Medical Ethics Advisor
RSSArticles
-
IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
-
New Tools to Facilitate Single IRB Process
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
-
How Should Researchers Proceed if They Suspect Neglect or Abuse?
If researchers interview a child during a minimal risk study at a school, and they suspect the child is a victim of abuse or neglect, investigators are ethically obligated to respond to this.
-
Be Careful About Informed Consent if Pelvic Exams Happen While Patients Are Under Anesthesia
Incorporate explicit discussions with patients about pelvic exams conducted while patients are under anesthesia. These discussions should occur during consent processes for gynecologic procedures. Specifically, patients would be told about the potential for medical student involvement in these exams.
-
Financial Conflicts Reported Inconsistently
It might be time to consider another approach to transparency on financial conflicts.
-
The Trouble with Electronically Tracking Study Medications
Digital pills allow data to be recorded automatically about patients’ medication adherence, but patients and providers have expressed significant ethical concerns.
-
Electronic Orders, Education Boost Requests for Ethics Consults
The electronic order is an important way to streamline ethics consultation requests, but additional, broader efforts will be needed.
-
Updated Guidance Provides Sense of Urgency to Improve Clinical Trial Diversity
Organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations.
-
Few People with Limited English Proficiency Participate in Stroke Studies
Rather than making the IRB processes more difficult for researchers who wish to include underrepresented populations in their study, IRBs should work with researchers to overcome obstacles.
-
New Guidance on Incorporating Patient-Reported Outcomes in Clinical Research
Patient-reported outcomes can be used to develop healthcare policy and regulatory decisions, and also to monitor symptoms to provide timely care tailored to the patient’s needs.