Bioethical implications of the use of digital technologies for mental health research during the social distancing period of the COVID-19 pandemic

Abstract

The need to apply ethical principles to protocols for mental health research using digital technologies was a central concern of ethics committees during the COVID-19 pandemic, which sought to ensure a fair selection of participants, appropriate adaptation of the informed consent process, protection of participants’ privacy, secure management of research data, and assessment of risks and benefits. This effort required the prevention of factors that could contribute to inequality, including a digital divide, that could lead to digital and social discrimination or exclusion in the choice of participants. This study addresses these bioethical implications in the use of digital technologies to conduct mental health research, as noted by the Research Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry during the social distancing measures during the COVID-19 pandemic in Mexico. The increased use of digital tools abruptly transformed the manner in which studies were conducted, especially for those not familiar with this modality. The transition to these new digital technologies must include consideration of the bioethical implications of these strategies, and ethics committees must work with researchers to identify the best ways to safeguard the dignity, autonomy, and rights of participants.

Introduction

At the beginning of the COVID-19 pandemic, social distancing was imposed as a basic strategy for preventing the spread of infection. This measure generated substantial changes in people's daily lives, including the shift to remote work, the closure of schools and implementation of online classes, and the cancellation of public events, disruptions that significantly reduced social interaction and physical contact with their loved ones. This strategy also caused economic hardship related to the interruption or loss of employment. In addition to these challenges, people lived under the constant threat of contracting the disease. All of these factors generated psychological responses, including fear, stress, frustration, and loneliness,^1–4 which are common and understandable reactions to situations of uncertainty or crisis, but in some cases can be prolonged and become more serious and disabling, which can lead to a higher rate of mental disorders in adults and children. ⁴

The negative effects on individuals’ mental health due to social distancing are associated with the breakdown or lack of emotional familiar and social ties, according to attachment theory. ⁵ Confinement, isolation, and quarantine, although justified, can result in a form of psychological deprivation given the significant decrease in social and emotional interaction, in addition, situations of grief were generated due to various losses (of work, routine, future plans, contact or the death of loved ones). ⁶ The unexpected and unwanted meaning of changes, for example, the transition or loss of a job not only represents an economic problem, but they entail changes in the structure of time, social relationships, the sense of belonging and attachment to place, which are part of people's identity. ⁷

Some studies have reported a negative rise in different mental health conditions, as well as a worsening of symptoms in two out of every three patients with existing mental disorders, especially during the first months of the pandemic.^8–14 According to the World Health Organization (WHO), in just the first year of the pandemic, depression and anxiety increased by over 25%. ⁸

In addition, the social distancing during the early stage of the pandemic also led to an increase in the use of digital technologies in various activities, mainly due to the need to replace face-to-face to online interactions; a transition was made in the field of mental health, fundamentally in research.

Although, in mental health research some of these tools were already in use, for example, in conducting online surveys and interviews, or accessing data in secondary sources, on social networks, or in digital medical records, ¹⁵ the use of online data collection was an essential method for rapidly carrying out studies that addressed the impact of the pandemic on mental health, particularly its effects on mood, anxiety, and general psychological distress. Data were obtained through the measurement of common self-reporting indicators. ¹³

However, when considering the transition from face-to-face to online research, it was necessary to consider, for example, that in mental health research with digital technologies it is also relevant to monitor participants in case they require support or safeguarding, or if there is a need to pause or end the study due to imminent harm or adverse reactions.

Anon ¹⁵ notes the important differences between face-to-face and online interaction. For example, the aspects of non-verbal communication or body language related to mood may be lost, and direct supervision of subjects’ behavior may also be difficult. These differences were made manifest with the need to use online tools during the pandemic.

The transition from face-to-face to online research methods also entails ethical changes. Accessibility to digital technologies, and to the internet in general, presents new ethical issues, such as the adaptation of procedures to guarantee the validity of informed consent and the protection of participants. In this regard, Anon ¹⁵ points out that appropriate formats should be established in the transition to online designs, since most research paradigms require specific modifications to assure the quality of the research. This transition represented one of the central challenges in mental health research that had to be redesigned during the COVID-19 pandemic.

The issue was not only about the potential benefits, or the challenge associated with the use of digital technologies, but the implementation of appropriate study designs and the context in which research is conducted. ¹⁵ Although digital technologies offer various methodological approaches for mental health research, their implementation during the social distancing phase of the pandemic led to several methodological limitations. Many studies were cross-sectional, lacked valid comparison groups, or relied on small and selective samples. ¹³ These issues primarily arose because participation was restricted to individuals with access to digital technologies, which was related to the social context and where the research was conducted.

