Bio-Ethic

Bio-Ethic

1. Define moral relativism and consider the role of biomedical ethics in a relative understanding of ethics and morals. If needed, provide a viable alternative to moral relativism.

Moral relativism is the view that moral judgments are true or false only relative to some particular standpoint (for instance, that of a culture or a historical period) and that no viewpoint is uniquely privileged over all others (Internet Encyclopedia of Philosophy, 2020). In a very biased society, we as humans tend to make many judgments on what we think is morally correct. From all different ages, from college campuses to downtown riots, it can be determined that there is no one standpoint is superior overall; otherwise, there would have been a resolution by then. Even though some people know they are incorrect, they will refuse and say moral relativism is dead, so the alternative would be divertentism. Divergent is the idea that as individuals grow out into the universe, they diverge from each other in thought-space. If you are a divergentist, you believe that as you age, the average answer to the fundamental Verizon question slowly drifts from yes, to no, to silence (Rao, 2015)

2. Considering the Yellow Fever case, describe the ethical, social, economic, and legal implications of this research example and its representativity for the state of research ethics at the beginning of the 21^st

The Yellow Fever Case in 1900 was composed of Major Walter Reed and a group of American doctors who conducted human experiments by exposing test subjects to the disease. His motive for doing this was to find more information on the illness. Although human experimentation is seen to be very morally unethical, the subjects were volunteers. These volunteers, however, knew they were a risk of performing in the experiments, but they saw there were compensation and rewards (Sager, 2020). This case, as seen today, shows that there has been an evolution of research design, and the perspective of medical treatment has changed drastically. Because of the growing medical research at the time, Kezia DePelchin, a nurse during the 1870s, describes Yellow Fever experiments as “economic growth” (Sager, 2020). “Indeed, as Susan E. Lederer has shown, participation in an experiment can resemble the exercise of politics, where participants can resist and negotiate the terms set upon them. Medical ethicists are becoming more cognizant of the political dimension—as exemplified by a vast literature and growing guidelines about the recruitment of patients into experiments, the significance of payments and monetary inducements, and requirements for providing and accepting informed consent (Mehra, 2009)

3. After reading the 2011 Presidential Commission statement “Ethically Impossible: STD Research in Guatemala from ’46-’48”, identify the arguments used to characterize this episode and frame it within the Research Ethics field after the 2^nd World War.

Starting in 1946, the U.S. Military was looking for new ways to prevent STDs such as gonorrhea, chancroid, and syphilis. The NIH funded this research study that was conducted on 5000 unconsented Guatemalans (Rodriguez, 2013). Guatemalans reported that “the investigation was immoral and constituted a crime against humanity.” They believe the American government has violated the “international human rights authorities and ethical principles such as United Nations Declaration of Universal Human Rights, the Interamerican Declaration on the Rights and Responsibilities of Man, the Rights of Man in the Charter of the Organization of American States, the 1978 Belmont report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the Declaration of Helsinki”. The subjects were not informed of the study, and they also did not consent. The clearest defensive argument in their case could be that they were trying to do what was good, and that was to treat the patients of their diseases as quickly as possible without all of the legal documentation and records.

4. Using the example of the zoological garden employed by Sir Francis Galton in “Eugenics: Its Definition, Scope, and Aims,” analyze and critique the analogy, and considering contemporaneous science determine how far should society go when choosing its best specimens.

As defined by Galton, eugenics is “well-born, of good stock, of a noble race” (Galton, 2020). Eugenics can also be seen as an “unnatural selection”; to an extent. We can control/enhance natural selection to bring out what a perfect individual looks like. Galton does a great jog using animals in the zoological gardens as an analogy to humans in the real world. He explains that no animals want to be sick and live at the bottom. He also goes on about the unfairness of different species and how they are the prey or the predator. There is an unevenness of a fair source of nutrition. Galton compares fish and birds to some humans by saying they would all protest the idea of eugenics because “society would be very dull” if everybody was at the top of their class.

Instead, we should all work through natural selection and work out our civilization on our own.

5. Define the concept of human enhancement and provide concrete instances of both acceptable and unacceptable human enhancements.

Human enhancement is the concept of applying science and technologies to expand cognitive and physical human capacities. Human enhancements have been abused in the past and present, mainly in sports. For example, doping has been a huge issue across the world in events like the Olympics. This is not approvable because the athletes are using unnatural behavior to perform better.

