Vulnerable Subjects Research

Vulnerable Subjects Research PROTECTION OF VULNERABLE SUBJECTS IN CLINICAL TRIALS BACKGROUND Aim: To throw light on the state of vulnerable subjects in Clinical Research. Objective: To understand current provisions and legislations available to protect the rights of vulnerable subjects with special emphasis on plight of sex workers enrolled in anti-HIV trials. VULNERABLE SUBJECTS IN CLINICAL RESEARCH Individuals who are comparatively or entirely inept of defending their own wellbeing are termed as vulnerable research participants. When study includes such subjects additional care has to be taken to protect their rights. It is the investigator and his research team’s responsibility to ensure that these subjects are not exploited in the name of research. The study design team, sponsor, investigator must be aware of the special requirements needed for vulnerable subjects and they should develop the study protocol, informed consent form and the confidentiality agreement keeping the vulnerable subjects’ needs in mind. The different types of vulnerable subjects included in clinical trials are classified on basis of their vulnerability. Some examples are as follows: 1. Cognitive and Communicative vulnerability: This includes children and adolescents. Patient’s suffering from mental retardation, dementia and other kinds of mental illness. Enrollment of people with educational deficits and unfamiliarity with language. Stressful emergency: conditions that do not permit otherwise capable adults to implement their capabilities efficiently. 2. Juridical or institutional vulnerability: Person who is under the official authority of others (egs. Parents, guardians, warders, officers and judges) who may have their own benefits in whether the individual agrees to enroll in the study. 3. Deferential vulnerability: Influence of other people in subjects life, determine their decision to enter the trial. Existence of an informal hierarchy (egs. Relatives, friends, masters, physician) 4. Medical vulnerability: Prospective patients who have a severe medical condition, for which there are no existing efficient or satisfactory regular cure (examples: very aggressive and malignant forms of cancer, last stage AIDS and some uncommon ailments) owing to their unusual medically tricky state, misuse of these patients throughout their hope for remission or improvement is not unusual. 5. Economic vulnerability: Prospective subjects with low economic background may join trial with hope of getting income, housing and healthcare facilities. Payment for participation or free access to healthcare services might constitute unfair inducements to enroll through exploitation of these subjects. 6. Infrastructural vulnerability: Patient is tempted to enroll in trials, as they pre-suppose the availability to them of resources or facilities (egs. a rapid communication system, a reliable dietary intake, skilled healthcare professionals) 7. Social vulnerability: Refers to individuals belonging to undervalued social groups or communities.(sex workers)[R. Colombo, The Most Vulnerable Subjects Of Biomedical Research IX General Assembly PAV – publications] EXPLOITATION OF VULNERABLE SUBJECTS THROUGH HISTORY Exploitation was rampant in the absence of regulations, laws, guidelines and codes. Escalating physician to god-like position with immense faith in them and failure to recognize vulnerable subjects has resulted in horrific incidents in history of research. These major mishaps have convinced the medical fraternity the need for developing ethical guidelines and code for research specifically for the vulnerable populations. The Nuremberg trial The 20th century will always be remembered due to the shocking and upsetting experimentation performed by Nazi doctors. During the World War II, the Nazi physicians took advantage of the prisoners of war; they carried out experiments unparalleled in their range and the level of anguish and harm. Appalling studies such as injecting the poor prisoners with gasoline and live viruses, immersing people in ice water, and forcing them to ingest poisons have gone down in the history books as the most inhuman experiments. The physicians in order to satisfy their scientific curiosity have performed these experiments which were of no use to the participants. These experiments usually resulted in the death of the participants. After the war ended, there was a huge public outburst against these experiments and 23 physicians were indicted at Nuremberg for their willing participation in these experiments. Sixteen were found guilty and sentenced while seven were hanged to death. This resulted in the origin of the Nuremberg Code, which made informed consent mandatory. The Willowbrook study The Nuremberg Code unfortunately did not put to end unethical research as not every researcher honored the Code. The three year long Willowbrook study is another example where vulnerable patients were exploited. Willowbrook State School, an institution for mentally defective children were intentionally infect with the hepatitis virus, by being fed stools from infected persons or later by being injecting with purified virus preparations, to observe the natural history of this disease and then to test the effects o gamma globulin in preventing the disease. Researchers defended the deliberate infection of these children by stating that the bulk of them acquired the infection in any case while at Willowbrook, and possibly it would be better for them to be infected under restricted research settings. What was worse was that during the course of these studies, new inmates were admitted only if they agreed to participate in the hepatitis program! There was obviously no full disclosure ad clearly coercion and undue pressure was used to enroll vulnerable subjects like children and mentally challenged. Jewish Chronic Disease Hospital Study At the other end of life’s spectrum, came the Jewish Chronic Disease Hospital Study where live cancer cells were infused into continually ailing and incapacitated patients. These patients had been told that they were getting a skin examination. The patients were provided oral information about the test but no consent was documented. Syphilis study The most notorious example of prolonged infringement of human rights of a vulnerable faction of research participants was the long-term study of black males performed at Tuskegee by the United States Public Health Service. Initiated in the 1930s to examine the natural history of untreated syphilis, continuing until 1972, this study recruited more than 400 black men suffering from syphilis. These participants were recruited without informed consent and were mislead that a few of the measures taken in the interest of research were essentially â€Å"special complimentary treatment†. Although along the way antibiotics become available, these were not given to the patients and the study resulted in 28 deaths, 100 cases of disability, and 19 cases of congenital syphilis. The Belmont report published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979 was one of the outcomes of the public outcry that resulted when the story of the Tuskegee study broke.