Topic: Doing research studies on patients without their consent
Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
It amazes me that those in the duck world don't seem to be able to do the things the way they should in many cases... and now they are going to follow an outline on who gets or who doesn't get what... WITHOUT THEIR PERMISSION... and call it "research studies"?
And they get 50 MILLION DOLLARS for the study?
Oh.. did I mention Hopkins was involved? Go FIGURE!
This reminds me of some VERY questionable tactics I saw being done in a hospital recently.
While patient X was in the hospital.. and their family was there... who also had the patients legal papers so THEY could make decissions and it was ON FILE in the patients chart...
Rather than discuss a "research study" with any of them... they waited until the patient was taken to have x-rays... and was away from the family.. and was left alone outside an x-ray room.
Then they approached the patient with papers to sign while the patient was drugged up and in severe trauma.... uncapable of making complicated medical decissions... and..
This "signing" of papers required ELECTIVE (NOT life saving) surgery, lots of extra meds due to the procedure, a longer hospital stay, repeated visits back to the hospital for check ups at the patient's expense, TONS more money to pay the hospital for bills related to it, etc...
When questioned about it.. they pulled out the papers that were signed by the patient... waved them in everyones face and said the patient gave permission! EVERY OTHER form that had needed to be signed HAD been signed by the family.
QUOTE- ``But Weisfeldt at Johns Hopkins said the critics would be unhappy under any circumstances. Some people object to the whole concept of doing any study whatsoever without permission," Weisfeldt said.
"We try to explain all the layers of approval we've gone through and that this is the only way we can do the kind of research that could save many more lives in the future."
May 26, 2007, 11:51PM
Medical experiments to be done without patients' consent
Five-year project aims to improve car crash, cardiac, other treatments
By ROB STEIN Washington Post
The studies are being conducted by the Resuscitation Outcomes Consortium, a network that includes medical centers in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and Ottawa and around Iowa and British Columbia.
WASHINGTON -- The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting the patients' permission.
The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.
The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries.
Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say.
The project has been endorsed by many trauma experts and some bioethicists, but others question it. The harshest critics say the research violates fundamental ethical principles.
The organizers said the studies are going forward only after an exhaustive scientific and ethical review by the National Institutes of Health, which authorized the funding in 2004, and the Food and Drug Administration, which approved the first phase about a year ago and the second phase six months ago.
The first experiments, involving nearly 6,000 patients, focus on people who are in shock or have suffered head injuries from a car crash, a fall or some other trauma.
About 40,000 such patients show up at hospitals each year, and the standard practice is to give them saline infusions to stabilize their blood pressure.
For the study, emergency medical workers are randomly infusing some patients with "hypertonic" solutions containing much higher levels of sodium, with or without a drug called dextran.
Animal research and small studies involving people have indicated that hypertonic solutions could save more lives and minimize brain damage.
The next experiment, which will involve about 15,000 patients, is designed to determine how best to revive those whose hearts suddenly stop beating. About 180,000 Americans suffer these sudden cardiac arrests each year.
Emergency medical workers often shock these patients immediately to try to get their hearts started again.
But some do a few minutes of cardiopulmonary resuscitation first. Researchers want to determine which strategy works better by randomly trying one or the other -- both with and without a special valve attached to devices used to push air into the lungs during CPR. That study is expected to start next month.
"We will never know the best way to treat people unless we do this research. And the only way we can do this research, since the person is unconscious, is without consent," said Myron Weisfeldt of the Johns Hopkins University School of Medicine, who is overseeing the project.
"Even if there are family members present, they know their loved one is dying. The ambulance is there. The sirens are going off. You can't possibly imagine gaining a meaningful informed consent from someone under those circumstances."
Before starting the research at each site, researchers complete a "community consultation" process. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements and through stories in local media.
Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.
The project proceeds only after also being vetted by a set of local independent reviewers known as an institutional review board. Another group of independent advisers known as a data safety monitoring board will periodically review the study for any signs of problems.
Despite such oversight, some previous similar projects have sparked intense debate. Most recently, a study testing a blood substitute called PolyHeme was criticized for putting patients at risk without consent.
In fact, concerns raised by the PolyHeme study and others prompted the FDA to launch a review of the entire program that permits experiments to be done without consent in emergency situations.
"The ethics and policy concern is how you balance the streamlining of research to get the best information to treat patients against the moral imperative to get consent," said Nancy M.P. King, a bioethicist at Wake Forest University School of Medicine.
"The emergency consent exception is supposed to carve out a very narrow window. What's been happening is that narrow window seems to be expanding."
Some bioethicists say the new research is more ethical than some of the earlier studies in several ways, including that patients are not being denied highly effective therapies. Most patients who receive the current treatments do not survive.
"I understand why there might be concerns, but I think ethically this is permissible," said Arthur Derse, a bioethicist at the Medical College of Wisconsin, which refused to participate in the PolyHeme study. "The treatments we currently have are unsatisfactory."
But others say that the studies could be done by finding patients or family members who are in a position to provide consent, even though that might make such studies more difficult.
"This just seems like lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible," said George Annas, a Boston University bioethicist. "I don't think we should use people like this."
