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Clinical Trials & Research Ethics

Bioethics Forum Essay

Newly Released Documents from Untreated Syphilis Study: Ethical, Just, and Respectful Use of Archival Materials

To mark the 50th anniversary of the end of the United States Public Health Service’s Syphilis Study, the National Library of Medicine recently digitized and released reams of historical documents on the “origin and development of the Tuskegee syphilis study.” The release of these documents is a poignant occasion to consider what qualifies as ethical, just, and respectful use of archival materials.
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Bioethics Forum Essay

Fear of Doing Too Much Too Soon or Too Little Too Late: Research on Covid-19

The Covid-19 pandemic has significantly affected the practice of clinical research. Researchers and IRBs have felt an urgency to respond more quickly than usual, aware that lives are at stake.
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Bioethics Forum Essay

Should We Enroll Our Child in a Covid-19 Vaccine Trial?

My partner and I are thinking a lot about this question. Moderna and Pfizer trials are running in our community–at the children’s hospital where I work as a clinical ethicist....
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Bioethics Forum Essay
gloved hands injecting a vaccine into an exposed shoulder

Ethics of Placebo Controls in Coronavirus Vaccine Trials

Multiple candidate vaccines for coronavirus are being evaluated scientifically in a process of unprecedented speed, and thousands of individuals around the world have volunteered to participate in placebo-controlled phase III field trials. If, or when, one of these candidate vaccines is proved to be safe and effective and receives an emergency use authorization by the Food and Drug Administration, will it continue to be ethical to enroll participants in other coronavirus trials that randomize half of them to a placebo?
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Bioethics Forum Essay
Krishna and Balarama ancient carving, Angkor

Volunteering for a Covid Vaccine Trial: Fulfilling Hindu Obligations or Fostering Pharmaceutical Company Profits?

Volunteering for a Covid-19 vaccine trial satisfied my altruistic goals and harmonizes with my Hindu beliefs. But I am troubled that a drug company is going to profit from my altruism and my religious obligations.
Read Volunteering for a Covid Vaccine Trial: Fulfilling Hindu Obligations or Fostering Pharmaceutical Company Profits?
Bioethics Forum Essay

Ethical Responsibility in Publishing Research Results on Covid-19 Treatments

There is little doubt about the urgent need for Covid-19 treatment. But premature publication of definitive recommendations based on inappropriate conclusions grounded in scant, hastily-acquired data serve only at best to confuse and at worst mislead at a time when tensions are high and need for help is great.
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Bioethics Forum Essay

Clinical Trials vs. Right to Try: Ethical Use of Chloroquine for Covid-19

Double-blind randomized clinical trials are the gold standard for answering the scientific question of whether a drug produces any effect, positive or negative, in Covid-19 patients. But is rational for a patient to choose to try a drug such as chloroquine for Covid-19 outside of a trial? Some patients may correctly hold that they have little to lose.
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Bioethics Forum Essay

Transcending Borders in the Ethical Oversight of Human Genome Editing

The bioethics and legal communities must come together to find ways to move with the same ease of the scientific research community--to transcend the geopolitical borders and jurisdictional concerns that make international regulation so difficult.
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Bioethics Forum Essay

Hannah Arendt in St. Peter’s Square

Neither one of us expected to be talking about Hannah Arendt at the Vatican. We had been invited to give talks at the Pontifical Academy of Sciences on the scientific and ethical challenges posed by personalized medicine. Walking across the cobblestones of St. Peter’s Square we began to discuss how society regulates biomedical research. Are institutional review boards capable of dealing with innovations like personalized medicine? Are they too bound by regulations? Can they ask larger questions of meaning when simply following the rules won't suffice? And most worrisome, has their bureaucratic function caused them to mistake regulatory compliance for ethical reflection?
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Bioethics Forum Essay
Chinese scientist speaking at international meeting

Chinese Bioethicists Respond to the Case of He Jiankui

A preliminary investigation by Guangdong Province in China of He Jiankui, the scientist who created the world’s first gene-edited babies, found that “He had intentionally dodged supervision, raised funds and...
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