Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.

Although experts have identified benefits to replacing paper with electronic consent (eConsent) for research, a comprehensive understanding of strategies to overcome barriers to adoption is unknown. To address this gap, we performed a scoping review of the literature describing eConsent in academic medical centers. Of 69 studies that met inclusion criteria, 81% (n=56) addressed ethical, legal, and social issues; 67% (n=46) described user interface/user experience considerations; 39% (n=27) compared electronic versus paper approaches; 33% (n=23) discussed approaches to enterprise scalability; and 25% (n=17) described changes to consent elections. Findings indicate a lack of a leading commercial eConsent vendor, as articles described a myriad of homegrown systems and extensions of vendor EHR patient portals. Opportunities appear to exist for researchers and commercial software vendors to develop eConsent approaches that address the five critical areas identified in this review.

[1]  P. Myles,et al.  Improving communication when seeking informed consent: a randomised controlled study of a computer‐based method for providing information to prospective clinical trial participants , 2010, The Medical journal of Australia.

[2]  Anand K. Gramopadhye,et al.  An investigation of format modifications on the comprehension of information in consent form when presented on mobile devices , 2012 .

[3]  C. Simon,et al.  Interactive multimedia consent for biobanking: A randomized trial , 2015, Genetics in Medicine.

[4]  Robert A Wise,et al.  Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. , 2015, Contemporary clinical trials.

[5]  Bo Yu,et al.  Informed Consent in Healthcare: A Study Case of Genetic Services , 2017 .

[6]  Saif S. Khairat,et al.  Assessing the Satisfaction of Citizens Using Teleconsent in Clinical Research , 2018, MIE.

[7]  Christopher A. Harle,et al.  Patient preferences toward an interactive e-consent application for research using electronic health records , 2017, J. Am. Medical Informatics Assoc..

[8]  J. Fortenberry,et al.  Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial , 2015, AIDS care.

[9]  Manolis Tsiknakis,et al.  Donor's support tool: Enabling informed secondary use of patient's biomaterial and personal data , 2017, Int. J. Medical Informatics.

[10]  C. McCarty,et al.  Long-Term Recall of Elements of Informed Consent: A Pilot Study Comparing Traditional and Computer-Based Consenting. , 2015, IRB.

[11]  J. Greenstein,et al.  The Effect of Graphic Organizers on the Performance of Electronic Consenting Systems , 2015 .

[12]  Alberto Moreno-Conde,et al.  Desiderata for digital consent in genomic research , 2017, Journal of Community Genetics.

[13]  C. Knowles,et al.  Risk based survey evidence supports electronic informed consent as a recruitment method for UK clinical trials. , 2016, Journal of clinical epidemiology.

[14]  Joseph M. Plasek,et al.  A rural community's involvement in the design and usability testing of a computer‐based informed consent process for the personalized medicine research project , 2014, American journal of medical genetics. Part A.

[15]  D. Ginsburg,et al.  Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study , 2011, Annals of Internal Medicine.

[16]  S. Cummings,et al.  Interactive Informed Consent: Randomized Comparison with Paper Consents , 2013, PloS one.

[17]  O. Nov,et al.  Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior , 2016, Journal of medical Internet research.

[18]  Xiaoqian Jiang,et al.  iCONCUR: informed consent for clinical data and bio-sample use for research , 2016, AMIA.

[19]  Connie K. Varnhagen,et al.  How Informed Is Online Informed Consent? , 2005, Ethics & behavior.

[20]  D. Jeste,et al.  Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research , 2012, Schizophrenia Research.

[21]  Leslie Lenert,et al.  Teleconsent: A novel approach to obtain informed consent for research , 2016, Contemporary clinical trials communications.

[22]  Yongqun He,et al.  Towards a common semantic representation of informed consent for biobank specimens , 2014 .

[23]  Terri Voepel-Lewis,et al.  Digital multimedia: a new approach for informed consent? , 2015, JAMA.

[24]  Thomas Bahls,et al.  Ethics Meets IT: Aspects and Elements of Computer-based Informed Consent Processing , 2015 .