In some contexts, little consideration was given to the type of social inequality known as the digital divide. Sparks ¹⁶ explains that this concept has been used to designate social differences in the availability and use of digital equipment and services, including internet access, and notes that research in this area has emphasized three major issues: internet access and the physical availability of devices, the competencies and skills needed to use technologies, and individual, social, and cultural factors. Thus, it is not only the availability and access to technologies, but also the ability to effectively use it, meaning that not all individuals are equally favored by the digital modality. ¹⁷

Although social inequalities such as the digital divide were already known before the COVID-19 outbreak, the pandemic highlighted these inequalities, including the lack of access to health services in poor and rural populations, and the disease burden and its impact on productive life, especially in vulnerable groups such as people with mental disabilities.^14,17

According to some authors, people living in rural areas, the elderly, and individuals with severe mental illness are the ones most affected by the digital divide, as they do not enjoy the benefits of digital technologies and are then relegated, a phenomenon known as digital exclusion. Such a situation restricts people's access to online information, obstructing, for example, their ability to register to be vaccinated against COVID-19 or access updated information about this disease, thereby exposing them to the risks of isolation and loneliness.^11–14,17

The digital divide and digital exclusion thus mean that not all people have the same opportunity to participate in online studies. This has important ethical repercussions on such issues as the equitable selection of participants and ensuring appropriate risk-benefit considerations.^{11–13,18,19} It is thus necessary to evaluate and identify ethical considerations and make decisions within the particular context of online research in mental health.

The UNESCO Declaration on COVID-19: Ethical Considerations from a Global Perspective,^20,21 in its ninth recommendation, recognizes digital technologies as an important tool in epidemiological monitoring, but warns that their use must always be guided by an ethical, responsible, and respectful paradigm that balances privacy, autonomy, security, and protection, and that ethical, social, and political issues surrounding these technologies must be adequately considered. The Declaration urges research ethics committees (RECs) to establish an ethical framework as a part of a health policy that guarantees care for all, especially those in situations of vulnerability, and that assures the proper use of digital technologies.

This translates into the challenge of carrying out an ethical evaluation of mental health research in a context of social and health inequalities and inequities, and of digital exclusion, while maintaining ethical principles of equity, distributive justice, beneficence, and reciprocity in responses. Within this framework, responses and recommendations should be proportional to the magnitude of the problem, guided by the precautionary principle to favor the adoption of measures aimed at protecting the population. The common good should be prioritized over individual autonomy and freedom, but always with respect for the dignity of people ²² in new situations and with emerging challenges.

The need to review the appropriate application of ethical principles in mental health research protocols using digital technologies during the COVID-19 pandemic became a central concern of ethics committees, especially in ensuring a fair selection of potential participants, in adapting and monitoring the informed consent process (ICP), and in protecting participants’ privacy from undesired uses of their personal data and research information. There was also a need to scrutinize future risks and benefits, ¹³ so as not to contribute to greater inequality, a digital divide, digital or social exclusion, or discrimination against potential participants. ¹⁴ In this context, we work under the hypothesis that digital tools offer greater accessibility and potential for inclusion of participants in mental health research, and they have been important instruments for carrying out studies during the pandemic, but without careful consideration of ethical issues, these tools can also contribute to participant exploitation and exacerbate the digital divide and other inequalities. This is especially concerning in regions like Mexico where significant disparities in digital access and literacy persist.

This study addresses these bioethical issues in the use of digital technologies, mainly those encountered by migration from face-to-face to online studies using digital tools, from a critical analysis of the ethical challenges and difficulties addressed by the Research Ethics Committee (REC) of the Ramón de la Fuente Muñiz National Institute of Psychiatry in the evaluation of mental health research protocols during the social distancing of the COVID-19 pandemic in Mexico.

Mental health research

Advances in digital technologies have provided important benefits and opportunities in mental health research, including the possibility of online surveys and interviews. Prior to the pandemic, online studies were carried out by social and behavioral researchers, but these tools soon became the most practical and accessible way to do other kinds of research.

Despite their advantages, it became clear that researchers in various fields needed training in the use of these resources and their possible ethical implication, for example, the vulnerable populations were much less likely to be able to use digital mental health technologies, ¹² which could constitute a barrier or a risk of discrimination against their participation in research studies. This could reinforce the stigmatization, discrimination, and human rights violations, coupled with growing social and health inequalities that people with mental illness have always suffered.

