Abstract
This chapter aims to prominently position the African philosophical notion of the self within the clinical trials context (and the larger bioethics project). As opposed to autonomy-based principlism, this other-regarding or communalist perspective is proposed as the preferred alternative model. The intent is to draw further attention to the inadequacy of the principlist approach particularly in multicultural settings. It also engenders a rethink, stimulates interest, and re-assesses the failed assumptions of universal ethical principles. As a novel attempt that runs against much of the prevailing (Euro-American) intellectual mood, this approach strives to introduce the African viewpoint by making explicit the import of the self in a re-contextualized (nay, globalized) arena. Viewed as such, research ethics is guided to go beyond autonomy-based considerations for the individual with absolute right to self-determination; to embrace more holistic-based approach, recognizing that the individual is embedded in his/her family, community, and the environment.
TopBackground
There has long been this earworm of an issue: the 1996 drug experimentation in Nigeria by Pfizer, Inc., which caused significant public health uproar in that part of the world. The current task revisits that event not as a clichéd issue but as a formidable topic of interest which has been reborn and relevant. After all, the likes of Nuremburg and Tuskegee trials still reverberate today.
Key Terms in this Chapter
Adverse Drug Reaction (ADR): A response to a drug that is noxious and unintended. This occurs at doses normally used in a person for the prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. Adverse drug reactions are classified into six types (with mnemonics): (1) dose-related (augmented); (2) nondose-related (bizarre); (3) dose-related and time-related (chronic); (4) time-related (delayed); (5) withdrawal (end of use); and (6) failure of therapy (failure).
Biota: All species of plants and animals occurring in a specific area.
Global North: Also known as the industrialized world, western, or Euro-American, this refers to the 57 countries with high human development that have a Human Development Index above .8 as reported in the United Nations Development Program Report 2005. Most, but not all, of these countries are in the northern hemisphere
Genetically Modified Mosquitoes (GMM): Also called genetically engineered mosquitoes, transgenic mosquitoes, or living modified mosquitoes, these mosquitoes have heritable traits derived through use of recombinant DNA technology. The technology alters the strain, line, or colony in a manner usually intended to result in reduction of the transmission of mosquito-borne human diseases.
Bio-Eco-Communalism (BEC): Like one-in-all, this refers to the inseparability of the individual within his/her community and environment.
Adverse Event (AE): Any untoward medical occurrence in a patient or clinical investigation subject to whom a pharmaceutical product is administered. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, if related to the medicinal (investigational) product.
All-in-One (One-in-All): A term to depict the suffusion and inseparability of the individual into his/her community and environment.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (ADR): Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Global South: The industrializing world or the Global South refers to the countries of the rest of the world, most of which are in the southern hemisphere. It includes both countries with medium human development index, human development index (88 countries with an HDI less than .8 and greater than .5) and low human development index (32 countries with an HDI of less than .5). Thus, the Global South is made up of some 133 countries out of a total of 197. Most of the Global South is in South and Central America, Africa, and Asia.
Holism: The interconnectivity and interdependence of all things.
Ecosystem: A biological system composed of a community of organisms and the nonliving environment with which it interacts (same for environment and ecology).