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GDPR is a comprehensive data privacy law enacted by the European Union in May 2018.
Its primary aim is to protect the personal data of EU citizens and ensure their privacy rights.
In clinical research, GDPR has significant implications as it regulates how personal data is collected, stored, and used.
GDPR has influenced data privacy regulations in the USA, prompting American organizations to enhance their data protection measures to comply with GDPR standards.
This has led to increased emphasis on data privacy and security across the board in the USA, encouraging the development of similar legislative measures to safeguard personal information.
GDPR is a comprehensive data privacy law enacted by the European Union in May 2018.
Its primary aim is to protect the personal data of EU citizens and ensure their privacy rights. In clinical research, GDPR has significant implications as it regulates how personal data is collected, stored, and used.
GDPR has influenced data privacy regulations in the USA, prompting American organizations to enhance their data protection measures to comply with GDPR standards. This has led to increased emphasis on data privacy and security across the board in the USA, encouraging the development of similar legislative measures to safeguard personal information.
‣ Consent: Researchers must obtain explicit and informed consent from participants for the collection and processing of their personal data. This consent must be freely given, specific, informed, and unambiguous.
‣ Data Minimization: Only the minimum necessary data should be collected for the purposes of the research. This principle aims to reduce the risk of data breaches and misuse.
‣ Anonymization: To protect participants’ identities, data should be anonymized (removing all identifying information). These measures help to maintain privacy while allowing researchers to work with the data.
‣ Transparency: Researchers must be transparent about how they use participants’ data. Participants have the right to know how their data is being processed, who is processing it, and for what purpose.
‣ Data Subject Rights: Participants have several rights under GDPR, including the right to access their data, the right to correct inaccuracies, the right to data portability, and the right to request the deletion of their data.
‣ Accountability and Compliance: Organizations conducting clinical research must implement appropriate technical and organizational measures to ensure GDPR compliance. This includes maintaining records of data processing activities and conducting data protection impact assessments (DPIAs) for high-risk processing.
‣ Data Breaches: In the event of a data breach, organizations must report it to the relevant supervisory authority within 72 hours and inform the affected individuals if the breach poses a high risk to their rights and freedoms.
