List of Abbreviations/Terms

In: Clinical Trials and the African Person
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List of Abbreviations/Terms

Adverse Drug Reaction (ADR)

A response to a drug that is noxious and unintended and 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): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject to whom a pharmaceutical product is administered. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

All-in-one (one-in-all)

A term I have coined to depict the suffusion and inseparability of the individual into his or her community and environment.

Alleles

Different forms of the same gene, usually arising through mutation, that are responsible for hereditary variation.

BEC

Bio-eco-communalism just like the concept of one-in-all, refers to the inseparability of the individual within his/her community and environment.

Biome

A term from the Greek bios, meaning relation to life; used in ecology to include major life in the area, such as tundra biome, tropical rainforest biome and grassland biome.

Biomass

The amount of matter of biological origin in a given area, for example, the living and decaying matter in the soil, as opposed to the inorganic mineral components such as sand, silt and clay.

Biosphere

(a) The zone on the earth’s surface where all life exists; (b) all living organisms of the earth.

Biota

All species of plants and animals occurring in a specific area.

CRS

Corporate social responsibility is a duty or an in-built commitment by corporate bodies to uphold ethical values and ensure quality of life of the workforce, the local community and the physical environment, while earning profits.

Ecosystem

A biological system composed of a community of organisms and the nonliving environment with which it interacts [same for Environment and Ecology].

GMM

Genetically Modified Mosquitoes, also called genetically engineered mosquitoes, transgenic mosquitoes, or living modified mosquitoes – mosquitoes that have heritable traits derived through use of recombinant DNA technology, which alter the strain, line, or colony in a manner usually intended to result in reduction of the transmission of mosquito – borne human diseases.1

The Global North2

Also known as the industrialized world, Western, or Euro-American – 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 located in the Northern Hemisphere.

Global South3

The industrializing world or The Global South refers to the countries of the rest of the world, most of which are located in the Southern Hemisphere. It includes both countries with medium human development index, HDI (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 defined, the Global South is made up of some 133 countries out of a total of 197. Most of the Global South is located in South and Central America, Africa, and Asia.

Holism

The interconnectivity and interdependence of all things in reality.

Serious Adverse Event, SAE, or

Any untoward medical occurrence that at any doseSerious Adverse Drug Reaction,results in death, is life-threatening, requiresSerious ADRinpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Vulnerable subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, pregnant women, and those incapable of giving consent.

Clinical Trials and the African Person

A Quest to Re-Conceptualize Responsibility

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