Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns.

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises.

Living with Mental Health Challenges: Personal Stories of Recovery from Across the Globe

This symposium includes twelve personal narratives from individuals who live with serious mental health challenges that are sometimes diagnosed as schizophrenia, bipolar disorder, major depression, posttraumatic stress disorder, or other conditions. Such challenges are often persistent, lead to stigma and discrimination, and can deeply affect quality of life. Serious mental health challenges are frequently approached as life-long medical conditions, given a diagnosis and treated with medications. However, some pursue non-medical treatments, peer support, use diet and exercise to promote wellness, embrace models of recovery, and function well even when symptoms persist. Approaches often differ across nations, depending upon their resources and philosophy of mental health challenges. Three commentaries on these narratives are also included, authored by experts and scholars in the fields of cultural psychiatry, refugee mental health, human rights advocacy, child's health, and global mental health. We intend this collection of stories to broaden the range of acceptable responses to mental health challenges, raise awareness of stigma and bias in mental health care, and share the wisdom and preferences of those living with mental health challenges.