Sunday, January 26, 2020

Ethics of Research Trials in Developing Countries

Ethics of Research Trials in Developing Countries Zoheb Rafique INTRODUCTION: Asia is the most diverse continent in the world in terms of culture, religion, population size, finance, education, health care, academic research, general population skills, and governmental drug regulations. Each Asian country has its own unique qualities when it comes to attracting industry sponsored clinical trials. Factors that influence selecting location of a study site for a sponsored trial are mainly population size, infrastructure, education levels, quality of health care, cost and drug regulatory platform. Some Asian countries such as Japan, Hong Kong and Singapore have among the longest life-expectancy, lowest infant mortality and highest per capita income worldwide, while others are in the lower end of such rankings. Several, notably China and India, are amid rapid economic development, as the Asian economy is more-or-less becoming the global axis, with the economies of US and Europe slowing. Asia has a population of 3.8 billion, at least ten times more than North Americ a or Europe. As the world’s most populous continent, Asia has by no means reached full capacity in contributing with subjects in testing new medical products in collaboration with the international pharmaceutical industry. This trend will certainly direct more sponsored clinical trials to Asia, but not necessarily benefit all Asian countries. Engaged in 18.1 % of all protocols globally Asia is involved in more sponsored trials than any other region. India, Korea and Taiwan standout as the most active locations for multi-national trials in Asia. When ranking is for cities Seoul is the most active Asia city, followed by Taipei, Hong Kong, Singapore and New Delhi. The globalization process of sponsored clinical trials has provided an opportunity for Asia to attract international companies to the region and also seemingly encourages development of local life-science industries (1). In this paper, I will discuss the responsibilities of researcher/funder when the research trial is conducted in developing countries and especially in our country Pakistan and I will also talk on ethical justifications of doing research trials in Pakistan and other poor and developing countries. DISCUSSION: Resource poor countries require a lot of attention from the medical research establishment in order to sustain the quest for treatments and remedies for diseases and other health-threatening conditions. However, the collaboration between rich countries and well-endowed agencies, on one-hand, and economically constrained research communities, on the other, requires a careful assessment of responsibilities and options for researchers and research subjects alike. Major players in international research also include big pharmaceutical companies who seek people living in developing countries as subjects. Safety and standard of care for human volunteers are also major issues. â€Å"I had not been exploring Big Pharma of third world ‘volunteers’ as cheap guinea pigs, observes writer John le Carre (2001). â€Å"Their role, though they may not ever know this, is to test drugs, not yet approved for testing in the US, which they themselves will never be able to afford even if the tests turn out reasonably safe† (le Carre, 2001). In the US, it costs on average $ 10,000 per patient to conduct a clinical trial, in Russia $ 3,000, and in the poorest parts of the world, much less. This is one of the strong reasons why clinical trials are now a Third World growth industry. In the end, the drugs under trial are for western markets. In its May 2000 edition, Center Watch, a newsletter for the burgeoning clinical trials business, published an exuberant article under the title Latin American Fever in which it said the continent ‘may offer a unique opportunity to reach much larger numbers of study subjects’. Eli Lilly tested 590 patients, in 1994, across Africa, the Middle East and Central and Eastern Europe. In 2001, the company expected to run tests in those regions on 7,309 patients. It is not only the human subjects who are at risk. In the rush to market, poorly constructed, weakly monitored trials are releasing untried and untested drugs for con sumption (le Carre, 2001). The Contemporary practice of biomedical research on a global scale has given rise to evolving forms of exploitation. Standards of justice and equality tend to be put in question in the face of research practices that often put heavy burdens on poor people and poor communities in poor countries. There is a need to remain vigilant in the prior review of these activities and the monitoring of their implementation in order to ensure that biomedical research is conducted in accordance with universally acceptable standards. One of the most important requirements for the conduct of research in developing countries is emphasized in the WHO-Council for International Organizations of Medical Sciences’ Guidelines for Biomedical Research Involving Human Subjects: to guarantee that those communities where these new drugs have been tested will be given affordable access to the newly developed and approved drugs. Otherwise, one might rightly argue that people in d eveloping countries have yet again been exploited by Western researchers without benefiting from the positive results their risk-taking has yielded (Del Rio, Kamarulzaman, and Schuklenk, n.d.). Ruth Macklin observes that it is not just individuals who can lose out when big drug companies carry out their tests. When industrialized countries do research in a developing country, the developing country can’t afford the products of that research. The researcher’s pullout and the successful products then become available in the Western industrialized countries and the population in the countries where the research was done get nothing. So that’s truly a question of justice, and we’re beginning to see a movement to rectify that injustice (2000). The wide disparities in resources that are available for biomedical research in developed and developing countries give rise to ethically relevant issues of research prioritization and collaboration. The international re search community has to accelerate the shift to an environment where researchers from developing countries are recognized as full and equal partners in biomedical studies; where the technologies of developed and developing countries are integrated and made widely available; and where the benefits of biomedical research for participant communities can be ensured (2). In resource-poor countries like Pakistan and majority of developing countries, the two primary means of protecting participants-IRB review and Informed Consent may be inadequate. IRBs in developing countries may lack training, experience, and resources. IRBs in the United States are unlikely to be familiar with conditions in the host country. Informed Consent may be problematic in a country where people are poorly educated and lack health literacy, and where physicians in clinical practice usually do not tell patients their diagnosis, admit uncertainty, or obtain consent. Participants may not accept Western models