Another relevant aspect is the context in which the research is carried out. In a country like Mexico, there are complexities related to the digital divide, communication and technological discrimination, specifically affecting those who have restricted access or low levels of technological literacy. In addition, during the pandemic the country presented an increase in violence, particularly towards women, and in symptoms of depression in people aged 65 or older.^23–25 The situation was also reflected in a lag in resource allocation infrastructure, and access to mental health services.^13,26,27

The challenges of improving and strengthening mental health and mitigating pre-existing problems to the COVID-19 pandemic have been the common denominator in governance, care, and prevention, as well as in information systems and research.^8,14 However, mental health research has its own challenges, particularly in questions of ethics. Work in this field involves vulnerable groups, such as the elderly, children and adolescents, people with psychosocial disabilities, and those in situations or conditions of social, cultural, economic, and political disadvantage, as well as those who have historically been excluded, abused, or simply ignored as beneficiaries of research and emerging technologies. ¹²

With the outbreak of the COVID-19 pandemic and social distancing measures, it was necessary to conduct mental health research, so it was indispensable to make a transition from face-to-face studies to studies using online tools, which implied not only a technical and methodological change, but also modifications in terms of ethical aspects. In this sense, it was essential to identify the ethical challenges posed by this unprecedented situation and to take advantage of the convenience of these tools. At the same time, it was necessary to mitigate the potential risks of increasing inequalities and vulnerabilities that could be exacerbated by their use, specifically, in privacy and data protection, in the identification of participants, in the monitoring of participants’ emotional risks, in access and equity in the use of the internet, in transparency and accountability ²⁶ and in procedures to ensure the validity of consent, withdrawal and protection of participants. ¹⁵ The key issue was to avoid reinforcing these problems and thereby widening the digital divide by excluding people eligible to participate in studies but who did not have access to these technologies or by exploiting participants who did have access to the technologies.

In this general overview of mental health research, we present the ethical challenges addressed by the REC of the Ramón de la Fuente Muñiz National Institute of Psychiatry in its evaluation of mental health research protocols during the social distancing policy of the COVID-19 pandemic in Mexico.

Ethical evaluation of research protocols

The RECs use a deliberative method to evaluate research protocol. This method is based on a practical reasoning procedure, and seeks to analyze problems in their complexity, weighing the ethical principles and values involved, the circumstances, and the consequences for research. The process of collective deliberation carried out by RECs consists of understanding the situation under study, the case-by-case analysis of the ethical issues involved, and rational argumentation about the possible and optimal courses of action, supported by ethical principles and legal aspects. ²⁸

The ethical challenges and dilemmas that arose during the social distancing period of the pandemic created a need for critical analysis of research protocols using the deliberative method, in addition to ethical regulations, like guidelines and declarations that RECs must follow by deliberating their application in evaluating research protocols. There are specific regulation for health emergency or extreme natural events; these are Guideline 20, “Research in Disasters and Disease Outbreaks” and Guideline 22, “Use of Data Obtained from the Online Environment and Digital Tools in Health-Related Research,” of the International Ethical Guidelines for Health-Related Research with Human Beings of the Pan American Health Organization (PAHO) and the Council for International Organizations of Medical Sciences (CIOMS). ²⁷

The CIOMS guidelines primarily guided the REC, as they emphasize how research must be carried out during a pandemic to help mitigate its impact. This is understandable in the case of experimental studies that seek new treatments to save lives, but it is not as applicable for social research, which was the main type of research that was conducted and assessed by the REC. The CIOMS Guidelines are limited in scope to “health-related research with humans, such as observational research, clinical trials, biobanking and epidemiological studies”. ^{27 (p. ix)}

Moreover, these guidelines also note that people rarely fully understand how their information will be used and stored, so it is important to consider how to protect their privacy and confidentiality by identifying and managing risks at all stages of a study. These oriented the REC to apply the CIOMS standards and adapted them to the needs of some studies. ²⁹

The extraordinary situation of the COVID-19 pandemic forced international organizations such as PAHO, WHO, the Nuffield Council on Bioethics, and the Mexican National Bioethics Commission to provide a series of ethical recommendations for research during the pandemic. ²⁹ These recommendations and ethical regulations guided RECs. It was important to assertively communicate these standards to researchers to include these ethical considerations in their studies.

However, the ethical challenges and dilemmas that arose during the social distancing period of the pandemic, for instance, the issue of people lacking access to online resources and being deprived of the benefits of such research or the opportunity to contribute for the benefit of others, highlighted a need for critical analysis of research protocols guided by the ethical frameworks like CIOMS and the newly developed pandemic-specific guidelines, considering the diverse realities of the different research protocols in a case-by-case manner, in a casuistic sense and with the ethical reasoning central to the deliberation in the context of a health emergency.

