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Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention.
In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19.
Introduction: The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. Methods: IRB Offices developed plans to rapidly review protocols related to the COVID-19 pandemic.
Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention.
The popular CIRTification program is now available for implementation at the institutional level. CIRTification is a free, web-based human research protections training program tailored specifically to the needs and roles of community research partners.
Introduction: Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our
Using the REDCap software platform, a team of researchers led from Vanderbilt University Medical Center have developed a new framework for electronic consent in clinical trials that’s designed to address both issues of transparency, efficiency and compliance while also improving participant recruitment and retention of under-represented minority groups. According to a preproof article for the
Building on previous forums that explored the importance of trust and trustworthiness in research, the 4th CCTS Bioethics Forum focused on new issues raised by the return of results in large population-based clinical and genetic studies. Leading PIs and bioethicists from the Alabama Genomic Health Initiative (AGHI) and the Jackson Heart Study shared lessons learned at the March 2019 event. A