of dis ease. Furthermore, participants might hear rumors and other misinformation about a research study. In several highly publicized cases, researchers from developed countries have been harshly criticized for allegedly conducting inappropriately risk studies in resource poor counties without adequate consent. The other problem is health priority and it would be an imprudent use of limited health care resources in a developing country to conduct human-participants research that does not address a health or public health priority in the host country. Because of scarce resources and logistical constraints, medical interventions that are standard in developed countries may not be available or feasible in resource poor countries where the trial is conducted. This creates an ethical tension between providing a benefit to research participants and obtaining generalizable scientific knowledge. According to the ethical obligation to minimize harm to participants, researchers should provide inter ventions that are known to be effective and feasible to prevent or treat the condition addressed in the clinical trial. Because participants in a research study help researchers, sponsors, and society at large, they should receive some benefit in return as a matter of reciprocity. Advocates contend that researchers and sponsors must avoid taking unfair advantage of participants and their communities by providing those who bear the risks of research appropriate benefits, in addition to the long-term benefit of generalizable knowledge. Researchers and Sponsors need to consider whether the study intervention will be available in the host country if it is shown to be effective and safe. Some ethics expert point out that providing reasonable access to study interventions after a trial may be an inadequate reciprocation for participation in research. First, it is too limited and weak an obligation. If the study is something other than a pivotal clinical trial (for example, an epidemiologi cal study), no additional benefits will be required. Even if the study is a clinical trial, it might be a negative study. Second, other benefits might be more useful to participants or their communities than the trial drug. For example, they might benefit more from better primary care or better education for host country health care workers. Third, the appropriate target group for benefits may be all persons in the community where the study is carried out, not just trial participants. Providing benefits only to trial participants will widen health disparities in the resource-poor host country and therefore raise concerns about causing injustice. Thus, providing benefits to the host country should be done in a way that ameliorates rather than worsens health disparities. For these reasons, some writers argue that researchers and sponsors from the developed world should provide fair benefits to the research participants and their communities in reciprocity for what they contribute to the research. Researchers could provide benefits to research participants in a number of ways, such as by providing health education or some basic health services; training local health care workers, researchers, and IRBs; donating equipment at the end of the study; and giving local investigators a key in analyzing data and writing papers. Such contributions ensure that the community where the research is carried out will receive benefits in reciprocity for participating in the research. By building infrastructure, researchers can help provide sustainable improvements that will help to narrow health disparities between rich and poor nations (3). Pakistan is also among the poor and one of developing country and the health care conditions here are same as any South Asian or African country. We will apply the same ethical and moral rules when we talk about research here in Pakistan. Ethical requirements for clinical research do not end when individuals either sign the consent form or are enrolled in research or refuse enrollment. Individuals must continue to be treated with respect from the time they are approached even if they refuse enrollment throughout their participation and even after their participation ends. Respecting potential and enrolled subjects entails at least 5 different activities. First, since substantial information will be collected about enrolled subjects, their privacy must be respected by managing the information in accordance with confidentiali ty rules. Second, respect includes permitting subjects to change their mind, to decide that the research does not match their interests, and to withdraw without penalty. Third, in the course of clinical research new information about the effect of the intervention may be gained. Respect requires that enrolled subjects be provided with this new information. Fourth, the welfare of subjects should be carefully monitored throughout their research participation. If subjects experience adverse reactions, untoward events, or changes in clinical status, they should be provided with appropriate treatment and, when necessary, removed from the study. Finally, to recognize subject’s contribution to clinical research, there should be some mechanism to inform them of what was learned from the research (4). CONCLUSION: The basic disclosure requirement for satisfying the informed consent provision in U.S. research regulations focus on information needed by a potential participant to decide whether or not to participate in a study. Of the eight basic disclosure requirements, one focuses on potential benefits: a description of any benefits to the subject or to others which may reasonably be expected from the research. Traditionally, such a disclosure has been required to ensure that potential participants understand whether there is any possibility that the intervention itself might benefit them while they are enrolled in the study. There is, however, no specific mention of any post-trial benefits. If any case, those who may participate in studies should be informed of the potential benefits, if any, that they might receive by doing so. Because this information is relevant to participants’ decisions to participate in the research, ethics review committees should require investigators to make th ese disclosures (5). In the end I will conclude by saying that research participants should know each and every thing regarding their participation in the research trial or rejecting it, and it is their right to know all risks and benefits while participating in the research trials and this should be applicable to all countries around the world including all developing countries and also our country Pakistan. REFERENCES: 1. Johan PE Karlberg. Development of Sponsored Clinical Trials in Asia. Clinical Trial Magnifier. 2008; Vol. 1:5: 77-100. 2. Leonardo D. de Castro Et Al. Bioethics in the Asia-Pacific Region: Issues and Concerns. 2003; 1-108. 3. LO B. Clinical Research in Resource-Poor Countries. Ethical issues in Clinical Research: A practical Guide. 2008; Ch.22:194-210. 4. Ezekiel J. Emanuel Et Al. What Makes Clinical Research Ethical? JAMA. 2000; 283(20): 2701-2711. 5. Ch 3; Voluntary Informed Consent. National Bioethics Advisory Commission. 35-53.