Annas was particularly disturbed that children as young as 15 might be included in the research. "Suppose a 15-year-old child is in the back of a car that is in a terrible accident," Annas said.
"The EMTs arrive and say: 'We are doing an experiment with two techniques. We think they are about equal. Is it okay if we flip a coin to see how we treat your son? Or would you rather we just give him the treatment we think is best?' Unless you think all parents would have the EMTs flip a coin, consent here is necessary."
Others are concerned patients may be getting experimental therapies that could turn out to be inferior to standard treatments.
"The most promising experimental medical interventions have often been shown to be less effective than standard treatment," said Kenneth Kipnis, a University of Hawaii bioethicist. The "community consultation" process has also come under fire.
"Community consultation is intended to be a collaboration with the community of potential subjects, not just letting them know what the plan is," said King, the Wake Forest bioethicist.
But Weisfeldt at Johns Hopkins said the critics would be unhappy under any circumstances.
"Some people object to the whole concept of doing any study whatsoever without permission," Weisfeldt said. "We try to explain all the layers of approval we've gone through and that this is the only way we can do the kind of research that could save many more lives in the future."
Cass A
Frequent Contributor (1K+ posts)
Member # 11134
posted
This is gross, but happens more often than people realize.
If you're interested, check out the website for the Association for Human Research Protection http://www.ahrp.org. They send out action alerts and info on this topic frequently.
Best,
Cass A
Posts: 1245 | From Thousand Oaks, CA | Registered: Feb 2007
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Beverly
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Wow, that is horrible! Posts: 6641 | From Michigan | Registered: Jun 2001
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Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
Cave said... "All I know is that if I were struck unconsious---- and had no one to give consent----and I might die while they tried to round up my daughter who was camping that week...."
Just so you know.. if you are in an emergency medical situation.. it is called implied or presumed consent.
That means rescuers assume that if you were able to speak or communicate you would want to live... so life saving measures can be taken immediately by the people on the scene.
As for Hopkins.. my GUESS is...
Since Maryland has the world's best Emergency Medical System.. and always has had the best, thanks in part to Adam Cowley, etc...
My GUESS is they don't want to mess up their record.. and someone... or many someones... are balking and/or screaming at this idiot idea BIG time because they CARE about the patients and refuse to let this insane idea happen in Maryland... and THEY don't want to be responsible for damages.
Notice how Hopkins is getting the money and playing "boss" with it but they aren't "DOING" it.. and other states have refused to join in this "experiment"... and Maryland is NOT on the list of states who WILL participate. Rather odd, you think?
Also consider you are an emergency worker.. a volunteer like I was for 30 years plus.
I arrive at an accident scene. There is a child unconcious and in need of emergency medical intervention to be able to save his/her life.
Here is what makes me angry... grrrrrrrr...
I want to know EXACTLY what the bag of IV fluids has in it when I administer it to that child. I don't have time to PLAY around. This is someones baby. I treat all victims as if they were MY family. I won't be limited by an experiment or wacked out protocol for a study.
I want to know all of the items I have available to try to save a life are up to standard... have been approved and used in the past.. that they meet protocol.... and are not some mystery substance that someone is testing on traumatized victims.
If we allow this to happen... What's next? Let's impregnate brain damaged women to run tests on them because they can't give consent and they don't care because they are unconsious and may not live anyway?
Ok.. as for the medical NEED to do this.. BULL!
Emergency workers... if they do ANYTHING... it is a TON of paper work for every little thing they do.
For MUCH less than $50 million dollars a team of people can sit on their tushes and review records to see that when X was done... this result occured.. and when Y was done.. this result occured. THAT is where you get your "study" results.
PLUS... what if there were 1,000 people in this study. I happen to know people on ambulances that I would cringe to see show up at MY door in an emergency. I also know workers who I would LOVE to see show up.
Lets say 500 of the "different" IV solutions are used by some emergency crews who aren't famous for their results (to put it nicely). And the other 500 were used by some better trained workers.
Human error here is so great that accuracy can't be depended on. And when it is all over... what if the results are 50/50. Could it have been 80/20 had everyone NOT used the experimental stuff?
If this is such an all fired good idea... why not make all Hopkins Emergency Room doctors do it?
If I were to lose a patient.. I would want to be able to look the family in the eye and tell them I did all I could to save their loved one and not have to worry that some experiment was being done and my "tools" or things I used were not what I thought they were.
And... and... and...
Yeah.. this is making me nuts.. because it is INSANE!
As a matter of fact.. if I am on an emergency scene.. and I have a choice to start CPR or SHOCK first THEN do CPR... I want to be able to make that choice depending on all the outside factors. In a study I couldn't do that.
And if this is allowed to happen.. what is to stop the drug companies from filling ER's or ambulances with all experimental drugs to see what happens?
My GUESS is that they won't use this stuff in NORMAL hospital settings because people CAN give consent.. and they won't.
My GUESS is that if someone is injured by these experiemnets the arguement would be.. the "accident" killed them.. not our methods.
And my GUESS would be it would also remove the ability to sue doctors and hospitals by putting this lame idea in a study.
