12
Feb2019

The 2018 Advancing Ethical Research Conference (AER18) presentation titled “It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule” provided information regarding the history of the Common Rule and the recent changes to it. It is important that IRB professionals and staff become familiar with these revisions, as they have important implications for the oversight and the conduct of medical research. Presenters Jeffrey A. Cooper, MD, MMM; Kristin Craun, MPH, CIP; Jessica Huening, JD; Heather Pierce, JD, MPH, helped to clarify much of the confusion concerning the recently revised regulations. Key changes in the revised Common Rule were emphasized. An important part of the presentation delineated what happens as these revised rules become effective. This was helpful in understanding how to transition from the “original” Common Rule to the revised Common Rule. Read more

5
Feb2019

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more

1
Feb2019

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

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

25
Jan2019

You are the chairperson of a central IRB. You have learned that one of the sites in a study you oversee is achieving subject recruiting and retention rates far superior to that of other sites. An investigation has found nothing unethical or unusual about the site’s activities — the subjects just find the investigator’s personality irresistible. 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