How can you ensure informed consent when sharing or processing data for research or innovation?

1 What is informed consent?

Informed consent is the voluntary and explicit agreement of a data subject or provider to allow their data to be used for a specific purpose, based on adequate information and understanding of the risks and benefits. Informed consent is a key principle of data ethics and data protection laws, such as the General Data Protection Regulation (GDPR) in the EU. It helps to protect the rights and interests of the data subjects or providers, and to foster trust and transparency in data sharing and processing.

2 Why is informed consent important?

Informed consent is important for several reasons. First, it respects the autonomy and dignity of the data subjects or providers, who have the right to decide how their data is used and who can access it. Second, it ensures that the data is used in a lawful, fair, and ethical manner, and that the data subjects or providers are aware of the potential impacts and outcomes of the data sharing or processing. Third, it reduces the risk of data breaches, misuse, or harm, and enhances the accountability and responsibility of the data users or processors.

5 What are the challenges and limitations of informed consent?

Informed consent is not a perfect or foolproof solution for data sharing or processing, and it may face some challenges and limitations in practice. For example, some data subjects or providers may not have the capacity, literacy, or awareness to understand or exercise their consent, or they may be coerced, manipulated, or deceived by the data users or processors. Some data sharing or processing may involve large-scale, complex, or dynamic data sets or systems, such as big data, artificial intelligence, or blockchain, that may make it difficult or impractical to obtain or maintain informed consent. Some data sharing or processing may have unforeseen or unintended consequences or impacts, such as discrimination, bias, or harm, that may not be fully disclosed or anticipated by the data users or processors or the data subjects or providers.

6 How to overcome the challenges and limitations of informed consent?

To overcome the challenges and limitations of informed consent, you should adopt a holistic and proactive approach to data ethics and governance, and complement informed consent with other principles and practices, such as data minimization, data quality, data security, data accountability, and data stewardship. You should also engage with the data subjects or providers, and other relevant stakeholders, such as regulators, researchers, or civil society, to co-design and co-implement the data sharing or processing, and to address any ethical or legal dilemmas or trade-offs that may arise. You should also follow the relevant standards and guidelines, such as the FAIR principles, the OECD principles, or the EDPS ethics framework, to ensure that your data sharing or processing is findable, accessible, interoperable, reusable, beneficial, responsible, and trustworthy.