Main topics evaluated

The REC of the National Institute of Psychiatry, from which the reflections here are derived, evaluates research protocols related to mental health, from the perspective of neurosciences, clinical (observational studies) and psychosocial research, and epidemiology. During social distancing, in a context of global uncertainty, scientific research focused on finding a cure and generating knowledge about COVID-19. For this reason, the REC prioritized studies associated with COVID-19, such as the mental health consequences in people who presented this disease, their emotional response, possible risk factors or phenomena associated with psychopathology, alcohol and psychoactive substance use, as well as social factors linked to the pandemic in patients, caregivers, the general population, and healthcare personnel.

Research related to COVID-19

Studies of the effects of the pandemic carried out during social distancing opted for using digital technologies such as websites, mobile devices, and various communication applications, focusing on remote interviews, surveys, and mental health questionnaires. The intention was mainly to avoid infection and obtain real-time information, approach the evidence-based panorama, and address the emergency. Given the urgency of this research, it was critical to avoid violating ethical principles or participants’ rights. ²⁶

Research prior to or not related to COVID-19

In the first months of the pandemic, projects unrelated to the effects of the outbreak or requiring participation in person were suspended until government authorities determined suitable health conditions. This delayed a large number of experimental and observational protocols. In time, it was considered unnecessary to completely halt research that did not address the pandemic. Some studies were reactivated and adapted to the new conditions, using remote digital technologies where possible. In this way, some studies that had originally been planned to be conducted in person, using focus groups, interviews, face-to-face surveys, and similar evaluation techniques, had to be modified and carried out remotely. ²⁹

However, researchers’ lack of familiarity with online technologies, and of the ethical issues in this type of study, such as the confidentiality and security of online data, anonymity of participants, procedures to obtain valid informed consent, and potential risks or harms to participants, made it difficult to adapt their studies to online modalities, and generated a constant discussion of ethical issues with members of the REC. This required making decisions regarding research protocols that considered ethical and methodological issues in the design of projects that use the internet to collect and obtain data. Under the new circumstances, the criteria would be that interventions and decisions had to be transparent and consistent, following the ethical principles of caution and responsibility.

The feasibility of research prior to or not related to COVID-19 had to be evaluated considering accessibility to potential participants, and any effects that would increase health disparities. As part of this process, the REC also identified challenges related to the limits of these technologies in mental health research in the context of social inequality, health, and digital exclusion.

Bioethical implications in the use of digital technologies during the evaluation of mental health research

The challenges noted concerning the use of digital technologies in mental health research were related to (1) recruitment of potential participants; (2) the ICP; (3) handling of research data; and (4) benefits and minimization of risks. It was necessary to consider these issues as applied to online modality, with ethical limits defined in such a way that technology did not pose a risk, and that the potential for generating knowledge did not become a threat by amplifying inequalities or the digital divide.

• (1)

Recruitment of Potential Participants

According to CIOMS Guideline 20, ²⁷ research participants in disaster situations and during disease outbreaks must be selected fairly and with appropriate justification for choosing or excluding a specific population. During the COVID-19 pandemic, the urge to start or modify a study might have led researchers to propose an inadequate strategy for recruiting potential participants, negatively affecting fair selection or the dignity and autonomy of people.

Social distancing during the pandemic requires changes in procedures for recruiting potential participants receiving clinical care. Before the pandemic, in-person appointments allowed a physician to introduce a patient to the research team, or for the latter to advertise their studies with posters in outpatient or inpatient areas, but with the pandemic, care was provided mostly through telemedicine, which made it necessary to find other strategies for recruitment. Some researchers proposed obtaining clinical data and telephone numbers from patients’ medical records and using this information to invite them to participate in studies. However, doing so would violate the confidentiality of the information and patients’ privacy, since they provided these data for clinical care, not for research purposes. It would be necessary to obtain the consent of study participants, but social distancing made this challenging.

The REC suggested several strategies to ensure adequate ethical conduct in inviting research participants: First, studies could be promoted through institutional electronic channels, aligning with broader strategies for utilizing digital technologies in research. Second, treating physicians could inform their patients about the protocol, and give the contact information of the researchers. So, if potential participants showed interest, they could contact them without breaking doctor–patient confidentiality. Third, since invitation to research protocol by treating physicians could represent a conflict of interest, it was suggested that researchers should invite participants to the study to guarantee the integrity and objectivity of the research and, in turn, maintain the quality of care and patient confidence in medicine.

The ethical challenges in the recruitment of participants suggest that, under these extraordinary and urgent circumstances in carrying out research on a critical issue, some researchers might consider study participants as a means rather than an end, thus violating the autonomy of the participants. That is, researchers sometimes believe they can exploit participants to obtain information, forgetting that they are autonomous agents who must freely decide if they wish to participate in a scientific study.

