Medical Ethics Advisor – April 1, 2022
April 1, 2022
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Lack of Basic Knowledge on Clinical Trials Makes Study Recruitment Harder
Survey respondents with a history of cancer and those who have heard of ClinicalTrials.gov knew more about trials. Such knowledge also was more abundant among college graduates and those who had been asked to participate in a trial.
Analyses: Older Patients Excluded from Many Research Studies
Investigators learned age disparities were worse for industry-funded trials; for trials with enrollment criteria restrictions based on age cutoffs or performance status; for trials that evaluated a targeted, systemic therapy; and for lung cancer trials.
Preventing Age Disparities in Cancer Trials
A leading researcher explains why patients should have equity regarding their ability to access clinical trials, to the greatest extent reasonably possible, in this Q&A.
IRBs Strive to Improve Consistency of Study Protocol Decisions
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB.
Too Many Scientific Articles End Up Retracted
Over five decades, the authors of a meta-analysis discovered guidelines represented a small percentage of total retractions (0.3%). Scientific misconduct (including data fabrication, plagiarism, and duplication) was found in 62.3% of retracted studies. The number of retractions and misconducts increased from 1980 to 2014, but declined after 2015. The median time from publication to retraction significantly decreased over the study period.
Ethicists Become Involved in Managing Aggressive, Violent Patients
A facility in Vermont created behavior response teams, with ethicists playing a major role in collaboration with other hospital leaders, a psychologist, security staff, and other stakeholders to better manage volatile situations and protect the well-being of patients and employees.
Updated Guidance on Informed Consent in Stroke Management
A new position statement aims to help neurologists provide the highest quality patient care for ischemic stroke by providing ethical guidance on how to navigate the decision-making process for stroke patients who may struggle to provide consent.
Tips for Researchers Looking to Recruit More Pregnant Black Women
It boils down to trust, communication, education, and building a presence within the community.
Uncertainties on Future Use of Study Participants’ Data
Generally, the informed consent process needs improvement, particularly when it comes to explaining to participants what data will be used and how. Responsible data-sharing rests on making quality data accessible to authorized researchers to meaningfully advance science while respecting participant values.
Many Parkinson’s Research Participants Cannot Recall Study Risks
Rather than consenting an individual in the office during the presurgical visit, at a time when the patient was already receiving a large amount of information, the outreach could be conducted by phone later. This would give the subject time to carefully review the study materials.