[Urmila Thatte, Etical issues in clinical Research chapter 4, of Basic principles of clinical research and methodology by S K Gupta] Guidelines for ethical conduct of research in human subjects that have came into picture: Nuremberg Code, 1947 Declaration of Helsinki, 1964 The Belmont Report, 1979 International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1982, 1993, 2002 The Ethics of Research related to Healthcare in Developing Countries, Nuffield council, 2002 Indian council for Medical Research Ethical Guidelines for Biomedical Research on Human subjects SPECIAL CONSIDERATIONS FOR CHILDREN Regulations that protect children, so as to prevent their exploitation are: OHRP 45 CFR 46 Subpart D FDA 21 CFR 50 Subpart D Special Considerations for Children are: Research that involves no more than minimal risk can be approved with adequate provisions for obtaining the assent of the child and permission from their parents/guardians. 45 CFR 46.404 The combination of assent by the minor subject and permission (consent) from the parents is deemed appropriate to enroll the child subject in the trial. In case of life threatening events only consent from parents would suffice, as there is expectation of direct benefit. However the child must be given full explanation of the trial. If the research presents an opening to comprehend, avoid or lessen a grave predicament affecting the health or welfare of children, but does NOT provide direct benefit to the subject or societal (indirect) benefit, than the research cannot be approved by the IRB unless HHS Secretary Approval is granted. 45 CFR 46.407 . Extremely rare- both Parent consent + child assent. When parents of the child are deceased, unknown or incompetent then the legal guardian must give is consent. Step parents, Grandparents, Adult siblings, adult Aunts or Uncles may not consent a child to research. SPECIAL CONSIDERATIONS FOR WOMEN Regulations that protect women, so as to prevent their exploitation are: OHRP 45 CFR 46 Subpart B Research studies involving pregnant women and fetuses must satisfy the following requirements to obtain IRB approval: Preclinical studies have been conducted, including studies on pregnant animals; clinical studies, that include non-pregnant women and provide data for assessing potential risks to pregnant women and fetuses 46.204(a) Risk to fetus is caused solely by interventions or procedures that hold prospect of direct benefit for the woman or the fetus or, 46.204(b) If no benefit, risk to the fetus is not greater than minimal and the research develops important biomedical knowledge not obtainable by any other means. 46.204(b) SPECIAL CONSIDERATIONS FOR PRISONERS The voluntary choice of the prisoners must not influenced by any potential advantages entailed to them due to the study, which outweighs the risks. For example, Parole decisions must not be affected for prisoners participating in the trial. The study is ethical, when the risk of participation is acceptable even to a non prisoner subject. Selections of subjects are carried out in a fair manner. When spoilt for choice, randomization techniques must be used. If necessary, adequate follow-up care must be provided to the volunteers. SPECIAL CONSIDERATIONS FOR DECISIONALLY IMPAIRED A combination of assent from the subject and permission from the concerned legal authorities constitute for the informed consent. The risk of participation would be agreeable to general volunteers too. Selection is fair and unbiased Adequate follow up is provided SPECIAL CONSIDERATIONS FOR SEX WORKERS Enrolling Sex workers in HIV vaccine trials that are ethical, valid and are not exploitative is a challenge that must be faced. Due to their nature of work, they require additional support. Sex workers are generally from the downtrodden community, they are illiterate and understanding the language in the informed consent is a major issue for them. Hence the informed consent must be in the local language and should be easily understood. The informed-consent must be prepared in such a way that it is in consultation with the community advisory and counsel board to ensure social sensitivity. Confidentiality is an important issue. These women may face physical abuse and abandonment from their clients, if they enter these trials. Supportive counseling should be provided before, during and after the test. Sex workers must not only be given male condoms but along with that they should be provided with female condoms. Proper guidance on safe sex must be dispensed. Clinical trial study team should increase awareness among the sex workers about AIDS. They should provide proper guidance to them, for prevention. Sex workers should be treated equally as general women would have been treated in a clinical trials. Study team should be sensitive towards them and not discriminate and look down upon them. CASE STUDY Health Minister, Urbain Olangnena Awono of the Cameroon government has decided that they may have to put a stop to the Tenofovir trials taking place in the port city of Douala due to various allegations by AIDS activists. The health minister had scheduled an audit for the same. The Tenofovir trial began in September 2004, Tenofovir is a established drug used for treatment of AIDS, manufactured by Gilead pharmaceuticals U.S. This trial was to determine whether Tenofovir can work as a prophylactic to prevent AIDS. The study recruited 400 sex workers free of infection. Half the women took a Tenofovir pill daily and the other half took a placebo. The study is conducted by Family Health and Insurance (FHI) with the support of U.S $ 6.5 million dollars from Bill and Melinda Gates Foundation. AIDS activists have demanded that this study be completely suspended on ethical grounds. They have said that the volunteers are vulnerable subjects and their rights have been exploited. Activists claim that the subjects have received inadequate counseling and healthcare. They have brought to notice that the sex workers are not fully informed