Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

Quality Improvement in Clinical Research: ESA Utilization to improve Patient Safety Monitoring, time management, and Research Compliance.

We analyzed the capabilities of Electronic Signature Administrators (ESA) in reporting adverse and serious adverse events (AE/SAE) in clinical trials to improve Principal Investigator (PI) oversight. The current and most conventional way to sing on AE/SAE reports, by wet ink paper signatures, faces long report completion times, miscommunications, and a high rate of error that can put the study and the patient at risk. We demonstrate here that ESAs can easily take over this task, speeding up the process and enhancing patient's safety and research compliance. Our results show that the average of 31 days to obtain wet-signatures on AE/SAE reports is reduced to merely 3 days after the implementation of ESA. We also found that research professionals spend more than half an hour in commuting each time they need to get PI signatures, while this time is zero if ESAs are used. Finally, an anonymous survey distributed to coordinators shows that ESAs can be well received when implemented since 86% have used an ESA and are satisfied with it or are interested in using it, while only 14% of the participants are either not interested or not satisfied.

What Are the Expectations of Legal Operators and Forensic Experts Regarding Photographic Documentation of Violent Death Autopsies?

The purpose of photography in violent death autopsies is to document the material evidence of the offense and guide decisions in the courts of law. The aim of the present study was to obtain the expectations of legal operators and forensic experts regarding what is expected as adequate photographic documentation in violent death forensics. For this purpose, a survey was prepared through an online form available on the “Google Forms” platform, whose link was sent by e-mail and by the WhatsApp Messenger® application. The 102 participants were divided into two distinct groups: legal practitioners, interested in the materialization of evidence (judges, prosecutors, criminal lawyers and police chiefs), and forensic experts, responsible for materializing the evidence (medical examiners, forensic dentists and criminal experts). The research showed that the inclusion of color photographs in the expert reports is essential for all research participants, as well as the marking of evidence in the images and the inclusion of explanatory text in the captions. It was also pointed out as fundamental for most participants to insert an image with simulation of the firearm bullets’ path, when applicable. In relation to the other aspects, it can be observed that the opinions of the participants were divergent between the groups of research professionals, especially regarding the size of the image to be incorporated in the reports. The differences found between the groups can be detrimental to the proper interpretation and judgment of evidence in the courts. Considering the found barriers, the authors suggest a form of photographic documentation that meets all expectations in a consensual way.

Exploratory diary study of survey request frequency among research professionals

The survey commons is a global common-pool resource that consists of all populations of potential survey participants that researchers share. As survey research methodology and technology advances, the survey commons has become more accessible and used by an ever-growing variety of professional and non-professional researchers, which creates a climate for potential survey participants of seemingly constant requests to complete various types of questionnaires. Among other factors, the frequency of survey requests likely influences burden, fatigue, and data quality. Yet, few studies have explored the frequency and characteristics of survey requests. In contribution to this growing research area, we conducted an exploratory diary study of survey requests among research professionals for a 1-month period. Participants tracked survey request dates, contact mode, response mode, title, sponsor, host, and completion progress. We observed participants receive a survey request every other day, on average, but only fully completed one-quarter of requests. Marketing surveys were the primary request source, the main contact mode was email, and the main response mode was web-based. While marketing surveys were the most frequently experienced by participants, they also had the lowest completion rate; administrative and academic survey requests had the highest completion rate. Overall, our exploratory diary study told an intriguing story of the quantity and characteristics of survey requests among a select population and adds to growing interests in survey request inquiry.

Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.