Debates on “Standard of Care” in Research

Debates on â€Å"Standard of Care† in Research Current debates on â€Å"Standard of Care† in Research on Human subjects in the Developing World Zoheb Rafique INTRODUCTION: For sometimes now, medical and bioethics communities have been facing some of difficult and divisive issues regarding the ethics of the international research. These issues often get fuel, when the interventional research is conducted on the poor and vulnerable people in the poor developing countries. Normal term â€Å"Standard of the Care†, against which some of new interventions and inventions are tested in the medical research has not been adequately defined. This term is often usually taken to mean the â€Å"best proved treatment† for any of the condition under investigation in any of the trial. The debate regarding what constitutes a reasonable and fair standard of care for subjects in the developing countries and those who participate in the clinical trials has been aroused by the critics of the studies on transmission of HIV. Those critics also argued that the placebo controlled trials of the new regimens as to prevent the vertical transmission of the HIV were hi ghly unethical because of the reason that they included the placebo arm rather than â€Å"best proven treatment† which is available in the developed countries. While some of the commentators considered criticisms to be unbiased and associated with imperialistic attitudes. This debate made it very clear that high standards of the research plans to have not been comprehensively and adequately defined. Although there was some justified concern that the pressure from US food and the drug administration could â€Å"dilute† declaration of the Helsinki, and critics were also confident that whether a trial was ethical could be deduced from text of a declaration. But some declarations such as declaration of the Helsinki, that governing international research ethics are accepted like the constitutions and needing interpretation. Also assuming what is ethical, goes beyond merely following all the prescriptions and also requires some moral reasoning (1). In this article, I will di scuss and comment on various debates on standard of care in human research in the developing world. DISCUSSION Equal standards of medical care during research, reflecting equal respect for the dignity of subjects, could be taken to mean any one or a combination of several requirements. It is arbitrary and not justifiable to select only one of these, for example, which drugs are used to compare the standard of care in developed and developing countries. In context of some disputed studies on the issue of HIV transmission, the forced emphasis on some â€Å"best proven drugs† having greater considerations of whether those drug regimen can be safely applied in the different settings. Also little attention has been paid to fact there were so many differences between the pregnant women in the developing countries, and in countries where â€Å"best proven† treatment previously been established. The pregnant women in the developing countries present to the antenatal clinics at much later in the pregnancy than women in original studies; they are often malnourished and anemic, and they of ten live within some context in which the breast feeding having different implications for the newborn infants. Moreover, the advice don’t breast feed would then contradict years of the intensive education by WHO (World Health Organization). Also concerning use of the placebos, the approach than also been simplistic. A placebo arm is legal and justified in any trial requires some careful consideration of the potential benefits and harms in those specific contexts and they cannot be just simply deduced from any general declaration. And of course it is very necessary to acknowledge the fact that many of the placebo trials are often unethical because they are performed largely for the marketing purposes just to show that â€Å"me too† drugs, have effects and actions greater than those placebo, and rather than to study that they are better than the existing similar, often cheaper, drugs. Also not only should nothing to be done to make it easier to perform such trials, but also each and every effort can be made to reduce and decrease wasting time, money on the â€Å"promotional studies†. In these situations where there are some good reasons for the placebo controlled trials, those should be considered on the merits rather than to be precluded by any bluntly designed clause in the declaration. To protect the host communities from the exploitation, most of the commentators argue that the efforts to improve the health care in developing countries should never ever involve the research that uses and utilizes less than â€Å"Worldwide best† methods, and meaning best of methods available anywhere in this world. Most notably, paragraph 29 of the Declaration of Helsinki states: â€Å"The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods†. The debate over the issue what standard of the care should be required for the individuals p articipating in the research trials typically focuses on the research conducted in the developing countries by the investigators from the developed countries. This focus makes some sense. Most of the clinical research is conducted by the investigators from the