Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis.
OBJECTIVE
To evaluate the informed consent process for a clinical trial of intravenous doxycycline for rheumatoid arthritis.


METHODS
Participants completed a self-administered questionnaire about the consent process at baseline and 16 weeks following enrollment in a clinical trial.


RESULTS
Respondents (n = 30) affirmed voluntary participation in the parent trial. Participants acknowledged hope and altruism as reasons for entering the trial more than expectation of personal benefit or outside influences. Many respondents did not understand randomization (14/30), placebos (15/30), or risks of study medications; 11/30 respondents believed that the study drug was completely safe.


CONCLUSIONS
Respondents generally understood the experimental nature of the trial and confirmed their participation was voluntary. However, gaps existed in participants understanding of trial design, raising the question of whether they were adequately informed about the research study prior to enrollment. Further education of potential participants in clinical trials may be required to achieve valid informed consent.
Criscione
Lisa G
LG
Duke University Medical Center, Durham, North Carolina 27710, USA.
Sugarman
Jeremy
J
Sanders
Linda
L
Pisetsky
David S
DS
St Clair
E William
EW
D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D032882:Comprehension; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007258:Informed Consent; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D011795:Surveys and Questionnaires; D014836:Volition
D018501:Antirheumatic Agents; D004318:Doxycycline