Glossary

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a

assent: agreement to participate in research given by an individual not able to provide free and informed consent.

authorized third party / authorized representative: a representative of an individual who is not competent to provide free and informed consent. The authorized third party acts in the interest of that individual.

b

Belmont Report: A document identifying the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects including guidelines to ensure that research is conducted in accordance with the principles.
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

c

competence: the ability of prospective subjects to give informed consent in accord with their own fundamental values. It involves the ability to understand information presented, appreciate the potential consequences of the decision, and provide free and informed consent.

confidentiality: the expectation that information communicated in the context of a special relationship will be held in confidence or kept secret.

d

data linkage: linkage of information about individuals in one database with information about some or all of those individuals in another database.

Declaration of Helsinki: the World Medical Association's (WMA) response to the Nuremberg Code. The Declaration of Helsinki was adopted by the WMA in 1964 and has been amended five times, at regular intervals. A note of clarification about placebo-controlled trials was added in 2002.
http://www.wma.net/e/policy/b3.htm

dissent: refusal to participate in research by an individual not able to provide free and informed consent.

e

ethics review: the process by which principles of ethics are applied to research involving human subjects.

expedited REB review: ethics review of research proposals within the range of minimal risk by an individual or subgroup of the REB. Expedited review may also be used for some annual renewals of approved projects, some research involving health record review, and for affirmation that the modifications requested by the REB as a condition for approval have been met.

f

free and informed consent: the dialogue, information sharing, and general processes through which prospective subjects choose to participate in research.

g

h

harms and benefits: the physical, psychological, social, economic or legal impact of research on a research subject and/or on society. Harms and benefits vary according to the research discipline and the methodology used. They may be difficult to predict.

i

identifiable personal information: information relating to a reasonably identifiable person who has a reasonable expectation of privacy. This can include information about personal characteristics such as culture, age, religion and social status, as well as their life experience and educational, medical or employment histories.

j

k

l

legal incompetence: a legal state, defined by procedures spelled out in provincial law, that an individual is unable to consent for him or herself.

m

minimal risk: a situation in which the probability and magnitude of possible harms associated with the research are no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research. This evaluation should be made from the perspective of the research subject.

n

Nuremberg Code: a series of 10 principles for permissible medical experiments involving human subjects, articulated in 1947 as part of the judgement in Nuremberg against some of the physicians who led the experiments on inmates of the Nazi concentration camps.
http://ohsr.od.nih.gov/guidelines/nuremberg.html

o

p

Personal Information Protection and Electronic Documents Act (PIPEDA): establishes rules to govern the collection, use and disclosure of personal information in commercial activities. It was designed to recognize the right of privacy of individuals with respect to their personal information and the need for organizations to collect, use or disclose information for purposes that a reasonable person would consider appropriate in the circumstances. In an era where industry-sponsored drug trials are commonplace and public-private partnerships are encouraged, some researchers may find themselves within the purview of the PIPEDA.

privacy: the claim of individuals, groups or institutions to determine for themselves when, how, and to what extent information about them is communicated to others.

Privacy Act: protects the privacy of individuals' personal information held by federal government institutions and gives individuals a right of access to personal information. It has requirements that pertain to collection, use, disclosure, consent, safeguarding, retention and destruction of personal information held by government institutions.

proportionate approach to ethics review: the attitude that the more invasive the research, the greater the care should be in assessing the research.

q

r

research: a systematic investigation to develop or contribute to knowledge (which is expressed, for example, in theories, principles, and statements of relationships). Intent to disseminate the results of the investigation in the form of a report, thesis, book, journal article or conference presentation may also signal a scholarly intent.

Research Ethics Board (REB): a multidisciplinary committee established by an institution to undertake the ethics review of research projects involving humans developed or undertaken within that institution.

research involving humans as subjects of research: research that includes observation of people going about their daily activities, evaluation of a new teaching method, testing of new drugs or medical devices, interviewing an individual in public life for a scholarly purpose, and research involving human remains, cadavers, tissues, biological fluids, embryos or foetuses. It does not include research about an individual (usually in the public arena or an artist) based exclusively on publicly available information such as documents, records, works, performances, archival materials or third-party interviews.

s

secondary use of data: the use in research of data contained in records collected for a purpose other than the research itself.

t

technology transfer: the process of moving research results from the laboratory to the marketplace.

Tuskegee Syphilis Study: From 1932 to 1973, physicians sought to trace the natural history of syphilis by observing 400 African-American men with syphilis in Tuskegee, Alabama. The subjects, poor share-croppers, were enticed into the study with offers of free medical examinations and special free treatments. These special treatments were actually diagnostic procedures such as lumbar punctures. The false belief that treatment was being administered prevented subjects from otherwise seeking medical treatment for their disease. Penicillin was withheld from the subjects after it was found in the 1940s to be a safe and effective treatment.

u

v

vulnerable persons: persons whose situation or characteristics may make them unable to provide free and informed consent to participate in research. This group includes children, institutionalized persons, those who have cognitive impairments, and those in a position of inferiority.

w

Willowbrook Studies: From 1956 to 1972, physicians in New York State infected approximately 800 profoundly mentally impaired children with the hepatitis virus at the time of admission to Willowbrook State School in order to study the course of disease from the earliest stages of infection. Entry to Willowbrook was initially most rapid if parents consented to the hepatitis research; later it was the only way for parents to get their children in.

x

y

z