DOI: http://dx.doi.org/10.18203/2349-3259.ijct20150591

Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting

Matthew J. Frelich, Matthew E. Bosler, Jon C. Gould

Abstract


Background: Electronic consent for research has shown success in clinical trial models, but has not been rigorously evaluated as an alternative to conventional paper consent.  We sought to design a 21 CFR Part 11 compliant iPad-based electronic Informed Consent Form (eICF) with Research Electronic Data Capture (REDCap). As a secondary aim, we sought to compare subject workload between eICF and paper consent groups.

Methods: This is a prospective, randomized study of subjects who completed an iPad-based eICF versus paper consent for research. The eICF was designed with REDCap and presented on an iPad. Subject workload was measured with the NASA Task Load Index (NASA-TLX) and subjective feedback in regards to consent process was collected.

Results: A total of 116 subjects were screened for consent. Of which, 51 (44%) subjects provided informed consent and completed all study related procedures. Twenty-five (49%) eICF and 26 (51%) paper consents were completed.  The eICF group rated a significantly greater preference to use the eICF for future research studies (6.4±1.5) compared to the paper consent group (5.0±1.9), p<0.01. There were no significant differences in NASA-TLX Weighted Scale or Total-TLX Scores between groups. One error resulted in the eICF group due to an inadvertent submission by a single subject.

Conclusion: In summary, we have demonstrated that an iPad-based eICF designed with REDCap is both 21 CFR Part 11 compliant and feasible in the clinical research setting.  The eICF does not appear to be more technically difficult or demanding than conventional paper consent.


Keywords


REDCap, iPad, eICF, Paper consent

Full Text:

PDF

References


Ness R. Influence of the HIPPA privacy rule on helath research. JAMA 2007;298(18):2164-2170.

Brink S. Subjects and E-Access: Why consider e-consenting. [Internet]. Acessed May 1, 2014. Available online: http://www.slideshare.net/susanbrink/brink-why-consider-e-consenting-for-clinical-trials.

Madathil K, Koikkara R, Obeid J, Greenstein J, Sanderson I, Fryar K, et al. An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting. Ijmi. 2013;882:54-863. Doi:10.1016/j.ijmedinf.2013.04.008.

Rowbotham M, Astin J, Greene K, Cummings S. Interactive Informed Consent: Randomized Comparison with Paper Consents. PLoS ONE. 2013;8(3):e58603. doi:10.1371/journal.pone.0058603.

United State Food and Drug Administration. 21 Code of Federal Regulation Part 11-Electronic Records. Electronic Signatures, 2014.

Research Electronic Data Capture. [Internet]. Accessed 2014 Sept 1. Available online: http://project-redcap.org/.

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81.

FAD Guidance for Industry Part 11. Electronic Records: electronic Signatures-Scope and Application, 2003.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff. January 11, 2002.

University of Pittsburg. Guidance: Electronic signature and Other Strategies for Documenting consent and HIPPA Authorization. [Internet]. Accessed 2013 April 1. Available online: http://www.irb.pitt.edu/sites/default/files/ElectronicSignature_4.1.2014.pdf.

Madathil K, Koikkara R, Gramopadhye A.An analysis of the general consenting process in an emergency department at a major hospital; challenges for migrating to an electronic health record. Proceedings of the 2011 Industrial engineering Research Conference; Reno NV, 2011.

Schlectweg P, Hammon M, Giese D, Heberlein C, Uder M, Schwab S. iPad-Based patient Briefing for Radiological examination-a Clinical Trial. J Digit Imaging. 2014;4:479-85. doi: 10.1007/s10278-014-9688-x.