Immunization Consent Form 2011: 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.

Strap in 'cos at ~2000 words this one is fairly long.The notion that mice could handily emulate human physiology has always strained credulity. After all, a mouse is a short-lived, four-legged, nocturnal, burrowing rodent. It beggars the imagination that the evolutionary selection forces that shaped its physiology remotely resemble those that shaped that of humans. It then follows that mouse physiology likely offers little by way of concordance to that of humans. And yet since post-WWII, the role of mice, and to a lesser extent, rats, has only become more deeply embedded in biomedical research.There are two parts to this predominance of mice and other rodents in experimental biomedical research; one, how this came about in the first place, and two, why it continues to remain the norm. As is often seen in history, the first resulted from the accidental confluence of a series of historical precedents in the first part of the 20th century while the second is dictated by prevailing cultural and economic imperatives in biomedical research, a process where the longer it continues, the more the ensuing historical precedence assumes perceived importance. A utilitarian mindset that presumes the expediency of such animals also helps sustain the process.Amateur mouse fanciers turned breeders, the rediscovery of Mendel, the birth of mammalian genetics, the creation of the modern scientific infrastructure: the chain of early 20th century events that led to mouse predominance in experimental biomedical researchIn the early decades of the 20th century, Abbie Lathrop, a mouse and rat fancier, was breeding fancy mice and rats on her Massachusetts farm and unusually for that time and especially given her non-scientific background, she kept excellent breeding records to boot.Around the same time, after languishing in obscurity for >3 decades, the rediscovery of Mendel's now famous pea breeding experiments jump-started American genetics research, creating a confluence of right resources, right finding and right timing since Lathrop's treasure trove of inbred and quasi-inbred mouse strains proved a godsend for mammalian genetics pioneers such as William Ernest Castle who were then just beginning their careers. In turn, Castle trained the next generation of world famous mammalian geneticists such as George Snell and Clarence Cook Little.Little was an excellent entrepreneur who took some mouse colonies from Lathrop's farm and ended up creating a rodent breeding facility at Bar Harbor, Maine, that over the subsequent decades morphed into the Jackson Laboratory, even today a pre-eminent global source of lab mice, rats and other experimental animals.Snell's research on those pioneering inbred mouse strains led to the discovery of the Major histocompatibility complex - Wikipedia. Having inbred mice with a single MHC haplotype proved not just crucial for this discovery but was also handy to use to maintain segregated mouse colonies, a key tool necessary for reducing confounding variables in biological experimentation.Meantime, the US emerged post-WWII as the wealthiest nation in the world and set about establishing the scientific research infrastructure and agenda that pretty much every other country ended up replicating in some shape or form.Vannevar Bush laid the groundwork for an unprecedented policy of government funding of scientific research and development in Science, the Endless Frontier, his 1945 report to the US president.Implementation of this policy over subsequent decades made the NIH and, to a lesser extent, the then-newly formed NSF, behemoths of US biomedical research funding. Such R&D funding at US universities transformed them into preeminent centers of scientific research.Legislative acts such as the GI bill further empowered US universities to train and graduate a scientifically trained workforce, a process that has only grown in the subsequent decades creating a workforce glut that academia can barely absorb.Guinea pigs had come to dominate biomedical research from the late 19th century. However, guinea pig colonies were expensive to maintain; they bred in small numbers, availability of few inbred strains meant that uncontrollable variables were introduced into each experiment, their housing and feed were expensive. In contrast, mice are relatively hardier, and easier to breed, feed and house.Mouse (and rat) animal husbandry thus proved far easier to standardize at an industrial scale and replicate in universities and other research institutions in the post-WWII years. The knowledge, expertise and influence of people like Little played no small role in the spread of mouse and rat as the models of choice in experimental biomedical research.Back then the American economic model was much better at fostering competition so other lab animal suppliers such as Charles River, Harlan and Taconic soon emerged, creating the current industrial pipeline of lab animal supply, consisting largely of mice and rats, that currently dominates biomedical research.In short, the fundamentals favored post-WWII predominance of mice and rats in biomedical research. Where the earlier guinea pig predominance left its mark on the English language, they have themselves long since ceded ground to mice and rats (below from 1).In a way, the baton passing from guinea pig to mouse as the pre-eminent animal model also represented the torch passing from Europe to the US as the global biomedical research leader. Where even into the 1920s, widespread acceptance