- To examine methods of assessing consent capacity in research protocols involving participants with impaired consent capacity, and examine instruments used to evaluate research consent capacity.
- As of April 27, 2020, the coronavirus disease 2019 (COVID-19) pandemic involved 2,916,338 reported cases and had claimed 205,923 lives.1 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is spreading in almost every country, causing widespread health challenges and social instability. People most vulnerable to COVID-19 include those with underlying health conditions.2 Yet the pandemic is disrupting clinical trials addressing these same health conditions.3 There were more than 300,000 studies being conducted worldwide registered on clinicaltrials.gov.
- The widespread social and economic disruption caused by the novel coronavirus disease 2019 (COVID-19) is clearly apparent and has affected all walks of life. The biomedical research enterprise is no exception. According to the 2015-2016 Global Participation in Clinical Trials Report published by the US Food and Drug Administration (FDA),1 there were 40,385 clinical trial participants in the United States during that time period. Given exponential advances in biotechnology, it is expected that this number has grown considerably over the past 5 years.