Medical Ethics Advisor – September 1, 2022

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.

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.

Financial Conflicts Reported Inconsistently

It might be time to consider another approach to transparency on financial conflicts.

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.

Ethical Considerations for Trauma-Informed Care

Use the tenets of trauma-informed care by realizing the widespread effects of trauma; recognizing signs and symptoms; responding by including knowledge about trauma in policies, procedures, and practices; and avoiding retraumatization.

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.

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.

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.

Updated Tactics for Parkinson’s Disease Study Recruitment

Remote, decentralized studies allow for the recruitment of large, geographically dispersed cohorts from a single location. In considering whether to use a decentralized design or to include remote assessments, the research team must determine if these methods can adequately answer the question under study.

For Individualized Therapy Trials, Remain Mindful of Transparency, Reporting Bias

Individualized therapy studies should be publicly and prospectively registered in a clinical trial database. The authors should report results regardless of outcomes. If these trials are not handled right, it might be a step backward in terms of transparency and reporting bias.