People with disabilities or those who are physically impaired will need enhancements to combat those disabilities. Human enhancements have also been improving and increasing in growth so much that we don’t even notice it. Everyday accessories like contacts, glasses, braces, medication, and prosthetics are all human enhancements, but these do not seem to be an issue in society (Whitman, 2018)). The line where human enhancements become unacceptable is when the enhancement is not used for the subject to survive or function as a normal being; normal being meaning someone healthy and not impaired by any means.

6. Please describe the elements of vulnerability in the example of using children as research subjects and propose measures to overcome them.

Research on orphans and vulnerable children (OVC) can be dated back to the 18^th century by Edward Jenner. He experimented with smallpox immunizations on 49 children, including his son (Ethics Guide Book, 2019). One of the main reasons why there has been so much research on OVCs is because although consent and assent are still required, there is minimal risk. Also, the “minimal risk procedures” are safer and easier to go about than “more than minimal risk procedures.” However, there have been many ongoing debates about whether we should continue to research OVCs because it could psychologically or sociologically affect their developmental childhood.”

The Highly Vulnerable Children Research Center of Tulane University defines highly vulnerable children (HVC) as “those children under age 18 whose safety, well-being, or development is at significant risk due to inadequate care, protection or access to essential services. HVC include those who are orphaned; receive inadequate adult support because of death, abandonment, economic distress, or chronic illness; have HIV/AIDS or are suspected of having HIV; are directly affected by armed conflict; live outside of family care, or in some other way have suffered from a collapse of traditional social safety nets in their communities” which can explain why there would be so many of these children wanting to volunteer in the experiments because there is compensation to those who follow throughout these experiments

7. Starting from the principle of Respect for Persons, present the differences between Research Informed Consent and Therapeutic Informed Consent and also between broad consent and dynamic consent. Also, identify one correct use for each of these concepts.

The principle of “Respect for Persons” is one of the principles of basic ethics in practice and research in which there are “two ethical convictions: (1) individuals should be treated as autonomous agents- morally required the acknowledgment of autonomy and (2) diminished autonomy persons- entitled to protection- morally require protection”. “Respect for a person requires that subjects, to the degree, that they are capable be allowed to choose what shall or shall not happen to them.” Research Informed Consent requires several pages of elements and criteria that the FDA covers, and Therapeutic Informed Consent can typically be just a one-page general document. Also, hospitals and the IRB have to approve specific information in a Research Informed Consent document whereas a Therapeutic Informed Consent may have a different consent process, (Sas, 2013)

8. In “Principles of Biomedical Ethics,” the three Theories of Justice that were discussed by Beauchamp and Childress were the Utilitarian Theories of Justice, Egalitarian Theories of Justice, and Libertarian Theories of Justice.

Under utilitarian theories, an ideal distribution of benefits would be one that produces the most overall happiness. “Whatever does the greatest overall goodwill be ‘just.'” Egalitarian theories of justice hold that all persons should receive an equal distribution of goods. This could be known as John Rawls’s “justice as fairness.” Rawls believes that the principles would be chosen by a person who is unaware of their characteristics, and those persons would agree on these principles: “First: each person is to have an equal right to the most extensive basic liberty compatible with a similar liberty for others. Second: social and economic inequalities are to be arranged so that they are both (a) reasonably expected to be to everyone’s advantage, and (b) attached to positions and offices open to all.” Lastly, libertarian theories of justice tend to focus on “the unrestrained operation of fair procedures.” He argues that the justice of any distribution of an individual does not depend on how much of the good they have but instead how that distribution came about. In terms of risks and benefits in research, the only clear and just theory of justice that can be used to efficiently distribute them are the Libertarian Theories of Justice. In support of that claim, it gives all people the same treatment and avoids any bias or prejudice. Although egalitarianism is correlated to communism, it is the only theory that primarily focuses only on people’s equality and fairness.

9. Please identify and analyze three Theories of Justice, as used by Beauchamp and Childress in “Principles of Biomedical Ethics,” and determine which of them could be used for an efficient distribution of risks and benefits in research.