about the risks involved in the trial. They also argue that the Study team has not promised to guarantee free healthcare if the workers become infected, which ideally every volunteer must receive. The FHI have counter attacked and cleared their stand by assuring that free medical checkups and tests have been carried out. Various tests like gynecological, medical care, HIV, pregnancy have been carried out for free. However various Activists have disregarded this claim and said that these are all false promises and haven’t been materialized. Another important issue that has been brought to notice was that, most of these sex workers were illiterate didn’t understand English and very little French, in spite of that the informed consent form were in English. However later it seen that the ICF shown to PlusNews was in French. The study team had provided 96 male condoms to sex workers. However imparting knowledge to prevent the infection of disease would be like a conflict of interest for the researchers. As the trial would be a success only if the women were exposed, become infected. The sex workers are misinformed and they feel that by taking this pill they are now vaccinated against the disease. In order to get their point across, so that the concerned authority would wake up to this injustice, AIDS activists in Paris staged a demonstration in front of the Cameroonian embassy in Paris. This demonstration got full coverage on the French T.V. This resulted in a public outcry against the trials. CRITIQUE The Tenofovir trial case study is an excellent example highlighting the profound impact media can have on the progress of the trial. The complete discontinuations of the trials prove that activists and non- governmental organizations with the help of the media can bring about change. These same activists are also involved in promoting research to combat the disease, but they can hinder the progress too. Hence researchers must be more aware about the ethical issues surrounding enrollment of sex workers. Engaging in discussion and consulting with the participant’s community before the trial begins can avoid such media spectacle. The case study rightly brings to one’s notice that lack of consultation with the support groups and community network was the biggest error on the part of the research team. Extensive discussion with community networks and a good flow of communication would bridge the gap and increase the trust of sex workers in the trials. The activists have rightly questioned why no subjects from general population have been enrolled to test safety of the drug. They have expressed concern and raised another important issue that the same trial would have provided women from Europe and U.S better benefits and adequate healthcare. The burning issue against this trial has been that since the primary outcome is HIV infection, researchers will provide inadequatecounseling to prevent infection. Since there exits a conflict of interest, sex workers will not be encouraged to have safe sex. Another important drawback of the trial has been its failure to provide sex workers with female condoms. They were provided with male condoms but negotiating for the same with their clients does not go down well with their trade. It is shocking that the sex workers were completely ignorant about the drug. They were misguided that the drug is a vaccine for AIDS, which made them more careless and prone to the disease. On the other hand, Tenofovir trials aimed at providing a prophylactic for AIDS, which would be a major breakthrough in combating this deadly disease and would definitely be of great benefit to the sex workers. Such uncontrolled and extreme protest has led to the complete discontinuation of the trial which in turn is bad news for the sex workers. The sponsor company had also promised to market this drug in Cameroon for much reduced prices. The validity of the media reports is doubtful as all the allegations made against the research team have been without any evidence. Activists instead of creating media backlash against the trial should have engaged in constructive dialogue with the research team stating their demands. CONCLUSION Clinical research has given millions of patients’ worldwide assurity that the medicine they purchase and consume, has been completely validated for its safety and efficacy. It ensures that these patients worldwide are getting the best medicine with utmost safety parameters. Investigators along with their research team bear the ultimate responsibility for their work with human subjects. They have the privilege of using human subject to advance scientific research, in turn society expects that investigators will show respect for their research subjects. Unfortunately as history has shown some scientists still continue to value their quest for knowledge and potential for personal fame and financial gain more highly then respect for basic human rights. Hence, various guidelines, regulations, codes and law have come into picture to protect the human subject. Special care and provisions must be made for subjects who are shunned from society. Sex workers live on the fringe of society and can rarely ask for their rights or support from public. In the interest of general health, to conduct trials for AIDS, this section of society must not be used as mere guinea pigs. Particular guidelines and ethical code of conduct for researchers must be drawn in order to protect these oppressed subjects. Providing them information on AIDS is not enough, they must be given free health care and female condoms. They need compassion and justice from us. REFERENCES Deanna Kerrigan et al, Environmental structural factors significantly associated with consistent condom use among female sex workers in the Dominican Republic, AIDS 2003 17:415-423 , Lippincott Williams and Wilkins. Arnaud L Fontanet et al, Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial, AIDS 1998, 12: 1851-1859, Lippincott Williams and Wilkins. Edward Mills et al, Media reporting of Tenofovir trials in Cambodia and Cameroon, 24 August 2005, BMC International Health and Human Rights. Edward J Mills and Sonal Singh, Health, human rights and the conduct of clinical research within oppressed populations, Globalization and health 2007, 3:10, BioMed Central Ltd. Peter H. Kilmarx et al, Protection of Human Subjects’ Rights HIV- preventive clinical trials in Africa and Asia: Experiences and Recommendations, AIDS 2001, 15 (suppl 5) : S73-S79, Lippincott Williams and Wilkins Geeta Yadav et al, Associations of sexual risk taking among Kenyan female sex workers after enrollment in an HIV – 1 prevention trial, J Acquir Immune Defic Syndr 2005; 38:329-334, Lippincott Williams and Wilkins Gielen AC, Fogarty L, OCampo P, Anderson J, Keller J, et al, Women living with HIV: Disclosure, violence, and social support, 2000, J Urban Health 77:480–491 R. Colombo, The Most Vulnerable Subjects Of Biomedical Research IX General Assembly PAV – publications. Urmila Thatte, Ethical issues in clinical Research chapter 4, of Basic principles of clinical research and methodology by S K Gupta Cynthia McGuire Dunn and Gary L. Chadwick, Protecting study volunteers in research, Third edition. Thomson Centerwatch. Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD; Christine Grady, PhD, What Makes Clinical Research Ethical? , JAMA.2000;283:2701-2711. Cohen J. Cameroon Suspends AIDS Study. Science, Science Now 2005 Feb: 4. Singh JA, Mills EJ. The abandoned trials of pre-exposure prophylaxis for HIV: what went wrong? PLoS Med 2005;2: e234 Atatah C. Douala AIDS drug controversy: medical council says trials violated ethical norms. Post News Line 2005. www.postnewsline.com/2005/02/strongdouala_ai.html (accessed 15 Jan 2008). http://www.actupparis.org/article1734.html?var_recherche=tenofovir (accessed 15 Jan 2008) http://medicine.plosjournals.org/perlserv/?request=get-documentdoi=10.1371%2Fjournal.pmed.0020234ct=1SESSID=3b4fdb3c51bc2ee0983c4abb37ad4ffa (accessed 15 Jan 2008) KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, in NATIONAL BIOETHICS ADVISORY COMMISSION, Ethical and Policy Issues in Research Involving Human Participants, op. cit., vol. 2, pp. G1-G13, p. G5. http://www.academiavita.org/template.jsp?sez=Pubblicazionipag=testo/et_ricbiom/colombo/colombolang=english (accessed 15 Jan 2008) www.medscape.com/viewarticle/408956_3

Coffee retail Essay

1. Introduction The report revolves around the Retail Industry. As it is a very generic industry we have taken the Coffee Retail Market as the highlight of scrutiny. Our scope of study is focused taking in consideration only India as the geographic segment. We broadly look at the Porter’s Five Forces of the industry specifically. Also the complementors are observed and how they affect the retail business of coffee houses. The major players identified in the industry are Starbucks, Cafe Coffee Day, Barista, Costa Coffee, and Nescafe. Grilling down further the report includes SWOT analysis, External Factor analysis matrix ,Internal Factor analysis matrix and PESTEL analysis. 2. Porter’s Five Forces The porter’s five forces model framework is very helpful in understanding the industry and market closely. It further helps in determining the profitability of the industry as a whole. Also helps the management in taking strategic decisions accordingly. 2. 1 Threat of New Entrants In the present world coffee has become a really popular beverage among Indians. This makes it an attractive market for the potential companies who are looking up for opening their retail coffee houses in India. Entering the industry is not that cumbersome in case a business house admires to open up a small coffee shop. Problem arises in respect to entering the industry when they aspire to set up retail coffee chains or speciality coffee shops. Due to many established names in the industry like Cafe Coffee Day and Costa Coffee, establishing brand name also becomes an issue. Companies already with established brand names like Coca Cola, Starbucks can enter the industry easily without much caution as they already have marketing strategies designed in their favour. As a conclusion, we can state that barriers to entry are Low especially for global brands and they can easily enter the coffee retail industry with established marketing strategy, name, and huge capital and financial stability. Otherwise, hard for new and unknown firms admiring to be in the business. 2. 2 Bargaining Power of Suppliers The suppliers for the coffee retail industry in India generally come from southern India i. e. Kerala, Karnataka and Tamil Nadu. Though these days different types of coffee are becoming popular among the Indians like, Gourmet, Organic, Eco-friendly coffee, and they are being sold for better prices in comparison to the traditional brewed coffee. Still the situation is not really in favour of these suppliers. These coffee growers are poor, competitive and rely on the buyers to a great extent. Therefore, power remains to be limited. This proves to be good for the retail outlets in the business. 2. 3 Bargaining power of Customers. The whole retailing coffee industry depends upon the customers. So it is of vital importance to satisfy the customers in order to give them a reason to visit again. In this case word-of mouth plays an important role. So, if people appreciate about a particular coffee shop or chain, others are likely to try it. Thus, retailers must find new strategies and techniques of luring away the customers. But it is very important for the localities coffee retail shops to understand that they cannot charge prices as high as the industry players like Starbucks, Barista or Cafe Coffee Day. They need to maintain a low price profile in order to attract customers. So in case of these small locality retail shops the bargaining power of customers is very high. Otherwise the other coffee retail chains (industry players) do hold some control over the prices charged but it becomes important to consider the customers purchasing power. Otherwise they would switch over to other brand as there is no switching cost for them. This establishes that the bargaining power of customers is high and really important measure for the conduct of efficient business. Also these coffee retail chains should understand that the customers can also make the coffee at home which justifies their higher bargaining power. 2. 4 Threat of Substitute products There are a lot of substitutes for the coffee retail industry in general. Specially, the soft drinks industry has always given fierce competition. Also, other products like ice cream, candy, and beer are also a part of substitute products. It becomes important for these retail houses to make coffee more popular and drinkable amongst the masses. People should never consider switching from their coffee shops. But with changing preferences of Indian masses in favour of coffee the players within the industry are making maximum efforts in favour of differentiating its products from the substitute products. Also strategic decisions and marketing activities are initiated to shift the customer base from the substitutes resulting in high demand of coffee from the retail sector. So the threat of substitutes is also moderate. 