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Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis.

Publication ,  Journal Article
Criscione, LG; Sugarman, J; Sanders, L; Pisetsky, DS; St Clair, EW
Published in: Arthritis Rheum
June 15, 2003

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. CONCLUSION: 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.

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Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

June 15, 2003

Volume

49

Issue

3

Start / End Page

361 / 367

Location

United States

Related Subject Headings

  • Volition
  • Surveys and Questionnaires
  • Research Design
  • Randomized Controlled Trials as Topic
  • Prospective Studies
  • Pilot Projects
  • Middle Aged
  • Male
  • Injections, Intravenous
  • Informed Consent
 

Citation

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ICMJE
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Criscione, L. G., Sugarman, J., Sanders, L., Pisetsky, D. S., & St Clair, E. W. (2003). Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum, 49(3), 361–367. https://doi.org/10.1002/art.11057
Criscione, Lisa G., Jeremy Sugarman, Linda Sanders, David S. Pisetsky, and E William St Clair. “Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis.Arthritis Rheum 49, no. 3 (June 15, 2003): 361–67. https://doi.org/10.1002/art.11057.
Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003 Jun 15;49(3):361–7.
Criscione, Lisa G., et al. “Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis.Arthritis Rheum, vol. 49, no. 3, June 2003, pp. 361–67. Pubmed, doi:10.1002/art.11057.
Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003 Jun 15;49(3):361–367.
Journal cover image

Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

June 15, 2003

Volume

49

Issue

3

Start / End Page

361 / 367

Location

United States

Related Subject Headings

  • Volition
  • Surveys and Questionnaires
  • Research Design
  • Randomized Controlled Trials as Topic
  • Prospective Studies
  • Pilot Projects
  • Middle Aged
  • Male
  • Injections, Intravenous
  • Informed Consent