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Public Health Service’s Syphilis Study, the National Library of Medicine recently digitized and released reams of historical documents on the “origin and development of the Tuskegee syphilis study.”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.

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.

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....

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?

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.

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.

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.

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.

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?

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...

In their single-minded venture of “producing” (shengchan, in their own word) the world’s first gene-edited babies, He Jiankui and his associates have posed numerous and daunting ethical challenges to China...

When the world’s first research on editing the genes of human embryos by Chinese scientists  was published in an international journal in 2015, a report in the New York Times...

The global scientific community has been unanimous in condemning Chinese scientist He Jiankui, who announced last week that he used the gene-editing technology called CRISPR to make permanent, heritable changes...

I started writing this on my way back to New York from the Second International Summit on Human Genome Editing, held in Hong Kong November 27 to 29, where the...

The advent of social media technology has opened many new avenues of research in population health, demographics, psychology, and the social sciences. It is crucial to consider whether researchers conducting...

Human infection challenge studies, which deliberately expose healthy volunteers to disease-causing infectious agents under carefully controlled conditions, offer a valuable method of biomedical research aimed at efficient initial efficacy testing...

The death of former first lady Barbara Bush at age 92 was noteworthy in many ways. She was by all accounts smart, sharp and funny, and a fine, helpful wife...

An investigative report The BMJ published recently about a failed tuberculosis vaccine trial conducted with infants in South Africa underscores several issues in translational science that are gaining increased attention:...

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the...

As I read a recently published report of an interesting and important placebo-controlled trial of arthroscopic shoulder surgery, one sentence in particular caught my eye: “The study was designed under...

Do the recipients of organ transplants have a right to know if the organs they are about to receive were part of a research study? If so, are the recipients...

Along with the recent public debates over  Confederate memorials, there have been calls to remove or modify the statue of Dr. J. Marion Sims, called the father of gynecology in...

The Precision Medicine Initiative plans to collect data and biological samples from one million or more individuals in the United States and engage in internationally collaborative research. That means that...

“There is a difference between remembrance of history and reverence of it,” Mayor Mitch Landrieu declared to explain the removal of four Confederate monuments in New Orleans in May. The...

In an essay in the May-June 2017 Hastings Center Report, Holly Fernandez Lynch and Michelle N. Meyer assess the impact of the revised Common Rule on biospecimen research. They believe...

After much anticipation, on April 22, HBO debuted The Immortal Life of Henrietta Lacks, a film based on Rebecca Skloot’s bestselling book, starring Oprah Winfrey. Lacks’s cells provided the foundation...

Clinical research with prisoners is ethically vital and challenging. Studies investigating novel psychological, behavioral, and pharmacological interventions are imperative for the health and experiences of the people they focus on....

On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement, Notice-and-Comment Rulemaking,...

Mainstream research ethics rests on an incomplete foundation.  For the most part, human subjects regulations and guidelines reflect the views of professionals and others who have never been subjects themselves. ...

On December 13th, President Obama signed the 21st Century Cures Act, a bipartisan, multidimensional health research and development bill.  The act allocates $4.8 billion to the National Institutes of Health...

Academic bioethics has never been popular with Republicans. Libertarians dislike academic bioethics because it seems too elitist and anti-free market.  Religious thinkers worry it is technocratic, soulless and crassly utilitarian....

Health apps, wearables, and other digital technologies that collect personal health data are profoundly changing the ways that biomedical research is conducted and the role of research participants. These technologies...

In 2013 the influential German magazine Der Spiegel published an expose about clinical trials conducted by Western drug companies in East Germany during the Cold War. The magazine reported that...

Big Data, which is derived from a multitude of sources including, social media, “wearables,” electronic health records, and health insurances claims, is increasingly being used in health care and it...

Editor’s note: This essay responds to an invitation (issued here and here) to submit commentaries on the ethical implications of partnerships between social media companies and biomedical researchers. The invitation...

The rigors of medical and surgical training require long hours dedicated to providing clinical care. While long hours are necessary to obtain the experience to eventually practice independently, performing too...

Editor’s note: This essay responds to an invitation (issued here and here) to submit commentaries on the ethical implications of partnerships between social media companies and biomedical researchers. The invitation...

Editor’s note: This essay responds to an invitation (issued here and here) to submit commentaries on the ethical implications of partnerships between social media companies and biomedical researchers. The invitation...

Editor’s note: This essay responds to an invitation (issued here and here) to submit commentaries on the ethical implications of partnerships between social media companies and biomedical researchers. The invitation...

Biomedical researchers are increasingly looking to Silicon Valley for access to human subjects, and Silicon Valley is looking to biomedical researchers for new ventures. These relationships could be a boon...

As the author of the article that claimed “vindication” for the SUPPORT study, I would like to respond to Professor Latham’s insightful interpretation of the issues in the case. Like Professor Latham, I will...

Last week’s New England Journal of Medicine featured, and had an editorial about, a short opinion piece by John Lantos about the recent decision in Looney v. Moore. In that case, a Federal District judge dismissed the...

Two days after a hidden camera video of Planned Parenthood’s senior director of medical services was released, the president of Planned Parenthood Federation of America, Cecile Richards, apologized for Dr....