developed countries, and most of communities lacking the access to good health care are located in developing countries. Researchers from the developing countries can also exploit the host communities. And also the communities in the developed countries lack access to best methods available in the world, and increasing the potential of being exploited. Then a complete analysis, should also address the potential for exploitation and independent of nationality of investigators, and the geographic location of any study (2). When the Helsinki calls for â€Å"the best proven therapeutic method† than does it mean [A] â€Å"the best therapy which is available anywhere in world†? Or does it say [B] â€Å"the standard th at is applicable in that country in which drug trial is conducted†? Helsinki is not very clear about this. But I must say that [1] a detailed and careful analysis of document and also its history tells us that the best therapy standard was intended initially and primarily as the standard of medial practice. This conclusion yields another conclusion: that [2] â€Å"the best proven standard of therapy must necessarily be the standard which prevails in that country in which clinical trial is being carried out. In part, interpretations A and B often differ over what I call the question of relevant reference point. Also emphasizing this disagreement makes it appear as the dispute hinges on question of whose medical practice constitutes relevant medical practice. So, the sides of the debate are divided into the proponents of local standard of care and also the critics who often champion the global standard of care. Framing the debate as the question of relevant reference point, how ever, effectively obscures a more fundamental source of disagreement. To see this, consider a crucial assumption that lies behind following argument. It is sometimes claimed that (1) because content of the standard of care is often fixed by local reference point and (2) because the prevailing treatment for preventing the maternal-infant HIV transmission in those countries where short-course AZT trials were conducted was no treatment at all, that (3) use of the placebo does not fall below established standard of care. Also it is important to see, however, that in order for (3) to follow from (1) and (2), we have to adopt the local reference point for standard of care (3). The ethics of the placebo-controlled trials to prevent the perinatal transmission of the HIV infection in continents like Asia and Africa have been widely debated. Some critics have argued that it is very unethical to leave the patients untreated when the proven life-saving treatment and therapy is being used in oth er parts of the world. We note, that conduct of the placebo-controlled trials in any developed country which would be unethical in some other developed country, has evoked some of furor that surrounded HIV perinatal transmission trials. The patients on other hand can choose not to take part in the trials. Reluctance to participate in the trail may be greater when there is some placebo control and the patients are asked to delay and forgo known effective therapy, also large number of the patients regularly agrees to take part in the placebo-controlled trials of the new agents. The perceived scientific value of the trial can contribute to this decision. Although care must be taken to ensure that manipulation of such considerations (e.g., by exaggerating scientific importance of trial), it seems very reasonable to allow the potential study participants to balance these benefits against some potential risk of the participation in this trial (4). Some of the observers noted more than dec ade ago that the research was conducted in the developing countries without the concern for the adherence of international ethical principles regarding the human subject’s research contained in 1947 Nuremberg code and also in the 1964 Declaration of the Helsinki. This situation has not improved. As for example, two years back, Food and Drug Administration decided that the research studies submitted to it for the review purpose need no longer be bound by Declaration of Helsinki and they must follow only the industry-sponsored Guidelines for the good clinical practice also outlined by International conference on the Harmonization. What is the legal status of Nuremberg code and Declaration of the Helsinki? Are they old outdated ethical rules that the researchers might ignore with the impunity? The question remains open, but just as clinical trials attempting to interrupt mother-to-child transmission of HIV in mid-1990s gave rise to some continuing debate about the global standar ds of care and also benefit sharing, so another mid-1990s research trial in the continent Africa has brought the international research rules back to the center stage (5). In addition to discussing recent debate and concerning international HIV research, also we should focus on whether or not to randomized, as the controlled trials must be conducted for the researchers to learn about intervention’s efficacy. The choice of the study design is not between ethically questionable perfect trials that produce the complete knowledge versus the imperfect designs that produce no knowledge. Moreover designs, such as the observational studies, that resolve the certain ethical