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Epigenetics is the study of changes in gene activity (expression) that do not involve changes in the underlying DNA sequence (genotype). Epigenetic changes are a regular and natural occurrence, but they can also be influenced by several factors “ including age, environment/lifestyle, and disease state “ through mechanisms that switch genes on or off.


Epigenomics is the study of the complete set of epigenetic modifications on the genetic material of a cell, known as the epigenome. The epigenome marks the genome in two main ways, both of which play a role in turning genes on or off.

In epigenomics, researchers try to chart the locations and understand the functions of all the chemical tags that mark the genome. Epigenomic maps may someday help doctors make diagnoses and tailor a patient's response to therapies.

Equity considerations

An assessment of how adoption of the new therapy might impact measures of fairness within the health system. For example, will the therapy lead to more benefits for people who are socially or economically disadvantaged?

Ethical Principles

Ethical principles exist both to protect the research participants and to ensure the integrity of the research. There are various codes and regulations which guide ethical research today, including the Declaration of Helsinki, although a number of common principles exist.

The World Medical Association (WMA) developed the Declaration of Helsinki as a statement of ethical principles specifically for medical research involving human subjects. It emphasises the procedures required to ensure subject safety in clinical trials including informed consent and review by research ethics committees.

Ethical Review Committee

Ethical Review Committee

Ethical, Legal, and Social Implications

Ethical, Legal, and Social Implications

Ethics Committee

An Ethics Committee is an independent body made up of a range of individuals including medical or scientific professionals and non-medical or non-scientific members (e.g. patients or lay members). An Ethics Committee may operate within an institution, or it may be national, or supranational or private.

Ethics committees have a responsibility to ensure the protection of the rights, safety and wellbeing of research participants, as well as assuring the public of that protection. It operates, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial, the adequacy of facilities, and on the methods and documents to be used to inform trial participants and obtain their informed consent. A trial should only begin when a favourable opinion by an Ethics Committee has been given.

Ethics Committees may also monitor studies once they have begun and once they are complete.

EU Regulation

A regulation is a written rule or law. European regulations are binding legislative acts. They must be applied in their entirety across the EU simultaneously from the date agreed. Regulations can be distinguished from European directives which are legislative acts that set out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Directives need to be ˜converted™ into national law before they are enforceable.


The European network for Health Technology Assessment was established to create a network for HTA across Europe, developing a framework (HTA Core Model®) by which a technology (for example a new medicine) can be assessed. It facilitates efficient use of resources, creating a sustainable system of knowledge, and promoting good practice in HTA methods and processes. The network connects public national HTA bodies, research institutions and health ministries, to exchange information and to support policy decisions by member states.


The EuroBioBank network is the first operating network of biobanks in Europe providing human DNA, cell, and tissue samples as a service to the scientific community conducting research on rare diseases. It was established by patients and researchers.

A biobank is a large, organised collection of samples, usually human, used for research. Biobanks catalogue and store samples using genetic, clinical, and other characteristics such as age, gender, blood type, and ethnicity. Some samples are also categorised according to environmental factors, such as whether the donor had been exposed to some substance that can affect health. Biobanks play a crucial role in biomedical research, such as in genomics and personalised medicine. Researchers access biobanks when they need samples with similar characteristics for their research studies.

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