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PubMedDate not supplied

Ethical dilemmas encountered during clinical drug trials.

We are fortunate to live in an era when medicine is making important progress in the diagnosis of many diseases, which have plagued mankind for centuries. The pace of progress is really staggering. New potent drugs are introduced continuously. The evaluation of their efficacy and safety is an arduous and costly process that involves laboratory work, animal studies and human trials. Someone must take a new drug first hence, human experimentation is unavoidable. Over the years, principles and rules have been introduced to guarantee respect for the individual. In our present state of knowledge, randomised clinical trials are necessary. They aim not only at the actual patient's treatment, but also to serve future patients who will need the drug. We should appreciate that conscientious people have established an ethical basis for the proper conduct of RCTs. Individual investigators in basic sciences, in institutions, and the pharmaceutical companies, all contribute to a common end--the production of useful drugs. Most of us are involved in clinical trials. The present review has discussed briefly some of the ethical dilemmas encountered during the clinical trial process in order to encourage the exercise of more humane medicine.

Authorship↗
PubMedDate not supplied

Why are African Americans under-represented in medical research studies? Impediments to participation.

OBJECTIVES: In accordance with the NIH Revitalization Act of 1993, the National Institutes of Health and the Alcohol, Drug and Mental Health Administration require grant applicants and cooperative agreement participants to include minorities in human subject research. In an environment characterized by diminishing research dollars, this mandate has increased the pressure on investigators to determine factors that impede minority participation and to develop strategies to overcome these impediments. METHODS: An extensive review of the literature was conducted to identify the factors possibly responsible for the low participation levels of African Americans in medical research studies and to highlight areas for further research. The items examined included the historical relationship between African Americans and medical researchers and the attitudes, perceptions and beliefs of potential participants and researchers as they relate to the low representation of African Americans in medical research. RESULTS: The factors identified as possible impediments to African American participation included distrust of the medical/scientific community, poor access to primary medical care, the failure of researchers to recruit African Americans actively, the alienation of minority health professionals, lack of knowledge about clinical trials, language and cultural barriers. CONCLUSIONS: Well-designed, relevant, ethical research in conjunction with an appreciation of the many barriers to participation are paramount to increasing African American presence in clinical research.

Black or African American↗
PubMed1997

The dark side to Donovanosis: color, climate, race and racism in American South venereology.

Medical experimentation on humans with "classic" sexually transmitted diseases (e.g., syphilis, gonorrhea) is not generally well known, but experimentation with others such as Granuloma inguinale, or Donovanosis, is even less so. Endemic to non-existent here, hyper-epidemic there, between 1880 and 1950 Donovanosis was linguistically and morally "constructed" as a disease of poor, sexually profligate, tropical, darkly-skinned persons. It was also experimentally produced on and in African-American patients in many charity hospitals in the American South. This essay analyzes Donovanosis literature of the period that heavily featured skin color, climate and tropicality, venereal sin, and racial susceptibility. It then recounts the history of human experimentation with it, and explains both its linguistic construction and its biomedical experimental history in terms of "disease narratives" produced not only by but for venereologists.

Black or African American↗
PubMed1999

Human subjects--are they protected?

From the time of Hippocrates, physicians have sworn to "abstain from all intentional wrongdoing and harm," (Lifton, 1986). They are guided by ethical principles and theories that are intended to help them in their practice of medicine and scientific research. The purpose of this paper was to define research and human subjects, to review cases of abuse, address benefits and risks of human experimentation, discuss regulations governing experiments on humans, and address ethical principles and theories regarding this type of research. Human experimentation is an important activity of great societal benefit that must be conducted in a manner consistent with basic societal beliefs and values about the rights and worth of an individual (Gray, 1975). Ethical issues in human experimentation defy definite solutions, and the problems involved in human experimentation will almost certainly continue to receive active attention in future years.

Bioethical Issues↗