EFF.ORG -> Human Research Loopholes: Alive and Well
DEC 29 @ 12:15PM
DECEMBER 28, 2015 | BY YONATAN MOSKOWITZ AND LEE TIEN
Human Research Loopholes: Alive and Well
In one of the darkest chapters in medical ethics, the United States government ran an experiment from the 1930s to the 1970s in which it withheld treatment and medical information from rural African-American men suffering from syphilis. The public uproar generated by the Tuskegee Syphilis Study eventually resulted in regulations restricting government-supported research testing on humans. These regulations are called the Common Rule, and they are right now up for their first full update.
The Common Rule, also known as the "Federal Policy for the Protection of Human Subjects," is supposed to affirmatively protect us from the abuses of the future. However, the proposed regulation is lousy with loopholes, including ones that could exempt tracking online behavior and experiments related to intelligence activities.
File a comment on the Federal Policy for the Protection of Human Subjects through Regulations.gov.
What is the Common Rule...
The Biospecimen Consent Loophole...
The "Public" Behavior Loophole...
The Intelligence Surveillance Activities Loophole...
Deadline Approaches
These loopholes discussed above are just a sample of many we hope to force HHS to reckon with when we file our comments by January 6, 2016. Please join us in respecting the memories of those abused by human subject research in the past by filing a comment of your own.
http://www.cdc.gov/tuskegee/timeline.htm
http://www.hhs.gov/ohrp/humansubjects/commonrule/
https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf
Igel
(35,359 posts)Tuskegee was invasive, abusive, etc., etc., and done without the subjects' knowledge or consent. In fact, the facts were misrepresented and they had few choices in the matter.
This wasn't just a Tuskegee "thing"; it was common, and included a lot of other research that provided information that was really useful. Perhaps it could have been obtained in other ways; perhaps not.
When I did some human research, I had to go through a board just because there was a small--very, very small--chance of harming the subjects. I used an eye tracker. An infrared source produced IR light. An IR camera was mounted on a frame and pointed at the subject's eye. A computer could figure out what the subject was looking at by monitoring the IR reflection on the subject's eye. This was deemed "invasive" and "dangerous" and the subjects had to be vetted. Often we had to use "clever" ways of describing the experiment so that the subject knew what was happening but couldn't figure out what was going on--otherwise the subject might be able to affect the outcome consciously, making the experiment pointless. Of course, the "danger" was mostly based on the possibility of older, heavier models of the headgear causing muscle aches or the person accidentally poking the camera into his eye. You'd get more IR incident on your eye from looking at a space heater.
The board thought having to vet this was just short of loony but the text of the funding source said to look at human-subject research protocol language, and that language could easily be construed as including the near-zero risk of the eye-tracking protocols. As the tech got more refined it was less and less intrusive, yet the same board that vetted experimental surgical procedures and drug trials was in charge of vetting this. Eye tracking was finally as invasive as asking somebody to put on safety goggles before an experiment, and less invasive and "abusive" than many typical high-school or Cub Scout activities for which far fewer precautions need to be taken.
At some point the protocols really need to be rewritten, not to be made stricter but laxer. If there's nothing abusive, if there's nothing personal, if there's nothing dangerous or invasive, then the only thing many people asking for even tighter protocols are working off of is fear and suspicion based on a kind of low-grade paranoia. Anti-intellectualism and fear of science that leads to rampant anti-vaxxer and anti-GMO and anti-clmate-change and ... and ... has to stop before we're entirely post-Enlightenment and firmly back in a pre-Galilean mindset but with much fancier toys.
bobthedrummer
(26,083 posts)Yes, America's Psychologists Abetted Torture
http://www.democraticunderground.com/1016129591
Chapter 21-Omaha
http://www.democraticunderground.com/1016139460
K&R.
proverbialwisdom
(4,959 posts)My familiarity with this issue is superficial, admittedly, but here's why your overgeneralized bluster is unacceptable - a counterexample in a heartbeat.
SOURCES:
http://www.democracynow.org/2007/1/19/medical_apartheid_the_dark_history_of
http://www.democracynow.org/2011/10/31/deadly_monopolies_medical_ethicist_harriet_washington
https://pritzker.uchicago.edu/about/news/pritzkerpulse/2007summer/washington.shtml
http://www.amazon.com/Medical-Apartheid-Experimentation-Americans-Colonial/dp/076791547X/
http://www.amazon.com/Deadly-Monopolies-Corporate-Itself-Consequences/dp/0385528922/
...A few months ago I came across the book Medical Apartheid by Harriet Washington. Washington has been a fellow in ethics at the Harvard Medical School, a fellow at the Harvard School of Public Health, and a senior research scholar at the National Center for Bioethics at Tuskegee University. Shes also the author of Deadly Monopolies.
Medical Apartheid is an impressive history of medical experimentation on African Americans throughout our history even back to the days of slavery. It won the 2007 National Book Critics Circle Award for Nonfiction.
I was especially interested in what Washington said about measles vaccine studies U.S. health officials conducted on black children.
p. 295:
"Between 1987 and 1991, U.S. researchers administered as much as 500 times the approved dosage of the experimental Edmonton Zagreb (EZ) measles vaccine to African Americans and Hispanic babies in black neighborhoods of Los Angeles. The parents of these children did not know mammoth overdoses were being administered nor that the vaccine was experimental. They also did not know that the vaccine had been given to two thousands Haitian children. . .with disastrous results. EZ-vaccinated children, all poor, began to sicken and die by the hundreds there and throughout countries in the Third World."
While Harriet Washington doesnt talk about the cover-up of MMR vaccine injury data on black boys,* she makes it clear there are plenty of reasons to be concerned...
Related: http://articles.latimes.com/1996-06-17/news/mn-15871_1_measles-vaccine
* http://www.morganverkamp.com/august-27-2014-press-release-statement-of-william-w-thompson-ph-d-regarding-the-2004-article-examining-the-possibility-of-a-relationship-between-mmr-vaccine-and-autism/