In “Principles of Biomedical Ethics,” the three Theories of Justice that were discussed by Beauchamp and Childress were the Utilitarian Theories of Justice, Egalitarian Theories of Justice, and Libertarian Theories of Justice. Under utilitarian theories, an ideal distribution of benefits would be one that produces the most overall happiness. “Whatever does the greatest overall goodwill be ‘just.'” Egalitarian theories of justice hold that all persons should receive an equal distribution of goods. This could be known as John Rawls’s “justice as fairness.” Rawls believes that the principles would be chosen by the person who is unaware of their characteristics, and those persons would agree on these principles: “First: each person is to have an equal right to the most extensive basic liberty compatible with a similar liberty for others. Second: social and economic inequalities are to be arranged so that they are both (a) reasonably expected to be to everyone’s advantage, and (b) attached to positions and offices open to all.” Lastly, libertarian theories of justice tend to focus on “the unrestrained operation of fair procedures” (The Principles of Biomedical Ethics). He argues that the justice of any distribution of an individual does not depend on how much of the good they have but instead how that distribution came about. In terms of risks and benefits in research, the only clear and just theory of justice that can be used to efficiently distribute them are the Libertarian Theories of Justice. In support of that claim, it gives all people the same treatment and avoids any bias or prejudice. Although egalitarianism is correlated to communism, it is the only theory that primarily focuses only on people’s equality and fairness.

10. Using the example of Tarasoff v. Board of Regents from 1974, elaborate on the principles of Privacy and Confidentiality and an optimum application in research of the mentioned elements.

One issue that may arise in international research is the duty to receive consent. When experimenting with a foreign country, there are many difficulties in communicating with indigenous or native citizens (Grady). The researchers may receive verbal and written consent, but the question is that are the subjects aware of what the real risks and benefits are. Because most experiments are done in third-world or developing countries, the subjects may only look at the benefits due to the sickness or diseases to which they obtain. For example, let’s consider the Guatemala STD study. The NIH and U.S. military were looking for new ways to prevent STDs by using unconsented Guatemalans. Out of the 1500 subjects, there were 83 deaths, none of which we’re aware of the consequences of what may occur. As also explained by the Emanuel, Wendler, Killen, and Grady, the three controversies of researching in developing countries are: “(1) the standard of care that should be used in research in developing countries; (2) the “reasonable availability” of interventions that are proven to be useful during research trials; and (3) the quality of informed consent” (Emanuel). For obvious reasons, those who participate in international research projects should get some sort of compensation, and whatever the researchers have done damage must be fixed or resolved by the researchers or the company for which they work for.

11. Please describe the ethical difficulties of international research. How would you reconcile the various ethical visions in an international research project? Please make use of the paper, “What makes clinical research in developing countries ethical? The benchmarks of ethical research,” written by Emanuel EJ, Wendler D, Killen J, and Grady C.

One issue that may arise in international research is the duty to receive consent. When experimenting with a foreign country, there are many difficulties in communicating with indigenous or native citizens (Grady). The researchers may receive verbal and written consent, but the question is that are the subjects aware of what the real risks and benefits are. Because most experiments are done in third-world or developing countries, the subjects may only look at the benefits due to the sickness or diseases to which they obtain. For example, let’s consider the Guatemala STD study. The NIH and U.S. military were looking for new ways to prevent STDs by using unconsented Guatemalans. Out of the 1500 subjects, there were 83 deaths, none of which we’re aware of the consequences of what may occur. As also explained by the Emanuel, Wendler, Killen, and Grady, the three controversies of researching in developing countries are: “(1) the standard of care that should be used in research in developing countries; (2) the “reasonable availability” of interventions that are proven to be useful during research trials; and (3) the quality of informed consent” (Emanuel). For obvious reasons, those who participate in international research projects should get some sort of compensation, and whatever the researchers have done damage must be fixed or resolved by the researchers or the company for which they work for.

12. Present elaborated arguments to sustain and oppose the use of animals in research.

The use of animals in research has been around for over 2000 years, and the data we humans have gathered from those experiments have only improved ever since. First, the main purpose of why we use animals for research purposes is to protect the human race from self-inflicted harm. It is to our advantage to use utilize natural selection to experiment on animals to discover life-saving cures and treatments rather than to sacrifice our own lives (ProCon.org, 2020). Animals such as primates, rabbits, and mice are similar enough in biological structure to where the medications used on them could also be used on humans. Because mice and rabbits reproduce so fast and very inexpensive, it is very easy to conduct trials and errors on such subjects as humans.