[25]  J. Gallo,et al.  Perspectives of IRB chairs on the informed consent process , 2017, AJOB empirical bioethics.

[26]  F. Rockhold.  The Society for Clinical Trials supports United States legislation mandating trials registration , 2005, Clinical trials.

[27]  Scott T. Weiss,et al.  Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research , 2016, Journal of personalized medicine.

[28]  Jihad Obeid,et al.  Development and pilot testing of a video-assisted informed consent process. , 2013, Contemporary clinical trials.

[29]  Philippe Ravaud,et al.  Blockchain protocols in clinical trials: Transparency and traceability of consent , 2017, F1000Research.

[30]  Björn Bergh,et al.  MAGIC: once upon a time in consent management—a FHIR® tale , 2018, Journal of Translational Medicine.

[31]  Anand K. Gramopadhye,et al.  An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting , 2013, Int. J. Medical Informatics.

[32]  David Lund,et al.  Dynamic Consent: A Possible Solution to Improve Patient Confidence and Trust in How Electronic Patient Records Are Used in Medical Research , 2015, JMIR medical informatics.

[33]  S. Beck,et al.  Dynamic Consent: a potential solution to some of the challenges of modern biomedical research , 2017, BMC Medical Ethics.

[34]  J. Kvedar,et al.  mHealth advances clinical research, bit by bit , 2017, Nature Biotechnology.

[35]  H. Draper,et al.  Informing Potential Participants about Research: Observational Study with an Embedded Randomized Controlled Trial , 2013, PloS one.

[36]  Eric L Eisenstein,et al.  Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study , 2018, Journal of empirical research on human research ethics : JERHRE.

[37]  M. Doerr,et al.  Consent Processes for Mobile App Mediated Research: Systematic Review , 2017, JMIR mHealth and uHealth.

[38]  Mengjun Xie,et al.  USign — A security enhanced electronic consent model , 2014, 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[39]  John Wilbanks,et al.  Design Issues in E-Consent , 2018, Journal of Law, Medicine & Ethics.

[40]  K. Lindsley.  Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting. , 2019, Patient education and counseling.

[41]  C. Simon,et al.  Traditional and electronic informed consent for biobanking: a survey of U.S. biobanks. , 2014, Biopreservation and biobanking.

[42]  H. Timothy Bunnell,et al.  A cognitive approach for design of a multimedia informed consent video and website in pediatric research , 2017, J. Biomed. Informatics.

[43]  S. B. King,et al.  Testing an Online, Dynamic Consent Portal for Large Population Biobank Research , 2014, Public Health Genomics.

[44]  Susan B. Newman,et al.  Improving informed consent: Stakeholder views , 2017, AJOB empirical bioethics.

[45]  Kapil Chalil Madathil,et al.  Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents , 2013, Clinical trials.

[46]  C. Suver,et al.  Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study , 2017, JMIR mHealth and uHealth.

[47]  K. Saag,et al.  A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study , 2016, Contemporary clinical trials communications.

[48]  María Adela Grando,et al.  Building and Evaluating an Ontology-based Tool for Reasoning about Consent Permission , 2013, AMIA.

[49]  Oded Nov,et al.  The Effect of Exposure to Social Annotation on Online Informed Consent Beliefs and Behavior , 2016, CSCW.

[50]  Soichi Ogishima,et al.  Authentication of Patients and Participants in Health Information Exchange and Consent for Medical Research: A Key Step for Privacy Protection, Respect for Autonomy, and Trustworthiness , 2018, Front. Genet..

[51]  Henri-Corto Stoeklé,et al.  Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine , 2017, Science and Engineering Ethics.

[52]  Anastasius Moumtzoglou,et al.  Design, Development, and Integration of Reliable Electronic Healthcare Platforms , 2016 .

[53]  C Rayner,et al.  Informed consent. , 2000, British journal of plastic surgery.

[54]  E. Karlson,et al.  Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations , 2016, Journal of personalized medicine.