TAG ARCHIVES FOR Blog Squad

1
Mar2019

After over five years of discussion—from the advance notice of proposed rulemaking and two implementation delays—the revised Common Rule finally went into effect on January 21, 2019. The delays in implementation, while frustrating at times, also gave institutions more time to plan and discuss best practices. Through all this discussion, however, many areas of ambiguity were identified including challenges on how to implement the changes. To help address these issues, PRIM&R held a panel on Operationalizing the Revised Common Rule at the 2018 Advancing Ethical Research Conference (AER18). While change can be challenging, working together to share ideas and best practices can help ensure the transition goes as smoothly as possible. Read more

14
Feb2019

The 2018 Advancing Ethical Research Conference (AER18) was my second PRIM&R conference, and this year I came armed with questions for specific organizations and agencies. At the top of my list was a question regarding the 2015 NIH Genomic Data Sharing (GDS) Policy: When children’s data is submitted to a national genomic data sharing repository, such as the database of Genotypes and Phenotypes (dbGaP), what are the consent expectations when those subjects reach the age of majority?  Read more

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

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