2. 5 Competitive Rivalry within the Industry Considering the entire coffee retail industry as the scope of study, there are number of retail chains serving the industry effectively. To top the list is Starbucks, and than many more such as Cafe Coffee Day, Barista, Costa Coffee, Gloria Jeans, Nescafe, Bru Cafe, Dunkin Donuts, Mc Donalds, and small Kiosks and coffee points are also emerging in localities. They all are different in size and serve different segments of the society but are competing with each other in some or the other way. Each retailer follows different marketing strategy to lure away their target segments. Also with moving times the industry is occupying a stable position in the retail sector and is saturated . Therefore, we can say that the competitive rivalry though on the higher side does not affects the profit margins for the industry. 3. Complementors There is a sixth force to the porter’s five forces model, the power and competence that the complementors provide to the business. The complementors are those that help in selling and adding value to the existing products of the industry. When these products are used together they help in satisfying customer demands more effectively. It is also to be believed that these complementors play an important role in drawing in the demand for the industry. This in turn helps in scaling up the profits. Conversely, the poor products being manufactured or supplied by the complementors may harm the profits and demand. So it becomes important on part of managers to analyse all the six forces and then think systematically how their strategic choices would affect the industrial competition. Majorly the complementors can be associated with high-tech industries wherein they literally help in hiking the sales and profits for the industry. In our case, coffee retailing is not an industry that has any such complementors that would help in boosting sales or profits. But certain products are identified by us that in a slight way might affect the coffee retailing business. Like, merchandising, snacks offered for sale in coffee retail chains. Merchandising includes apparels and coffee mugs and other products such as soft toys and key chains available for sale by many coffee retail houses Cafe Coffee Day, Barista, Starbucks etc. Snacks are offered mainly by all the coffee houses in the form of cookies, patties, croissants, sandwiches, pasta, oats etc. So these complementors directly help in pushing up the sales of the business. 4. SWOT Analysis 5. External factor Analysis External strategic forces. Weight Rating Weighted score Comments Opportunities 1. India Large market .18 4 .72 Second most populated nation of the world 2. Increase in spending power .15 3 .45 The GDP or the purchasing power is rising adequately 3. Youth population .13 4 .52 Youth are the ones who are more prone and exposed to cafes 4. Favourable labour cost .07 2 .14 Easily available manpower at lower costs 5. Favourable infrastructure cost .07 2 .14 Low and easy access to infrastructure 6. Opportunity to serve the tea drinking segment .05 1 .05 A major portion of population is attracted towards tea drinking. Threats 1. Low per capita income. .07 3 .21 Huge requirement to extend products at competitive prices 2. Increasing health consciousness .04 1 .04 3. Competiton from fast food joints .04 3 .12 Mc Donalds, Pizza Hut, Subway 4. Hiking coffee prices .06 3 .18 5. Tea drinking segment .10 4 .4 This segment consumes tea at least twice a day 6. Rare habit of travelling to cafes .04 1 .04 Total score 1. 00 3. 01 The EFE matrix is made by comparing the coffee industry with the other beverage industry in India and weights and ratings are assumed according to personal knowledge. Considering the external factors effecting the industry EFE matrix is created. A score of more then 2. 5 reflects that the industry has more than average capability in response to external forces particularly the beverage industry in India. 6. Internal Factor Analysis Internal strategic forces Weight Rating Weighted Score Comments Strengths 1. Increasing Coffee demand .18 4 .72 Changing lifestyle leading to coffee adaptation 2. Favourable labour relations .15 3 .45 3. Non-perishable commodity .12 4 .48 Coffee is a non-perishable commodity which has no threat of being spoiled easily. Weakness 1. Low dominance over price .15 2 .3 Due to competitors in the industry. 2. Heavy export of coffee .05 1 .05 Low domestic consumption 3. High operating cost .2.5 1 .25 Total 1 2. 25 In the above tables, Column 1 depicts the strategic factors Column 2 depicts weight assigned to each strategic factor from 0 to 1 i. e. not important to most important Column 3 depicts the rating assigned to each factor wherein a scale of 1-4 is used. It signifies industry’s present response to each factor. In EFE matrix 1-4 is responses from poor to superior and In IFE 1-2 is major and minor weakness and 3-4 is major and minor strength. Column 4 gives in the weighted score. Column 5 represents the comments for the strategic factors Since internal factor analysis is used to judge wether the company is performing inline with the expected strengths and weaknesses or not. Generally an average score of 2. 5 on 10 is expected. After the analysis, we conclude that the internal weigted score of coffee industry in India is almost in line with 2. 5,reflected that the respected industry is running as astrong business internally as well. 7. Value Chain It is a series of activities aimed at delivering maximum value to a customer, through a product or service, at the minimum cost. This model analyses how a firm procures raw materials, adds value to these material through various processes and sells the finished product to the ultimate consumer. All these functions are performed with the objective of maximizing customer value at minimum cost. The value chain of the retail coffee industry consists of the following processes and activities: 7. 1 Primary activities 7. 1. 1 Inbound Logistics: This is primarily concerned with the procurement of raw materials in the form of coffee beans and various types of dairy products, required by all the coffee retail outlets. The aim is to procure high quality materials so that best of the flavours is served to the customers. Cafe Coffee Day does in-house sourcing through coffee estates owned by the company. Starbucks Coffee and Barista Lavazza chains have sourcing agreement with Tata Coffee. Cafe Nescafe, owned by Nestle works through community farming, where it provides high yielding quality, disease resistant seeds to the farmers for improved productivity. The company provides regular and fair remuneration to the farmers. Dairy products are also sourced through community farming. 