Saturday, January 18, 2020

Business coursework; Fish and Chip shop (Burnham high street) Essay

Introduction I am doing an investigation on a small local business to identify ways that it could be improved and what the business is doing wrong at the moment that is preventing it from making the progress that it could make. The local shop that I chose was the fish and chip in Burnham high street, SeaWorld. I chose this shop because I am a fan of seafood and when I go into a seafood place I expect to find many items that are actually seafood but normally they have different varieties of food but rarely any seafood. They normally have kebabs, chips, burgers, but chips are a necessity with fish. Preparation We started off making our individual surveys for both customers and workers and chose the best survey to be printed out. We also were planning on tasting the food in SeaWorld as well to see how good the product was. We thought of the types of shop that would be competitors. What we did For our research we had about an hour to go to the fish and chip shop in Burnham high street, but unfortunately SeaWorld was closed so we decided that some of us would take out the surveys on the public while the other group would see how the point of sale looked and find anything wrong with it. There were quite a few surveys done, and we managed to figure out some problems with the point of sale. Luckily there was a worker inside SeaWorld who did not mind us asking questions about his workplace. I think that we had taken a few surveys of people who go there regularly, but would have liked to see how the business was when it was open. Things like how many people go there, what there menu was, how well priced the food was, what majority of the regular customers thought of the seafood shop. We also looked out for competitors and how accessible their shops are, how their shops looked and how close they are to SeaWorld. Place SeaWorld is in Burnham high street and because it is quite a small high street even a small number of competitors would be a problem. There aren’t any seafood restaurants or seafood take-away as such in Burnham high street but there are cafes and fast food shops and there is a seafood shop in Burnham. These are also competitors because if people go into these shops it can pose a threat to the business of SeaWorld by reducing its market share. The other issue with the place is how easy it is for the customers to access the shop in terms of parking, distance and is there a contact number so they can order over the phone? The restaurant has a telephone number next to the restaurant’s name which is convenient for the customers and the business because it won’t be crowded so they will have enough seats but they will still be getting the sales and revenue. The first take- away or restaurant that you see when you enter the high street from hog fair lane is SeaWorld which means that for ease of access and to save time people will go here. Therefore I think that the place that the seafood shop is not bad, but the look of the point of sale from the inside and outside needs to change. It needs to be re-painted and the inside needs to be looking more spacious to attract more customers. Product I did not have the opportunity to get a good look at their menu because at the time they were not open, but from what I saw there was a range of fried and battered fish food, chips and drinks which is what their customers would expect and this makes them look good. There was a problem though which was that on the outside of the shop there was a label that said ‘kebabs’ that is something that you wouldn’t expect in a fish and chip shop and I don’t know if they do sell kebabs but if they didn’t then that would be misleading the customers which would be irritating for them and they could potentially lose customers. If they did have kebabs then it would be inappropriate. Price I was not able to ask or look at the prices that they had for their food but the price needs to be below five pounds for each product and above a pound. If the products are priced too highly customers would not buy from that shop and if it was too low then they will be at a loss and will not be able to run efficiently. Theoretically the lower the price the more demand there is for that product, but you also need to balance between charging high enough to cover