In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018.
One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more
You are the principal investigator/owner at an independent clinical research site that is struggling financially. The first person you enrolled in a cardiology study had a serious stroke after one week in the study. The person had no history of strokes or related conditions. After unblinding, your SAE report to the very large CRO identified the study drug as causation. After a heated discussion, the CRO’s medical monitor says he will “overrule” your conclusion and report the SAE (on your behalf) to the IRB and FDA with unknown causation. To prevent further issues, the study will be closed at your site.
Should you tell somebody about the situation? Read more
Tremendous progress continues to be made against the Emperor of All Maladies, cancer. One of the most exciting areas of progress involves immunotherapy, a treatment strategy that harnesses the natural ability of the body’s own immune cells to attack and kill tumor cells. A lot of extremely hard work has gone into this research, so I was thrilled to learn that the Food and Drug Administration (FDA) just announced on August 30 its first approval of a promising type of immunotherapy called CAR-T cell therapy for kids and young adults with B-cell acute lymphoblastic leukemia (ALL)—the most common childhood cancer in the U.S. Read more
In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest. Read more
This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments. Read more
On March 1, 2017, PRIM&R held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center). I am pleased to announce that the proceedings and other information from the day are now available on PRIM&R’s website. Read more
In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule.
The effective and compliance date for the revised rule is January 19, 2018, and with this date on the horizon, webinar attendees had many questions for the presenters about the new rule and what implementation might look like in their own human [...] Read more