TRAINING AND RESOURCES IN
RESEARCH ETHICS EVALUATION
FOR AFRICA

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TRREE Glossary


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A | B | C | D | E | F | G | H | I | J | K | L | M | N | O
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A

Adverse Drug Reaction

:
Réaction indésirable à un médicament (RIM) -- Unerwünschte Arzneimittelwirkung (UAW)
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.1
Keyword(s):

Adverse event (AE)

:
Effet indésirable (EI) -- Unerwünschtes Ereignis (UE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable 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.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.2

Approval (of a research ethics committee)

:
Approbation (d’un comité d'éthique de la recherche) -- Genehmigung (einer Forschungsethikkommission)
The affirmative decision of the Research Ethics Committee (REC) that the clinical trial has been reviewed and may be conducted within the constraints set forth by the REC, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

B

Beneficence

:
Bienfaisance -- Fürsorgliches Handeln
1) Beneficence refers to the ethical obligation to maximize benefits and to minimize harms.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles
2) Literally, ‘doing good’. Physicians are expected to act in the best interests of their patients.
World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary
Keyword(s):

Benefit

:
Bénéfice / avantage -- Nutzen / Vorteil
Which refers to the magnitude of a good outcome.

C

Clinical Equipoise

:
Equilibre clinique -- Klinisches Gleichgewicht (Klinische Gleichwertigkeit)
Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participation.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

Clinical Trial/Study

:
Essai/étude clinique -- Klinische Prüfung / Studie
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.12

Community

:
Communauté -- Gemeinschaft
A community is a group of people understood as having a certain identity due to the sharing of common interests or to a shared proximity. A community may be identified as a group of people living in the same village, town, or country and, thus, sharing geographical proximity. A community may be otherwise identified as a group of people sharing a common set of values, a common set of interests, or a common disease.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 21

Confidentiality

:
Confidentialité -- Vertraulichkeit
Principle according to which personal information can only be disclosed with the informed consent of the person concerned and solely to authorized persons.

Conflict of interest

:
Conflit d’intérêts -- Interessenkonflikt
1) "Set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest."D.F. Thompson, "Understanding financial conflicts of interest" (1993) 329 New England Journal of Medicine 573-6,
Québec health and social services network, Tutorial in research ethics, Resources – Glossary
2) A conflict of interest arises when a member (or members) of the EC holds interests with respect to specific applications for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the research focused on the protection of the research participants. Conflicts of interests may arise when an EC member has financial, material, institutional, or social ties to the research.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 21

Contract research organization (CRO)

:
Organisme de recherche sous contrat (ORC) -- Auftragsforschungsinstitut (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.20

D

Database

:
Base de données -- Datenbank
A trial results database provides the results of completed studies, and should be accompanied by methodological details to place the results in context. The results may or may not have been peer reviewed. A results database may be separate from a trial register. Thus, a trial may be registered in one register and have its results reported in a different results database.
WHO, International Clinical Trials Registry Platform (ICTRP)

Direct benefit

:
Bénéfice direct -- Unmittelbarer Nutzen
A direct benefit to a person’s health signifies not only treatment to cure the patient but also treatment that may alleviate his/her suffering thus improving his/her quality of life.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, explanatory report, Article 6 (risks and benefits)

G

Good clinical practice (GCP)

:
Bonne pratique clinique (BPC) -- Gute Klinische Praxis (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.24

H

Harm

:
Inconvénients, préjudice, dommage -- Schaden
Which refers to the magnitude of a bad outcome.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

I

Inclusion/exclusion criteria

:
Critères d’inclusion/exclusion -- Einschlusskriterien/Ausschlusskriterien
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
US National Institut of Health, ClinicalTrials.gov, Glossary of Clinical Trials Terms

Incompetent adult

:
Majeur Incapable -- Nicht urteilsfähiger Erwachsener
In the context of research, an incapable adult is an adult who cannot consent to research alone.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary

Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

:
Comité indépendant de contrôle des données (CICD) (Comité de contrôle de l'innocuité et des données, comité de contrôle, comité de contrôle des données) -- Unabhängiges Datenüberwachungskomitee (IDMC)
1) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.25
2) One function of such a board is to protect the research subjects from previously unknown adverse reactions or unnecessarily prolonged exposure to an inferior therapy.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 8

Indirect benefit

:
Bénéfice indirect -- Indirekter Nutzen
Benefits […] include not only direct benefits but also the benefits of the research to science or society. This is particularly relevant in the case of research that has not the potential to produce results of direct benefit for the health of the person concerned.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, explanatory report, Article 6 (risks and benefits)

Informed consent

:
Consentement éclairé -- Einwilligungserklärung
1) Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 4, General considerations
2) A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.28

Investigative Product

:
Produit de recherche -- Prüfpräparat
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.33

Investigator

:
Investigateur -- Untersucher / Prüfer / Prüfarzt
A qualified scientist who undertakes scientific and ethical responsibility, either on his/her own behalf or on behalf of an organization/ firm, for the ethical and scientific integrity of a research project at a specific site or group of sites. In some instances a coordinating or principal investigator may be appointed as the responsible leader of a team of subinvestigators.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.34

J

Justice

:
Justice -- Gerechtigkeit
Justice refers to the ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him or her. In the ethics of research involving human subjects the principle refers primarily to distributive justice, which requires the equitable distribution of both the burdens and the benefits of participation in research.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles

M

Minimal Risk

:
Risque minimal -- Minimales Risiko
1) It is deemed that the research bears a minimal risk if, having regard to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and temporary negative impact on the health of the person concerned.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Article 17/1
2) Intervention risks that do not exceed those associated with routine medical or psychological examination of such persons.
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9

N

Non-maleficence

:
Non-malfaisance -- Primum nil nocere-Prinzip, Schadensvermeidung
1) This principle proscribes the deliberate infliction of harm on persons
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles
2) literally, not doing wrong. Physicians and medical researchers are to avoid inflicting harm on patients and research subjects.
World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary

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