The key way in which the adequacy of research governance was signalled was through the process of providing consent. The ways in which personal data were handled, the care that was afforded to guarantees of anonymisation, the handling of sensitive material and the security of databases, were also diagnostic of whether research governance was working well and could be trusted. Of least importance were the models of governance themselves. Which structures of governance were in place made little difference to participants’ willingness to participate in biomedical research. They played a limited role in participants’ constructions of what constituted ‘proof’ that governance was working or in providing reassurance in the face of concern. It was rather the outward manifestation via material ‘proofs’, such as seeking explicit consent, for example, that signalled that governance was working…
[R]ights over personal information with regard to issues of consent are invariably viewed as related; it is not enough to identify what personal data means but rather what people decide they will or will not allow with regard to that information. Strongly related to this are concerns about the use, storage, access, and protection of personal data via different types of databases. Discussions invariably alluded to a combination of these topics whereby one would impinge on the other. For example, a discussion about sensitive personal information would also bring in issues about storage or third-party access. Personal information is subsequently linked to the topic models of governance because the handling and protection of this information are the outward signals that mechanisms are functioning, thereby offering the necessary assurances…
There was strong agreement across all the groups that explicitly being asked for their consent to take part in biomedical research was a good thing. Even those that were very positive about taking part in biomedical research, and would readily give consent, stressed the importance of the consent-seeking process. There was some variation in how stringent the consent requirements were for different types of research: the most minimal consent procedures were required for routine compilation and analysis of statistics.
Implied consent was not welcomed as a model of the consent process. Implied consent was equated to no consent.
Friday, July 20, 2007
Consent is the signal of good research governance
Thanks to an Oxford colleague who sent me another fascinating piece of research on patient attitudes to research governance. Public Perspectives on the Governance of Biomedical Research: A qualitative study in a deliberative context, commissioned by the Wellcome Trust in 2006, has some strong conclusions on the necessity of explicit consent (pp.5—7):