Ulysses contracts for the doctor and for the patient.
Research subjects participating in randomised clinical trials have a right to drop out of a study without specifying any reason for this. However, leaving a trial may be contradictory to their own general interests in medical research since drop outs may lead to biased conclusions and loss of valuable medical information. We suggest in this paper that self-binding "Ulysses contracts" that are non-exploitative and based on autonomous decisions by research subjects as well as by investigating doctors should be implemented with stopping rules adjusted to the needs of different kinds of randomised clinical trials.
Hansson
Mats G
MG
Centre for Research Ethics and Bioethics at Uppsala University, Dept of Public Health and Caring Sciences, PO Box 563, SE-751 22 Uppsala Universitet, Sweden. Mats.Hansson@crb.uu.se
Hakama
Matti
M
D032982:Contracts / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005060:Europe; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010352:Patient Dropouts / Q000331:legislation & jurisprudence; D026684:Personal Autonomy; D010817:Physician-Patient Relations; D016032:Randomized Controlled Trials as Topic; D012108:Research Personnel / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence; D015983:Selection Bias; D035502:Trust