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Assessing usefulness and researcher satisfaction with consent form templates

  • Elaine L. Larson (a1) (a2) (a3), Alan Teller (a2), Alejandra N. Aguirre (a2), Jhia Jackson (a4) and Dodi Meyer (a3) (a5)...
Abstract
Introduction

We aimed to improve the research consenting process by developing and evaluating simplified consent forms.

Methods

Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.

Results

At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (p<0.001).

Conclusions

Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Corresponding author
*Address for correspondence: E. L Larson, R.N., Ph.D., Anna C. Maxwell Professor of Nursing Research and Associate Dean for Research, Columbia University School of Nursing, 617 W. 168th St, Room 330, New York, NY 10032, USA. (Email: Ell23@columbia.edu)
References
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