On the other hand, it may seem very cruel and inhumane to harm such natural life when no particular has been done on us. All animals have a thought process and can feel pain, so forcing drugs into their system would almost be equally as inhumane as doing it to a human. An estimated 25 million or more animals, including rats, mice, and birds, are used yearly in the U.S. in all areas of research, testing, and education. Due to evolving technology, we can use human cells and create artificial cells to conduct experiments on. The benefits of research on different animals would not be 100% correlated and similar to the benefits of humans; for example, the cure for breast cancer on a mouse, may not mean that it could cure breast cancer on a human.

13. Present a short historical overview of the research with human stem cells in the U.S., mentioning the crucial events in the field, both scientific and regulatory.

Research with human stem cells in the U.S. has only been a recent addition to scientific inquiry. At first, the U.S. government refused to support and fund stem cell research in 1974. “Scientists discovered ways to derive embryonic stem cells from early mouse embryos more than 30 years ago, in 1981. The detailed study of the biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. The cells were called human embryonic stem cells, which were used for reproductive purposes in fertilization procedures. In 2001, President Bush had addressed the nation that bioethics was a national priority, so he permitted the NIH funds for research. In 2006, a new type of human stem cell was created: induced pluripotent stem cells, which “specialized adult cells to be ‘reprogrammed’ genetically to assume a stem cell-like state” (Kington,2016). With the discovery of technology to create human stem cells, this allows us to treat diseases and illnesses. This also allows us to experiment with new drugs without the harmful effects on mindful living beings. In 2009, President Obama issued an order that would support and conduct stem cell research. In response to this issue, the NIH issued new and revised guidelines of federal funding towards stem cell research.

14. Debate the moral status of the embryo. Identify ethical arguments for and against the use of human embryos in research.

In 1996, a ban of funds for human embryonic research was signed into law; however, four years later, the ban was partially reversed when the NIH announced that they would fund certain embryotic research (Human Embryo Research, 2020). According to the past addition and subtraction of funds, there must be reasons why these funds have supported and unsupported. Most who are against the use of human embryos in research would apply the transitive property; as Peter Singer said, every human being has a right to life, and a human embryo is a human being. Therefore the embryo has a right to life. The work that builds up to obtain an embryo may be costly, so if there mistakes where an embryo is completely unused and goes to waste, then all of the work that went out to receive that embryo has gone to waste. Also, “the early embryo has no brain, no nervous system. It is reasonable to assume that, so far as its mental life goes, it has no more awareness than lettuce” (Howard). What is morally unethical of manipulating a mindless multicellular organism at its earliest development stage? Torture- the infliction of intense pain, Suffer- to endure death, pain, or distress, both of which are associated with sensation and perception, and an embryo has neither so what another harm is done to an embryo?

15. After defining Biobanks and Virtual Biorepositories, briefly point out the ethical challenges of storing and using stored human tissue in research.

Biobanks, in general, are biorepositories that store genetic material. The “genetic material” they store can be blood, whole blood, RBC, white cells, buccal swab, DNA, RNA, protein, cell lines, marrow, plasma, serum, fluid, urine, stem cells, and solid tissue such as tumor and biopsy materials. The samples’ original owner’s health information is provided on those samples (“Biobanking”). The samples are typically kept for the future to observe human development and also because research on such samples can take an abundance of time (Jones, 2020). Virtual biorepositories are inter-connected biobanks with independent storage and access that have centralized access under one large domain. They are globalized, and the purpose of them is the need to provide easy, fast, convenient access to relevant samples for research. There is a risk of donating human tissue to research because you may not always know what will happen to that tissue. When someone has passed away or died of an accident, they may use their organs for research, although it is technically morally unacceptable because there wasn’t consent given. It is also very easy to falsify data such as characteristics, health, and ancestry. Only so much can be done with donated human tissue. Tt’s a risk making generalizations towards the sample because of possible falsification of data.

16. Starting from the case of Association for Molecular Pathology v. Myriad Genetics, ascertain the economic aspects of research and explain why these are relevant to the field of Research Ethics.

