隐私权和提高知识不是层次需求:数据保护和良好的流行病学标准 (DP_GOES) 检查清单用于使用二次数据的回顾性观察研究
Giovanni Corrao1,2,3, Marco Greco4, Olivia Leoni3
1Emeritus Professor in Medical Statistics, University of Milano-Bicocca, Milan, Italy.
研究人员制定了数据保护和良好流行病学标准 (DP_GOES) 检查清单,以确保在追溯观察研究中数据的伦理处理. 该工具将数据保护原则与流行病学标准相结合,以实现可靠可信的研究.
科学领域:
- 公共卫生和流行病学
- 医学伦理与研究治理医学伦理与研究治理
背景情况:
- 像纽伦堡法典这样的历史指导方针为人类研究制定了伦理标准.
- 使用二次数据 (注册,数据库) 的回顾性观察研究越来越普遍.
- 现有的指导方针往往忽视了这些研究中数据保护和访问的关键方面.
研究的目的:
- 引入数据保护和良好流行病学标准 (DP_GOES) 清单.
- 为开发和评估使用二次数据进行回顾性观察研究的协议提供一个工具.
- 确保遵守监管要求和数据保护原则,同时促进可靠的证据生成.
主要方法:
- 开发DP_GOES检查清单,包括四部分,九个部分和68个项目.
- 该清单系统地将流行病学研究标准与数据保护原则相结合.
- 它作为研究人员和评估人员的结构化工具.
主要成果:
- DP_GOES检查清单提供了一个全面的框架来评估研究方案.
- 它有助于验证遵守监管要求和数据保护条款.
- 检查清单有助于为促进健康和改善医疗保健提供可靠的证据.
结论:
- DP_GOES检查清单是回顾性观察研究的新和整合性工具.
- 它提高了涉及二次数据的研究的严谨性,透明度和伦理可接受性.
- 这个检查清单支持生成更好的医疗保健系统的强有力的证据.
更多相关视频
10:46A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
10:38Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
相关概念视频
Observational Studies
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Introduction to Epidemiology
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Statistical Methods for Analyzing Epidemiological Data
Data Collection by Observations
An astronomer viewing the motion and brightness of stars in the sky and recording the data is an example of observational data collection. A botanist recording...
