修改知情同意以帮助解决在迷幻临床试验中的功能性揭露问题
Michelle Matvey1, D Parker Kelley1,2, Ellen R Bradley1,3
1Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco.
JAMA psychiatry
|January 8, 2025
概括
在迷幻药试验中修改知情同意可能会改善研究掩盖,但会带来伦理风险. 需要仔细实施,以平衡科学严谨性与心理研究参与者的安全性.
科学领域:
- 心理药理学 心理药理学
- 临床试验方法论 临床试验方法论
- 神经科学是一个神经科学.
背景情况:
- 越来越多的人对精神疾病的迷幻疗法感兴趣.
- 由于药物效应,在迷幻临床试验中使参与者失明的挑战.
- 不有效的掩盖可以导致研究结果偏差,并使有效性评估复杂化.
研究的目的:
- 探索修改知情同意程序,以改善在迷幻药试验中的参与者盲目化.
- 调查心理研究中改变知情同意的使用和伦理影响.
- 解决在迷幻药物开发中无效掩饰的方法学挑战.
主要方法:
- 审查当代 (2000-2024) 临床试验,涉及迷幻或甲基二氧化甲胺 (MDMA) 治疗.
- 与试验调查人员的通信,以收集有关知情同意修改的数据.
- 分析与修改知情同意相关的伦理风险和监管考虑因素.
主要成果:
- 在几次迷幻药试验中,对知情同意的修改被用来增强掩饰.
- 这种方法给参与者带来了重大的伦理挑战和风险.
- 检查了修改的例子,监管背景和风险减轻策略.
结论:
- 经过修改的知情同意可能会提高幻觉临床试验的解释性.
- 修改同意的有效性和适当性需要进一步测试.
- 缓解策略和仔细考虑道德风险对于在迷幻研究中实施修改知情同意至关重要.
相关概念视频
01:11Blinding
2.4K
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.
2.4K
01:06Altered States of Awareness
147
Altered states of consciousness represent significant deviations from one's normal mental state. These deviations can range from subtle changes in awareness to profound transformations in perception, thought processes, and sensory experiences. Altered states of consciousness can be triggered by various factors, including drug use, meditation, hypnosis, illness, or even intense fatigue.
The ingestion of substances like stimulants or hallucinogens leads to chemical alterations in the brain...
The ingestion of substances like stimulants or hallucinogens leads to chemical alterations in the brain...
147
01:56Ethics in Research
22.9K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
22.9K
02:07Blind 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
01:27Hallucinogens and Psychedelics
156
Hallucinogens are psychoactive substances that profoundly alter perceptual experiences, generating unreal visual and sensory images. Often referred to as psychedelic drugs — a term derived from the Greek words "psyche" (mind) and "delos" (revealing) — these substances include marijuana and lysergic acid diethylamide (LSD), among others. These drugs vary in intensity and effects.
Marijuana, derived from the dried leaves and flowers of the hemp plant, contains...
Marijuana, derived from the dried leaves and flowers of the hemp plant, contains...
156
01:22CNS Stimulants: Psychedelic Agents
123
Hallucinogens, also known as psychedelic drugs, are a class of substances known for their ability to alter perception, cognition, and emotions. Despite their profound effects on the mind, these drugs are non-addictive, setting them apart from many other abused substances. The mechanism of action of these drugs lies in their impact on the 5-HT2A receptor in the brain. Upon activation, this receptor couples to Gq-type G proteins, triggering a cascade that releases intracellular calcium. This...
123