Economic aspects such as patenting are very relevant to the field of research ethics because let’s use the case of Association for Molecular Pathology v. Myriad Genetics, for example. The Association for Molecular Pathology and many other doctors and researchers challenged the United States Patent and Trademark Office and Myriad Genetics that they should be able to place patients on breast cancer-related genes to allow diagnostic screenings for the genes(Oyez, 2020). The patent companies argued, but the patent prevailed. Because of this case, the cost for screening the two breast cancer genes, BRCA1 and BRCA2 are $3,000. There have been many other lawsuits and acts that involved patents and biomedical research such as Diamond v. Chakrabarty and the Federal Technology Act. The purpose of patents is to avoid other businesses and companies from making money off a drug or cure that you invented/discovered. It may not sound like it, but research is a business, and many different companies are working to find a discovery or a cure to something first. When that company finds it first, a patent must be placed on that discovery because if it not, someone else may find it and patent it themselves, which would make all of your work go to waste because you would have no shares in it. The failures of taking economic aspects in research ethics may cost your job or your business.

17. Elaborate on the elements of Scientific Misconduct making use of the Legal and Ethical documents provided in the syllabus.

Misconduct in science means fabrication, falsification, and plagiarism or other practices that are commonly unaccepted within the scientific community for proposing, conducting, or reporting research according to U.S. Public Health Service in 1989 (Bauchner, 2018). Falsification is manipulating research materials or changing or omitting data so that the research is not accurately represented. Fabrication is making up data and reporting them. Plagiarism is the allocation of another person’s ideas without giving appropriate credit . Scientific misconduct has unfortunately been quite common in past research. One case for example, the South Korea stem cell scandal involved Hwang Woo-Suk who was suspiciously receiving oocytes for research in return for cash, incentives, promotions, and admissions to international universities. In another case, David Anderson of University of Oregon was found to have falsified and fabricated data in 4 neuroscience publications from 2011-2013. He then entered into a Voluntary Settlement Agreement and has voluntarily agreed for three years. This involved his research to be supervised, affected his applications to other institutions, and forced him to assist publishers of the need to correct papers. In another case, Dr. Jon from Oslo fabricated and falsified data of the effects of lesion ploidy upon patients. He lied about the number of patients who were involved in the study. He had 15 of his paper retracted. Now, he is permanently excluded from contracting or subcontracting with any agency of the U.S. government. He is also permanently excluded from serving any advisory capacity to Public Health Service. Scientific misconduct is very important to biomedical research and should always be taken into consideration. Losing your job or being responsible for the deaths of many people may result in scientific misconduct.

18. Choose and present an example of Conflict of Interest in biomedical research and identify the ethical implications of this concept.

One conflict of interest in biomedical research is an occupation’s salary. An employer may say that their salary has no effect on how they work, but most people don’t even notice it. For higher-paid occupations such as physicians, it is sort of difficult to perform differently, especially when their main task is to take care of a patient. Still, for other occupations such as custodians, waiters, or teachers, your pay may contribute to your level of happiness, which may then affect your level of care towards your job. Working dependently or independently can also correlate with your salary and work ethic; for example, if you work for someone else, you may tend to work less as hard, but if you work for yourself, since there are larger risks involved, you would tend to work harder and more carefully (Klein et al., 2016).

19. After following the course on The Ethics of Biomedical Science Research, propose and present one topic, case, notion, or concept that sparked your interest and provide analysis from the existing literature. Also, bring your own opinion and conceptualization of the identified subject.

One topic that sparked my interest was the one on whether we should use animals in research. It was sort of correlated to the idea of human exceptionalism. Because humans are the most intelligent beings on Earth and possibly the universe, what/who gives us the right that we shouldn’t be able to use animals in research. The document states, “Design animal experiments only if necessary and meaningful. Show proper care and compassion and minimize pain and suffering during the experiments” (Shah, 2011). Humans outside of the research realm have never really thought about what is done in labs for biomedical research. It is almost like that thought that never comes up when you are eating meat: how were the animals treated before they became someone’s meal. It wasn’t just animals in biomedical science research that sparked my thought, but also some other related topics discussed in the lecture; for example, is owning a pet morally unethical as conducting biological research on animals. Humans have very different opinions about animals. Some are pet lovers but are completely against the idea of animal research. I can understand there is a difference, but morally, it has similarities. Both involve the captivity of an animal who is basically under your demand, so we should all be able to hold animals as pets, we should be able to conduct biomedical research on animals.

References

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