Medical Consent Form - Children'S Hospital Of: Fill & Download for Free

No, that isn't completely accurate.Who: Bill & Melinda Gates Foundation (BMGF), https://en.wikipedia.org/wiki/PATH_%28global_health_organization%29 (PATH) and Indian Council of Medical Research (ICMR)The BMGF funds PATH, a Seattle-based NGO and main recipient of BMGF grant money for global public health initiatives. Since 1998, BMGF has funded PATH to the tune of ~$2 billion. The ICMR is the Indian Government's primary agency tasked with conducting biomedical research.What: A Phase V human papilloma virus (HPV) Phase V vaccine trial in Andhra Pradesh & Gujarat, IndiaPATH carried out a large HPV Phase V vaccine trial in India. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question, Gardasil from Merck and Cervarix from GlaxoSmithKline, were granted marketing approval in India in 2008 while the PATH-sponsored trial began in 2009 as a joint project with the ICMR, using donated vaccines.The purpose of the trial was to generate data to support the inclusion of the HPV vaccine in India's Universal Immunization Programme (UIP).Specifically recruiting from low-income rural, largely tribal, households, the trial was conducted on girls aged 10 to 14 using Gardasil in Khammam district of Andhra Pradesh (AP) state (n=13000), and using Cervarix in Vadodara in Gujarat state (n=10000).The ProblemsPublic recognition of problems with this trial started with the reported death of 7 girls. This led to immediate suspension of the trial in 2010 even though it was supposed to run until 2011. Investigations showed these deaths weren't directly connected to the vaccines (see table from the initial official investigation report, 1).However, investigations triggered by these deaths instead uncovered serious violations of the process of informed consent (see official investigation reports below from 1, see also 2). Aged 10 to 15, girls in this trial were obviously below the age of consent meaning their participation in the trial required the consent of parents/guardians. In the course of Government of India (GOI) investigations, the trial investigators 'were asked to submit 100 consent forms, chosen randomly, for both AP and Gujarat for independent verification' (1). These consent forms turned out to have several problems (see reports below from 1).Investigations (1) revealed thatIn Andhra Pradesh, 'Signatures of one parent were obtained on 9543 forms, thumb impression of one parent on 1948 forms and signatures of Hostel Warden/Head Master as Guardian in 2763 forms'The investigators noted, 'The legality of the signing by the Hostel Warden/Head Master in Andhra Pradesh needs to be examined by an appropriate authority'.In Gujarat, 'In Gujarat one parent has signed on 6217 forms, has provided thumb impression on 3944 forms and Legal guardian has signed or put thumb impression on 545 forms'.As a newspaper report summarized, signature of ~2800 consent forms had instead been signed by school teachers, principals or hostel wardens, even in cases where the girls had parents (2).The Indian Parliament's Standing Committee on Health began its investigation in April 2010 and concluded that 'safety and rights of children were highly compromised and violated' (3).The Committee's report (3) foundThe girls' consent was not fully informed.Post-vaccination adverse events weren't adequately monitored or reported.PATH and ICMR hadn't sought mandatory permission from the Drug Controller General of India (DCGI) or the Indian National Technical Advisory Group on Immunization (NTAGI).PATH wasn't even a registered legal entity when it began working with the ICMR.DGAI culpable for dereliction of duty.The Committee's report stated, 'PATH resorted to an element of subterfuge by calling the clinical trial as 'observational studies' or 'demonstration project' and recommended legal action against PATH (3). However, the Union Government of India decided legal action couldn't proceed based on the its assessment of the country's prevailing laws. Instead in 2014, it issued a warning letter to PATH (4).PATH's dubious and unconvincing defense was that this wasn't a clinical trial, only an observational study of an already approved vaccine. As such, it argued that neither provision, i.e., informed consent and monitoring/reporting of post-vaccination adverse events, was necessary (5). This is patently incorrect.Bibliographyhttp://icmr.nic.in/final/HPV%20PATH%20final%20report.pdfThe Hindu, May 25, 2011. Editorial. A shockingly unethical trialPage on preventdisease.comThe Hindu, August 25, 2012. Aarti Dhar. Government warns PATHLaMontagne, D. Scott, and Jacqueline D. Sherris. "Addressing questions about the HPV vaccine project in India." Lancet Oncology 12.14 (2013): e492; Statement from PATH: cervical cancer demonstration project in IndiaFurther ReadingKumar, S., and D. Butler. "Calls in India for legal action against US charity. Nature News [Internet]. 2013 Sep 9 [cited 2013 Oct 22]." Calls in India for legal action against US charitysSharma, Dinesh C. "Rights violation found in HPV vaccine studies in India." The Lancet Oncology 14.11 (2013): e443.Thanks for the A2A, Shivanshu Siyanwal.

