1. What were some of the events that caused the Belmont report to be written?
The Belmont Report was a product of many events in human history, but most notably those that have occurred in the last century, in my opinion, as a result of mass communication making the world more aware of such transgressions than was previously possible.
If anything good could ever be said about the likes of Adolph Hitler, it could only be that his regime made the world aware of the atrocities of which people are capable, and to set the world on a mission to prevent it from happening again.
Most of the Holocaust reports concern the mass killings of nearly an entire culture, but it is the inhumane treatment and even torture of these prisoners that lead to their deaths, often in the name of “research,” that pushed these people to the depths of human endurance, that is the true crime against humanity.
This realization of the complete and utter disregard for human life with which the Nazis treated so many people has enraged better-informed generations to come, who have to live with that disgrace as a part of our shared humanity. The Nuremberg War Crime Trials were an attempt to punish those responsible, and to understand what had happened so that we could come to grips with the social dynamics that allowed it to happen.
The nature of these abuses are not often, or often enough, depicted as being in the name of “research,” the Belmont Report sets forth a standard by which researchers should be made aware of the fallibility of the selection process, albeit in gruesome comparison to the Holocaust.
2. What are the “Basic Ethical Principles” cited in the Belmont Report?
The nature of the ethical principals evinced by the Belmont Report are simple and humanitarian in their foundation, primarily respecting people and their right to “Life, Liberty, and their Pursuit of Happiness.”
The report further defines this respect by promoting “beneficence” which strives for “the greater good,” considering society as a whole, but primarily toward the subject’s well-being. The distinction is made between “risk” as a probability that some outcome will occur, and the “benefit” which is the degree of improvement (or detriment) that can be expected as a result of the research process.
The report also strives to ensure that research subjects will be selected fairly, and that the potential subject will submit with a full understanding of all of the risks and rewards that may result from the study, without coercion that may otherwise result from a biased selection process, such as a bias toward, or against, a sample population.
3. How are the “Basic Ethical Principles” assured in research practice?
Basic Ethical Principals are ensured by requiring consent that is completely informed of all reasonably known consequences, and even of the nature of “unknown consequences” that are often the case in research situations. The subject must understand that the outcome may be unpredictable, or that such incomplete disclosure is truly necessary to accomplish the goals of the research. However, the burden is on the researcher to ensure that the subject, or in some case, as concerned third party (who is able to act in the subjects best interests), fully understands the nature of the research requirements as well as the nature of the undisclosed risks.
The Belmont report describes methods to be used as examples. However, while the Belmont Report does not codify their methods to be used, respect for the subjects ethically mandates that subjects demonstrate informed consent voluntarily, and are fully able to comprehend the nature of the research, the procedures required, the health-related, social and economic risks involved, and the availability of alternative treatments.
Subjects, or a third party, must also be able to withdraw the subject at any time during the process, should such withdrawal be warranted. Subjects of research must also have access to the results, as well as being made aware as to whom those results will be disseminated.
Researchers are required to assess the need for the proposed research based on risks and benefits to the subjects, and to society as a whole, including advantages over alternative tested procedures that may provide similar results.
Sunday, October 7, 2007
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