7. 1. 2 Operations: There are various operations involved in the business of retail coffee outlets. The most important operation to be performed is roasting of the coffee beans, which gives the taste, flavor and smell to the coffee. Tata coffee provides roasting services to Starbucks and Barista through its own roasting facility. The outlets undertake all the operations to run an outlet like preparation of items, serving them to the customers and billing, etc. Starbucks and Cafe Coffee Day work on the model wherein order is taken and served to the customers on the table, whereas Barista works as self-service outlet. 7. 1. 3 Outbound Logistics: The customers are serviced through company owned or licensed retail outlets, which may be in the form of lounge, highway cafes or store-in-store. The stores are set up in centralized locations, which are easily accessible to the customers, in order to achieve maximum footfall. According to a business standard report, top 40 cities in India have around 1700 coffee outlets. CCD is the largest coffee chain in India with 1200 outlets, followed by Barista having 154 outlets and Starbucks having 21 outlets. Starbucks also sells some of its products through retail stores and super markets. 7. 1. 4 Marketing and Sales: Companies undertake various promotional activities to attract a large number of customers, which may be in the form of sponsorships and co-marketing initiatives. Customers are also benefited through loyalty card programs, carrying various offers and advantages. Value meal combos attract students who have low purchasing power. Marketing is also done through TV and media sources. All this is done to maximize sales. 7. 1. 5 Services: Coffee retail industry relies on the quality of service to the customers. These chains don’t sell coffee, they sell experience. For this, highly trained staff is recruited to provide high quality customer service. Other services offered are newspapers, magazines and free Wi-Fi to the customers. 7. 2 Support services 7. 2. 1 Firm Infrastructure: In order to have a smooth flow of operations, the companies need to have sound infrastructure for accounting, planning, finance, management, etc. The retail outlets have inviting interiors and comfortable seating space. 7. 2. 2 Human Resource Management: Human Resources are the most valuable assets of any organization, and same also goes with these retail coffee chains. Highly trained people are recruited to provide high quality customer service. Various training and motivation programs are conducted to further enhance the skills of these people, which will add to the customer value. 7. 2. 3 Technology: Companies have started using latest technology to perform their operations. Computerized roasting machines are being used to maintain the consistency in the flavour of coffee beans. Barista has installed control systems like Total Quality Management to ensure the quality of materials distributed. Latest software is being used to achieve maximum operational efficiency. 7. 2. 4 Procurement: In order to achieve maximum customer satisfaction, companies need to procure raw materials that are of best quality available in the market. Companies also need to source furniture, kitchen equipment, utensils, etc. , which act as complements in the operations of coffee retail outlets. All the above-mentioned activities aim to maximize the customer value at the minimum cost. 8. PESTEL Analysis A strategic framework of macro economic , political, economical, socio-cultural, technological, environmental, and legal factors include :- 8. 1 Political factors. Indian coffee board has proved a helping hand to the coffee industry of the same after 1996 de-regulation of coffee marketing. after it it has grown up as a free market leading to a four times growth in its trade. around 70-80% of the country’s production is exported . A coffee produced with set standards named fair trade coffee is one of the major constituents to coffee retailing. the one managing this in the country is fair trade alliance , kerela. Starbucks in India is certified to fair trade coffee provider ,whereas barista lavazza has fair trade coffee compliance abroad buit not in India and same is the case with dunkin donuts. 8. 2 Economical factors Development in lifestyle of people and coffee turning as a delighting factor in the economy ,the consumption of coffee is taking a pace. Increase in consumption by urban young generation is expected to take the industry at a whopping business of around 2250 crores by the year 2017. Though it currently stands at Rs. 1100 with its major players trading like barista, CCd etc. The infrastructure developements, the enhancing demand and smoothing trade procedure leads to incremental trade for the industry. A coffeeproduced with set standards named fair trade coffee is one of the major condstituents to coffee retailing. The one managing this in the country is fair trade alliance,kerela. Starbucks inIindia is certified to fair trade coffee provider , whereas barista lavazza has fair trade coffee compliance abroad but not in India and same is the case with dunkin donuts 8. 3 Socio- Cultural factors Catering to the ever increasing population of the country, it is the responsibility of the businesses to look for to the socio economic factors in place . For instance, the development in lifestyle of people is leading to increase in the coffee consumption in the country. Keeping these factors into mind businesses like cafe coffee day claims of training 400-500mpeople every month to enhance employment and as a part of responsibility to the society, MC Donalds along with CCD keep staff to clean right under your feet. Similar to those dunkin donuts provides 21 day training program to the staff to help customers better. As a part of social responsibility 50% Costa coffee employees in Delhi and NCR are deaf people. 8. 4 Technological factors With the changing lifestyle and gezmo addicted generation, one cannot afford to have a internet free cafe . The presence of bluetooths and wifi within the outlets of coffee companies is the basic requirement to get on the customer to the shop. The comfort of checking the emails, organising commercial meetings in the coffee shops an sitting there for hours requires the business to have a wifi enabled cafe. For eg -starbucks (India) uses help AT&T(India) to provide a click, no password facility for easy internet accessSalong with there mobile apps and various online facilties. Moreover whotspot also helps in proving in these facilities. Barista lavazza uses strategy ‘ internet with mugs’ named strategy to lure customers in contract with spectranet. Along with this value addition it also provide facilities like hot deals with customers downloading deal on their tablets or smartphones and avail the services on the spot. 8. 