Tyrer P, Seivewright H, Ferguson B, Johnson T
Department of Psychological Medicine, Division of Neuroscience and Psychological Medicine, Imperial College School of Science, Technology and Medicine, London, UK.
J Med Ethics. 2003 Aug;29(4):238-42. doi: 10.1136/jme.29.4.238.
The ethics of cold calling-visiting subjects at home without prior appointment agreed-in follow up research studies has received little attention although it is perceived to be quite common. We examined the ethical implications of cold calling in a study of subjects with defined neurotic disorders followed up 12 years after initial assessment carried out to determine outcome in terms of symptoms, social functioning, and contact with health services. The patients concerned were asked at original assessment if they would agree to be followed up subsequently and although they agreed no time limit was put on this.
To decide if cold calling was ethically justifiable and, if so, to set guidelines for researchers.
The study was a cohort study of patients with neurotic disorder treated initially for 10 weeks in a randomised controlled trial.
At follow up by a research medical practitioner 18 of the 210 patients had died and of the remaining 192 patients 186 (97%) were seen or had a telephone interview. Four patients refused and two others did not have interviews but agreed to some data being obtained. However, only 104 patients (54%) responded to letters inviting them to make an appointment or to refuse contact and the remainder were followed up by cold calling, with most patients agreeing readily to the research interview. The findings illustrate the dilemma of the need to get the maximum possible data from such studies to achieve scientific validity (and thereby justify the ethics of the study) and the protection of subjects' privacy and autonomy.
More attention needs to be paid to consent procedures if cold calling is to be defended on ethical grounds but it is unreasonable to expect this to be obtained at the beginning of a research study in a way that satisfies the requirements for informed consent. A suggested way forward is to obtain written consent for the research at the time that cold calling takes place before beginning the research.
在后续研究中未经事先预约就登门拜访受试者这一“突然拜访”的伦理问题，尽管被认为相当普遍，但却很少受到关注。在一项对患有特定神经症的受试者进行的研究中，我们探讨了突然拜访的伦理影响。该研究是在首次评估12年后进行随访，以确定症状、社会功能以及与医疗服务接触方面的结果。在最初评估时询问了相关患者是否同意随后接受随访，尽管他们表示同意，但并未设定时间限制。
确定突然拜访在伦理上是否合理，若合理，则为研究人员制定指导方针。
该研究是一项队列研究，研究对象是在一项随机对照试验中最初接受了10周治疗的神经症患者。
在由一名研究医生进行随访时，210名患者中有18名已经死亡，在其余192名患者中，186名（97%）接受了当面访谈或电话访谈。4名患者拒绝，另外两名未接受访谈，但同意获取一些数据。然而，只有104名患者（54%）回复了邀请他们预约或拒绝联系的信件，其余患者通过突然拜访进行随访，大多数患者欣然同意接受研究访谈。这些结果说明了从这类研究中获取尽可能多的数据以实现科学有效性（从而证明研究伦理的合理性）与保护受试者隐私和自主权之间的困境。
如果要从伦理角度为突然拜访辩护，就需要更多地关注同意程序，但期望在研究开始时以满足知情同意要求的方式获得同意是不合理的。一个建议的前进方向是在突然拜访进行时、研究开始前获得研究的书面同意。
