Conflict between Medical Research and Ethics
The importance of medical research cannot be undermined. It is because of continuous research that science has brought to mankind numerous drugs and cures to ailments and diseases that were incurable just about half a century ago. However, the practice of carrying out medical research on humans carries with it a lot of controversy, as it raises several ethical concerns. Overtime, there have been researches which have breached basic human rights, and it has been questioned whether the benefits of the research justify the harm done. One such case is that of the Tuskegee syphilis study conducted by the U.S. Public Health Service from 1932 to 1972. This paper uses this case as a basis for the discussion of the conflict between medical research and ethical considerations.
Benefits of Medical Research
The development of new cures and new drugs revolves around intense experimentation. Without such experiments, the effectiveness of the new drug cannot be tested, nor can the possibility of harmful side effects be eliminated. Thus, before any new medicine is offered to the public at large some sort of research must be carried out to ensure that the medicine will in fact benefit the society by doing what it is supposed to do.
The importance of such experimentation is accentuated by the fact that each individual is biologically unique, and if a particular drug has a particular effect on one individual, there is no guarantee that it will have the same effect on another. Thus, most experiments require the drug to be tested on a sample of individuals to see how the human body reacts to the drug and whether it is safe to offer the drug to all patients suffering from a particular disease.
The need for medical research exists because the field of medicine is and always will be faced by an indefinite number of unanswered questions. There will never be an end to the complexities of the human body and its reactions to various stimuli. New diseases continue to arise before cures are found for the ones which already exist. There needs to therefore be continuous research in this field in order to deepen the understanding of the human body, to find causes of various ailments and finally, to find ways of prevention and cure. In this way, research aids medical professionals in their quest to find new ways of benefitting the society (World Medical Association).
Ethical Violations
Despite the various benefits medical research has for the society, when medical research is carried out on human subjects, it raises several ethical questions. Such was the case in the infamous Tuskegee syphilis study whereby for forty years, from 1932 to 1972, 399 African-American males were made the subjects of a study carried out by the United States Public Health Service. The study was carried out with the objective of justifying treatment programs for African Americans, and this would be done by studying the natural progression of the untreated disease.
The ethical hue and cry began when it became known that the human subjects were denied proper medication (penicillin) even after it had been discovered, and as a result, few of them lost their lives (Heller, 1972).
The participants in the research were told that they were being treated for “bad blood”. Thus, they were misinformed about the real objectives and implications of the research, because in reality, the intent was to deny them of any medication for their disease. The study was forced to a close when, in 1972, a public outcry led to the formation of an Advisory panel which immediately called for its termination.
Hence, in the name of medical research, vulnerable people were deprived of fundamental human rights. It was though by the researchers that to study the untreated natural progression of the disease would benefit the society, but, in effect, the study made an example of itself as one of the most unethical medical researches of all time. It is cases like these which make obvious that medical research can sometimes cross the line and lead to behavior which is ethically and morally unacceptable.
As a reaction to the atrocities of the Tuskegee syphilis study, the Tuskegee Syphilis Study Legacy Committee was formed to address the issue and take corrective actions. In a final report the committee urged President Clinton to make a public apology, which he did on May 16, 1997. (Claude Moore Health Sciences Library) Also as a result of this and similar ethical misconducts in the name of medical research, several independent ethics committees and institutional review boards have risen to ensure that the rights of participants in medical research are not compromised upon.
Role of Ethics Committees
The World Medical Association passed the Declaration of Helsinki in 1964, and the latest version is the 2007-2008 revision. This declaration contains clauses that all medical researchers must adhere to in order to ensure that there are no ethical or moral violations. The function of independent ethics committees is to overlook medical researches according to the clauses put forward by the declaration.
The process followed is that all medical researchers must put forward a research protocol, making clear the objectives and methodology of the research. This protocol has to be reviewed by the ethics committee, which then has the right to approve, disapprove or modify it. The research should ideally continue to be reviewed by the committee until its conclusion (Tyebkhan, 2003).