costs but low enough to keep the customers buying. Sometimes even if the prices are high the demand still remains the same, this is because things like customer service is good and the product also should be better than others. For the seafood shop it means that they need to be friendly to customers, deliver orders on time and put the customer’s needs and requests first. Promotion Walking along Burnham high street I did not see any form of promotion for the seafood shop. This is one of the crucial factors of getting a small business to succeed. If people do not know where you are or even if you exist then how will you get more customers? The seafood shop does not even have a website which means that it makes it harder for people find out about such a shop. The locals around Burnham high street might know about the shop but not many other people will. Therefore they need to find a form of promotion that will allow them to be known but not too expensive either. Picking the promotion The ways of promotion best for SeaWorld is through leaflets through letter boxes, this is a form of promotion suited to this business because it will be spread throughout the local area, because people from other areas are not going to travel a long way just to get to SeaWorld and it is not that expensive. The down side to leaflets is that it is often seen as junk and discarded, so it has a low success rate and you would need to find someone to hand them out or put them in letterboxes this means they need to pay that person as well. Another way that is cheap and affordable is advertising in the local newspaper, this would reach a wide local audience and there is only the cost of publishing it in the newspaper. The size of the advert can be adjusted so that it fits the budget of the seafood shop, but to get a large sized advert that is well designed it may be expensive. Another promotion that is totally free, very reliable and trustworthy is customer word-of-mouth recommendation; this is when customers recommend the shop to family and friends. When it is recommended by family and friend’s people trust that it is a good shop and go there, but it is the customer’s choice to do it and you cannot control it. You can aid this by providing excellent customer service, good value for money and good standard of food. A good thing to advertise is offers like buy one get one half price or tokens on newspaper or leaflets that have good offers which they can claim. Offers for a meal are actually cheaper than buying them all individually so it encourages customers to buy more and they would chose a place that has offers on food to one that does not. Loyalty cards are also a good incentive to get new customers and keep existing customers to come back for more and this would increase sales because a certain number of purchases would get them a reward, which is normally more food. Frequent customers would feel angry that they do not get discounts or complimentary food. Survey of worker We did a questionnaire on the worker about the Seafood shop, and working conditions and he seems to be very positive about working there, but from how he spoke we realised that he was being bias so we cannot really trust everything that he said. He said that it was a good environment to work in and that the working conditions were good. The environment would be good because it would be busy. The workers seem happy and motivated therefore I would expect the customer service to be good as well and the food to be of a good standard. I asked what kinds of fringe benefits or monetary benefits they get but it seemed that he did not get any. The staff cannot be kept well motivated for long without any benefits. The owners can make the staff more motivated by giving monetary benefits at first and then fringe benefits. At first they would find that money is what they need and will be motivated when money is at the other end and it will be cheaper to give small monetary benefits than fringe benefits. When the business grows it can afford fringe benefits and the workers need benefits other than money to motivate them. The easiest fringe benefit could be a discount on the food in the fish and chip shop, or free lunch for the workers. To keep them well motivated there needs to be a better fringe benefit that they will get for working well or achieving a target number of sales.

