Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study

Abstract

Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.

Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study

“…The first type of intervention was a modification to the language used to disclose information about the survey to potential respondents. In order to develop the modified disclosures, standard consent disclosure language used in the parent study [ 8 ] was augmented following a formative, qualitative phase to elicit consent preferences and expectations of mHealth researchers, ethicists, and members of the public in Colombia and Uganda [ 12 , 20 , 21 ]. Wording of standard and modified disclosures is provided in S1 Table .…”

“…While mobile phone-based NCD risk factor monitoring presents opportunities for the advancement of global public health surveillance, emerging practices ought to align with and inform the evolution of existing norms and requirements for ethics and governance of public health surveillance and research [ 9 , 12 , 13 ]. Unfortunately, little empirical evidence exists to advance thoughtful application of these requirements to the novel terrain of MPS.…”

“…Unfortunately, little empirical evidence exists to advance thoughtful application of these requirements to the novel terrain of MPS. Studies are needed to advance understanding of a variety of data-related considerations–e.g., data privacy, security, ownership, access and use–and also to support careful development and implementation of consent processes that promote adequate disclosure, sufficient depth of comprehension, and authentic remote authorization during MPS [ 12 , 14 – 16 ]. Systematic assessment of these and other ethics and regulatory considerations is critical to the stewardship of a foundation of trust upon which much of global digital health rests.…”

“…Recent qualitative and conceptual research related to consent for MPS suggests a challenge with identifying and prioritizing key information during very concise consent disclosures, a potential for inadequate respondent understanding, and a risk of uninformed “click-through” authorization with remote consent and automated disclosure processes [ 9 , 12 , 17 ]. Remote consent is defined as a consent process with no in-person components, [ 18 ] while automated disclosure refers to use of only pre-recorded informational messages during the process of consent.…”

Ethical considerations of phone-based interviews from three studies of COVID-19 impact in Bihar, India

“…3 Phone-based data collection presents a unique set of ethical challenges around consent, confidentiality, representativeness, data quality and respondents' privacy, posing conceptual and practical considerations. [4][5][6] Concerns around informed consent for phone-based data collection include communicating consent information clearly and with brevity, considering the time burden on the respondents. 4 Respondents' understanding of consent and the challenges faced by researchers in gauging their comprehension in the absence of non-verbal cues are more pronounced.…”