Medical Research? Be an Informed Participant

I do see your point, Politisite, but, in this instance, I was addressing any and everyone who may be asked to join or who may be considering joining any kind of study. The link in my previous comment highlights folks signing up for monetary reasons. According to one of my friend's daughter, the monetary compensation is a huge factor in some cases.

Thanks so much for the praise! My program is commentary, almost like what I do here except, I read what I've written. Alas, my station manager has me on a varying rotational schedule so, it's pretty much catch as catch can! We're working on developing a show for me to do interviews and when I begin, I will see if you'd like to be on the list.  

I agree 100% with your beliefs why certain groups are targeted, which were some of the same reasons African Americans were targeted, with the race aspect making it less objectionable for many in society.

The legendary Tuskegee Experiment, tracking the progession of syphillis, was not a secret and continued until 1972. It was regularly written about in medical journals. It was conducted on poor African American men in the South. The men were not allowed to seek treatment outside of the clinic where they had been assigned for the length of the study. The majority of the medical community was silent as these men passed the disease to their wives and girlfriends, with some of their children being born with the disease, suffering from blindness due to the disease.  

There was a list that named the men. Even after treatment was available, they were denied treatment, with doctors and clinics turning them away when their names were found on the 'do not treat' list. What does that oath say about do not harm!    

If you're not familiar with my pieces, you'll find that I've written quite a bit about what I see as a 'hole' in a system that needs to assure all of us in need of medicine and medical treat that our safety is not an afterthought, as it sometimes appears to be.

I wrote about two studies I found particularly unconscionable for reasons comparable to those you've stated, the patients inability to state their approval nor would parents or guardians be sought to give their consent.

These two studies were the Pediatric Seizure Study and the study conducted by the Resuscitations Outcomes Consortium. There are several companion articles that provide additional information archived at my page.

Anyway, in both these studies, because of the U.S. government removing specific safeguards, individuals that find themselves in positions where they are incapable of accepting or refusing treatment. In the pediatric study, involving children and infants, as young as three months, in the midst of unrelenting epileptic seizures and in the other study, teenaged to adult patients, suffering from head trauma or stroke, all were included in these studies without consent being sought prior to inclusion in either of the studies. Any parents or guardians were notified after the fact.

It was argued and included in these new guidelines that, IF an experimental drug or treatment would not result in any GREATER harm to the patient, as in, if death may have been the outcome for any existing drug or treatment that may be administered, then involving these patients in the experiment that could cause that same outcome was acceptable.

In my article, Who Will Speak for the Voiceless?, I wrote:

".... In a report entitled Waiver of Informed Consent for Emergency Room Research, published by the American Medical Association (AMA) in 1997, it states :

Research involving human subjects requires obtaining informed consent from patients or surrogate decision-makers prior to enrollment in any clinical trial. This is designed to safeguard patient autonomy and protect vulnerable populations from assuming undue research risks. Existing federal regulations had allowed an Institutional Review Board (IRB) to approve a waiver of informed consent only when research involved MINIMAL risk (My emphasis). Investigators, arguing that this limitation unduly hinders scientific advance, petitioned the federal regulatory agencies (i.e., the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to revise their stance. The FDA released proposed rules in the fall of 1995 and final regulations on October 2, 1996. "

I feel some line has been crossed or someone dropped the ball on this, since it was those lobbying who were lamenting there were too many restrictions tying their hands for doing investigational work. 

Anyway, this information and more is included in the linked articles above and archived at my page. I believe I did link some of them together and the titles kind of clue you to which ones are related.

I thank you so much, Politisite, for taking an interest in and reading my work. It is much appreciated!