Medical Ethics
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IRB Collaborations With Tech Companies Could Mean What to the IRB?
Tech companies increasingly are partnering with research institutions. These partnerships include sharing data and project collaboration. What IRBs will want to know as this trend continues is what it means from a human research protection perspective.
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Bypassing an IRB Review, Researchers Held Herpes Vaccine Trial on an Island
The human research protection community recently learned of a troubling clinical trial that involved private funding, a U.S. medical college researcher who died this summer, and a study held on a Caribbean island. The clinical trial was for a live attenuated herpes simplex virus-2 vaccine injected in human participants, and it was never reviewed by an IRB.
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‘Ever-Expanding Options’ Prolong Life, but Spark Conflicts
Surrogates may be struggling to let go of a loved one, may not understand clinical realities, or may have religious or cultural beliefs about withdrawal or withholding of life-sustaining medical interventions. Regardless of the reason, families sometimes want to “do everything” when the clinical team feels it’s time to stop.
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Study: Only About One-third of Adults Completed Advance Directives
Only about one-third (37%) of U.S. adults had completed any type of advance directive, found a recent review of studies.
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Revised Common Rule Is Changing Informed Consent
The recently updated Federal Policy for the Protection of Human Subjects, also called the Common Rule, is changing informed consent practices in two important ways.
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Can Intoxicated Patients Provide Informed Consent for Research?
It’s not uncommon for ED patients to present with acute intoxication. This complicates not only their clinical care, but also the informed consent process. A recent study set out to determine to what extent acute alcohol intoxication affects capacity to assent, consent, or refuse research participation.
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Unethical Marketing Practices for Stem Cell Treatments Continue
Recently passed legislation allows Texas clinics to bypass FDA approval for investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses. The law alarmed ethicists who have been monitoring these practices.
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Patients Without Surrogates Pose Ethical Challenges at End of Life
The issue of incapacitated patients lacking surrogates has received growing attention, resulting in a newly updated position statement and several case studies.
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Newest Oncology Studies Raise Ethical, Other Questions for IRBs
Clinical research — especially involving oncology trials — is evolving with the introduction of new therapies and therapeutic mechanisms. These raise new and sometimes challenging questions for IRBs reviewing the study protocols.
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Does Cancer Patient Want Fertility Preserved? Ethical Issues Arise
Oncofertility, a fairly new but growing field, addresses the special reproductive needs of cancer patients — but guidelines for how to deal with ethical dilemmas have not yet been established.