Medical Ethics
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Gene-Altered Twins Face Uncertain Future
Chinese twins born in 2018 face a future fraught with potential health complications after a rogue gene-editing experiment that “basically broke every single principle of ethical medical research,” an expert says. The experiment shocked many in the scientific community, who cited widespread agreement that there were too many unknowns to proceed with CRISPR in human research subjects.
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Bioengineered Organ Research on the Recently Deceased
The next frontier in transplant medicine includes bioengineered organs, which raise ethical issues but could help alleviate a critical shortage that leaves more than 100,000 people on organ wait lists annually in the United States.
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Ethical Issues and Standards in Case Management, Part 2
In October, we began our discussion on ethical issues of relevance to case management professionals. The principles should provide case managers with a framework when dealing with the tensions between providing quality healthcare and containing costs. However, it is doubtful that the tension can be overcome completely. Even when payers or health insurance plans make legitimate decisions, healthcare professionals may sometimes find that they cannot support these decisions in good conscience. How you respond to these dilemmas is significant in terms of maintaining ethical integrity.
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‘Re-Consent’ a Gray Area for IRBs
Wading into a thicket of ethical and legal issues, SACHRP is trying to clarify the concept of “re-consent” and when is it necessary.
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Ethical Issues and Standards in Case Management, Part 1
This month, we will discuss principles related to ethics and how they affect one’s role as an RN case manager or a social worker. These principles include patient advocacy, which applies to all the roles and functions that case managers perform.
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Indigenous People Grill NIH on All of Us Protections
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.
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Identifiable Data Are Not What They Used to Be
IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.
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Tips for IRBs Reviewing Pragmatic Trials
Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.
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Pragmatic Trials on the Rise as Data Collection Pushes Trend
Several recent changes are driving the pragmatic trial trend nationally, including acceptance from regulators and the growth of big data. Pragmatic clinical trials measure effectiveness of a study drug, device, or intervention on a wider range of people. Unlike clinical trials that exclude people based on health conditions and other criteria, pragmatic trials study a treatment’s effect on a group of people who are more representative of patients in clinical practice and the real world.
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IRB Methods for Reviewing Gun Violence Study Protocols
Gun violence researchers must be sensitive to the emotional risks of participants.