During the recruitment process, the studies modified the inclusion criteria for their samples, requiring potential participants to have technological devices such as computers or smartphones in order to participate, for example, some researchers assumed that people would have printers and scanners, when even some researchers did not have this equipment. Other researchers suggested that participants download, print, sign, and scan documents, such as survey questionnaires, which could be impossible or complicated for some participants and represent an unnecessary investment of time. Not all participants have the required computer equipment or technical knowledge to do so, which leads to the exclusion of some of these individuals or groups that might have benefited from these studies. These would include people with cognitive impairment, the elderly, or people with limited resources.

Requiring people to have digital technology in order to participate in studies was reasonable during social distancing. Even if it was not a fair or equitable selection criterion, the priority was to reduce the risk of COVID-19 transmission. ¹⁸ However, as the pandemic progressed, this inclusion criterion should not be maintained because it could have contributed to an inequitable distribution of the benefits of research, to digital exclusion, and to discrimination. Even those participants with the necessary equipment could have faced different difficulties; for example: the process could be challenging if they were not familiar with the use of the equipment, programs, or platforms, or if they did not have a reliable internet connection The exclusion of part of a sample based on reasons other than the objectives or inclusion criteria of the research might also have had repercussions on study results.

Therefore, when activities were reactivated, alternatives were sought so that people without access to these resources could still participate in studies. For instance, if participants were physically present at the hospital, they could be provided with the devices and technical assistance for digital participation or, when possible and with the necessary preventive measures according to the pandemic stage, complete their participation in person rather than through digital means.

• (2)

Informed Consent Process (ICP)

A challenge in the ICP for COVID-19 research was the documentation of participant consent, whether for interventions, or social studies. According to the PAHO, the strictness of the ICP under a health emergency should not be less than in normal circumstances. However, it recognizes the difficulties inherent in this process during a health crisis, whether from the point of view of the participant or of the researchers, who may have been overwhelmed with the clinical needs of this emergency. For this reason, under certain circumstances the ICP can be exempted, even if it is necessary to share or analyze epidemiological surveillance data, provided that appropriate governance systems are in place to manage these health data.^27,30

ICPs had to be adapted for studies conducted online. Although the ethical issues surrounding this modality were known, some physician-researchers were not fully familiar with them, and it was not easy for them to adapt. Some of them proposed emailing the informed consent (IC) document to the potential participants so that they could read it, discuss it with the researcher, and have questions answered in a video call or through a digital platform. Then, they could sign it, scan it, and return it to the researcher. This implied that the participants had access to a printer, paper, a scanner, and the extra time to complete the process.

For instance, the REC recommended new mechanisms for creating a record of the IC, taking a photo of the signed document or using IC electronic formats, ²⁸ given that the recording of the process of IC during the video call does not satisfy the legal and ethical requirements in Mexico.^29,31 Such measures were already allowed in online studies, and the adjustments made under a health emergency must be ethically supported and certified so that the REC could approve them.

In mental health research, it is especially important to assure that the ICP requirements are fulfilled. These include seeking ways to facilitate communication between the researcher and potential participants while discussing the necessary information, answering any question and confirming that information is understood by these individuals, allowing them to make an autonomous, free, and unforced decision on whether to participate. Among other aspects, this information includes the aims and objectives, methods, nature and time of participation, risks, and benefits of the research. Some people who participate in such studies may have different forms of impairment. They may also be experiencing psychosocial crises such as violence and unemployment. These situations can make it more difficult for them to protect their rights and interests or affect their ability to make decisions, especially in a health emergency such as the COVID-19 pandemic. In such cases, the clinical judgment of physicians was decisive in ensuring that they were able to make free, rational decisions when they consented to participate in the studies.^12,18,27

The REC appealed to the principle of autonomy, collaborating with researchers to determine the practical conditions for the ICP according to the most appropriate ethical standards. The REC sensitizes researchers to use technologies more efficiently. For instance, it was not necessary to print and scan informed consent, nor screening instruments, but to implement digital instruments to solve these situations such as electronic forms, with the objective of documenting people's free and voluntary participation. ²⁹

An important ethical conflict, linked to respect for autonomy, was that treating physicians proposed inviting their own patients to be participants in their studies, which could represent a conflict of interest. As professionals, physicians have to prioritize their patient's health and well-being, while as researchers they are driven by the pursuit of knowledge. This dual role creates a conflict of interest that can compromise the judgment and objectivity of the physician. When recruiting their own patients, doctors are prioritizing the interest of knowledge over their primary responsibility to care for patients’ health. Moreover, patients will hardly be able to refuse to participate in the research that their treating physician is offering, maybe because they will not be able to differentiate the limit between clinical care and research, potentially leading to an undue influence and biased decision. Additionally, this scenario is often viewed as a form of exploitation. ³²

