Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Human Subjections Protection. Show all posts
Showing posts with label Human Subjections Protection. Show all posts

Thursday, December 7, 2017

Attica: It’s Worse Than We Thought

Heather Ann Thompson
The New York Times
Originally posted November 19, 2017

Here is an excerpt:

As the fine print of that 1972 article read: “We are indebted to the inmates of the Attica Correctional Facility who participated in this study and to the warden and his administration for their help and cooperation.” This esteemed physician, a man working for two of New York’s most respected hospitals and receiving generous research funding from the N.I.H., was indeed conducting leprosy experiments at Attica.

But which of Attica’s nearly 2,400 prisoners, I wondered, was the subject of experiments relating to this crippling disease, without, as Dr. Brandriss admitted, adequate consent? Might it have been the 19-year-old who was at Attica because he had sliced the top of a neighbor’s convertible? Or a man imprisoned there for more serious offenses? Either way, no jury had sentenced them to being a guinea pig in any experiment relating to a disease as painful and disfiguring as leprosy.

And what about the hundreds of corrections officers and civilian employees working at Attica? Even if no one in this extremely crowded facility was actually exposed to this dreaded disease, one in which “prolonged close contact” with an infected patient is a most serious risk factor, were these state employees at all informed that medical experiments being conducted on the men in their charge?

This is not the first time prisons have allowed secret medical experiments on those locked inside. A 1998 book on Holmesburg Prison in Pennsylvania revealed that a doctor there, Albert Kligman, had been experimenting on prisoners for years. After the book appeared, nearly 300 former prisoners sued him, the University of Pennsylvania and the manufacturers of the substances to which they had been exposed, but none of the defendants was held accountable.

The article is here.

Friday, June 16, 2017

Do You Want to Be a Cyborg?

Agata Sagan and Peter Singer
Project Syndicate
Originally posted May 17, 2017

Here is an excerpt:

In the United States, Europe, and most other countries with advanced biomedical research, strict regulations on the use of human subjects would make it extremely difficult to get permission to carry out experiments aimed at enhancing our cognitive abilities by linking our brains to computers. US regulations drove Phil Kennedy, a pioneer in the use of computers to enable paralyzed patients to communicate by thought alone, to have electrodes implanted in his own brain in order to make further scientific progress. Even then, he had to go to Belize, in Central America, to find a surgeon willing to perform the operation. In the United Kingdom, cyborg advocate Kevin Warwick and his wife had data arrays implanted in their arms to show that direct communication between the nervous systems of separate human beings is possible.

Musk has suggested that the regulations governing the use of human subjects in research could change. That may take some time. Meanwhile freewheeling enthusiasts are going ahead anyway. Tim Cannon doesn’t have the scientific or medical qualifications of Phil Kennedy or Kevin Warwick, but that hasn’t stopped him from co-founding a Pittsburgh company that implants bionic devices, often after he has first tried them out on himself. His attitude is, as he said at an event billed as “The world’s first cyborg-fair,” held in Düsseldorf in 2015, “Let’s just do it and really go for it.”

People at the Düsseldorf cyborg-fair had magnets, radio frequency identification chips, and other devices implanted in their fingers or arms. The surgery is often carried out by tattooists and sometimes veterinarians, because qualified physicians and surgeons are reluctant to operate on healthy people.

The article is here.

Sunday, March 19, 2017

Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations

James G. Hodge Jr. and Lawrence O. Gostin
JAMA. Published online February 22, 2017

On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.

Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.

The article is here.

Monday, August 1, 2016

Panel slams plan for human research rules

by David Malakoff
Science  08 Jul 2016:
Vol. 353, Issue 6295, pp. 106-107
DOI: 10.1126/science.353.6295.106

In a surprise development certain to fuel a long-running controversy, a prominent science advisory panel is calling on the U.S. government to abandon a nearly finished update to rules on protecting human research participants. It should wait for a new high-level commission, created by Congress and the president, to recommend improvements and then start over, the panel says.

Policy insiders say the recommendation, made 29 June by a committee of the National Academies of Sciences, Engineering, and Medicine that is examining ways to reduce the regulatory burden on academic scientists, is the political equivalent of a comic book hero trying to step in front of a speeding train in a bid to prevent a wreck.

It's not clear, however, whether the panel will succeed in stopping the regulatory express--or just get run over. Both the Obama administration, which has been pushing to complete the new rules this year, and lawmakers in Congress would need to back the halt--and so far they've been silent.

Still, many researchers and university groups are thrilled with the panel's recommendation, noting that they have repeatedly objected to some of the proposed rule changes as unworkable, but with little apparent impact.

The article is here.

Friday, June 24, 2016

Former FDA Commissioner Charged in RICO Lawsuit

The Alliance For Human Research Protection

A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.

The drug is one of the controversial group of antibiotics, including  Levaquin, Cipro, Avelox and other fluoroquinolones. Public Citizen petitioned the FDA in 1996 and again in 2006, to issue Black Box warnings for tendon rupture and tendinitis. Had warnings been issued, the death toll from Levaquin– reputedly more than 5,000 — and the tens of thousands who were debilitated with life-threatening diseases would likely have been averted.

The article is here.

Sunday, January 31, 2016

U.K. researcher details proposal for CRISPR editing of human embryos

By Erik Stokstad
Science
Originally published January 13, 2016

Here is an excerpt:

In a statement about the application, Hugh Whittall, director of the Nuffield Council on Bioethics in London noted: “The changes to DNA made for the purposes of this research could not themselves be used as part of a treatment procedure. There are, however, possible future scenarios in which a modification made in a research context—for example to correct a disease-causing genetic mutation—could, if this were to become permissible, be used in a treatment that would result in the birth of a child.  Such research, which could also be licensed under current legislation, would raise a number of significant questions that should be addressed before any such work is undertaken, including about whether, and under what circumstances, a move into treatment (which would require new legislation to be permissible in the U.K.) could be desirable.”

The article is here.