父母对一项使用在出生时放弃知情同意的试验的观点
Anup C Katheria1, Georg M Schmölzer2, Brenda Law2
1Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA. anup.katheria@sharp.com.
概括
大多数家长发现,在新生儿研究中使用放弃同意的做法是可以接受的. 他们报告说,他们理解信息,对这个过程感到舒服,对孩子的健康几乎没有担心.
科学领域:
- 新生儿研究伦理学
- 儿科临床试验儿童临床试验
- 在研究中获得知情同意.
背景情况:
- 豁免同意有时用于新生儿研究,以促进及时招生.
- 对于伦理研究实践来说,父母对豁免同意的观点至关重要.
- 了解父母的接受是完善同意程序的关键.
研究的目的:
- 在新生儿研究试验中评估父母对放弃同意的接受程度.
- 为了评估父母的理解和舒适度与放弃同意程序.
- 收集关于放弃同意对父母对新生儿研究观点的影响的反.
主要方法:
- 匿名调查对在未经同意的情况下注册的婴儿的亲生父母进行了匿名调查.
- 数据收集发生在婴儿出院后,以确保隐私并减少研究的直接影响.
- 对调查答案的定量分析评估了可接受性,舒适性,理解和感知到的健康影响.
主要成果:
- 高比例的家长 (92%) 认为,在新生儿研究中,放弃同意是可以接受的.
- 大多数家长 (96%) 表示,他们对未来在类似条件下的参与感到满意.
- 大多数 (91%) 报告对研究信息有充分的理解,并有足够的时间进行考虑.
- 少数人 (4%) 对这项研究对孩子健康的影响持负面看法.
结论:
- 使用放弃同意的研究设计在新生儿时期对回答的父母来说在很大程度上是可以接受的.
- 父母对研究过程的看法是积极的,对孩子健康的担忧很小.
- 建议进行进一步的研究,以探索各种各样的家长参与和替代儿科同意方法.
相关概念视频
Nurses' Legal Responsibilities I
748
In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
The legal responsibilities of a nurse regarding informed consent include the following:
748
Ethical Dilemmas I
919
Ethical dilemmas in nursing are of utmost importance, as they often arise from the tension between adhering to core ethical principles and the practical realities of healthcare delivery. These dilemmas require nurses to navigate complex situations where competing ethical considerations pull them in different directions.
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
919
Blinding
2.5K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
2.5K
Milgram's Obedience to Authority
6.4K
Obedience to authority is classically demonstrated in a more famous series of social psychology experiments performed by Stanley Milgram. He was a social psychology professor at Yale who was influenced by the trial of Adolf Eichmann, a Nazi war criminal. Eichmann’s defense for the atrocities he committed was that he was “just following orders.”
6.4K
Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K
Obedience
32.9K
According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...
32.9K