of research findings required the imprimatur of European researchers, typically French or German, post-WWII till date it's the US all the way.Cul-de-sac or the mouse that roared: Be it ever so counter-productive, prevailing historical, cultural and increasingly economic imperatives dictate mouse predominance in experimental biomedical researchFollow the money. Cliched, overused and yet it remains on the nose for explaining mouse predominance in biomedical research.The industrialization of molecular biology since the 1980s has only served to further accelerate and deepen this predominance. For example, as the technological capability to knock-out and knock-in genes became easier starting in the late 1980s, the trend began among the powerful stakeholders within the scientific community such as the granting agencies, and scientific journals and their peer reviewers to initially seek, then to insist and lastly to demand that results of in vitro cell culture knock-out and knock-in studies be validated in vivo.The by then well-established industrial pipeline of inbred mouse strains easily stepped in as the obvious choice for such in vivo tests. That started off a new wave of creating mouse strains with various genes knocked-out or knocked-in, a trend that continues unabated till date.Thus as molecular biology took off, mouse animal husbandry expanded, further cementing its predominance, creating hundreds of new genetically engineered mouse strains, strains whose study now consumes the entire careers of thousands upon thousands of biomedical researchers studying various physiological systems.Biochemists to endrocrinologists to all manner of other specialists who'd previously used molecular biology tools to study their favorite molecules and processes at the cellular level using in vitro cell lines now swarmed into the mouse husbandry business, creating unique mouse strains, maintaining their colonies and studying them while specialists in other fields such as developmental biology and immunology had already glommed on to the mouse model decades earlier.While developmental biologists still hedge their bets and continue using fruit flies, nematodes and even zebrafish as model experimental organisms, from about the 1970s many immunologists went all in wedding themselves to their mouse models so much so that grotesquely, knowledge of mouse immunology is today miles ahead of knowledge of human immunology.To add insult to injury much of that vaunted knowledge rests on shockingly shaky grounds. Consider just one example, perhaps the most important of all, which stems from the most popular mouse strain used in all of biomedical research in general and in immunology in particular. This turns out to be a strain called C57Bl/6 (2). Prone to obesity, it entirely lacks a whole MHC molecule, the one called I-E, due to a translocation event at some point in its breeding history. Thus, its immune responses could in no way, shape or form be considered representative of those of even a prototypical inbred mouse strain, let alone be considered an adequate surrogate for any human immune response.Of course the most pernicious and stickiest ingress of the mouse and other rodent models proved to be in the drug development and drug approval processes, a choice sped up in the wake of the thalidomide scandal in the early 1960s, with the 1962 passage and implementation of the Kefauver Harris Amendment - Wikipedia, which codified and granted the FDA the authority to approve new drugs for marketing and sale. Rather than their scientific suitability, a cultural dependence on preclinical rodent models has since driven regulator preference for such data and of course, the longer this goes on, the longer the weight of historical precedence accrues perceived importance.We humans are preternaturally talented at outsourcing. Among ourselves, we effortlessly contrive convoluted and seemingly inconspicuous processes that unerringly steer the most undesirable jobs in the economy towards those deemed most undesirable, the poorest and most otherized, among them refugees and immigrants.I'm sure we would likewise seek to outsource our diseases just as easily if we could but we can't. And yet in our uniquely muddled way we've chosen to outsource as much of the risk in drug development to poor benighted animals who have no say in the matter and decidedly cannot provide informed consent, or at least not in a manner or language we could comprehend; muddled because no animal could conceivably be a scientifically adequate surrogate for human physiology, and yet we unabashedly choose to wallow in such a fanciful notion.Why do we do this? Same answer as for so many other human decisions, because we can, being a species just smart enough to cause real and lasting havoc.Thus, mouse strains serving as surrogates for human physiology, regardless that such extrapolations be ever so tenuous, has only become more deeply embedded in biomedical research, with newcomers simply unquestioningly learning the ropes from earlier generations and taking our almost single-minded reliance on mouse models to ever newer heights.Every now and then, a certain amount of caterwauling about the lack of suitability of mice as experimental models bubbles up in the scientific literature. Issues include the inherent limitations of inbred mouse strains in being able to recapitulate basic wild mouse physiology, let alone their ability to emulate those of their human counterparts, how mice are housed, what they are fed, how lack of housing “enrichment” prevents a full manifestation of their “mouse” traits such as foraging.In addition, everything from cage design, ventilation systems, light cycle, temperature and humidity settings to diet to how they are handled are just a few of the factors that profoundly influence the readouts of every single lab mouse experiment. But then prevailing economic, read scientific career, imperatives being what they are, things settle back to the uneasy status quo of mouse predominance.This system is now creaking, sagging and almost hopelessly broken. Mouse husbandry costs are considerable for any biomedical research lab, even more so in this era of ever-shrinking research funding, which only intensifies competition.Rigorous statistical procedures now considered the norm in clinical research such as randomization and blinding continue to remain as alien in experimental animal research as proverbial aliens on planet earth. Even the most basic of standard statistical analyses routine in clinical research such as meta-analyses and systematic reviews remain impossible for experimental animal research data simply because experimental procedures and data collection choices remain unstandardized and thus vary vastly between labs and often even between different experiments within the same lab.Ever increasing pressure to publish plus tight budgets mean that not enough mice per group and not enough repeats of any given experiment have become more the norm than outlier. The possibility that things are stretched almost to breaking point shows up in the form of shoddy, irreproducible data (below from 3).Astonishingly the economics of animal research remain hardly explored even though they could potentially explain every relevant issue about modern biomedical research. Even in that, EU numbers are somewhat easier to find compared to those in the US since the US Animal Welfare Act excludes mice, rats and fish, though it does have other regulations to ensure animal welfare. Thus, of the ~11.5 million experimental animals used in the EU in 2011, ~61% were mice and ~65% of total animal usage was for basic R&D (below from 4).Bibliography1. The Mouse Trap: Can One Lab Animal Cure Every Disease?2. The Trouble With Black-63. Hartung, Thomas. "Food for thought look back in anger–What clinical studies tell us about preclinical work." Altex 30.3 (2013): 275. https://pdfs.semanticscholar.org/88e1/b6ec27357a21ae7314dbf434098ae665b0db.pdf4. Meigs, Lucy, et al. "Animal testing and its alternatives–the most important omics is economics." ALTEX-Alternatives to animal experimentation 35.3 (2018): 275-305. https://www.altex.org/index.php/altex/article/download/1134/1131Thanks for the R2A, Daniel Kaplan.

Hii Ankita Ghosh , As you know in our country, waste management is governed by Ministry of Environment, Forest and Climate Change (MoEF) who work together with State Pollution Control Board set up in various States. Certain laws are also present in the legal setup which helps in regulation of waste in India. The National Environment Policy, 2006 laid emphasis not only on disposal of waste but also recycling and treating waste.Let us now look at some of the laws, which are there for the purpose of waste regulation.The Environmental Protection ActThis Act was enacted in 1986, and it aims to establish a sufficient protection system. This Act confers powers to the Central Government to regulate all forms of waste. It is one of the primary legislatures to protect the environment and regulation of waste. Some of the important provisions of this Act is given as under-Section 7 of this Act places a principal prohibition on harming the environment by stating that no person carrying any activity should emit or discharge environmental pollutants in excess of the prescribed standards.Section 9 of the Act states that if any event takes place which harms the environment through any foreseen or unforeseen event, the person responsible for the harm is duty bound to prevent or alleviate the pollutant, discharged as a result of such event. The person is also obliged to inform the proper authorities about the event which may harm the environment.*Polluter Pays Principle– Section 9 (3) of the Act embodies the “Polluter Pays Principle” which states that any expense which has been incurred to restore the environment to its natural state shall be paid by the person who is responsible for such degradation. This concept of a continuing punishment is very important.The Act also contains provisions which remove the corporate veil. In case any environmental offense was committed by a company, with the connivance or consent of any director, manager, secretary or any other officer of the company, they’ll be help personally liable for committing offenses in the name of the company.Environmental Protection Rules-Commonly known as the Environmental Protection Rules, 1986, these rules were formulated by the government under the power conferred to them by the Environmental Protection Act. Through these powers, the government has the authority to give specific directions, without changing the principle Act.The Hazardous Wastes (Management, Handling and Transboundary Movement) Rules, 2008Management of hazardous waste is a very complex issue. Certain rules and regulations are required, which together form the legal regime. The Rules places an obligation on the occupier of hazardous to safe and sound handling of environmental waste. The occupier is that person under whose charge there is a plant or unit or factory which produces hazardous waste as a result of their operation. The occupier must sell or send the hazardous waste to a re-processor or recycler, who is authorized by the government to dispose of the waste in a safe manner. Any person who is engaged in storage, package, collection, destruction, conversion, processing, etc., also has to take authorization for the State Pollution Board.The recyclers, occupiers, re-users, re-processors can store the waste for up to 90 days.Sale or transfer of hazardous waste can be done only after obtaining a valid registration form Central Pollution Control Board (CPCB). Use of the waste as a source of energy also requires registration from the CPCB.The trans-boundary shipment of hazardous waste is regulated by the Basel Convention, to whom India is a signatory. Import of hazardous waste for disposal in India is prohibited by law, although import for the purpose of reuse, recovery as an energy source and recycling is allowed subject to certain restrictions. India allows for the export of hazardous waste but only with the prior informed consent of the importing country.The Plastic Waste (Management and Handling) Rules, 2011The PWM Rules are set of regulatory framework set up to control the use, manufacture, and recycling of plastic waste. Plastic waste includes any plastic product which has been discarded after it use of end of the products life. The Rule has uniform applicability towards all distributors, users, retailers and manufacturers of plastic products. Rule 9 makes it compulsory for every manufacturer of plastic products and recycler to obtain registration from State Pollution Control Board. This registration has to be renewed every three years. Rule 10 states that no retailer can provide plastic bags free of cost. This is done to ensure that people use plastic bags judicially. The PWM rules also specify details of plastic products such as the classification of the types of plastic like compostable, recyclable or virgin plastic, thickness, and color.Recycling of plastic products is to be done in a fixed procedure laid down by Bureau of Indian Standard Specification.Bio-Medical Waste (Management and Handling) Rules, 1998The aim of these Rules is to ensure that bio-medical wastes are safely disposed of. Bio-medical waste can be defined as any waste or byproduct generated during treatment, immunization and treatment of human beings or animals or in research activities.Schedule I of the Rules, differentiates biological wastes into different categories like microbiological and biotechnological, human anatomical, animal anatomical, discarded medicines, chemical related waste, etc.The BMW Rules apply to various institutions like nursing homes, animal houses, veterinary homes, blood banks, dispensaries, pathological laboratories, etc.the BMW Rules prohibit mixing of biological wastes with any other type of wastes. The general rule provided is that bio-medical wastes can’t be kept stored beyond the period of 48 hours without being treated. Rule 8 (1) requires every occupier or any institution which is dealing with biological waste to take an authorization form the State Pollution Control Board. Further, according to Rule 5 (2), all institutions covered under the rules are to mandatorily set up treatment facilities like microwave system, autoclave, etc.The E- Waste (Management and Handling) Rules, 2011The prime aim of the EWM is to put in place a system which manages e-waste in an environment-friendly way by regulating the issue of recycling and disposal of e-waste.E-waste management is a problematic issue in India. With the growing economy and the technological advancement, India is becoming a hub for the IT Sector. This creates a lot of e-waste, disposal of which is necessary. A lot of e-waste also gets illegally imported into India, which worsens the problem. The E-waste Rules apply manufacturer and consumer. It is important to note that there are bulk consumers of electronic products also. There are many big corporate houses, who have fully automated their system and use a lot of electronic devices to meet their purposes. Factories are also considered as bulk customers.E-waste defined under the Rule 3 (k) means any electronic or electrical equipment which has been rejected after use or have been discarded. The byproducts which are discarded during the manufacturing process also falls under this category. The producer of electronic and electrical goods must obtain permission from State Pollution Control Board under rule 4. E-waste Rules also delineate the responsibilities of collection centers, consumers, bulk consumers, dismantlers, and recyclers.The Batteries (Management and Handling) Rules, 2001The Batteries Rules were notified to set up a mechanism in place which dealt with the disposal of lead acid batteries. The Rules apply to every manufacturer, recycler, dealer, importer, assembler, bulk consumer (like organizations and department purchasing more than 100 batteries) and consumers. Rule 10 makes it compulsory for every consumer to deposit the used batteries back with the dealer, manufacturer, recycler or labeled collection centers. Bulk consumers are also required to file half-yearly returns with the State Pollution Control Board, about the usage. Under Rule 6, if a recycler wants to import used batteries in India, for the purpose of recycling, he must first obtain Custom clearance. Additionally, import of batteries will be allowed only upon producing valid registration with Reserve Bank of India and MoEF and providing an undertaking in prescribed format along with a copy of the latest half-yearly return.Hope this helps you. Incase of any query, you have my number.Sandeep Chatterjee