Ruth Chadwick (Cardiff, Wales) led a discussion on issues of privacy and consent in genomic research. It is becoming impossible for medical researchers to guarantee privacy to the research participants they recruit - especially with the pressure from funding agencies who insist upon open-access archiving of genomic sequence data, as these data inevitably contain potentially identifying information. Indeed, it would now be misleading to promise privacy of personal genome information to research participants in exchange for consent to donate samples.
There are difficulties at the level of the technology (sample collection and storage, and data generation, storage and access) and the interpretation of information collected. It has been argued that the very concept of privacy will have to be renegotiated in the context of the rationale(s) for data sharing, especially at international level. Indeed, there has been a move from ‘traditional’ notions of informed consent to one of a broad consent and then to open consent. One must either strengthen the traditional practises of consent - ensuring that participants understand the difficulties of ensuring privacy before giving consent (while at the same time pursuing the data protection strategies that are possible) - or re-think the whole notion of privacy . In clinical practice, there may be recurrent difficulties when molecular studies of a malignancy, designed to guide therapeutics, thereby, also yield unwelcome information about prognosis or implications for close relatives . In the context of research, however, new forms of consent (e.g. broad consent taken online) may well be readily accepted . One approach is for the researcher to move from guaranteeing (and so protecting) privacy to practising veracity, explaining to potential participants that their data will be accessed by, and shared with, others; those consenting to research have to be open to this .
Those participating in ‘personal genomics’ would be deluding themselves if they thought that privacy was still possible once their genome sequences became accessible online [58, 59]). This is the age of bioinformatics, surveillance, Facebook and Twitter. There is inevitably a risk of personal consequences for research participants when their data are released. These will take different forms under different circumstances. Access to health care may become more difficult in countries without state health care or universal and compulsory health insurance, as when health care is made available through commercial insurance schemes. In addition, if information about other family members becomes available, then biological family relationships might be shown to differ from the pattern of social relationships presented in public (e.g. paternity may have been misattributed).
One perspective reveals a clash of research cultures: molecular scientists (who seek instant open access to all data to maximise the scientific - and perhaps commercial - exploitation of the data) and the clinicians (who are often more insistent upon protecting their patients and more modest in their assessment of the likely short-term benefits to the participants, and other patients, of the research itself).
One key notion is that of the acceptable uses for research data. Participants tend to trust ‘the system’ to use their data in a ‘good’ way. The system of research governance is designed (in part) to ensure that such trust is warranted - although the system of governance also serves other, more institutional purposes. The prospect of internet-based marketing corporations using access to research data and to electronic health records as an opportunity to market more products seems both manipulative and cynical.
The concept of ‘consent’ is also problematic in ways unrelated to the concept of privacy. As Raymond explained, families participating in research studies could allow their genuine altruism to lead them to sign the research consent forms because their thoroughly worthy impulses blinded them to the potential for problems to arise from participation. Such problems might include results of uncertain significance, which may remain difficult to interpret for many years or whose significance might only be clarified through the performance of family studies that could be confusing or distressing; even with such family studies, the significance of the results may remain opaque. If the reasons underlying the importance and relevance of consent to research were explained, then many families might decline participation.
One response to these possibilities has been the suggestion that a solution should be found through information technology itself, with the development of a system of ‘data enclaves’, within which researchers can utilise data in a predefined analysis but from which they cannot export any data about individuals - only aggregate data and the derived results of analysis.