Thursday, January 9, 2020

The Benefits of Samples of a Mission to Mars Essay

The Benefits of Samples of a Mission to Mars Essay Many facets of our modern lives wouldn't be possible if it weren't for our interest in space. Intensity is about how much men and women push themselves to finish a job. It would be an issue of time prior to the urge for exploration would start to peak and make endless possibilities. As time passes, several concept missions are studied, but not one of them got beyond the analysis phase. The company is presently running an on-line auction to induce competition and lower the sourcing cost. That means you can imagine a mission statement for a combo of what your small business or non-profit does and how and why it does it, expressed in a manner that encapsulates the values which are important to you. In addition, a customer may ask the writer to submit part of the job for review and, if needed, ask them to make corrections. The search at every step is accomplished in a brute-force fashion, but an important element of MARS is tha t because of the essence of hinge functions the search can be accomplished relatively quickly utilizing a fast least-squares update technique. Leading businesses and agencies offer an estimate on the price of tripping to Red Planet. The key conditions of the treaty included the cessation of numerous Jesuit missions to Portugal. This info can help you to prepare the ideal speech on Chandrayaan two mission of India, ISRO. Chandrayaan two mission will help to learn more about the south polar area of the moon that's very less explored. Samples of a Mission to Mars Essay - Is it a Scam? Additional seasonal caps of frost show up in the wintertime. Among the long standing regions of research regarding the Martian atmosphere is its effect on the presence of liquid water. These massive scale waves propagate from the decrease atmosphere upwards and cause altitude changes of the primary ionospheric peaks as a function of planetary longitude. These channels look as though they might h ave been created by running water. It is advised to look for the one which has an excellent reputation and offers high-quality papers at very affordable prices. Normally, the movie isn't badmuch better than the remainder of the science-fiction productions we are being fed regularly. It is a fairly complicated thing,'' he explained. For some individuals, it can help to think back on why they started their company in the very first spot. The main reason why the date is so specific is as this is the closest time that Mars and Earth is going to be aligned in an appropriate approach to lessen the roundtrip to Mars. There's a hard-working explorer that is now attempting to answer that question about Mars! The technology to reach Mars isn't inexpensive, and nobody appears to be willing to cover it. To start with, Hinners pointed out, much important science can't be carried out remotely at Mars. If You Read Nothing Else Today, Read This Report on Samples of a Mission to Mars Essa y Citations and extracts from assorted sources have to be formatted properly. This mineralised type of iron-oxide may be used for the preservation of aqueous processes. Additionally, many content on Science Trends is written by the key author of the peer-reviewed research in which they're writing. Things You Should Know About Samples of a Mission to Mars Essay These critical players developed over two thirds of the spacecraft parts for the probe in addition to the rocket. So, Musk's very first step was to create an affordable rocket. In addition, the system should be user-friendly for the astronauts. In reality, the first mention of Earth is in ancient Egyptian hieroglyphics. This is believed to be due to the blood-red color of the planet that was also employed by other ancient cultures. Other civilizations throughout history also have named the planet owing to its color. Additionally, it gathered praise from all over the world. In this instance, the aim is to purchas e packages from several suppliers at the minimal possible price tag. Occasionally it looks like Watney doesn't fully realize the scales of his circumstance. The primary problem is handling the faint young sun. The issue of all modern-day rockets is they are, in reality, disposable. Mars is the solitary planet that has a workable atmosphere that is vulnerable to Terraforming methods in the range of human technology. It's beneficial to compare MARS to recursive partitioning and this is achieved below. NASA also utilized the probes to seek out micro-organisms. For astronomers, it's just as important to know where the planets are so they can observe them. The Fight Against Samples of a Mission to Mars Essay The cost of shelter is going to be integrated into the expense of travel. Astronauts on interplanetary travel, on the flip side, are wholly exposed. Subsequently, it would lower the price of the manned mission significantly. Opportunity, on the flip side, landed on the other side of Earth. Samples of a Mission to Mars Essay - Is it a Scam? The Chandrayaan two mission grabbed the interest of the entire world to India. It's because uniform men and women in a team might be comfortable, but they can't understand the things that they don't know. All that's missing is a wonderful name, he explained. All that's missing is a wonderful name! The Tried and True Method for Samples of a Mission to Mars Essay in Step by Step Detail The cost of an essay is dependent upon the total amount of effort the writer has to exert. Here we've given some suggestions to assist you in your speech on Chandrayaan two mission in English. Individuals are motivated to get there at work in time, finish a project a couple of hours early, or aim for a number of other targets. Students will make a visual about their assigned mission to grow the class timeline.

Wednesday, January 1, 2020

Reflection On Writing - 801 Words

Throughout this semester I learned a lot about writing essay. Before this course I knew only one style of essay, because in high school, I wrote essay only for Literature classes. In this class I found that writing could be structured in many ways. Moreover, all reading that I have helped me to think critically and analyze all information that I get. A large number of examples in these readings and my own experience in this course introduced me that sometimes people are getting mislead, because of misinformation or setting wrong belief into the reader. All of these I get from this class, including practicing writing in the formal style and improving my English. The first project was unfamiliar to me, because of my little experience in the†¦show more content†¦The â€Å"factcheck† part was very interesting, because it opened my eyes that some of the trusted and huge news corporation like â€Å"CNN† could mislead their readers. Beginning from that time I’m trying to analyze all information that I get from new, social networks and TV. It developed in me the sense of evaluation information. The last and largest project the most interesting one. We have to write argumentative essay about how mass media trying to mislead us and set’s wrong belief in the reader. I appreciate that our professor gives a free for students to choose their own theme. Because of my interested in the theme I was dived into researching and finding articles which prove my argument. When I was finding counterarguments for my writing, I saw different views on my argument. It is very helpful to see other points to think critically and you could be more confident in your argument if you know both sides. The fear of something usually set mass media and we have to dispel the fog of obscurity. An this is the most worthy occupation. 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