Healthy Paid Research: An Ethical Debate

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

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

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

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.

The example of unethical or questionable science behavior I have decided to discuss involves informed consent. An article written in the Journal of Advanced Pharmaceutical Technology & Research describes informed consent as the process by which individuals are advised of the different facets of research, including risks, that they will be participating in that allows them to make a voluntary and informed decision as to their willingness to engage in the procedure.

Clinical Trial Participation In the popular television drama, Grey’s Anatomy, the main stars conducted a series of clinical trials that introduced Seattle into a new form of research. After their trial called the “Shepard Method” grew into a success, the program's audience became aware of clinical trials in reality. In the previous years, clinical trials have evolved and made a big impact on society. However, there is controversy about whether or not one should take part in clinical trials.

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.

Research groups that utilize clinical trials for the “Research that includes treatment of an individual must obtain the patients authorization to disclose any protected heath information to all health care providers other than those involved in the direct care of the patient” (Axia College, 2007). For example, Jan participates in a clinical trial at CEDRA Clinical Research for the study of a new pain medication sponsored by ABC Labs. After the trial, Jan sees her primary care physician in regards to ongoing headaches. Jan informs her doctor that she participated in a clinical study but stated that the medicine give did not contain this side effect, the next day, her physician called CEDRA to obtain information regarding the treatment and information on the outcome of the patient’s results. CEDRA advised the doctor that that patient did not provide authorization to release any information to other healthcare providers other than those involved in the clinical trial. According to

“Guinea pigging initially entered the mainstream American vocabulary in January 2008, when an article by that name was distributed in New Yorker Magazine. Guinea pigging alludes to healthy people (overwhelmingly poor, occasionally understudies) who partake in clinical medication trials for pay (Weitz, 2013).” Before, most members in medication trials were either therapeutic understudies or workers who at any rate mentally comprehended the risks they faced or persons battling with ailments who may profit by the medications they tried. In the course of recent years, be that as it may, as medication testing and improvement have exploded and have to a great extent moved from charitable to revenue driven operations, the need to rapidly discover expansive quantities of exploration subjects has prompted the boundless utilization of exploration subjects has steered towards the prevalent use of healthy subjects for pay in timely trials of medication.

Site Management Organizations (SMO) are guided by the ethical principles applied to all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). These principles are defined in the Belmont Report (Appendix A) as follows:

Another question we come across in this case is "Should these pharmaceutical companies have a moral obligation to make the drugs available to the people who they performed clinical trials on?". Again we clearly should see that the pharmaceutical companies should allow the access of these drugs to the people that are being used to test their products. There is a huge risk for these people who are taking a new drug, not knowing exactly what the outcome can be and are merely treated as guinea pigs for the

Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the high dollar amounts they receive for compensation. People that frequently enroll in drug trials are often called “guinea pigs.” The monetary amount people are paid can go as high seventy-five hundred dollars. The more invasive the procedure is the higher the compensation. These “Guinea pigs” are required to pay taxes on the money they do make. (Elliott, 2008)

Undue inducement in human subject scientific research occurs when scientists offer an incentive that incites participants to enter a study that poses significant risks which they otherwise would not participate in, or when participants could be recruited for less compensation. The main concern about undue inducement is that its coercive influence may distort the test subjects’ judgment, compromise their voluntariness, or impair their ability to give informed consent. Without informed consent, the researchers are no longer respecting the partakers’ autonomy, the research then cannot be deemed as ethical. Three monetary payment models were proposed to mitigate the potential risks of undue influence: the market model, the reimbursement model, and the wage-payment model. Using the principlist approach, I will argue that while it is ethical to pay research subjects for their participation in a study, undue inducement is still an existing issue, and the wage-payment model is the most morally permissible model for this case.

The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see