On April 1, a $1 billion lawsuit was filed by three law firms based in the United States and Venezuela against Johns Hopkins University, the Rockefeller Foundation, and Bristol-Myers Squibb on...

In October, the federal Office for Human Research Protections issued a “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” It follows the controversy that erupted in 2013...

“The capacity for suffering and enjoying things is a prerequisite for having interests at all, a condition that must be satisfied before we can speak of interests in any meaningful...

Several aspects of a recently published experiment conducted by Facebook have received wide media attention, but the study also raises issues of significance for the ethical review of research more generally. In...

I was born in the John A. Andrew Memorial Hospital in 1974 where the Tuskegee Syphilis Study took place. I have had a lifelong curiosity about the ethics of the study and...

Is research misconduct and abuse the norm in the University of Minnesota’s Department of Psychiatry? A recent investigative report from KMSP News in the Twin Cities suggests that the answer may well...

I appreciate the thoughtful responses to my essay on the ethics of the Bucharest Early Intervention Project (BEIP), from its investigators, Drs. Fox, Zeanah and Nelson and from Dr. Millum, one of the bioethicists...

The New York State Task Force on Life and the Law released its Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity today, which analyzes the ethical and legal implications...

Last summer’s revelations that malnourished Aboriginals in Canada served as unwitting and unprotected subjects in nutritional experiments in the 1940s and 1950s brought a sharp reaction–though the research took place...

Last month, Joseph J. Fins published a commentary on this blog criticizing the ethics of the Bucharest Early Intervention Project (BEIP)–a randomized, controlled trial of Romanian children who had been in orphanages,...

We appreciate having an opportunity to respond to the commentary on the Bucharest Early Intervention Project (BEIP) by Joseph Fins. We respect his status as a leading bioethics authority, although we are...

Some of the most hotly debated questions making the rounds these days include who should interpret, distribute, review, and receive data, and with good reason. From WikiLeaks to National Security...

If the mutilated body of one of your research subjects is discovered in a blood-soaked bathroom, who should investigate the death?  If you want to be cleared of blame, it’s...

Recently I had a Susan Reverby moment. Reverby is the Wellesley historian best known for unearthing the revelations of the Guatemalan syphilis and gonorrhea studies conducted by the United States Public Health...

This used to be a purely academic question: If you could know, years before you had symptoms of Alzheimer’s disease, that you were likely to develop it–and there was no...

For those following the SUPPORT Study controversy, the New England Journal of Medicine published this week a letter to the editor organized by Ruth Macklin, Alice Dreger, and me, and signed by 45 “physicians,...

In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put...

The clinical research community and a number of prominent bioethicists have swiftly come to the defense of investigators conducting the SUPPORT study, in which approximately 1,300 premature infants were randomly...

In his April 18 Bioethics Forum article, John Lantos criticized the findings of the Department of Health and Human Services Office for Human Research Protections that the conduct of the Surfactant,...

Public Citizen, the so-called “citizen’s advocacy group,” continues to criticize the NIH-sponsored clinical trials of oxygen therapy for premature babies.  They followed up their April 10th letter with another, on May 8th. ...

Over the past month, a petition asking the governor of Minnesota to investigate a research scandal at the University of Minnesota has been steadily gathering momentum.  The scandal in question originated in...

On March 7, 2013, the federal Office of Human Research Protections notified the principal investigator of the Surfactant, Positive Pressure, Oxygenation Randomized Trial (SUPPORT) that “the conduct of this study...

“Mr Mayor,” said K., “you keep calling my case one of the smallest, yet a great many officials have put their minds to it, and while it may have been very...

In December, the Presidential Commission for the Study of Bioethical Issues released a 200-page report, Moral Science: Protecting Participants in Human Subjects in Research. Continuing a decades-old tradition, the report treats...

On November 14, Geron, a pioneer in the field of human embryonic stem cell research, announced that it would discontinue its stem cell programs. This abrupt decision, which shocked the...

What tools does a university administration have at its disposal to shut up critics on its own faculty? The University of Minnesota wants to know. The university’s administration is exploring...

Last week, the journal Human Nature published via open access an article I wrote following a year of historical research. That article, “Darkness’s Descent on the American Anthropological Association: A...

I know that when my medical school sends us all an announcement that we’ve broken a record for funded research, I’m supposed to be happy. Wrong week for that. Shortly...

 I might easily have missed it. I was being a compulsive historian, going to one more archive (having already been to many) to find more material for what would become...

It’s hard to say what is most horrifying in Carl Elliott’s report in the current issue of Mother Jones of a young man who died caught up in a pharma...

Two weeks ago, Time magazine reported on our ongoing efforts to protect the rights of pregnant women offered dexamethasone, a risky Class C steroid aimed at female fetuses that may...

In “The Rhetoric of Dehumanization: An Analysis of Medical Reports of the Tuskegee Syphilis Project,” Martha Solomon brilliantly demonstrates how the project’s researchers hid their work in plain sight. Specifically,...

Our Bioethics Forum essay from a little over a month ago has already spawned three further essays. So we’ve asked the editors to indulge us in this single reply and update....

“Why don’t you just go through the IRB process to protect yourself?” one of my colleagues asked me (again) the other day. And I sighed (again). My tendency is to...

Because for about the last decade I have been a medical humanist working to change the way physicians treat people born with socially-challenging bodies, I’m frequently asked about doing activism...