Informed consent: too much information

The principle of informed consent was one of the fundamentals of the Ethics Committee’s ‘constitution’, as termed by Elizabeth Mumford. At the very first Committee meeting, Michael Furmston outlined what he felt were the central questions: Although the Committee’s minutes state ‘Naturally the mother should be asked to give consent to her own participation in the study’,1 when the process of enrolment was described by Professor Golding at the same meeting, it was agreed that a consent form as such was not necessary: It is doubtful that it would be acceptable now to enrol participants without written consent, although whether this would comprise a risk to patients is dubious. The return of self-completion questionnaires continues to be considered acceptable as ‘implied consent’. At that time, self-completion questionnaires and biological samples were the only suggested methods of data collection for ALSPAC, with written consent strictly observed before any analyses of biological samples.