Conflict of interest must be transparent and be declared. Physicians/researchers should openly disclose their interest to patients, to ensure there is no doubt about their independence and integrity. However, simply declaring a conflict of interest is not sufficient to resolve it. Safeguards must be implemented, or alternative mechanisms should be adopted. In this respect, the REC recommends that members of the research team without any conflict of interest invite individuals to participate in the study. This approach guarantees the integrity and objectivity of the research while maintaining the quality of care and ensure-patient-physician confidentiality.^32,33

In addition, some researchers considered the figure of the witness in the IC as required in a face-to-face study, due to their lack of familiarity with online research and the requirements of the ICP in its electronic form. However, it was necessary to reconsider whether witnesses were essential in all cases, and how they would provide their certification as witnesses. Each research group had to think about the most appropriate strategies for its ICPs and have them clearly justified in order to present them to the REC.

Finally, an increase in social and health inequalities, as well as digital exclusion due to the COVID-19 pandemic, have been added to the stigma and discrimination against people with mental health problems. Under emergency conditions, many participants will not be able to consent in keeping with the usual procedures. However, special protections must be adopted for people with mental conditions who do not have the capacity to give IC in a study, such as children or some older adults. ²⁷ Otherwise, there will be continued exclusion and discrimination against these people and a widening of the digital divide.

• (3)

Management of Research Data

The implementation of social distancing measures required people to stay at home with their families. This scenario faced challenges to conduct research in mental health. Some participants did not have suitable spaces for interviews or surveys using digital platforms like Zoom or Google Meet where sensitive or private topics were addressed, such as substance use. This lack of privacy could imply risks, either for the participants and for the study itself, for instance, a risk of further abuse for women experiencing domestic violence. There is also the risk of acquiring unreliable data from participants who may feel vulnerable when disclosing personal information. In extensive discussion between the REC and researchers, the suggested solutions included prioritizing self-administered scales when feasible, as they can reduce discomfort and protect participants’ safety, implementing measures to assess and ensure their well-being.

In other cases, some researchers proposed having participants send their responses via email, which implied new ethical issues regarding the privacy and confidentiality of data, for example, providing their personal email addresses, the possible risk of getting a malicious software in their devices, phishing or hacking, human errors such as the possibility of emails being sent to unintended recipients, as well as the costs of mobile internet for sending this information. ³⁴

The main ethical considerations in using digital technologies for mental health research are privacy, confidentiality, and data protection. The primary ethical concern in this area is the safeguarding of shared information and avoiding the potential for misuse, even by corporate digital platforms or the government, since mental health data is of such a personal, sensitive, and possibly stigmatizing nature. ¹²

Some researchers worked with the REC to determine the procedures for data management on a case-by-case basis, focusing on equity. Distinct types of studies required specific procedures to protect the data collected. These procedures were impartial, fair, and respectful of all participants’ rights, so as not to increase inequities.

The recommendations of the REC for handling data indicated ways of safeguarding it (e.g., secure storage, firewalls, encrypted email, or encryption in transit), as well as practices related to privacy, confidentiality, non-discrimination, proper handling of personal data collected for clinical and research purposes, and the right to know or not to know the findings. Researchers used various methods to safeguard the collected data. Each research protocol required to specify the mechanisms that would be implemented throughout the study.^34,35

The use of digital technologies in mental health research during social distancing was essential, and it was of the utmost importance to carry it out according to ethical principles. However, these applications, platforms, and digital tools have enabled an increasing amount of confidential mental health information to be managed, shared, and stored without adequate protection. For example, “non-health-related digital data collected on a smartphone, such as location, can be used to generate highly personal behavioral and health information, such as evidence of depressive or manic episodes, psychosis, or Parkinson's disease onset.” ¹²

Technology companies have been singled out for carrying out deceptive, non-transparent, and unfair practices, and with obvious deficiencies in data protection. Users generally have no alternative but to accept the incomprehensible terms and conditions regarding privacy and the use of data from these companies in algorithms for advertising and marketing purposes, including its transfer to third parties without the prior consent of the user.^12,34 According to Celedonia et al., ³⁶ the suicide risk detection strategy through Facebook is unknown to users. Although they are consenting to collecting sensitive data, such as those related to mental health, by accepting the platform's terms and conditions to access it, there is no prior authorization for the use of their health data. This represents risks to privacy and can lead to exposure and harm to people. The authors mention that for this reason Facebook's suicide algorithm is prohibited in the European Union (EU).

