Challenges and Possible Solutions to Adapting to Virtual Recruitment: Lessons Learned from a Survey Study during the Covid-19 Pandemic.

The Covid-19 pandemic required rapid changes to research protocols, including immediate transitions to recruiting research participants and conducting the informed consent process virtually. This case study details the challenges our research team faced adapting an in-person, behavioral-intervention and survey study to virtual recruitment. We reflect on the impact of these rapid changes on recruitment and retention, discuss protocol changes we made to address these challenges and the needs of potential and enrolled participants, and propose recommendations for future work. Using computer technology to display professional return phone numbers, being flexible by contacting potential participants through various means, minimizing email communication due to added regulatory requirements, and partnering with the institutional review board to shorten and improve the consent document and process were critical to study success. This case study can offer insight to other researchers as they navigate similar processes. Virtual recruitment is likely to continue; it is important to ensure that it facilitates, rather than hinders, equitable and just recruitment practices.

Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic.

We assessed public perspectives of microbiome research privacy risks before and after a nationwide emergency was declared in the United States regarding the Covid-19 pandemic. From January to July of 2020, we conducted an online survey of perceived privacy risks of microbiome research among U.S. adults. Among 3,106 participants (the preemergency group), most expressed that the microbiome posed privacy risks similar to those associated with DNA (60.3%) or medical records (50.6%) and that they would prefer detailed explanations (70.2%) of risk in consent materials. Only 8.9% reported moderate to high familiarity with microbiome privacy risks. In adjusted analyses, individuals who participated in the study after the Covid-19 emergency was declared (the Covid-19 emergency group) were less likely to express that microbiome privacy risks were similar to those of DNA or medical records and more likely to report familiarity with the privacy risks of microbiomes. There was a trend toward increased concern after the Covid-19 emergency was declared (p = 0.053). Overall, the study revealed that many U.S. adults believe that microbiome privacy risks are similar to those associated with DNA or medical records, and they prefer detailed explanations in consent documents. Individuals who participated after the Covid-19 emergency was declared reported greater knowledge of microbiome privacy risks but had more concern.

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.

The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

Concerns and needs of research participants with visual disabilities amid the COVID-19 pandemic

As COVID-19 is contagious, researchers stop or delay the data collection requiring in-person meetings with research participants. Potential research participants may consciously or unconsciously change the perspective about human subjects research, probably leading to developing reluctance to participate in it. This study aims to advance knowledge of how potential research participants develop, sustain, and/or change their perspective towards human subjects research during the COVID-19 pandemic as well as how to adequately address their needs and concerns. A convenient sample of 28 participants with visual impairments and blindness completed a phone interview. The interview data were analyzed via open coding, axial coding, and selective coding. The data analysis resulted in 7 main themes and 10 subthemes that covered the study preparations and procedures. We referred to Rogers' Diffusion of Innovation Theory to discuss a set of facilitators to resolve potential participants' uncertainty and concern about participating in human subjects research. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Guidance and Lessons Learned from COVID-19 for Human-Subjects Research

The goal of this effort was to identify innovative strategies, approaches, and methods that have enabled researchers to continue doing meaningful human subjects research during the COVID-19 pandemic. Many organizations and recent literature primarily focus on efforts for future research in a post-COVID environment. Additionally, there have been no systematic efforts across the agency or broader human factors community to coordinate or share strategies. Therefore, the focus was on acquiring knowledge gained by researchers from experiences during COVID that could be valuable to continue human-subjects research under existing restrictions.

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general "culture of exclusion" of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.

COVID-19 messed up my research: Insights from physical activity and nutrition translational research.

The COVID-19 pandemic led to significant challenges in conducting physical activity and nutrition translational research. This encompassed all phases of translational research, including recruitment (e.g., lack of trust in the scientific community), assessment (university regulations restricting in-person assessments), intervention (conversion of face-to-face interventions to online formats), and retention (loss of employment, phone service, or housing among study participants). The COVID-19 pandemic has had varying impacts on research productivity as well. While some groups found the pandemic led to increases in productivity (as evidenced by increases seen in both manuscript and grant submissions), junior faculty, women (particularly caregivers), African American, Asian, and Latinx faculty, and mid-career and senior scientists all faced unique career and personal challenges during this time. This included competing demands on time that interfered with research productivity and mental and physical health stressors. Therefore, in order to ensure we retain promising scientists in the field of translational physical activity and nutrition science, it will be important to consider these challenges when it comes time to review tenure files and grant applications. Reviewers of these applications should note creativity in moving research forward, continued mentoring of students or other faculty, and plans to get back on track after a pause in their ability to conduct impactful physical activity and nutrition work.

Creating a pediatric advisory board for engaging youth in pediatric health research: A case study.

Youth are an understudied population requiring additional safeguards when participating in research. Their input is necessary to facilitate participation and interest in studies. To address this, Mayo Clinic established one of the first pediatric advisory boards (PAB) comprised of 18 diverse youth aged 11-17. The PAB members participated in quarterly meetings (in person and then by video conference with the advent of COVID-19) where they provided feedback to researchers on recruitment strategies, study materials, and procedures. The PAB meetings fostered bidirectional conversations with researchers on several health research topics, including mental health. Youth advisory boards can promote engagement in pediatric research.

SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Healthy Young Adults First.

In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (WHO) as an alternative to conventional approaches. In such trials, healthy volunteers are deliberately infected with the pathogen of interest, enabling scientists to study the infection process and facilitate further research on treatments or prophylactics, including vaccines. While human challenge trials would offer a collective benefit to society, minimizing the risks is always difficult. Ethical controversy thus inevitably surrounds these trials. Typically, healthy young adults are recruited to serve as the first candidate subjects for human challenge trials because they are generally considered to represent a low-risk population. Here, we present three reasons for doubt about this healthy-young-adults-first criterion and give justification for also recruiting healthy older adults (or not-young adults), meaning those over 30 years of age, to participate in such trials for SARS-CoV-2.

The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic.

In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

Human Infection Challenge Experiments: Then and Now.

In the midst of the Covid-19 pandemic, ethicists, researchers, and journalists have recommended studies that deliberately infect healthy volunteers with the coronavirus as a scientific means of expediting vaccine development. In this essay, we trace the history of infection challenge experiments and reflect on the Nuremberg Code of 1947, issued in response to brutal human experiments conducted by Nazi investigators in concentration camps. We argue that the Code continues to offer valuable guidance for assessing the ethics of this controversial form of research, with respect particularly to the acceptable limits to research risks and the social value of research necessary to justify exposing human participants to these risks.

Ethical Inclusion of Health Care Workers in Covid-19 Research.

Employees are often considered a vulnerable research population due to concerns about consent and confidentiality, but there is insufficient guidance regarding their ethical inclusion in research. In the context of Covid-19, frontline health care workers comprise a particularly relevant research population in light of their risks of viral exposure and psychological strain, among other factors. They may therefore be targeted for research conducted at their place of employment and benefit from participating in such research. Beyond Covid-19, there are other circumstances in which health care workers may be considered for inclusion in research conducted by or with the involvement of their colleagues and employers. As investigators, sponsors, institutional review boards, and others assess the ethical permissibility of these scenarios, as well as relevant protections, we recommend systematic consideration of social and scientific value, validity, fairness, risks and benefits, voluntary consent, respect, and independent review. There is often good reason to specifically target health care workers for inclusion in Covid-19 research (beyond convenience), and they should not be excluded from research offering the prospect of direct benefit. However, additional safeguards may be necessary in employer-based research to avoid scientific bias, promote voluntariness, and solicit stakeholder input. Research personnel should be permitted to enroll in their own Covid-19 studies only when participation offers them the prospect of unique benefits.

Self-Defeating Codes of Medical Ethics and How to Fix Them: Failures in COVID-19 Response and Beyond.

Statements of the core ethical and professional responsibilities of medical professionals are incomplete in ways that threaten fundamental goals of medicine. First, in the absence of explicit guidance for responding to cases in which there is significant uncertainty or disagreement about the relative therapeutic, prophylactic or diagnostic merits of available interventions they perpetuate self-defeating practices. Second, without addressing the role of advertising in shaping patient and community preferences they risk creating moral loopholes that bypass and undermine professional duties of fidelity, honesty and transparency. In both cases, these flaws are exacerbated by an individualism that ignores the critical role of health systems in managing and reducing uncertainty and conflict over best practices, and in communicating with and shaping the expectations of the public. These points are illustrated with examples from the response to COVID-19 and suggestions for reform are proposed.

Advantages of Using Lotteries to Select Participants for High-Demand Covid-19 Treatment Trials.

As hospitals have experienced a surge of Covid-19 patients, investigators of Covid-19 treatment trials face a difficult problem: when an institution has more eligible and interested patients than trial slots, who should be enrolled? Defining a clear strategy for selecting participants for "high-demand" Covid-19 treatment trials is important to avoid ad hoc and potentially biased decision-making by local investigators, which could inadvertently compromise a trial's social value, participants' interests, or fairness. In this article, we propose a set of ethical criteria for evaluating participant-selection strategies for such trials. We argue that the pandemic context-in particular, great urgency to develop safe and effective treatments, uncertainty surrounding Covid-19, and strain on the health care system that limits the time and effort available for trial enrollment-favors participant-selection strategies that optimize the ease of enrollment and, ideally, social value. A lottery and, where possible, a weighted lottery have important advantages in these respects.

Pregnant Women in Trials of Covid-19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials.

Ethical issues abound during this unprecedented international public health crisis of Covid-19. While the trade-off between societal and individual interests that occurs at the intersection of public health ethics and clinical ethics affects all populations, this calculus has particular relevance for pregnant women and the question of when they will have access to new Covid-19 therapies and vaccines. Pregnant women are a "scientifically complex" population whose inclusion in clinical research must be done with consideration of the unique state of pregnancy. Yet research on the impact of Covid-19 on pregnant women is lagging. In a rush to prevent and treat SARS-CoV-2 infection, it is crucial that the interests of pregnant women be prioritized to enable them to make autonomous, informed decisions about participating in clinical trials. The global pandemic calls for a revisiting of frameworks for the inclusion of pregnant women in research, as these women have an important stake in the prevention and treatment of Covid-19.