The teaching of ethical principles is included in many courses that train researchers on “responsible conduct of research”. The IRB 101sm preconference program at the 2018 Advancing Ethical Research Conference (AER18), however, was unique in describing the history of the development of modern research ethics, and then providing practical application in real research practice. Read more
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
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
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
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
