Human Research During the COVID-19 Pandemic: Insights From Behind-the-Scenes.

The researchers' stories collected here demonstrate how many ethical and practical challenges routinely associated with conducting human research were amplified during the COVID-19 pandemic. These challenges include designing studies to minimize risks and maximize potential benefits, working with institutional review boards (IRBs), recruiting and enrolling participants, obtaining valid informed consent, promoting data integrity, managing budget constraints, and finding time to fulfill research obligations along with other duties. By offering insights about not only the barriers and challenges researchers encountered but also the creative solutions they and their colleagues found to conduct research, this behind-the-scenes peek at researchers' experiences helps us to identify barriers and potential lasting improvements for human subjects research even in the best of times.

Research During the Pandemic: Views from Both Sides of the Fence.

The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.

Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators.

BACKGROUND: During the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called 'fast-track-review-procedures' (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs). METHODS AND FINDINGS: An explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats. CONCLUSIONS: This study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.

A Productive Scholar's Guide to Respectful, Responsible Inquiry During the COVID-19 Pandemic: Moving Forward.

As a result of the COVID-19 pandemic of 2020, schools across the country have pivoted to providing a range of instructional opportunities including remote, hybrid, and modified in-person options with a commitment to keeping our society safe and supporting our nations' youth in continuing their education. One byproduct of this most challenging situation has been the interruption of scientific inquiry in many fields, including educational research. Using a framework of self-leadership, in this feature article, we provide reflections to guide discussion among scholars involved in school-based research during and after the COVID-19 pandemic. Based on lessons learned in our own mentee-mentor relationships and from our collective experiences, the purpose of this article is to offer considerations primarily for early-career scholars, but also to engage dialogue among mid- and late-career scholars to promote school-based inquiry in this defining moment in history, at a time when educators are concerned with mitigating learning loss. We focus on (a) revisiting and refining programmatic lines of inquiry, (b) crafting articles to disseminate lessons learned from research conducted to date-including those with lost time points, (c) retooling in a focused area of inquiry (e.g., methodology), (d) conceptualizing future studies featuring procedures that do-and do not-allow for interpersonal contact, and (e) appreciating and acknowledging individuals who have facilitated inquiry. We conclude with a note of encouragement and call to action for future educational research.