5 Environmental factors The weather conditions play a major role in production of coffee. Environmental factors in case of coffee is the seasonal dependecy of the amount of coffee produced across different seasons. For instance:- with on time monsoon this year in the country,the coffee production in southern area of country raised upto 8-10%. in india other factors on which the coffee production depends are the pest infestation and limitation of mechanisation. conserving water, recycling,energy and plastic management etc are also few termenologies which companies takecare off. 8. 6 Legal factors Legal establishments popping up prooved as aiding cushions to the domestic market of the industry as well along with the outside trade. with liberalisation of industries in 1991 this particular industry was also benefited. One of the drastic help was with the FDI in retail industry i. e around 51% which turned trade more smoother then before. Tarrif charges in india are 40-605 on raw material and 60-100% on semi finished goods. Mc Donalds bring its coffee reatailing from its brand mccafe originated in melbourne,australlia. Starbucks got the way to enter in Indian markets after FDI was allowed by government but still restriction to get 30% of sourcing from SME’s of India. Indian institute of plantation management, Banglore (IIPM)usually takes up the responsibility of coffee retailing in the country along with its entrepreneurship and development. 9. Conclusion The coffee retail industry in India is on the expansion path and has doubled over the last decade. The present size of the market is estimated at Rs. 1520 crore, which is expected to reach Rs. 3775 core by the year 2018, a CAGR of around 20%. Earlier there was no such demand for moving out of the houses for coffee consumption but the emerging coffee retail chains have changed the scenario triggering consumption need amongst the young adults. Serving the evolutionary phase exceptionally well, these coffee retail chains are overwhelmed with the response in the Indian market are planning further expansion of their networks in the country. The above analysis of porter’s five forces highlights that the profitability of the industry is expanding with westernised culture being adapted by Indians. (Porters 5 force analysis). The snack and merchandise industry are complementing the coffee retail industry very effectively thereby leading to inflated sales and profits for these retail houses. (complementors). Reflected by the study of strategy of coffee industry hereby conclude that the Indian coffee industry is a strong respondent to the external factors (EFA matrix) as well as internally also industry is doing well(IFA matrix). To increase the figures of sales and profitability, a number of varieties of coffee and eatables are offered, targeted at different price-points of the market. The companies are using innovative strategies and marketing tactics. A large young population, rapid urbanization and changing lifestyle, coupled with not-so-difficult entry into the market have attracted a large number of domestic and foreign players in the country. Global brands like Starbucks are keen in investing in the Indian market due to the huge potential it displays. This is evident from the sizeable revenues that these brands have generated over the years. (PESTEL and Value chain). Only home grown coffee is served in the Indian market as coffee import attracts a duty of 120%. Coffee beans are sourced from company owned estates or through the means of community farming. Companies with established brand names are able to run their business successfully, whereas small business houses are in a way struggling to compete in the market. 10. Bibliography Unknown. 2013. [online] Available at: http://pure. au. dk/portal-asb-student/files/3785/khrystyna_diaz_final_theses. pdf [Accessed: 12 Oct 2013]. Unknown. 2013. [online] Available at: http://coe. brown. edu/documents/StarbucksaStrategicAnalysis_R. Larson_honors_2008. pdf [Accessed: 12 Oct 2013]. Unknown. 2013. [online] Available at: http://www. google. co. in/url? sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CEYQFjAD&url=http%3A%2F%2Fojs. cnr. ncsu. edu%2Findex. php%2FJTATM%2Farticle%2Fdownload%2F1917%2F1205&ei=tqhRUsevEIrprQeNjoHQCg&usg=AFQjCNHBlG5wSoXga_TfbHIkiBKAffxb2g [Accessed: 12 Oct 2013]. Sites. google. com. 2013. Porter’s Five Forces – Starbucks and Dunkin Donuts. [online] Available at: https://sites.google. com/site/starbucksanddunkindonuts/porter-s-five-forces [Accessed: 12 Oct 2013]. Slideshare. net. 2013. Tata Starbucks Ltd A Strategic Analysis. [online] Available at: http://www. slideshare. net/ranganathpandit/tata-starbucks-ltd-a-strategic-analysis-15117792 [Accessed: 12 Oct 2013]. Dudovskiy, J. 2012. Starbucks Value-Chain Analysis – Research Methodology. [online] Available at: http://research-methodology. net/starbucks-value-chain-analysis/ [Accessed: 12 Oct 2013]. Emergingstars. com. 2013. ‘A lot can happen over coffee’ | Success Story | Emerging Stars. [online] Available at: http://www. emergingstars. com/success-stories/lot-can-happen-over-coffee [Accessed: 12 Oct 2013]. Unknown. 2013. [online] Available at: http://www. iipmthinktank. com/functions/marketing/compartive. pdf [Accessed: 12 Oct 2013]. Diplom-Kauffrau (FH), M. 2013. GRIN – Coffee Shop Industry – A Strategic Analysis. [online] Available at: http://www. grin. com/en/e-book/111348/coffee-shop-industry-a-strategic-analysis [Accessed: 12 Oct 2013] Kulkarni, M. 2013. India slips to 7th rank in global coffee production. [online] Available at: http://www. business-standard.com/article/markets/india-slips-to-7th-rank-in-global-coffee-production-113090400124_1. html [Accessed: 13 Oct 2013]. The Economic Times. 2009. Indian coffee industry: A paradigm of sustainable development. [online] Available at: http://articles. economictimes. indiatimes. com/2012-01-17/news/30635685_1_domestic-coffee-consumption-indian-coffee-coffee-beans [Accessed: 13 Oct 2013]. Unknown. 2013. [online] Available at: http://www. indiacoffee. org/userfiles/PCP%20in%20Coffee%20Entrepreneurship-IIPM. pdf [Accessed: 13 Oct 2013]. Profit. ndtv. com. 2013. FDI in single-brand.

