Informed Consent In Medical Research

Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles

Due to the lack of money but the high demand of need of specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren’t treated unjustly (following an appropriate standard of justice), the subjects weren’t coerced (in terms of any plausible interpretation of the word), and the subjects weren’t being exploited (if they themselves gain access to the treatment after the study).

The art of medicine and curing diseases was not always approached in a scientific way. In fact, many advances occurred between 1919 to 1939, after technological advances allowed scientists to apply the scientific method to medical research. At this time, the ethics of using patients as test subjects either for new medicines or as samples for further testing were not considered. An extreme example of this was the Nazi’s using concentration camp inmates – including children – to run painful and invasive experiments. More modern examples are not so easy to identify as unethical, however. While amputating a leg to develop methods to deal with fractures and war wounds is obviously unethical, harvesting cells to develop a vaccine is not so clear cut, as the disadvantage to the patient is hard to identify. Coming from the various Nazi testing and especially the Nuremberg testing and trials, another code of ethics was developed, called the Nuremberg Code.

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

The Doctor and Patient relationship aspect of Medicine has changed drastically in the last twenty years. It has evolved from paternalism (the doctor makes the decision for the patient) to shared decision making where the patient is considered an equal partner in his/her own health related decisions. Informed consent is the cornerstone for this view. When a patient or a research subject makes an autonomous decision after understanding, the risks and benefits involved with the decision is Informed consent. Complete Informed consent covers the following components: competency, disclosure, comprehension and voluntary. Competency refers to the requirement for the individual to be of legal age and be mentally competent to understand the process.

The concept of informed consent that we have today did not exist in the 1950s when Henrietta’s cells were obtained. Patients were regularly used in research without their knowledge. Nevertheless, some doctors had unethical standards. Dr. Chester Southam, a credible researcher of cancer, developed a theory that “the cancer was caused by either a virus or an immune system deficiency” (Skloot 128) and the bodies of patients’ who had suffered with cancer in the past would reject the HeLa cells. He tested the patients and “he said nothing about injecting them with someone else’s malignant cells” (Skloot 128). Southam believed that revealing details to patients would create a “phobia and ignorance” (Skloot 130) in their mind. He injected “more than six hundred people for his research, about half of them cancer patients” (Skloot 129), telling them “he was testing their immune systems” (Skloot 128). Southam expanded with his experiments on testing

Additionally human medical research studies often targeted those who came to public teaching institutions desperately seeking free medical treatment and who generally looked up to doctors and experimenters as experts in the field who were there to help them. While this motivation may seem logical, it is often faulty as many human medical research studies throughout history demonstrate that the motivation of medical researches is often not the care of those currently suffering from a particular condition but the future returns on the cures or medical treatments that may be discovered during the study (McKie). As with many such unethical studies, the participants often do not give consent and are not informed of known dangers to the procedure, medications or lack of treatment. The use of individuals who are poor, uneducated, and lack medical insurance in combination with prestigious university research institutions and the white coated, well-educated researchers motivated by discoveries of cures on the scientific frontier results in abuses of individuals.

“Taking the Least of You” by Rebecca Skloot was about the medical ethics of whether it is okay to test tissues excised from patients and use them for tests that the patients are unaware of. These tests can lead to the researchers making money off the tissues and blood samples. Skloot interviewed Doctor Anna O’Connell who talk to her about a test subject named Ted Salvin. Ted Salvin was one patient that gave full consent for medical researchers to test his blood for hepatitis and other diseases to make advancements of their data. Without this research there wouldn’t be vaccines for epidemics or genetic disorders or cancers. Anna O’Connell agreed that researchers should make sure patients had given full consent before any tests were done on the samples taken.

During the Saturday Academy, the group presentations on the book, The Immortal Life of Henrietta Lacks, and the films—Hózhó Life in Balance and The Greater Middle East— taught me very informative and useful tips for becoming the best healthcare provider. The group presentations represented the idea that there should be consent when doing further research on their patient. With consent the patient is able to build that trust connection with their physicians. Without consent the patient is not able to open and loses the lack of trust for their physicians. As a result, with the lack of trust between the patient and the physician, the physician is not able to help out their patients in a way that would benefit them because they are too afraid that

Hermann, Donald H.J. Lessons Taught by Miss Evers' Boys: The Inadequacy of Benevolence and the Need for Legal Protection of Human Subjects in Medical Research, 15 J.L. & Health 147 (2000-2001). Retrieved January 20, 2016, from http://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1180&context=jlh

Potential grave consequences that can result from irresponsible, or criminal, medical experiments. While we must be vigilant to protect innocent victims from such experimentation we cannot let that stifle our duty to continue making advances in healthcare and improving the lives of patients.

The Johns Hopkins Hospital has been considered the top medical center in the United States for over 21 years, however, it has had its fair share of unethical treatments and trials along the way to finding great success. Each study, whether ethical or unethical, concluded in the answers that needed to be found to help solve many epidemics. For example, Henrietta Lacks’s cells were taken in hopes to find a cure for cancer. In the end her cells have contributed to solving many questions concerning the human body and took part in the creation of the polio vaccine that saved millions of lives. Fortunately, the Johns Hopkins Hospital now tries their ultimate best to provide the finest patient care providing consent forms with complete descriptions before any type of operation or research is taken place.

The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient’s life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view.

Over the course of one hundred years, medicine has changed astronomically. We have taken steps to discover cures for fatal diseases and innovate new technologies that would change the way we heal patients. Compared to the 19th century, where most medicine was just being discovered, the 20th century had more regulations as well as new experimentations, including self-experimentation, because of information learned through the Medical Revolution that was challenged by moral issues. Before the William Osler’s code of ethics was put into place, physicians weren’t regulated so they did what they wanted regarding medicine.

In the past, there have been many cases of doctors mistreating and using patients as unknowing participants in their research. For example, Henrietta Lack was treated in the public ward of John Hopkins Hospital, where she underwent a procedure to