TAG ARCHIVES FOR AER18

20
Dec2018

The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes. Read more

18
Dec2018

As research activities go, the use of archival tissue has ranked pretty low on my list of ethical concerns. After all, the tissue has been or will be collected during a clinical procedure that patients would undergo regardless of their participation in research; there is no additional physical risk to subjects, and the primary ethical dilemma (or so the thinking goes) is the potential for a breach of confidentiality. By the end of the full-day preconference program Biobanking in an Era of Precision Medicine Research: Approaches to the Ethical, Regulatory, and Practical Challenges, the presenters had changed my thinking on this topic. I now have a much better appreciation of the complex relationship between researchers, patient-participants, pathologists, and IRBs, particularly when specimens will be used to investigate precision medicine applications. Read more

12
Dec2018

PRIM&R recently hosted a full-day preconference session at the 2018 Advancing Ethical Research Conference (AER18) discussing the challenges and strategies for successfully implementing single IRB review. Conferences like PRIM&R’s are an important venue for institutions to get together to discuss these challenges and find solutions. Read more

14
Nov2018

As I was pursuing my doctorate, I worked as the compliance administrator for the IRB office. My dual-role afforded me an insider’s view into the challenges student researchers face when accessing IRB related information. As the newly hired full-time research compliance manager, I continue to support students new to research. I am attending the 2018 Advancing Ethical Research Conference (AER18) to learn how other compliance administrators support new researchers and build trust between researchers and diverse communities. I am particularly interested in how other compliance administrators support intercultural communication. Read more

12
Nov2018

I was very excited to learn of the opportunity to become a member of the Blog Squad for the 2018 Advancing Ethical Research Conference (AER18). I am the Research Director for the Department of the Emergency Medicine and serve as the Vice Chair for the IRB at The Lincoln Medical Center in The Bronx, New York. Initially, I became familiar with the IRB as a Principal Investigator, when I conducted a research project to fulfil the requirement for Pediatric Emergency Medicine (PEM) fellowship training. I quickly realized that research is vitally important to for the advancement of medical science and I also understood that human subjects protections, particularly in children and other vulnerable populations, is critical. As I practiced in a neighborhood of diverse and low-income households, I appreciate the importance that subjects’ rights not be violated, and that they not be unduly coerced to participate in research. It is also important that participants enter into research studies voluntarily and with sufficient information and understanding. Read more