Thus, the ethics committee forms a neutral and independent body which objectively reviews the research, making sure that it does not violate the rights of the participants or endanger them in any way.
Participant Consent
A very important aspect of upholding ethical considerations is to gain “informed consent” of the research participant. This means to communicate to the participant the nature and objectives of the research, as well as full disclosure of any risks involved. If the participant then, without any undue influence, agrees to participate in the research, this is informed consent.
Gaining informed consent in medical research also requires that the participant be made clear on the difference between therapy and medical research. If the intention of the doctor is to experiment a new drug, for example, for the therapy of the participant, this classifies as therapeutic research. However, if the intention of the doctor/researcher is to benefit the society at large, then this falls in a broader definition of medical research. The participant needs to be made clear on whether the research is therapeutic in nature or not, and then chose whether or not to take part (Daugherty, 1999).
Thus, we see that the Tuskegee syphilis study was inherently unethical, because the participants were never informed of the researchers’ true intent. In fact, after penicillin was discovered as the cure for syphilis, this information, too, was kept from the participants, and they were made to suffer at the hands of the disease without any cure.
Role of Management
The management of the research is in a position to maintain ethical standards during the research. It is up to the management to decide which approach they want to take. For example, as far as ethics in medical research is concerned, broadly speaking, there are three approaches which can be followed; the goal-based approach, duty based morality, or right-based deontological moral thinking. (Foster, 2001) The goal based approach states that the morality of the research should be judged by the outcome or end result. The duty based approach states that the morality should be judged by the means to the end rather than by the end in itself. The right-based approach has to do with the participant’s autonomy in the research, e.g. his right to free and informed consent.
For example, during the Tuskegee syphilis study, the doctors who initiated the research thought that to study the untreated natural progression of the disease would eventually be of benefit to society at large. Thus, to complete the study at the expense of a few men was justified. They took the goal-based approach.
In my opinion, however, it is an amalgamation of the three approaches which result in an absolutely ethical research. The end result should benefit the society at large, but if it puts the lives of even a few in danger, then it is unethical. Moreover, even if the research both benefits the society, and also does not pose any serious risk for the participant, but the participant has not been given the opportunity to give free, informed consent, the research is still unethical. Thus, all three approaches should be taken in order to ensure the research is ethical.
Conclusion
Medical research should be carried out with the intent of curing illnesses and finding new ways of preventing disease and enabling people to live healthier lives. In order to validate new findings, experimentation is necessary. For example, with the development of any new drug, it must be tested for effectiveness and for possible side effects. In the same way, continuous research must be carried out to further understanding of the human body.
Carrying out experimentation on human participants is therefore necessary. However, it carries ethical concerns as it can violate their fundamental human rights. For example, when the effects of a particular drug on the human body are not fully known, is it safe to test it on a sample of individuals to check for possible side effects? Ethically speaking, putting people through this kind of risk is unacceptable. However, I believe, that ethical violations can be avoided if the management takes responsible decisions, and these decisions are backed by independent bodies. In order to uphold ethical standards, it is imperative that the research participant be informed fully of the researcher’s intention and research objective, as well as any risks that might be involved. The researcher himself must also be weary of the fact that the participants must not be used simply as guinea pigs for their experiments. It is important to bear in mind that the loss of lives of even a few does not justify saving the lives of a million more.
References
- Claude Moore Health Sciences Library. Bad Blood: The Tuskegee Syphilis Study.
- Daugherty, C, K. (1999). Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective. Journal of Clinical Oncology, Volume 17.
- Foster, C. (2001). The ethics of medical research on humans. Cambridge University Press
- Heller, J. (1972). Syphilis Victims in U.S. Study Went Untreated for 40 Years; SYPHILIS VICTIMS GOT NO THERAPY. Web.
- The World Medical Association. Ethics and Medical Research.
- Tyebkhan, J. (2003). Ethics Committee. Indian Journal of Dermatology, Venereology, and Leprology, Volume 69, pages 300-302. Web.