quandaries are not necessarily free of the other ethical problems. One problem is that these studies can provide only limited guidance for the public health policy. The other issue is of informed consent, which is one of corner-stones of the research ethics. The quality of the informed consent is compromised when t he potential patient participants believe, wrongly, that the medical care is contingent on their agreeing to participate in the research. Also it is important to emphasize the potential participants that neither their access to the medical care, nor quality of care they receive, will be affected in any of the respect by their decision. It is sometimes very difficult to clarify this separation of the research from the medical care; the potential participants can be made aware through the effective communication that the decision about the research has no implications for their medical interests. Some more challenging situation occurs when the potential participants rightly believe that the medical care is contingent on their agreeing to enroll in the research (6). CONCLUSION The concept of standard of care has prominently figured in the recent controversies over use of placebos in design of the randomized controlled trials conducted in United States and the developing countries as well as the control group selection in critical care RCTs conducted in the United States. The traditional understanding of standard of care to which the physicians are held responsible refers to the typical practice of physicians in professional community. To answer the clinically valuable questions, it is often necessary for the clinical trials to randomize the subjects to interventions that deviate from standard of care in the medical practice. Nevertheless, the control groups that represent standard of care are mostly required to promote clinical value of the randomized trials and also to protect the research subjects. In case of the critical care trials, question whether RCTs should include a control group raises some complex scientific and also ethical issues that call for the careful assessment and judgment (7). In conclusion it is stated that every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subjects or to others. REFERENCES: Solomon R Benatar, Peter A Singer. A new look at international research ethics. BMJ. 2000; Vol. 321, 824-826. David Wendler Et Al. The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs? American Journal of Public Health. 2004; Vol. 94, No. 6, 923-928. Alex John London. The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research. Journal of Medicine and Philosophy. 2000; Vol. 25, No. 4, 379-397. Susan S. Ellenberg, and Robert Temple. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Annals of Internal Medicine. 2000; Vol. 133, No. 6, 464-470. George J. Annas, J.D. Globalized Clinical Trials and Informed Consent. N ENGL J MED. 2009; 360; 20, 2050-2053. Ruth Faden, Nancy Kass. Editorial: HIV Research, Ethics, and the Developing World. American Journal of Public Health. 1998; Vol. 88, No. 4, 548- 550. Franklin G. Miller and Henry J. Silverman. The Ethical Relevance of the Standard of Care in the Design of Clinical Trials. American Journal of Respiratory and Critical Care Medicine. 2004; Vol. 169, 562-564.

Impact of Excessive Government Regulation :: Over-regulated America

  Ã‚  Ã‚  Ã‚  Ã‚  Some believe the government regulates business too much others feel that the government does not do enough. I believe the government is regulating business far too much and furthermore putting businesses out of business and causing many workers to lose jobs. In this paper I will point out the common problems dealing with government regulation. I will also focus on three major aspects of government regulation which include: 1) regulation interferes with production by halting innovation and discouraging risk taking, resulting in declining employment, 2) government over regulates by setting standards for every aspect of manufacture when it could allow businesses to set overall objectives for their business, 3) regulation cost too much in business compliance, which is passed on to the consumer and finally forces the company out of business. The objectives of safety and health will better be achieved in the absence of government regulation. Government regulatory agencies have spent billions of dollars and there is little evidence that the world is any better off than it was without the agencies and costly reforms. When reading further ask yourself the question, does the costs or regulation outweigh the benefits, I believe they do not.   Ã‚  Ã‚  Ã‚  Ã‚  Regulatory programs normally are started by a group of people with a single interest and pressure the government and people to believe that there is a major crisis, creating panic to an alleged problem. When this happens it pressures Congress to pass a reform law in fear of not being reelected. Media groups also aid in creating panic by focusing on the bad and not the possible solutions to fix the problem. What happens is Congress passes a reform that they have little thought over and create costly new standards that could make little difference in the world. A good example of this happened during the adoption of the auto emission standards of 1970. When Congress passed a bill with little debate and few people having any idea on what the bill was about, creating costly reforms and forcing cut backs on business expenses. In all of the cases of 1970 the Congress chose to regulate instead of the alternatives; court penalties for polluters, tax penalties for employers with poor safety records, or government-funded information programs. The health and safety regulators were created in response to a nonexistent crises, therefore it is not surprising they have made little impact.   Ã‚  Ã‚  Ã‚  Ã‚  Sam Peltzman, University of Chicago economist, did a cost-benefit analysis of the drug regulations that followed the thalidomide tragedy in Europe. In his analysis he focused on the Food and Drug Administration (FDA) which is alike the older single-industry regulators and some of its problems are typical

