TAG ARCHIVES FOR AER18

31
Jan2019

Innovations in medical practice are critical to the advancement of medicine, but the question of “innovative treatment” versus “medical or surgical research” can often become clouded.  It was with great interest that I attended the breakout session led by Stephanie Cargill, PhD, and Jeremy Corsmo, MPH. When does a doctor’s innovative treatment of a patient become surgical or medical research? This question comes up frequently and is also posed when research takes place outside the surgical theater. I was relieved to find out I was not the only person on the planet to have dealt with this issue. As the co-chair of an independent IRB, Read more

24
Jan2019

In the regulatory world, time is a precious commodity. Though we are frequently tasked with high volumes of work,  taking time to work on professional growth and advancement is critical. The "Advancing Yourself as a Regulatory Professional" session at the 2018 Advancing Ethical Research Conference (AER18) provided practical tips on how to advance professionally. Read more

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