Conflict between research and ethics Sample

Abstract

Since the potential of genetic engineering in health  or clinical research escaped to the public forum, bioethics debates have been louder than at any other time in the history of science. Bioethical debates, education and establishing of guidelines and regulations accompanied any new developments in research. there are grater challenges of bioethics in this era of animal cloning, stem cell research, gene cloning and tissue engineering. the weaknesses of the present regulatory framework to safeguard ethical research led to more frameworks being put in place to avert the potential of scientists to change nature.

There exist codes and principles of research that are enshrined in the constitution and these guidelines seek to protect individuals participating in research from potential harm by adopting a risk benefit ratio that is acceptable to all the individuals participating in research. This paper therefore seeks to examine all the ethical codes, principles and regulatory benchmarks for ethical regulation of biomedical research.

The Tuskegee Syphilis Study  carried out between 1932 and 1972 became one of the studies to launch the bioethics debate. Four hundred African American men were studied for the effects of untreated syphilis. The researchers deliberately withheld treatment to these patients despite the fact that penicillin was widely available. This was a harsh deception considering that the patients had the belief that they were  under treatment.

By the time of termination of the study twenty eight people had died, one hundred patients died from syphilis related medical complications, forty wives of the research participants had syphilis infection and an additional nineteen children contracted syphilis at birth. public outcry led to the Belmont Report of 1979 and the eventual establishment of National Human Investigation Board.

Between the years of 1963 and 1966, the  Willowbrook State School carried out a study for mentally defective persons. the main study had the objective of understanding the natural history of hepatitis. the study also aimed at testing the effects of gamma globulin in the prevention of the disease. the subjects were  deliberately infected with the virus from stool extracts or from purified virus preparations. The defense of this action was quite absurd, the researcher argued that in any case these children

usually acquired these infections at  Willowbrook and therefore infection at controlled research conditions was ethical. these children were used in the research without their own informed consent or even that of their parents. the public outcry was enormous and it facilitated much tighter control on medical research.

These researcher carried out the inoculation of hepatitis in institutionalized children and continued admission of children through the researcher unit without due regard to the health hazard exposure the children were deliberately exposed to. Another case in history is the Jewish chronic disease cancer experiments where elderly patients in the hospital were injected with live cancer cells without their informed consent.

The benefits of research that involve people directly or indirectly must far outweigh the potential risk of such research. Such research must respect the autonomy of others as well as have absolute respect for human life. these were some of the key benchmarks that gave rise to institutional compliance and ethical codes of conduct and principles governing research.

Institutional compliance committees continually reviews compliance of guidelines in high risk research works.  Reviews of protocols that control human research occur quarterly and the reports are submitted to compliance offices for effective action.  Reviews of compliance also encompasses environmental health, environmental safety and information security.

The pivotal role played by health research in addressing the existing inequalities in health care programs and the development of humans cannot be over-emphasized.  This therefore means that the push for bioethical guidelines for health research most be seen to balance with the potential benefits of research in alleviating human suffering from health conditions and diseases.  To achieve this, the research objectives must not only be based on sound ethical principles but also sound scientific principles.

Present breakthroughs in genetic engineering present the world with many opportunities but unfortunately this also comes with predicament.  A complete host of debilitating diseases can be treated or prevented while on the other hand scientists armed with genetic knowledge can manipulate nature by  making our children more genetically advanced and more advantaged.  These issues continue to draw profound public debate and there is no certainty that such debates will die out soon.

There exists various ethical codes that should be adhered to by both the researcher and those being used as subjects in the research.  Key among these codes is the capacity of individuals involved in the research to make an informed legal consent, individuals are given the freedom to exercise their power of choice, without any discrimination or coercion whatsoever.  Such decisions should only be made after an individual has been given sufficient knowledge and they have attested that they fully comprehend the subject matter.

Elements of the subject matter includes, the nature of the research experiment, the overall duration and a full description of the purpose of the experiment.  The methods used in the research all inconveniences or hazards that an individual can be reasonably subjected to and the potential effects of the experiment in the health of the individual participating in the research.

These codes of conduct of biomedical research are further strengthened by the existence of ethical principles of research.  These principles include, privacy of the individual, autonomy, risks or benefits of the research to the individual or the society, right to informed consent, truthfulness, vulnerability of  the research and confidentiality of information given to the researcher.

Fundamental ethical principles are also enshrined in the laws that are used in the regulation of biomedical research.  This principle recognizes the personal dignity of an individual, autonomy and special protection for those who are deemed to be with diminished autonomy.

Beneficence as a principle seeks to protect all persons from potential harm through maximum minimization of risks.  Justice is another universal ethical principle that dictates that there should be fair distribution of research benefits and possible burdens.

To make sure that these laws are adhered to the federal government enacted law for instance the federal regulations (45 CFR 46) of 1974 is the National Research Act.  This act created the National Commission for protection of Human Subjects in Biomedical and Behavioral Research.  It provides the fundamental federal regulations that spell out all the relevant bioethical laws and regulations.

According to the Tri-council policy statement, research that involves living individuals in the public arena, quality assurance studies, rural educational testing or cases of performance review are exempted for ethics reviews.

Further participant observation in situations like  public demonstration, public meetings or even political rallies are also exempted from ethics review.

Because biomedical research depends on the level of invasiveness in terms of potential risk either psychological, emotional or physical; guidelines that regulate hazards that are always associated with these kinds of research are welcomed.  The element of vulnerability of individuals is a natural phenomenon in any given environment whether the research is carried out or not.  It is a pre-existing condition and therefore should never be exacerbated by research.  The key to research therefore solely lies on balancing the bioethical guidelines and regulation of research with research benefits to humanity.

References

Belmont(1979). The Ethics of Inquiry: An introduction to Ethical Issues in the scholarship of Teaching and Learning.

Jeremy Sugarman. Protecting Human Participants in Research:Historical and Ethical Perspectives. <apps.rgp.ufl.edu/research/training/ppt/CC05.0_RATS-RACOC.ppt>

Jill Parsons. Research Ethics in the Health     Sciences.<www.library.utoronto.ca/rir/ethics/pdf/presentations>

Zulfidar Armed Bhutta; Ethics in International Health Research : A perspective from the         developing world.