In the context of open science, which emphasizes transparency, collaboration, and data sharing, there are new risks to human research participants, particularly concerning privacy. Open science practices in health and life sciences might involve sharing detailed datasets, including personal health information, genetic data, and medical images. Inadequate anonymization can compromise participant privacy. Moreover, even with anonymization, the risk of re-identification sometimes persists, especially when integrating datasets or employing advanced analytics, potentially revealing identities unintentionally.

Ensuring respect for autonomy and privacy in open science may necessitate novel approaches to participant engagement and consent. For example, informed consent should include information about sharing data in open access and acknowledge the limitations around withdrawing data once shared or controlling its subsequent use, which might be unforeseeable at the time of data collection. Researchers must recognise the complexities of obtaining informed consent in open science, as participants often maintain ongoing interests in how their data is used, including concerns over potential misuse. For instance, participants might consent to their health data being used for broad health research but object to its use in studies sponsored by industries they disagree with (Holm, 2006). Participants may not fully grasp the extent of data sharing, and this may lead to a decrease in trust. They might be unaware of potential secondary uses of their data, raising issues about misuse and loss of control. Concerns might also arise over the direct benefits of data sharing, especially if they perceive the advantages as skewed towards researchers or institutions rather than the broader community or themselves. 

ROSiE General Guidelines on Responsible Open Science point to the responsibilities of different stakeholders to ensure research participants' rights:

3.1. Research participants' autonomy, dignity, and other rights should always be respected. In an open science environment, alternative modes of engagement and consent might have to be considered and ethically reflected on by researchers and research ethics committees.
3.2. Informed consent forms and procedures should include at a minimum, information on open science practices, privacy protection, limitations, and risks of reidentification. Researchers should ensure that informed consent processes ensure understanding among the research participants.
3.3. Protecting the privacy and control interests of research participants and their communities is essential in an open data environment. Researchers, research ethics committees, Research Performing Organisations, and policymakers should analyse the risks of reidentification and dual use in different fields and develop governance mechanisms and technical solutions to address these risks. Exploring other approaches to protect privacy, other than anonymization, is increasingly becoming important and is thus recommended.

To mitigate the risks, health and life science researchers must prioritize ethical considerations, provide clear and transparent participant information, employ stringent anonymization methods, and comply with data protection and privacy standards. Striking a balance between open science principles and the protection of participant rights and privacy is essential for ethical research practice.

References

1. Holm, S. (2006). Who should control the use of human embryonic stem cell lines: A defence of the donors' ability to control. Journal of Bioethical Inquiry, 3, 55-68. https://doi.org/10.1007/s11673-006-9004-7