The original context in which the samples and data are collected is associated with expectations and relationships that are understood both by researchers and participants.13
Researchers may feel a strong sense of responsibility for ‘their’ samples and feel a legal and moral responsibility for research participants that often extends beyond the original terms of consent. This responsibility may not be felt by secondary researchers who have no connection with the research participants, and see themselves as only dealing with data. While secondary researchers have an obligation to use data in a scientifically sound, ethical and lawful manner, these obligations are not the same as the researchers enrolling patients in a study. Informed consent forms, which try to be succinct, may not embody all of the expectations that are associated with enrolment in a study and an on-going clinical relationship, and may leave room for differing interpretations of the scope of consent.
In data-sharing policies, researchers are given the opportunity to justify why raw data should not be shared. Given their knowledge about the types of uses that may be made of data, based on the original consent, researchers are in a good position not only to decide on appropriate uses, but also to protect against possible misuse. In particular, when samples are collected and analysed as an extension to ongoing epidemiological work, cohort studies, or disease-specific work where the relationship develops in a clinical setting, the obligation to share genomic data may be perceived as an imposition on the relationships that have been built up between researchers and participants.
The challenge for funders is to ensure that this sense of stewardship is respected, by ensuring that new systems for sharing data acknowledge these perceived responsibilities. There is a danger that data sharing policies may be experienced as being punitive, or that those who feel uncertain about sharing may be characterised as obstructive and short-sighted. However, reluctance to share may have sound justifications. These claims should not be automatically dismissed as researchers being territorial. Such concerns cannot be ignored, as they can have practical as well as ethical implications in a project, where the trust and support of participants is vital. In addition, researchers who are perceived to be uncooperative could be excluded from key areas of activity, such as developing strategic policies and being involved in peer-review. Funding bodies must be prepared to consider the claims of those for whom data sharing, because of the nature of their research and situation, may create difficulties. At the moment, requests for exemption from data sharing are judged by funders but it may be better for this assessment to be made by bodies which are independent from considerations about future funding for the applicants.