Platforms such as Facebook or Instagram apparently provide health advice and intervention, but do not comply with the regulations and laws approved for mental health care providers in countries such as Mexico or the US, raising questions about their ethical standards in the matter.^36,37 Regulatory work in defense of people's information on social networks is still pending, although the application of legislation at different levels is also required, for example, government agencies can also intercept and use text messages through extensive surveillance programs.^12,34

There are laws regulating the protection of personal data, and some measures were reinforced during the pandemic to protect people's privacy. In Mexico, the National Institute for Transparency, Access to Information, and Protection of Personal Data (INAI), ³⁸ has issued the COVID-19 Safe Personal Data recommendations, which describe the right to protect personal data regarding diagnosis, care, monitoring, and potential infection that were used in mitigating the pandemic. Public and private institutions carry out appropriate processing of personal data in the various actions that were required for the care of people. However, in the field of health research, there are legal gaps that represent a present and future threat if efforts are not made for an effective regulation concerning this matter.

• (4)

Benefits and the Minimization of Risks

During a health emergency, it is essential to provide a direct benefit to research participants. An example of people needing such a benefit would be those with COVID-19 who collaborated in mental health research, or studies with especially vulnerable populations that have not always benefited from scientific research. Ethical regulations hold that the benefits and risks of participation must be equitably distributed in emergency situations such as the pandemic. ²⁷

Research conducted online has addressed and managed the issue of benefits to participants. The most critical issue during the pandemic was the question of what the benefits could be and how they could be distributed. Some researchers proposed offering people brochures or other educational materials that could be beneficial. Initially, these benefits were only offered to those who completed a study, for example, at the end of the intervention, survey, or interview, which could be interpreted as an inappropriate incentive or even a breach of the principle of justice. Benefits must be distributed to all participants, not only to those who complete the activities or tasks of a study. In this respect the REC informed researchers of this issue, emphasizing the need to ensure that benefits are provided to all participants, not just to those who fully complete the study. The most common solution was for benefits to be available to participants throughout the study, for example, throughout the interview or survey.

There were also studies that proposed that the benefit of information be extended to the general public. For instance, everyone would benefit from visiting the web page of study, and there could be indirect benefits for the community and society. ³⁹ In other cases, researchers offered the study results as a direct benefit. Beyond the fact that people who participate in a scientific study have the right to information, they must decide whether they wish to receive this information and, therefore, that it be given in an understandable, clear and useful way. However, it was observed that with the use of online tools in research, there was a risk that researchers would not precisely describe the results and that participants could have different reactions to these results or misinterpret them. In fact, this situation could become a risk for the participant rather than a benefit.^29,31 Similarly, in this case the REC sensitized researchers about this situation and urged them to develop alternatives tailored to each research protocol.

Regarding the risks of participation in a study, international agreements ²⁷ note that an emergency like the COVID-19 pandemic increases people's willingness to assume a high level of risk and enroll in studies and clinical trials. It is thus necessary for researchers to evaluate the possible risks as well as benefits, considering the nature of the research, and ensuring that these are disclosed.^27,29,39,40

The REC's decisions regarding research protocols respected the ethical principles in scientific research processes, prioritizing the balance of known risks and benefits and the fair selection of participants.^27,29 Emphasis was placed on the social value of the studies in alleviating the burden of morbidity or suffering, especially among the most vulnerable population.

Discussion

The COVID-19 pandemic has officially ended, but its consequences and effects on mental health have generated a crisis that is only beginning.^8,40 Increased prevention, care, and research will be needed to understand the long-term consequences of health emergencies. Digital technologies will remain standard practice ¹⁷ ; in fact, many of the studies previously carried out in person have gained wider accessibility through the use of these digital technologies, which will ultimately be a benefit for the generation of knowledge.

The shift to these new digital technologies is not a straightforward process, and in the migration from face-to-face research to online designs with digital tools, it will be essential to evaluate the possible ethical considerations that emerge from these transitions to avoid harming the study population, for example, it is important to consider new ways to approach potential participants, to adapt the ICP, and to maintain equity, in order to avoid ethical shortcomings, both during the COVID-19 pandemic^15,26 and in future emergency situations and regular scenarios where digital technologies offer an alternative for conducting research.

It is also important to collaborate closely with researchers to make them aware of these ethical considerations and to find the best way to safeguard the dignity, autonomy, and rights of participants. In moments of constant change, it is essential to maintain close and, if possible, direct communication with researchers, to highlight ethical issues that are not necessarily detected in an initial analysis of the process. This strategy will avoid long review processes and inadequate implementation of ethical principles in times of transition and crisis.

