Medical Ethics Advisor – December 1, 2021
December 1, 2021
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IRBs Scrutinizing Remote Consent, Screening, and Participation in Study Protocols
It is critical to remember face-to-face contact remains the best way to conduct the process of informed consent. Remote processes should not be used as an alternative if face-to-face contact is safe and practical.
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IRBs Face Unique Ethics Questions About Big Data Research
There is a need for ethics review committees to improve oversight capacity for big data research, the authors of a recent paper argued. Researchers assessed the weaknesses of ethics review committees, some of which are not specific to big data research but could be exacerbated by it, and some that are specific to big data research.
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Paying Participants? Incentives Should Be Reasonable for Research Activities Involved
Remember two central ethical concerns: Undue inducement, meaning an offer so attractive it leads to bad judgment, and unjust inducement, meaning payment is more attractive to lower-income people, putting too much of the burden of research participation on them.
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Medical Providers’ Views Vary on Refusals of Life-Sustaining Treatment
Ethicists can help determine how best to proceed with treatment decision-making in cases in which patients lack decisional capacity. They can explain why the tie between treatment decision-making and capacity is morally important and essential for sound ethical medical practice.
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Decisional Capacity Is Most Common Issue in Neuro-Oncologic Ethical Consults
For a terminal condition, goals of care need to be identified so they can be honored. If discussions do not happen early, when the patient likely is at his or her peak functional status, it leaves caregivers, families, and physicians with little guidance.
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Moral Distress When Caring for Patients on Mechanical Circulatory Support
Clinicians pointed to palliative care and ethics consults as ways to mitigate moral distress.
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Data Show Larger-Than-Expected Market for Ethics Consultation Training
Based on the survey responses collected from participants at hundreds of U.S. hospitals, researchers estimated approximately 62,000 individuals would benefit from basic-level training on how to perform ethics consultation, and 37,000 would benefit from advanced-level training.
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Positive STI Test Results Not Always Shared with Study Participants
Investigators should develop a plan to return test results to participants, and document their actions in protocols and manuscripts. IRBs should require researchers to include these details in their proposals.
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Novel Ethics Curriculum for Neonatal-Perinatal Medicine
At three academic institutions, faculty members recently piloted 13 ethics modules for neonatology fellows. Of the 44 neonatology fellows who participated, baseline ethics knowledge and confidence in addressing ethical dilemmas improved significantly.
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IRBs Often Reluctant to Approve Inclusion of Pregnant Participants in Research
Some IRB members cite uncertainty on whether inclusion of pregnant participants could affect the study’s scientific validity. Others acknowledge they rely on the common, default practice of excluding pregnant individuals without requiring justification. Guidance is needed for characterizing the risk level of research procedures in the context of pregnancy.