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      Teleconsent: A novel approach to obtain informed consent for research

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          Abstract

          Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent) help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called “teleconsent”, which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.

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          Barriers to participation in randomised controlled trials: a systematic review.

          S. Ross, A. Grant, C. Counsell … (1999)
          A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.
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            Interventions to improve research participants' understanding in informed consent for research: a systematic review.

            James Flory, Ezekiel J. Emanuel (2004)
            Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all P<.05), but 5 of 6 trials were of limited quality, casting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P<.05) but were flawed in that they may have mistaken rote memorization for improvement in understanding. Another 5 trials were put into a miscellaneous category and had varying impact on understanding. Some demographic factors, particularly lower education, were associated with less understanding. Satisfaction and willingness to enroll were never significantly diminished by an intervention . Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants' understanding; however, further research is needed.
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              The taxonomy of telemedicine.

              Rashid Bashshur, Gary Shannon, Elizabeth Krupinski … (2024)
              The purpose of this article is to present a taxonomy for telemedicine. The field has markedly grown, with an increasing number of applications, a variety of technologies, and newly introduced terminology. A taxonomy would serve to bring conceptual clarity to this burgeoning set of alternatives to in-person healthcare delivery. The article starts with a brief discussion of the importance of taxonomy as an information management strategy to improve knowledge sharing, facilitate research and policy initiatives, and provide some guidance for the orderly development of telemedicine. We provide a conceptual context for the proliferation of related concepts, such as telehealth, e-health, and m-health, as well as a classification of the content of these concepts. Our main concern is to develop an explicit taxonomy of telemedicine and to demonstrate how it can be used to provide definitive information about the true effects of telemedicine in terms of cost, quality, and access. Taxonomy development and refinement is an iterative process. If this initial attempt at classification proves useful, subject matter experts could enhance the development and proliferation of telemedicine by testing, revising, and verifying this taxonomy.
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                Author and article information

                Contributors
                Brandon M. Welch
                Journal
                Journal ID (nlm-ta): Contemp Clin Trials Commun
                Journal ID (iso-abbrev): Contemp Clin Trials Commun
                Title: Contemporary Clinical Trials Communications
                Publisher: Elsevier
                ISSN (Electronic): 2451-8654
                Publication date PMC-release: 31 March 2016
                Publication date Collection: 15 August 2016
                Publication date (Electronic): 31 March 2016
                Volume: 3
                Pages: 74-79
                Affiliations
                [a ]Biomedical Informatics Center, Medical University of South Carolina, 135 Cannon St, Suite 405, Charleston, SC, 29425, United States
                [b ]College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St, Charleston, SC, 29425, United States
                Author notes
                [∗ ]Corresponding author. welchbm@ 123456musc.edu
                Article
                Publisher ID: S2451-8654(15)30050-8
                DOI: 10.1016/j.conctc.2016.03.002
                PMC ID: 5096381
                PubMed ID: 27822565
                SO-VID: 6ac2263b-93b5-4e30-9322-6e14aa480df6
                Copyright © © 2016 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 6 November 2015
                Date revision received : 16 January 2016
                Date accepted : 14 March 2016
                Categories
                Subject: Article

                Keywords: informed consent,clinical research,clinical trials,telemedicine
                Data availability:
                Keywords: informed consent, clinical research, clinical trials, telemedicine

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