Assessing the ethics of medical research in emergency settings: How do international regulations work in practice?
Assessing the ethics of medical research in emergency settings: How do international regulations work in practice?
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DOI：
10.1007/s11948-007-9026-5
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发表时间：
2007-09-01
影响因子：
3.7
通讯作者：
Halila, Ritva
中科院分区：
文献类型：
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作者：
Halila, Ritva
不同的伦理原则在应急研究中相互冲突。临床护理及其发展应以研究为基础。临床情况危急的病人最需要更好的药物。患者的危急情况和关键时期患者代表的缺席使得在试验开始前请求知情同意变得困难，有时甚至不可能。在紧急情况下，必须在短时间内作出护理决定，浪费的时间越多，死亡或严重组织损伤和丧失能力的风险就越大。征得同意需要时间，因此治疗前的这段时间可能会危及患者的生命。在审判前不征求同意也是矛盾的。一个人不应该被强迫违背他或她的意愿参加审判。由于以往医学研究的黑暗历史，国际宣言和公约为医学研究确立了伦理原则。他们强调研究参与者——或其法律代表——在研究开始前给予自由和知情同意的自主权。在严重的紧急情况下，病人的无意识状态、家庭成员的情绪压力或没有时间开始维持生命的措施，往往会限制与病人或其代表进行沟通的可能性。因此，书面知情同意很难实现，其在紧急情况下的自愿性充其量是有疑问的。在急诊研究中，缺乏临床干预的患者死亡率很高。随机选择病人是困难的，需要急诊室人员的额外工作。招募、提供信息和征求同意也可能需要时间，推迟开始治疗，增加死亡和不可逆转的组织和器官损伤的风险，因此对患者有风险。因此，招募合适的研究参与者的卫生保健专业人员必须有良好的积极性和良好的训练。紧急情况下的医学研究应始终被视为需要特别规定的特殊情况。只有在其他条件下不能做的研究才应该做。一个独立的机构必须批准研究方案，以及寻求参与者或代理人同意的方式。此外，试验必须预期会给研究参与者带来直接和显著的好处。如果未经事先同意的研究不被批准，急诊护理的发展将受到威胁。另一方面，如果不需要事先同意，一个人可能会违背他或她的意愿被招募参加临床试验。在急诊医学研究的背景下，善与避，尊重病人的自主权是冲突的。为了给遇到急症的病人开发更好的药物，应该允许对这种情况进行研究。研究参与者应该有可能参加或拒绝参加可能对他们和其他患者有益的研究。由于拖延征求同意而造成不可逆转损害的风险是不可接受的。如果事先知道参加临床试验的意愿，应予以尊重。可以在国家和国际上确定并商定紧急情况下医学研究可以接受的条件。
Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient's life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant-or his or her legal representative-to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally.