Consent Form For Participation In A Research Study - University 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.

How should an amateur start practicing psychological experiment and/or research?An amateur should not do psychological experiments or studies on his/her own, particularly if they involve direct contact with either human or other animal participants.I’ll answer this question in terms of expectations in the USA. Some of the rules and expectations may be different in other countries (I notice the questioner lives in Vietnam.)Here are the problems (each discussed further below).You won’t know what you are doing.You may engage in unethical behavior (perhaps without meaning to)You won’t know what you are doing.For an experiment to yield useful data, it has to be conducted in ways that deal with issues such as recruitment and compensation for human subjects, acquisition and treatment of animal subjects, assignment of subjects to different treatment conditions, control for extraneous variables, valid measurement of outcome variables, and many other aspects of research design. For an experiment to address a question that has not already been studied extensively and that is of interest or practical value, you need to read existing past research on the question. Sometimes beginning students design studies that are simply impossible to do, or that yield data that cannot be analyzed, and waste a lot of effort in the process.Solution: get training in psychology and find a research mentor to guide you, and read the past research related to your question.You may engage in unethical behavior (perhaps without meaning to).Psychologists have given a great deal of thought about ethical problems that can arise in research, and detailed codes of ethics have been developed.For research with human participants, see the American Psychological Association ethics code at:http://www.apa.org/ethics/code/This paragraphs below mention some of the most important points, but you need to read the entire ethics code for full information.(In cases where these standards cannot be satisfied and the research question is extremely important, an ethics review committee (called an Institutional Review Board or IRB) may approve some procedures even thought they depart from these rules. Generally, IRBs apply these rules strictly.)Researchers are required to obtain informed consent from human research participants. There are detailed guidelines about what must be included in an informed consent form. There must not be any coercion for people to consent.Researchers must not expose human participants to risk or harm. This includes not only risk of physical injury, but also issues such as embarrassment, anxiety, invasion of privacy, and so forth. It’s important to have an IRB evaluate this, because sometimes the nature of possible harm is not obvious, and you need experts to judge this.Researchers should not deceive participants.Researchers must not reveal confidential information about individual participants (research conducted on the web raises special technical problems with this.)For research involving non-human animals, there are also detailed rules, summarized here: Guidelines for Ethical Conduct in the Care and Use of AnimalsA committee called the Institutional Animal Care and Use Committee (IACUC) reviews plans for animal research. Animal welfare includes adequate housing conditions. (At my university, research animals require air conditioning, by law…. faculty and students do not). Animal treatment must minimize stress and pain to the extent possible.What are the consequences of not having ethics review, or of violating ethical standards?If your goal is to publish your results in a professional journal, that journal will require at least a statement (and perhaps additional evidence such as a letter) that you have had your study approved by an IRB or IACUC.You could conceivably be sued by a human research participant. If this happens, and you are at a university that has approved your research, they should back you up. If not, you are on your own.If you are working with animals in unethical ways or in substandard housing and care conditions, the Society for Prevention of Cruelty to Animals (SPCA) or People for the Ethical Treatment of Animals (PETA) may come after you. The SPCA can confiscate animals and /or bring a lawsuit.If you really want to do psychological research, the best approach is to look for a job as a research assistant, or volunteer to work with a research psychologist, or offer access to data collection at your facility or organization to a researcher in a psychology department or business school. The researcher would know how to design a good study and would handle ethics review.It is possible that you could ‘fly under the radar’ and collect data on your own, and that no one would challenge what you are doing. I don’t recommend that.A classic book called “Unobtrusive Measures” by Eugene Webb and Donalt Campbell described an incident that occurred a long time ago, in which a research assistant clicked a counter in public places to track behaviors of shoppers. Here’s what happened…Please consult with a professional psychologist in your area before undertaking research on your own!

Research Studies!I went to college at a large research university. At any given time there are dozens of labs recruiting participants. One nutrition lab paid me like $15 an hour to eat and answer questions about how full I felt after each course. I did this for a week and then they invited me back for another week. The food was incredible!I also got around 10–15 MRIs and was paid $25 per MRI. Half the time they had me play games, the other half of the time I just had to lay there and power nap. Paid to eat and nap? Is this real life!?Some of the medical/health studies required blood work, but I would coordinate it so the nurse would stick me once and get blood for 3 or 4 studies at once; each lab would pay me for the same blood draw. I never knew my blood could be so valuable! :)At a food science lab I was paid around $15 to $20 for 20 minutes worth of tasting flavors for candy and sports drinks (I think? Not 100% sure what the flavors were for because it was so long ago.) All I had to do was taste it and rate the flavor from 1 to 10. The grad student told me 1 was equivalent to “walking barefoot on pavement on a hot summer day” and 10 was equivalent to “winning the lottery.” Thankfully, I didn’t come across any 1’s!There were some really unusual studies that involved very odd tasks, but paid extremely well. One handed me a consent form, had me make a list of fruits, a list of vegetables, a list of animals, and then handed me $25. I don’t even think I was there for more than 10 minutes.