Meanwhile, the US Public Health Service hired Funes and another Guatemalan physician, Dr Salvado, to continue “the observation of certain of the patient groups” after Cutler left Guatemala. Funes’s staff collected data on residents of the orphanage, inmates of the penitentiary, individuals from the psychiatric hospital, schoolchildren, and the members of “various Indian tribes in the vicinity of Guatemala” who had participated in the experiments. Several of those subjects tested positive for syphilis during the follow-up experiments. The subjects from the psychiatric hospital were followed until at least 1953. The published work resulting from the Guatemala experiments also indicates that Funes continued to do serological testing on the children at the orphanage until at least 1949. All the efforts described to this point promoted regulations and procedures based on an ethically sound approach to protecting human subjects who, by consent or proxy, will be participating in research.
In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected. Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research. The assistance it gives to investigators means that ethical considerations form an integral part of the scientific approach. The essential concern of the IRB is to ascertain the compliance of submitted projects with the internationally-accepted ethical principles for research on human subjects. In Nuremberg in December 1946 began the trials of the physicians accused of having participated in organizing or conducting experiments on humans under the Nazi regime.
In this way the autonomy of the subject should be more strongly protected, not only during the informed consent process but also throughout the experiment itself. Along these same lines of legal and ethical reasoning, the National Bioethics Advisory Commission issued an important report, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, in 1999. Ironically, Germany, later infamous as the site of Nazi crimes against research subjects, was the first country to enact informed consent laws. In the 1890s in Breslau, Prussia, German dermatologist and bacteriologist Albert Neisser (1855–1916) studied syphilis and intentionally infected several prostitutes, but then claimed that they had contracted the disease while following their profession.
These protections range from ensuring that the individual understands and is freely participating in the research, to excluding the individual from harm. Department of Health and Human Services developed regulations for research with human subjects that were included in Title 45, Part 46 of the Code of Federal Regulations. Subsequent changes to Part 46 included the addition of subparts what candy bar is considered good luck in japan? addressing specific concerns for vulnerable populations. Subpart D pertaining to children and adolescents was added in 1983 and revised in 1991. To eliminate any concern regarding potential exploitation in developing countries because of illiteracy and poverty, it is in the interest of every pharmaceutical sponsor to maintain high ethical standards for clinical trials.
This chapter discusses these guidelines and checklists, the important milestones in shaping biomedical ethics in the United States, and a variety of frameworks that can be used to guide decision-making and best practice in the clinical setting. The need for ethics review committees is imperative in the conduct of research to ensure the protection of the rights, safety and well-being of research participants. However, the capacities of most ERCs in Africa are limited in terms of trained experts, competence, resources as well as standard operating procedures.
This principle advocates fair treatment for all and a fair distribution of the risks and benefits of the research. It forbids exploitation of vulnerable people or those who are easily manipulated as a result of their situation. It also requires that the researcher verifies that the potential subject pool is appropriate for the research and that the recruitment of volunteers is fair and impartial. An even more aggressive study included at least 7 women in a psychiatric institution who were infected by the injection of syphilis specimens directly into the subarachnoid space surrounding the brain.