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Definitions
In this section you will find a directory of terms used in the field of research ethics. Several have been reproduced from the Nuffield Council on Bioethics.
A
Autonomy
Personal capacity to consider alternatives, make choices, and act without undue influence or interference from others.
B
Basic research
Such research is usually laboratory-based and includes studies at the cellular level, and of immunity and pathogenesis. Basic research is often dependent on the use of samples from patients. [Source: Nuffield Council on Bioethics]
Beneficence
People are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of "beneficence", which is often understood to cover acts of kindness or charity that go beyond strict obligation.
C
Capacity building
Developing the ability of individuals, organisations and countries to carry out certain activities, such as providing effective healthcare or designing and conducting resarch. Capacity building may involve a number of components, such as providing and maintaining equipment and developing human resources (for example, through appropriate training courses).
Clinical research
Such research is often conducted with patients in a medical setting, such as a hospital, and is designed to obtain better information on the natural history or pathogenesis of a condition that may lead to improved strategies for diagnosis, treatment or prevention of a disease. See also Phase I-IV trials. [Source: Nuffield Council on Bioethics]
Control group
A control group in clinical research and clinical trials (see clinical research and clinical trials) contains participants who are not given the intervention being tested, and is compared with a group who are given the intervention. In clinical trials, the intervention would normally be a novel treatment, such as a medicine or vaccine, but interventions may also be social and behavioural in nature (for example, safe sex campaigns). [Source: Nuffield Council on Bioethics]
D
Distributive justice
This formulation of justice deals with the fair allocation of society’s benefits and burdens. In the research context, distributive justice requires that no group or social class is disproportionately exposed to the risks and inconveniences experienced by participants in research that aims to develop medical interventions to benefit the entire population. (See also justice.)
E
Epidemiological research
Such research usually involves population-based investigations, which may be cross-sectional surveys of selected populations ('case-control studies') or all members of a community, or may involve longitudinal study of a population over time ('cohort studies'). Such studies are conducted to obtain an improved understanding of the natural history of a disease or to identify factors that increase or decrease the risk of disease in individuals. [Source: Nuffield Council on Bioethics]
Ethical review
The requirement that the ethics of research involving human participants be reviewed is now widely accepted. Issues considered during the review process typically include the predictable risks involved in the research, anticipated benefits to participants and communities from the research, provisions for their care and protection, procedures for recruitment and selection, and processes for obtaining informed and voluntary consent from participants. (See also research ethics committees and institutional review boards.)
H
Health services and operational research
Such research is concerned with the study of methods of delivery of healthcare, and access to treatment and quality of care, with the aim of finding improved methods that lead to better care. Such studies often include an evaluation of the cost of providing the intervention and the benefit it provides. [Source: Nuffield Council on Bioethics]
I
Institutional review board (IRB)
Ethical review of research in the US, and countries using the US model is conducted by IRBs. The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities that are conducted under the auspices of the institution with which it is affiliated. (See also ethical review.)
J
Justice
Justice refers to a fair and equitable distribution of benefits and burdens, taking into consideration what is deserved or due and the fair selection of participants, as well as the idea that participants should be treated equally.
P
Perinatal transmission
Transmission of an infection-causing agent (such as HIV) from mother to child in the period either shortly before or after birth. [Source: Nuffield Council on Bioethics]
Phase I trials
Phase I trials are the first time that human subjects are exposed to a potential novel medicine. The objectives behind the study will be to investigate the biochemical and physiological effects of the drug and its mechanisms and, in the case of vaccines, immune response, and to determine the maximum dose that can be tolerated by participants. In the case of most new medicines these studies will be undertaken in a small number of healthy volunteers. It is not expected that evidence of the medicine's efficacy will be provided by Phase I trials. (See also clinical research.) [Source: Nuffield Council on Bioethics]
Phase II trials
Using information regarding the safe dosage range obtained from the Phase I studies, the compound is administered to patients suffering from the target disease. Almost always these trials will be conducted in a number of clinical centres and will include significant numbers of individuals. The objective of the Phase II trials is to seek evidence of the efficacy of the medicine against the specific disease. More information about the safety of the medication will emerge from these studies as larger numbers of individuals are exposed to it. In Phase II trials the patient will often be randomly assigned to the novel treatment group or to a group receiving a placebo (a compound possessing no therapeutic effect) or, more usually, a conventional and established treatment. (See also clinical research.) [Source: Nuffield Council on Bioethics]
Phase III trials
Where a compound has shown evidence of efficacy without significant side effects it will enter Phase III trials in which many hundreds, or sometimes a few thousand patients will be enrolled. These trials generally seek not only to confirm the clinical efficacy of the novel compound, but also to establish its efficacy in comparison with existing treatments. These studies areoften multi-centre and sometimes undertaken on an international basis. Again, careful attention is paid to possible side effects as larger numbers of patients are exposed to the intervention. The end-points for Phase III studies include demonstration of a statistically significant improvement in the efficacy of the novel medicine over established therapies, if any such exist. (See also clinical research.) [Source: Nuffield Council on Bioethics]
Phase IV trials
Once a new medicine reaches the market it is subjected to post-marketing surveillance in order to identify side-effects and other adverse effects which only become evident as much larger numbers of individuals are treated with it. In addition, formal clinical trials continue in order to develop a greater understanding of the compound and its effects in a wider clinical environment, but also to extend its use for other indications or for different patient groups, such as children or the elderly. Special study designs may be used according to the objectives of the study to evaluate safety or efficacy, and may include the study of temporal trends, case-control studies, or the phased introduction of an intervention in different areas. Phase IV trials may also be designed to measure the impact of the intervention on the epidemiological pattern or transmission of an infectious disease. (See also clinical research.) [Source: Nuffield Council on Bioethics]
Placebo
A treatment known to be without effect, usually used as a control to be compared against a potentially effective substance or method which is being subjected to clinical trial. [Source: Nuffield Council on Bioethics]
R
Randomised controlled trial
An experiment in which investigators randomly allocate eligible participants into control and intervention groups to receive one or more of the interventions that are being tested. The results are assessed by comparing outcomes of the two groups. (See also control group.) [Source: Nuffield Council on Bioethics]
Research ethics committee (REC)
Research ethics committees are convened to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards. The purpose of such a committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. In contrast to IRBs, research ethics committees are often not affiliated with the organisation conducting the research. (See also institutional review boards, ethical review.)
Respect for persons
Research ethics committees are convened to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards. The purpose of such a committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. In contrast to IRBs, research ethics committees are often not affiliated with the organisation conducting the research. (See also institutional review boards, ethical review.)
S
Social and behavioural research
Such research is often a component of epidemiological research and focuses on factors that may modify risk of disease in individuals or in populations. It may involve the collection of sensitive information about a person and their lifestyle (such as sexual behaviour). While some forms of social and behavioural research may only involve observation others may include studying or testing ways of changing behaviour or social circumstances. (See also epidemiological research.) [Source: Nuffield Council on Bioethics]
Standard of care
The phrase 'standard of care' can be interpreted in a number of different ways. For the purposes of this dossier it is defined as 'the nature of the care and treatment that will be provided to participants in research'.
U
Universal standard of care
The best current method of treatment available anywhere in the world for a particular disease or condition. For most diseases and conditions such a standard of care is routinely available to only a small proportion of the world’s population. [Source: Nuffield Council on Bioethics]
