Understanding and informed consent in longitudinal studies : what action we take when we have reason to believe subjects lack sufficient understanding?

• Taking the point of departure in empirical research data we discuss what action should we take when we are uncertain of to what extent participants in a prospective, longitudinal screening for pre-diabetes lack sufficient understanding?The empirical case study showed that, on one hand, an overall majority of respondents reported being satisfied with the information in several respects, but, on the other hand their knowledge and comprehension of aim, purpose and potential benefit varied widely to the extent that doubt must be put as to whether they have sufficient understanding. In this situation we need criteria or guidance as to what constitutes a sufficient understanding. A brief sutvey of ethical codes and ethical theory show, we argue, that while they enumerate some important items that the subject should be informed about, like aims, methods, anticipated benefits and potential risks, nothing substantial is said that can guide us as to what the meaning of "a sufficient understanding" is. The second question concems what is then the ethically right thing to dor We propose we have five possible alternatives: a), we can ignore the data, b), we can exclude individuals who lack sufficient understanding, c) we can give complementary information, without renewed consent, d), inform and ask for a renewed consent, and finally we can ask participants if they want to increase their understanding. We conclude that due to the ethical problems involved in screening and genetic testing of children, there is a need to develop theories or principles for guidance.

Nyckelord

MEDICINE

MEDICIN

Publikations- och innehållstyp

vet (ämneskategori)

ovr (ämneskategori)