Enhancing consent forms to support participant decision making in multimodal learning data research

Advances in the field of multimodal learning analytics (MMLA) research is often accomplished by actively exploring new technologies and techniques related to the collection and analysis of data. Exploration of ethical principles and procedures for governing the use of new technologies and techniques, however, is not as readily pursued. As collected data grow in complexity and invasiveness, potentially, a growing need is arising to scrutinize ethical aspects of MMLA research. In our study, we introduce an informed consent comprehension test for educational technology research and assess the effects of enhancing MMLA consent forms on comprehension of informed consent and on rates of enrollment in a MMLA study. One form is written from a researcher perspective and the other from a participant perspective. Results of the study involving first-year undergraduate students suggest that the overall level of comprehension did not differ between conditions. Yet, the participant-oriented consent form resulted in significantly lower rates of enrollment. Implications for MMLA researchers are discussed.

[1]  André Schulz,et al.  Heart rate response to post-learning stress predicts memory consolidation , 2014, Neurobiology of Learning and Memory.

[2]  Michael A. Cowling,et al.  Mixed Reality Multimodal Learning Analytics , 2020, Encyclopedia of Educational Innovation.

[3]  Jerry Chih-Yuan Sun,et al.  The effects of attention monitoring with EEG biofeedback on university students' attention and self-efficacy: The case of anti-phishing instructional materials , 2017, Comput. Educ..

[4]  A Shonde,et al.  Recall of informed consent information by healthy volunteers in clinical trials. , 2008, QJM : monthly journal of the Association of Physicians.

[5]  Sue Heath,et al.  Informed consent, gatekeepers and go‐betweens: negotiating consent in child‐ and youth‐orientated institutions , 2007 .

[6]  Michael K Paasche-Orlow,et al.  Readability standards for informed-consent forms as compared with actual readability. , 2003, The New England journal of medicine.

[7]  Colin Hamlin,et al.  The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis , 2017, PloS one.

[8]  Peter Peduzzi,et al.  A brief measure of perceived understanding of informed consent in a clinical trial was validated. , 2006, Journal of clinical epidemiology.

[9]  Gauthier Chassang,et al.  The impact of the EU general data protection regulation on scientific research , 2017, Ecancermedicalscience.

[10]  I. M. Barrio-Cantalejo,et al.  Validación de la Escala INFLESZ para evaluar la legibilidad de los textos dirigidos a pacientes , 2008 .

[11]  L. Tamariz,et al.  Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review , 2012, Journal of General Internal Medicine.

[12]  Matthew E Falagas,et al.  Informed consent: how much and what do patients understand? , 2009, American journal of surgery.

[13]  Bonne Lorenzen,et al.  Using principles of health literacy to enhance the informed consent process. , 2008, AORN journal.

[14]  Paulo Blikstein,et al.  Using learning analytics to assess students' behavior in open-ended programming tasks , 2011, LAK.

[15]  Terri Voepel-Lewis,et al.  Priorities for disclosure of the elements of informed consent for research: a comparison between parents and investigators , 2002, Paediatric anaesthesia.

[16]  George Siemens,et al.  Ethical and privacy principles for learning analytics , 2014, Br. J. Educ. Technol..

[17]  Davinia Hernández Leo,et al.  Ethics in educational technology research: Informing participants on data sharing risks , 2019, Br. J. Educ. Technol..

[18]  Xavier Ochoa,et al.  Editorial: Augmenting Learning Analytics with Multimodal Sensory Data​ , 2016, J. Learn. Anal..

[19]  Peter Caputi,et al.  Assessing Clinical Trial Informed Consent Comprehension in Non-Cognitively-Impaired Adults: A Systematic Review of Instruments , 2009 .

[20]  Marcelo Worsley,et al.  Multimodal Learning Analytics and Education Data Mining: using computational technologies to measure complex learning tasks , 2016, J. Learn. Anal..

[21]  Emilio Mordini,et al.  The Transparent Body: Medical Information, Physical Privacy and Respect for Body Integrity , 2012 .

[22]  E Bjørn,et al.  Can the written information to research subjects be improved?--an empirical study. , 1999, Journal of medical ethics.

[23]  Roberto Martínez Maldonado,et al.  Towards Collaboration Translucence: Giving Meaning to Multimodal Group Data , 2019, CHI.

[24]  Robert Edson,et al.  Evaluating the quality of informed consent , 2005, Clinical trials.

[25]  María Jesús Rodríguez-Triana,et al.  Learning analytics in small-scale teacher-led innovations: Ethical and data privacy issues , 2016 .

[26]  James Flory,et al.  Interventions to improve research participants' understanding in informed consent for research: a systematic review. , 2004, JAMA.

[27]  Gurpreet Kaur,et al.  What information and the extent of information research participants need in informed consent forms: a multi-country survey , 2018, BMC Medical Ethics.

[28]  Xavier Ochoa,et al.  Multimodal Learning Analytics , 2017 .

[29]  David Wendler,et al.  What Should Research Participants Understand to Understand They are Participants in Research? , 2008, Bioethics.

[30]  Nguyen Phuoc Long,et al.  Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis , 2015, Bulletin of the World Health Organization.

[31]  Jeremy Sugarman,et al.  Examining Provisions Related to Consent in the Revised Common Rule , 2017, The American journal of bioethics : AJOB.

[32]  Vilius Dranseika,et al.  Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure , 2017, Sci. Eng. Ethics.

[33]  L. Beskow.  Lessons from HeLa Cells: The Ethics and Policy of Biospecimens , 2016, Annual review of genomics and human genetics.

[34]  M. Jefford,et al.  Improvement of informed consent and the quality of consent documents. , 2008, The Lancet. Oncology.

[35]  R. Kadam.  Informed consent process: A step further towards making it meaningful! , 2017, Perspectives in clinical research.

[36]  Adele Diamond,et al.  Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. , 2015, Developmental psychology.

[37]  Li Lin,et al.  Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention , 2016, Genetics in Medicine.

[38]  E F Cook,et al.  Quality of informed consent: a new measure of understanding among research subjects. , 2001, Journal of the National Cancer Institute.

[39]  F. E. Freeberg,et al.  Informed consent documents: increasing comprehension by reducing reading level. , 1990, IRB.

[40]  Christopher R. Trudeau,et al.  Improving readability of informed consents for research at an academic medical institution , 2017, Journal of clinical and translational science.

[41]  Zachary P. Hallinan,et al.  Barriers to Change in the Informed Consent Process: A Systematic Literature Review. , 2016, IRB.

[42]  N. Kass,et al.  A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results , 2015, Clinical trials.

[43]  Sanna Järvelä,et al.  Sympathetic arousal commonalities and arousal contagion during collaborative learning: How attuned are triad members? , 2019, Comput. Hum. Behav..

[44]  S. Sonnad,et al.  From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making. , 2016, Journal of patient safety.

[45]  R. Flesch.  A new readability yardstick. , 1948, The Journal of applied psychology.

[46]  Adam A. Nishimura,et al.  Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials , 2013, BMC Medical Ethics.