Case Scenario: Big Time Toymaker Essay

1. At what point, if ever, did the parties have a contract? Our textbook defines a contract as â€Å"a promise or a set of promises enforceable by law† (). A contract does not necessarily has to be in writing. A contract can be oral and enforceable. Big Time Toymaker and Chou took part in an oral contract. Big Time Toy Maker and Chou held a meeting where an oral distribution agreement was reached. In addition, Big Time Toy sent an email to Chou confirming the agreement. 2. What facts may weigh in favor of or against Chou in terms of the parties’ objective intent to contract? The facts that may weigh in favor of Chow are the exclusive negotiation rights for a 90-day period, the oral agreement that was reached at the meeting and the email he received from Big Time Toy. The facts against Chou would be that there is never an actual written agreement drafted by Chou. In addition, the exclusive negotiation rights agreement stipulated that no distribution contract existed unless it was in writing. Finally, no written agreement was turned in within the original 90-day period stipulated in the exclusive negotiation right agreement. 3. Does the fact that the parties were communicating by e-mail have any impact on your analysis in Questions 1 and 2 (above)? Yes, because the email represents the acknowledgment by both parties of the distribution agreement made in the meeting despite the e-mail failing to mention the word â€Å"contract.† In addition, the subject line of the email read â€Å"Strat Deal† and it explained in detail the price, time frames, and obligations. Also, as soon as Big Time Toy sent a fax to Chow requesting the draft of the contract, he faxed it to them immediately. 4. What role does the statute of frauds play in this contract? â€Å"The statute of fraud is the law governing which contracts must be in writing  in order to be enforceable† (Melvin, 2010). The role of fraud applies to this scenario. The statute of frauds refers to the requirement that certain kinds of contracts be memorialized in a signed writing with sufficient content to evidence the contract. Traditionally, the statute of frauds requires a signed writing in the following circumstances. A defendant in a statute of frauds case who wishes to use the Statute as a defense must raise it in a timely manner. The burden of proving that a written contract exists only comes into play when a Statute of Frauds defense is raised by the defendant. A defendant who admits the existence of the contract in his pleadings, under oath in a deposition or affidavit, or at trial, may not use the defense under the Uniform Commercial Code (UCC), however under common law they may still use it.

Kate Chopin s The Awakening - 1109 Words

Kate Chopin is the author of the book The Awakening published in 1899. â€Å"Kate was born February 08, 1850 in St. Louis, Missouri and died on August 22, 1904† (Feminist Writers). â€Å"Born as Katherine O’Flaherty and she graduated from the Academy of the Sacred Heart in 1868† (Feminist Writers). â€Å"Kate married Oscar Chopin in 1870 and had five sons and one daughter† (Feminist Writers). â€Å"Kate wrote fictional novels; her most known novel is â€Å"The Awaken† and short stories; her most known short story is called, The Storm† (Feminist Writers). â€Å"Chopin’s fiction details the social and sexual subtleties of the Cajun and Creole culture in which she lived during her childhood and marriage† (Feminist Writers). â€Å"Chopin represents ironic and seven daring treatments of the sexual, racial, and moral underpinnings of polite southern Louisiana society† (Feminist Writers). â€Å"The Awaken has become a re quired reading for any student of the history of women’s cultural oppression† (Feminist Writers). According to Carley Bogard, â€Å"Kate Chopin’s â€Å"The Awakening†, though placed in the highly structured New Orleans Creole Society at the turn of the century, is still the clearest statement of the feminine dilemma that we have† (Bogard, Carley). Looking through the eyes of Carley Bogard, she looks at the The Awakening as â€Å"a refusal to compromise†. She says that, â€Å"I want to argue that Edna’s awakening is a double one. The first is her awareness that she wants autonomy as a human being. At the same time,Show MoreRelatedKate Chopin s The Awakening935 Words   |  4 PagesKate Chopin’s â€Å"The Awakening† can arguably be considered a feminist piece, but regardless of whether it is or not, the short story unmistakably describes how life was for women in the late 1800’s. Her story is a great