Conflict between research and ethics arises from a conscious awareness of perceived social consequences of research actions on the community. A genuine conviction exists within the medical fraternity across the board, that anything that can be done to enhance the lives and well being of people is a core duty. But that is set against another ethical claim, that we should do no harm. Right there is the conflict. This paper aims to look at this conflict.
It becomes essential then, in light of this, to measure the benefits vis-à-vis the demerits.
“One method is to conduct a risk/benefit analysis to determine which action produces the greater benefit (good) while limiting harm (evil)” (military medical ethics, volume 2 Pp 541)
Various ethical issues are of concern to the moralists. One of them is the patients’ informed consent. A free and informed consent from a participant of a research, prior to the experiments is crucial. Plomer cites the Helsinki Declaration of 1964:
“In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed……….. After ensuring the subject has understood the information, the physician should then obtain the subjects freely given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.” (Plomer, 2000)
There is every sense in ensuring the subjects know all the details concerning the research as this affects critical decisions on participation or non-participation. In the case of Tuskegee Syphilis study for example, the subjects were misled to believe they were to receive free medical care (read tests) and that the purpose of the experiment was to test for bad blood (a term used to describe a variety of illnesses then).
They were not told, once tested, that they had syphilis or that the purpose of the test was to study the effects of untreated syphilis on living subjects. (Jones 1981). All the myriad of misinformation that was supplied to the Black-American men intended for the study was intentionally intended to hoodwink them to think that the research was intended to benefit them, a far cry from the truth.
In the Tuskegee case study, we also realize that the subjects were pressured or felt coerced to be part of the study. The use of doctors, nurses, community leaders, black leaders and plantation owners were all aimed at this objective. People like doctors and other medical practitioners are all perceived as authorities in medical research issues. The community leaders are also opinion leaders. Use of all these people therefore, does nothing but pressurize subjects to agree to be part of the studies. Some of these leaders may even blackmail or arm twist their people to consent to participation. That can only be seen for what it is, a violation of the rights of the person to an informed consent.
In medical research, a conflict is also bound to occur concerning the withholding of treatment of the sick subject. This is done specifically to serve the interests of the medical research while ignoring those of the subjects (Heintzelman 2003). All along, in the Tuskegee case, the public health service (PHS) officials did not allow any treatment to the participating subjects. They went further to prevent other medical agencies from giving treatment to the subjects (Jones 1981)
In 1952, the PHS would begin working with local health departments to keep track of subjects who had left Macon County, the area of Tuskegee. Up to the time of termination of the study in 1972, local health department would liaise with PHS to see to it that the study subjects did not receive treatment.
In the few cases where treatment of syphilis was administered it was at levels deemed insufficient to cure the disease. After PHS started administering penicillin as a cure for syphilis, still it had give the same to the study participants (Heintzelman 2003). While giving treatment to participants might defeat the researchers efforts, it is questionable how morally right it is to keep denying the subject treatment, even when it is available.
Various other issues arise too regarding ethics in research. There is need to keep proper records during research studies. The records act as an accurate store of happenings. In the Tuskegee case, it would be hard establishing the exact number of deaths of among the Tuskegee subjects. Guess work and approximations abound and therefore accurate inferences are hard to make about such a study. This could be taken advantage of as a loophole to conceal what really transpired in an experiment involving human subject. This could be catastrophic.
Research studies involving minority groups or raced people groups are bound to be rife with generalizations and assumptions about these people (Heintzelman 2003). Their behavioral or therapeutic responses to treatment could be used to their disadvantage. In the Tuskegee case, assumptions about the syphilis in black men and the sexual behavior of Blackman were all present prejudices. This undoubtly led to exposure of whole communities to a communicable viral disease. This can lead to a pandemic spread of the disease.
Issues of confidentiality of the subjects’ information are also bound to come to the light in medical researches. Along with this is the issue of disclosure of results (Plomer 2005) and privacy of the subject.
Untold mental or physical distress is experienced by medical research subjects. This is of concern to moralists. Another issue of concern is the sponsorship of these studies. Sponsoring bodies have interests they are pursuing and ready to protect. If human dignity stands in the way of achieving these goals, the sponsoring bodies more often that not, spare anything to do away with it. This raises question where it was the man then the research or the research then the man.
The Belmont Report (1979) outlined three basic principles for guiding ethics in research involving human subjects. The first was respect for persons, which stipulates the autonomy of subjects, beneficence which is for maximizing possible benefits and minimizing possible harms to individuals and society and finally principle of justice, which calls for equitable distribution of benefits and burden of research. The research outcomes should benefit the society, the medical fraternity and on the small scale the individual and his/her immediate society (Heintzenlman 2003)
The National Research, Act stipulated a requirement that research institutions, especially those federally funded, should put in place Institutional Review Bodies to ensure the adherence to ethics in research. Ethics committees help ensure that the research methods, facilities and instruments maintain the ethics of research. All institutions should seek compliance in this regard.
The ethical principles and guidelines for the protection of human subjects of research (Belmont Report) of 1979, harmonized the various codes and regulations that had since been established in the US by federal agencies, universities, professional organizations and private research institution as well a codes in other countries (Heintzelman 2003). That should make it potentially easier to adhere to the ethics of research for any institution.
The management should be charged with the responsibility of facilitating compliance of ethical issues, formulation of policy, formation of ethic committees, ensuring periodical review to ensure compliance and also ensure continuous education of the researchers on current ethical issues in their area of research. (Plomer 2005)
If I were in a position of power, I would take a participatory managerial approach. I would seek to ensure all members of my organization, even those not directly involved in research help in formulating an ethics policy for the organization. Those directly involved would then be helped to keep up to date ad relevant.
In conclusion we can say that issues that arise from the conflict of ethics in medical research are surmountable. With the right policy and compliance to ethical guidelines in the Belmont report and the National Research act, them it is possible to ensure ethical research in an organization
Heintzelman A Carol .2003. The Tuskegee syphilis study and its implications for the 21st century Fall 2003 volume 10.
Jones J 1981 Bad Blood: The Tuskegee Syphilis Experiment. A tragedy of race and medicine. NY: The free press.
Military Medical Ethics, volume 2 Diane Publishing
Plomer Aurora. 2005. The Law of Ethics of Medical Research International Bioethics and Human rights, Routledge Cavendish.