The COVID-19 pandemic exacerbated the pre-existing technological gap in countries like Mexico, where there are only 84.1 million internet users. This figure represents 71.3% of the country's women and 72.7% of its men aged six years or older, being smartphones the most widely used means to connect to the internet (96.0%), followed by laptops (33.7%) and televisions with internet access (22.2%). In this sense, accessibility problems arising from social and health inequalities, exclusion resulting from digital illiteracy, lack of equipment or other difficulties are some of the barriers that prevent vulnerable populations from accessing digital mental health research, and its potential benefits, so they should be considered as potential participants and, to the possible extent, strategies should be proposed to avoid further widening the gap.^14,17

The General Principles of the Declaration of Helsinki indicate that groups underrepresented in medical research must have appropriate access to participation in research. ⁴¹ The second CIOMS guideline also refers to low-resource settings, ²⁷ such as those described in Mexico, indicating that in this context, research should be encouraged especially when addressing priority health problems, such as mental health during or after situations like social isolation and the COVID-19 pandemic.

In Mexico, it has been essential to dedicate efforts to gradually increase Internet access in less favored regions or provide support for obtaining digital devices, involving not only individuals, but also families, organizations, society and the government, as a way to solve, reduce or mitigate the barriers of the digital divide.

Norman Daniels specifies that all individuals must have equitable access to public health care in order to have equal opportunities in society. ³⁵ This justice-based approach to public health is the responsibility of those involved in guiding and justifying public policies, in this case: the recommendations and decisions of the REC. Most of the decisions of the REC were focused on actions that favored equal opportunity for all, appealing to justice and equity. It was necessary to consider the commitment to promote and restore health in order to achieve equal individual opportunity and exercise individual autonomy, while prioritizing the common good. In this regard, the committee was careful to prevent potential participants from being excluded for any reason of social disadvantage or discrimination.

A clear example of the application of the principles of justice and equity was the modification of the inclusion criteria for studies so that people all had the same opportunities to participate and those who did not have the required digital technologies for participation were not excluded. Researchers were urged to extend their invitations not only to current users of digital technology, but also to those who had limited use of technology, such as social networks or internet access, to avoid possible discrimination and increasing the inequality that already existed. Other options involved telephone calls and taking advantage of family networks to promote collaboration between younger and older members of households, to increase people's knowledge and access to technology and the sharing of devices and internet costs. It was recommended that participation be voluntary, without prioritizing participants who used digital tools to seek medical care in conventional or face-to-face care settings, or through undue monetary incentives or those that promised access to health services.

Research using digital technologies also had positive implications, including a reduction in inequality in the form of better individual opportunities for online mental health services. People that used to experience barriers when participating in face-to-face studies concerning their mental health, even those who face stigma, such as migrants, people with HIV, people with reduced mobility, those with different abilities, or those who live in remote areas, could benefit from these technologies. Another advantage is the reduction in costs and travel time, which could have a positive effect on people's mental health by alleviating stress and reducing other negative factors, including on their physical health, for example, the exposure to pollutants, including particulate matter and gases associated with lung and cardiovascular damage, as well as reducing mortality and morbidity from COVID-19. ⁴²

Digital technologies will prevail in people's daily lives. For many who can interact with this digital world, it will bring benefits; for others, it will become another form of social and health inequality. ¹⁷ The responsibility of RECs is to monitor the fair and equitable implementation of these technologies in research in order to reduce social inequality in mental health, to prevent digital exclusion and discrimination.

Conclusion

The work sought to expose the main ethical implications observed during the analysis of mental health research protocols, based on the transition forced from face-to-face research to online research or research using electronic devices due to social distancing of the COVID-19 pandemic. Because the problem of the digital divide still prevails in Mexico, digital technologies play a double role that must be considered during the ethical evaluation of online research. In this sense, it is better understood that the main ethical challenges were related to aspects of justice (for example, in the selection and recruitment of participants), autonomy (guaranteeing the ICP), confidentiality (for example, management of research data), as well as the evaluation of benefits and minimization of risks; the committee therefore made recommendations to resolve them in the best way possible and thus guarantee the protection of research subjects.

REC-INPRFM's efforts were focused on mitigating, to the possible extent, the consequences of the digital divide in the field of mental health research, mainly in the various population groups facing the problem of digital exclusion, by avoiding the exploitation of participants and exacerbating the digital divide. Finally, the REC worked on the implementation of the ethical aspects to consider in research that uses digital tools and that always offers greater accessibility and inclusion of participants in mental health research, but especially in a health crisis.