research studies of interventions for life-threatening emergencies, such as cardiac arrest, neurological emergencies including stroke, and some instances of major trauma. In these circumstances, a potential subject may be eligible for a research study but be unable to give prospective consent owing to impaired consciousness, severe alteration in cognition, or aphasia. Often with such research protocols, the subject must be enrolled immediately so that the potential physiological effects of the experimental intervention can be maximized before the onset of irreversible organ damage. 9, 10The FDA defines the “therapeutic window” as “the time period, based on available scientific evidence, during which administration of the test article might reasonably produce a demonstrable clinical effect.” 11, 12 It is this therapeutic window that is limited or effectively nonexistent for research studies of life-threatening emergencies. There generally is not time to seek out a legally authorized patient representative for disclosure and consent. In addition, consent under such emergency circumstances may not meet the standards of informed consent, because there is little time for the investigator to explain the study, and little time for the patient representative to assess the various treatment options available. 13 In addition, the emotional state of the patient representative may eliminate the possibility of reflecting objectively on the situation. It is especially difficult to obtain informed consent in pediatric populations, in which it has been shown that “the emotional trauma of the diagnosis decreases a mother’s ability to absorb and understand vital information, and the emergent nature of the children’s condition and the urgency to begin treatment further compromise informed consent.” 14