And did anyone notice who besides Hopkins was involved?
Oh! The FDA and NIH too!
Even if I LOVED Hopkins.. that would still turn me away.
Like I said about some of their other ideas...
Once the FDA can get right what they are already suppose to be doing... and do it succcesfully..
THEN maybe we can add more responsibilites to their work load.
Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
Ks mom..
You posted your comment while I was ranting and raving.. so I just saw it.
You said.. "It paved the way for what they are doing now. If I remember correctly, it also sets the stage for this to happen beyond ER care."
BINGO!
Exactly one of my points. Thanks for sharing that. Good to know.
And.. and.. and...
Yes.. I am still
Imagine you jumped out from your warm bed at 2 AM for an ambulance call.
You dress, rush to the scene, do your very best in the dark, the muck and mud, the sirens blaring, snow on the ground, people screaming, broken glass, cars going by, lights blinding you, having to cut people out of seat belts when the car is upside down and even cut through cars to get to them.
You hold their neck steady for 35 minutes while your arms ache and you want to give up.. but you don't. You are covered in dirt, blood, spit, and lots of other stuff that isn't normal.
You have police wanting info, the media snapping photos, the passerbys getting in the way.. etc.
Then you finally get your patient in the ambulance and you are rocking down the road at incredible speeds and every sligh curve you take feels like you are on a carnival spin ride and it is nearly impossible to sit upright or stand at all. You are trying to breath them, start IV lines, radio for doctors at the ER, grab drugs, tube them, mast trousers, etc...
If they don't make it... YOU really want to die... because you've done all you could possibly do.
I've been awake for hours on end after cals like that... wondering over and over and reviewing in my mind if there was anything else possible I could have done to save that person.
I DON'T WANT TO LIVE WITH THE FACT THAT THE PERSON WHO DIED HAD BEEN PART OF A STUDY AND IT WAS THE STUDY THAT KILLED THEM AND NOT ME.
I would NEVER know those answers... and those who made up the STUPID study would not feel ONE ounce of that trauma and pain.
They would only see Patient 5676 lived and patient 7434 died. NO responsibility for them.
I think the researchers should do their own GARBAGE studies and be 100 percent responsible!
Carol in PA
Frequent Contributor (5K+ posts)
Member # 5338
posted
Something else to consider.
Recently there was an article in Newsweek about patients whose hearts had stopped.
Their organs don't get enough blood for a while, and then the heart is shocked, and the cardiac muscles are flooded with oxygen and nutrients, and the patient dies.
This is a frequent occurrence. The number of people who live after having their heart stop, even though they get CPR and are rushed to a hospital, is dismally low.
According to the article, experiments found that people whose core temperatures were reduced, survived more often after going through the above scenario.
The initial experiments were inadvertent. The patients had been immersed in cold water, or suffered exposure to freezing weather.
So...how do we conduct experiments to find out if this protocol will save more lives.
Just some thoughts. Carol
Posts: 6956 | From Lancaster, PA | Registered: Feb 2004
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I see your point Carol, but what gets me is the potential for abuse here.
As Tin pointed out and Ive read elsewhere, where will it end. The ones who came up with the amendmant already see the potential for studies in other areas besides ER care.
I mean they have already taken away patients end of life wishes, now this.
And what about the drug companies who are already getting away with doing clinical trials on drugs without patient consent or knowledge?
I'd like to know what law was passed that brought THAT into the mainstream.
Not trying to argue or start something, it just gets me that there is so much already going on without most people's knowledge, now they want to take away more of it.
I don't like the idea they are taking away options. From care providers and patients.
Foggy
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I loath when a resident is allowed to do a proceedure without your consent or notifying you in advance of this. Posts: 2451 | From Lyme Central | Registered: Aug 2001
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bettyg
Unregistered
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tc, thanks for posting and your observation of the family at top plus your work experiences!
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shazdancer
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Gee, I hope by "Portland" they mean Oregon...
The study on CPR first v. immediate defibrillation puzzles me on so many levels. We were specifically taught in CPR training that CPR is what you did until better intervention (defib) arrives. That was the whole point in making defibrillators easier to use and installing them in public places like golf resorts and YMCAs.
So I thought it was already known that faster access to defib was important. (And yes, I can think of a couple of unusual scenarios where a defibrillator might not be the first choice.)
I agree with you, TC -- couldn't a statistical study of EMT and hospital records show which approach worked better?
-- Shaz
Posts: 1558 | From the Berkshires | Registered: Jul 2001
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treepatrol
Honored Contributor (10K+ posts)
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****but what gets me is the potential for abuse here. ***
Anytime theres someone doing anything to a persons body or property without permission its abuse
-------------------- Do unto others as you would have them do unto you. Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.
Truthfinder
Frequent Contributor (1K+ posts)
Member # 8512
posted
One of the articles said:
quote:Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.
Gee, they didn't even bother to tell anybody HOW to get that accomplished..... and I'll bet that YOU will have to pay for the bracelet to protect yourself from somebody 'experimenting' on you.
Good grief.
Tracy
-------------------- Tracy .... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�. Posts: 2966 | From Colorado | Registered: Dec 2005
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