Introduction COVID-19 dominates daily news headlines as communities and organizations evaluate policies regarding public gatherings, quarantines, and other issues. Many states, including New York and…
Complying with research ethics is notably challenging during global health emergencies such as the outbreak of coronavirus disease (COVID-19). Investigators must have an ethical framework…
As COVID-19 continues to impact research organizations and clinical sites, federal agencies are issuing guidance for clinical trials. Organizations are closing or dramatically reducing operations…
Both the journals Science and The Lancet have recently published studies showing a lack of compliance with posting clinical trials results on ClinicalTrials.gov. Be sure…
Evolving technology now makes 3D printing an inexpensive technology for reproducing replica bones. Digital bone repositories around the world are currently working through the ethical…
The National Academy of Sciences, Engineering, and Medicine will be hosting An Examination of Emerging Bioethical Issues in Biomedical Research on February 26, 2020 at…
For two decades, the federal government has encouraged transparency in research. As a result of these efforts, it established ClinicalTrials.gov, a national registry of U.S….
Read about the approach to drug development that includes tolerability, ease of use, compliance with therapy, and quality of life as topics addressed along with…
View OHRP’s 2020 edition of the International Compilation of Human Research Standards. This compilation of laws, regulations, and guidelines is helpful to CITI Program organizations…
The NIH Office of Extramural Research (OER) provides a decision tool to help determine if research is considered human subjects research and if it may…
The U.S. Departments of Health and Human Services and Education have released “Joint Guidance on the Application of the Family Educational Rights and Privacy Act…
On January 20, 2020, the sIRB requirement under the revised Common Rule went into effect. This marked the final step in the timeline for full…
