Funder(s): Wellcome Trust and The Medical Research Council
MI Researcher(s): Graeme Laurie
‘Reconsent to research: views of participants’ is a collaborative project with colleagues at the University of Leicester. The project is led overall by Prof Mary Dixon-Woods at Leicester. Professor Graeme Laurie and Emily Postan are leading the legal and ethical input to the study along with Dr Susan Wallace at Leicester.
The aim of the study is for the team from the University of Leicester to conduct qualitative empirical research to investigate research participants’ views on the use of their data and tissues which they have donated for research purposes. There are several angles within this – (i) what do participants understand any conditions set by the terms of their consent forms to mean – for example, if these offer assurance that donations will only be used for non-commercial or medical research (ii) how amenable are participants to reinterpretation of these terms or what kind of re-consent practices would they like to see if proposed research uses change and (iii) participants’ views on commercial uses of personal data and tissues they have donated for research in light of the kinds of interests they view themselves as having in these.
The research conducted by Professor Laurie and his team is to provide a solid legal and ethical foundation on which the protocol and interview guide for the empirical work will be based. Hitherto, the focus of this research has been the question of the legal status of consent forms signed by research participants. That is, when and how might the terms of a consent form impose legal obligations on researchers limiting what kinds of research they may conduct and what legal remedies are available to participants if excluded research purposes are pursued. They have investigated three possibilities: (i) the consent form as a regulatory requirement; (ii) the consent form as a pseudo-contractual basis for the allocation of property rights; and (iii) the consent form as the basis for actions protecting personal autonomy.
The next steps in the ethico-legal strand of this project are likely to involve an investigation how the possible interests of participants in tissues they have donated for research purposes (for example in terms of property and self-determination) compare with what the current legal situation is in terms of who has property rights over donated tissues and the products, including IP, derived from these, and any legally recognised claim to resultant commercial benefits.