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The Meaning Of Informed Consent

Questions posed by Paul Basch are very thought provoking. Some of these questions require a lot of consideration and research. Taking this course has helped me answer them to the best of my knowledge and provided me with a different perspective of global health. I would have responded to these questions the same before taking this course but my concepts have become stronger. Following are my responses to 5 questions. 3. When are we justified in conducting drug or vaccine trials in developing countries? We can conduct drug or vaccine trial in developing countries as long as it is ethical.

The standard of care for these trials should be same as for developed countries. The quality of informed consent is very important. “A cautious approach is appropriate in the conduct of vaccine trials among children in any circumstances because of their particular vulnerability in view of their inability to give informed consent and their sometimes greater potential to adverse reaction to vaccines”(WHO,2002). People in developing countries are more susceptible to unethical practices as they are caught in the poverty, and high disease burden.

Increased vigilance is necessary while conducting trials in these countries so that these vulnerable people are not taken advantage of. We need to make sure when these trials are conducted based on existing ethical guidelines. 6. Do the richer countries have any moral obligation toward the less developed ones? If so, what are the limits? “According to the World Bank, over 1 billion people—at least one quarter of the world’s population—live in poverty. Over half of these people live in South Asia; most of the remainder in sub-Saharan Africa and East Asia” (Andre & Velasquez. 2015).

The contrast between the lifestyles of people living in these countries and access to health care is very severe. “In the poor nations of South Asia, the mortality rate among children under the age of 5 is more than 170 deaths per thousand, while in Sweden it is fewer than 10. In sub-Saharan Africa, life expectancy is 50 years, while in Japan it is 80” (Andre & Velasquez. , 2015). For these reasons people living in rich countries should have a moral obligation to aid those in poor countries till they become self-sustainable.

As can be seen many people in poor counties are fighting hunger and diseases and are dying every day. Some financial aid to these countries can help in preventing suffering and death from starvation. I think the aid should also help the developing countries to enhance their economy and help them become self-sustaining. Once, these countries come out of their poverty trap than the aid could be reduced and redirected towards the more needy areas. 15. What is the meaning of informed consent of an illiterate person? Informed consent means the person giving the consent has complete understanding of the procedure.

The person also understands the risks and benefits of the procedures. “Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding”(USFDA, 2016). For an illiterate person it is very important to be able to demonstrate competency and be able to indicate acknowledgement or disapproval by other means when consistent with applicable state laws.

If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study.

An impartial third party should witness the entire consent process and sign the consent document” (USFDA, 2016). 17. Are we justified in altering people’s customs and traditions when we know that they are not conducive to improved health? “Culture is defined as the shared traditions, beliefs, customs, history, folklore, and institutions of a group of people. Culture is shared by people of the same ethnicity, language, nationality, or religion. It’s a system of rules that are the base of what we are and affect how we express ourselves as part of a group and as individuals” (CTB, 2016).

It is important for public health professionals and all medical professionals to understand the cultural competence. This will help in understanding different behaviors, attitudes, of a particular culture and help develop policies which work better in cross-cultural settings. People must show respect and compassion for people from a different culture. Medical professionals need to learn and understand the behaviors that are consistent with cultural competence. “There is an ethic to culturally competent practice.

When professionals practice in a culturally competent way, programs that appropriately serve people of diverse cultures can be developed” (Cultural competency and diversity, 2013). A perfect example of this case is the book “The Spirit Catches You and You Fall Down”, by Anne Fadiman. This book is a story of a Hmong girl (Lia) with epilepsy and the battle between the Hmong community and the Western-trained medical personnel over how to treat her. The doctor’s did not have any understanding of her culture or language and her parent’s had no faith in the doctor’s.

The western system kept focusing on her biological symptoms failing to educate her parents about the importance of medicine and her parents were non-compliant with her western treatment as they believed that the disease was primarily spiritual. Because of misunderstanding mutual distrust and hostility developed which lead to Lia becoming brain dead (Fadiman, 2012). I think cultural competency courses for professionals will help them develop characters of warmth, empathy and compassion towards other cultures and they can understand their customs better.

Based on these values it will help them educate the patients as they will be more congruent with cultural competence. This in turn will help the patients being more compliant with the treatment and can help patient’s modify their behavior to improve their health. 18. How much corruption should we tolerate? Corruption is multifaceted phenomenon. “Its roots lie deep in bureaucratic and political institutions, and its effect on development varies with country conditions.

But while costs may vary and systemic corruption may coexist with strong economic performance, experience suggests that corruption is bad for development” (The World Bank, 1997). Corruption can be very complex and can cause deleterious effect on the country. “The causes of corruption are always contextual, rooted in a country’s policies, bureaucratic traditions, political development, and social history. Still, corruption tends to flourish when institutions are weak and government policies generate economic rents” (The World Bank, 1997).

I personally think corruption is so deep rooted in developing countries that it is very difficult to control. Another reason for corruption to flourish is that people are not getting paid adequate salaries and are not getting annual raises. Corruption seems to be prominent when the government institutions are themselves corrupt. “The motivation to remain honest may be further weakened if senior officials and political leaders use public office for private gain or if those who resist corruption lack protection.

Or the public service may have long been dominated by patron-client relationships, in which the sharing of bribes and favors has become entrenched” (The World Bank, 1997). I think corruption should not be tolerated at all and policies need to be formulated where there would be severe consequences for people encouraging corruption. If a senior person is corrupt it might be demoralizing for the staff to see that people can lose their jobs if they try to report their senior officials.

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