example of th e sexist views of the time and existing social roles for each gender. The literature includes a large interplay between society and gender roles, which affected the reader’s response to the plot and other literary devices such as imagery back then and even today. ChopinRead MoreKate Chopin s The Awakening1553 Words   |  7 Pagesare evident throughout The Awakening by Kate Chopin. Chopin uses contrasting characters such as Edna Pontellier and Adele Ratignolle to further embody the differing aspects of feminism. Adele Ratignolle represents the ideal woman of the time period, a mindless housewife working to serve her family, whereas Edna signifies an independent and daring woman who does not conform to society’s beliefs. These two women’s differing characteristics and personalities allow Chopin to further compare and contrastRead MoreKate Chopin s The Awakening1497 Words   |  6 PagesEdna Proves that Society Does Not Control Her In Kate Chopin s novella, the awakening, Chopin portrays a story of how the protagonist, Edna Pontellier, undergoes a realization that she has been dumbfounded by the way society assert roles for women. Mrs. Pontellier s awakening stirs up issues in her marriage with her husband. For Mr. Pontellier does not understand why his wife is acting different as someone who does not share the values and duties that society withholds women to. Edna even fallsRead MoreKate Chopin s The Awakening Essay1450 Words   |  6 Pagesâ€Å"The beginning of things, of a world especially, is necessarily vague, tangled, chaotic, and exceedingly disturbing† (Chopin 67). Change: the most frightening word in the English language; it has never came quickly, never came easily, never come without casualties. Throughout history, countless revolutions have fought with blood, sweat, and tears for the acceptance of new ideas to foster change within mainstream culture. Naturally, there is always a resilient resistance to revolution, the norm thatRead MoreKate Chopin s The Awakening1875 Words   |  8 Pageswomen s rights on the grounds of political, social, and economic equality to men.† The Awakening, by Kate Chopin, was written in 1890 during the height of the women s suffrage movement, and essentially the public felt that the author â€Å"went too far† due to â€Å"the sensuality† of the protagonist (Toth 1). The â€Å"male gatekeepers† that scrutinized her work saw her piece as a statement that â€Å"the husband is a drag†, and that traditional American values should be forgotten (Toth 1). In truth, Chopin did notRead MoreKate Chopin s The Awakening2531 Words   |  11 PagesDress to Impress Kate Chopin’s novel, The Awakening depicts sexual affairs, inner struggles, and the conquest of motherhood that most women face today. The conquest of motherhood involves the battle between being a supportive wife and selfless mother. The story revolves around the characters’ dialogue and appearances described beautifully throughout the novel by Kate Chopin. The story is a familiar one that, sadly, most women can relate to: A woman is married without knowing what true love is. HerRead MoreKate Chopin s The Awakening1685 Words   |  7 Pagesconforms, the inward life which questions† (Chopin 18). The Victorian Era created a clear distinguishment between male and female roles in society, where women were expected to behave feminine-like, be responsible for domestic duties and have little involvement in society. This created a heavy oppression upon females and as a result forced many of them to remain entrapped in a male dominant society, in fear of being outcasted . In the novel The Awakening, Kate Chopin depicts how Edna’s defiance of VictorianRead MoreKate Chopin s The Awakening1981 Words   |  8 Pagesthe 1800s The Awakening by Kate Chopin published in 1899 is a novel that can teach the true meaning of family, the importance of friendship, and the value of independence. Chopin teaches the true meaning of family by showing how Edna receives no support from her own family and struggles to succeed without them. Chopin shows the importance of friendship when Edna has no one by her side until she meets a woman named Adele and a man named Robert. The primary area that Chopin focuses on is the satisfactionRead MoreKate Chopin s The Awakening1198 Words   |  5 Pageswoman’s freedom is the driving force behind Kate Chopin’s contextual objections to propriety. In particular, The Awakening and â€Å"The Story of an Hour† explore the lives of women seeking marital liberation and individuality. Mrs. Chopin, who was raised in a matriarchal household, expresses her opposition to the nineteenth century patriarchal society while using her personal experiences to exemplify her fe minist views. Katherine O’Flaherty, later Kate Chopin, was born to Eliza and Thomas O’FlahertyRead MoreKate Chopin s The Awakening1870 Words   |  8 Pagessymbolizes the Marxist cause. A multitude books throughout history and the current day are representing the groundbreaking thoughts of Marxism, and they help to demonstrate how vile Capitalism truly is. In Kate Chopin’s The Awakening there lie countless subtleties of Marxism and its standards. Chopin skillfully injects the ideals into the novel through characters’ actions and behaviors. Three characters in particular represent the evils of Capitalism in the teachings of Marxist, and those characters