I was working in the Neurosurgical ICU, and we had a sudden admission from the ER. The patient was a 72 year old comatose male with a subdural hematoma, sustained from a fall from a ladder while he was cleaning out his roof gutters. He was accompanied by his wife, who had witnessed the fall and arranged immediate emergency transport.This is the best case scenario in the case of a subdural hematoma, because the blood clot is directly under the skull, not bleeding into the brain tissue, and thus a hole can be drilled through the skull, right at the bedside, and the clot easily removed. If this is done timely, full recovery follows. The patient actually awakens from the coma before our eyes, and it is one of the most rewarding cases for an NCU nurse.So I prepared the consent form for the patient’s wife to sign, while the neurosurgeon was busy getting set up to do the procedure. “I just need the next of kin signature, so we can proceed. As his wife, we need your permission, legally, in order to do the procedure.” But she hesitated. She looked distressed. “I’m not his wife,” she said, “I can’t legally sign for him.” She explained that they had lived together for many years, but never married because their Social Security payments would have consequently been reduced.Ok so now the timing became ever much more important. “Who can sign?” “His children, he has three, any one of them can sign.” I called and was ready to get telephone consent from the patient’s eldest son. But he wouldn’t give it. “Let me talk to my brother,” he said. I had the neurosurgeon explain to him how dire the situation was, but still no dice. So we waited. Meanwhile we started the process to obtain administrative consent. The patient’s domestic partner stood by his bedside, crying and talking to him, holding his hand, stroking his face. She clearly loved him.The son got back to me. Yay! But, no, wait, “We’re coming in,” he told me over the phone. “Don’t do anything until we get there.” “How long will you be?” “We’ll get there as soon as we can. Don’t treat him until we get there.” So now we hit a snag with administrative consent because there was in fact a family member who was coming in to sign.Time was of the essence. The clock ticking out the minutes, then an hour, then another, was excruciating. This was before cell phones. We kept calling the house, but no answer. Every minute that went by meant prolonged and increasing intracranial pressure that would reduce the chance of recovery. There was so much tension in that room, so much concern for the brain damage that we knew was occurring, as we stood by helplessly.Finally two sons and a daughter arrived. But they refused to sign consent, demanding to see their father. The patient’s anguished partner left the bedside, and the children gathered around, conversing right over their comatose father. “If we sign consent, and he recovers, they might get married.” “Yes and then the house will go to her.” “And if she dies then it will go to her children.” “We always knew that was a possibility, but here’s our chance to change things.” “It looks like fate has stepped up for us.”Hearing this conversation, we realized in horror that these adult children never intended to sign the consent. They deliberately wasted precious time, knowing full well what the result would be. They were going to let their father die. By the time we got administrative consent at this point it would be too late. “Yeah, we’re not going to sign consent,” the oldest son said. And they left. My fists balled up in anger and incredulity, and I so wished that the patient’s partner had just kept the fact that they weren’t married to herself, and signed the consent. A lie would have saved him. A white lie, a good lie. But she was too honest.So the one who truly loved him came back to stay with the patient until he died later that day. And that was the saddest scene I ever witnessed as a nurse.

To give you my analysis from a few first hand accounts of how the institution is and what it is like to study and live in the AIMS campus,The hospital is arguably one of the best multi speciality hospitals in the entire state and this is a huge asset to a medical student. The faculty is of very good quality as well and the standards of teaching are as good as they get.However, if anyone wishes to be treated like an adult at this institution, all the more so if you are a girl, AIMS Kochi is not the place to be.Female students are simply not allowed to leave the campus as the outside world is “unsafe” and drug infested. The only taste of the outside world they are allowed is when they are taken to shop and eat out overseen by wardens twice a month. This reminds one of a kindergarten school trip. The wardens rule with an iron fist and a range of repercussions are threatened if anyone is seen outside campus. The logic that parents would want their children to be safe is twisted to such an extent that students live in constant fear. The glaring difference between how girls and boys are treated is painfully obvious.Students cannot leave campus without a guardian to sign them out. Leaving campus on an unsanctioned day can lead to fine. There is a total restriction of movement and denial of any sort of rights whatsoever. Nobody questions this state of affairs fearing action from the management that could endanger their certificate.Good medical education comes with this price, apparently. The “for their own good” motto is what they sell it with. Parents believe it and sign the consent forms. This same motto was what Hitler said when he sent the Jews to the ghetto. The purpose of education is to broaden the mind and not to hammer it into submission.