Orginal writing Essay

      He had relied on stray sheep and animals as he knew he couldn’t go past the village as he’d die, he decided to wait to see if anyone comes back he’d use his brother killing him with the knife he’d been given my his late master, exchanging his brothers soul for his own freedom to travel beyond the borders. He also knew the only other thing that could send him to his ultimate fate was also the knife; he also knew that the opposite to what he wanted to happen could happen. He could if struck by the knife be killed also. In the air the very essence of evil hung in the air, the endless darkness sweeping forward devouring everything in its path. Cobwebs hung everywhere filled with decaying flies; the only light came in from the holes in the walls piercing the darkness. The small of centuries of decomposition stung the nostrils and the throat. The only sound was the drip of water and the occasional settling of giant spiders; the cobwebs snared the skin hoping to catch the person as if he was a fly. It was startling the in contrast with the cold air in the hills. He was anxious, he’d reached his objective, and half knew the old man was right. It was suicide. The man with jet black hair stooped low moving surprisingly quickly and quietly for a man his age following David to stop the worst thing that could ever happen, happen by doing he risked the worlds safety. David’s worst fears were realized stood in front of him but facing the other was the monster, he was like a huge upright wolf with huge black eagle like wings. The dark hair that covered his body was like needles, he looked that he could destroy anything. He flew out of the window, looking for stray sheep or so he thought. He ran through endless rooms and corridors before finally stopping in a room. A room filled with gold it gleamed newly polished beyond perfection. A room that within its walls tucked into a corner was a blood red handled knife. He took it just incase and ran until he came across someone, or something. The old man with jet black hair stumbled in agony; the monster had just caught him! Breathing both of his legs unable to move he sat and waited, waited for the inevitable for the knife to pierce him. He knew he was making a mistake, but if he did die, the worst possible thing couldn’t happen, this thought calmed him, as he slipped into unconsciousness. The monster searched and searched for thee knife knocking over wall after wall trying to find it. He was excited the time had come and the world would pay. He saw out of the corner of his eye he saw David stooped low shaking in fear. He snatched the knife off him. Then slammed him into one of the castle walls, not killing him but David were wise enough to pretend to be. David waited till the monster as a distance away then thought of what he had just seen. The monster had big red inflamed eyes, razor like teeth and two gleaming fangs. He stood on two legs not all fours and looked as powerful as he was deadly. David decide to get out while he could, he sprinted to the exit. The monster loomed over the old man with the knife. Stabbed him. His blood splashed on the ground forming a crimson puddle. The knife itself seemed to glow, the blood on the blade instantly congealed. A wisp of grey crossed from body to blade, sealing the world’s fate. David saw this hiding in one of the corners. He knew he should run but his legs would not allow it he wondered why the monster never had the time to kill him. Now he knew. He was taken over by something he sprinted over to the monster that was taken by surprise. He then reached out a hand a jumped almost horizontally through the air. In all one move he took the dagger and plunged it deep into the monsters neck. He landed. The ground below him started to shake soon the ground gave way but not before the monster erupted into an inferno instantly killing David. His last thought was one of relief that the monster was dead and pride that it was he that had done it. The castle collapsed into itself. The knife and the two bodies buried under the ruins with them the knife, waiting for a new master to control it.

Movie Analysis Macy Rivet - 1733 Words

Macy Rivet November 22, 2015 MC 3080 Assignment #4 It is no secret that dead celebrities sell. In many cases certain celebrities could rack in more bucks after their death than they did before it. But who gets this money? New York legislature knows this is an issue, and they are proposing a bill, S.5650/A.709, that calls for statutory right of publicity for the deceased. This bill, if passed, would extend the right of publicity for 70 years after death for anyone- not just celebrities. This would mean the name, voice, signature, image or likeness illustrating any person who was a resident of New York before they died would require a valid federal copyright and the permission from their heirs for use for â€Å"commercial purpose.† It protects artistic and creative works and allows books, plays, magazines, newspapers, music, film, radio, television and other media to use a living or deceased individual’s name or likeness in a range of fictional and non-fictional works. The boundary between publicity rights and the First Amendment rights is the main legal issue being called into question in this case. There has been a struggle to clearly articulate where the line separating publicity and free speech lies. Arguments can be made on both sides and many famous cases have come about from this issue, most of them going in favor of the first amendment. There is a definite conflict between a celebrity’s right of publicity and the public’s right to free expression represented in the