A global pharmaceutical company is developing a new drug. The research and development (R&D) process involves extensive clinical trials, requiring the collection and analysis of highly sensitive patient data across multiple jurisdictions with varying data privacy laws. The board is concerned about potential legal and reputational risks. Which of the following is the MOST important action for the CRISC professional to ensure ethical due diligence in data handling?
- AObtain explicit, informed consent from all trial participants for data sharing and usage.
- BConduct regular audits of data handling practices to ensure compliance with legal and regulatory requirements.
- CImplement robust technical controls such as encryption and access management for all patient data.
- DEstablish a comprehensive data governance framework that includes ethical guidelines for data collection, use, and retention.
Show answer & explanationAnswer & explanation
Correct answer: D. Establish a comprehensive data governance framework that includes ethical guidelines for data collection, use, and retention.
Establishing a comprehensive data governance framework that includes specific ethical guidelines provides the overarching structure and principles for responsible data handling. This framework will guide all technical controls, consent processes, and audit activities, ensuring a holistic and proactive approach to ethical due diligence.
Why the other options are wrong
- A. Informed consent is a critical component of ethical data collection but is only one piece of the broader ethical due diligence puzzle; it doesn't cover the entire lifecycle of data use and retention.
- B. Regular audits are important for verifying compliance, but they are a monitoring activity within a larger framework. They don't establish the ethical principles or proactive design of data handling practices.
- C. Technical controls are essential but are reactive measures. A framework provides the proactive ethical principles that guide the implementation of such controls.
Ethical Data Governance Framework
A structured system of policies, processes, and responsibilities that ensures data is managed, used, and protected in an ethically responsible manner throughout its lifecycle, beyond mere legal compliance.
- Guides all data handling decisions.
- Integrates ethics into data lifecycle.
- Proactive and comprehensive approach.
Memory trick: Govern data ethically, from its birth to its grave.