Anonymity
In a research context, anonymity refers to the collection of data. Anonymous data is of an unknown or undeclared source.
Anonymity differs from confidentiality – please refer to the definition of confidentiality.
Approval Deferred
This term describes the status of an ethics application which has been considered by AUTEC or a delegated authority of AUTEC, but which raises substantial issues or questions which need to be clarified or remedied prior to the research commencing. In this instance, a revised application must be resubmitted to AUTEC. The research can only commence once the revised application has been considered and approved by AUTEC. In these cases, AUTEC arranges for advice and guidance to be available to assist applicants to meet requirements.
Approved
This applies to an ethics application which has been considered by AUTEC or under delegated authority from AUTEC, which has been accepted as sound and ethical research and which can proceed.
Approved Subject to
An ethics application which has been considered by AUTEC or a delegated authority of AUTEC and has been accepted as sound and ethical research but which has several points which need to be clarified or remedied prior to the research commencing. The research can only commence once these points have been addressed to AUTEC's satisfaction. If the points have not been addressed to AUTEC's satisfaction within six months, the application will be closed and a new application will be required if the research is to go ahead.
Assent
This is the agreement to participate in a project, which has been given by a child who lacks the capacity to give full consent. Where a parent or guardian gives the necessary consent to a project involving a child, the child's assent must be obtained if this is possible.
Audit
An investigation into whether an activity meets explicit standards, as defined in an auditing document, for the purpose of checking and improving the activity audited. Audit involves examining practice and outcomes in a particular time and place to see whether they conform with expectations, with a view to informing and improving management rather than adding to general knowledge.
AUTEC
Auckland University of Technology Ethics Committee
Clinical Practice
The day-to-day activities normally regarded as the regular duties of a body of health practitioners during the course of delivering a health service.
Clinical Trial
The following definitions are both in use:
"A clinical trial is any systematic research study involving humans, whether they are patients or non-patient volunteers. The objective of the study would be to obtain clinical and scientific information about a pharmaceutical product, medical items, treatment, medical procedures, etc. The study would be limited to a specific time frame and should have been approved by an accredited ethics committee." [ACC booklet: Clinical Trials, September 1996. A copy of this booklet is held by the Secretary of AUTEC]
or
Any research on human subjects conducted to gain new knowledge into mental and physical health and disease. It would exclude research based on the analysis of secondary sources of health information. Clinical trials involve a wide range of health professionals with different qualifications, skills and expertise and would usually be conducted in hospitals, other health care settings, the community and academic host institutions (Definition from Guidelines for Injuries Caused as a Result of Participation in a Clinical Trial and the Role of Ethics Committees).
In the context of the evaluation of investigational products, a clinical trial means the systematic study of investigational products (medicines or devices) in humans for the collection of information. Studies conducted to discover or verify the effects of and/or identify any adverse reactions to those products; studies of the absorptions, distribution, metabolism and excretion of a product (Phase I/II); studies to ascertain the efficacy and safety of a product (Phase III); and quality of life data and/or pharmacoeconomic studies (Phase IV) all lie within this definition.
Note: All research which is deemed to be a clinical trial must be submitted to a Regional Ethics Committee for ethical review. Please refer to the section titled Approval of Health Research.
Compensation
Payment or medical care provided to participants injured in research. This does not refer to payment (remuneration) for participation in research.
Concurrent Application
An ethics application which is being forwarded to another ethics committee at the same time as it is being submitted to AUTEC. This does not apply where an application is submitted to a Regional Ethics Committee.
Confidentiality
The obligation on persons to whom private information has been entrusted not to use or divulge the information without permission for any purpose other than that for which it was originally given. This includes protecting the identity of individual research participants in addition to any information they may provide throughout the course of their participation. Confidentiality differs from anonymity. Please refer to the definition of anonymity.
Consent Form
This is an acknowledgement signed by potential participants when they have been fully informed about the research (through an oral explanation and/or through a research participant Information Sheet) and are agreeing to participate in the project. Projects may require more than one type of Consent Form. Consent forms should be stored separately from research data for a period of six years.
Please refer to the Consent Form Exemplar in Appendix E and please note that certain people e.g. legal minors cannot give consent (see Assent above).
Delegated Authority
This refers to AUTEC's delegation of authority to specified persons to act on its behalf.
Several people in faculties and across the University have the ability to approve research under special conditions. Please refer to the section on Special Approval Provisions. The AUTEC Chair, Executive Secretary and members also have delegated authority in particular circumstances. Please refer to the section on Committee Decision Making Processes.
External Researcher
An external researcher is someone who is not a student or staff member of AUT. Such a person may be working either for another institution or independently.
Human Materials
Includes the substance, structure, and texture of which the human body or any part or organ is composed and which is removed or separated from that human body; includes cells, blood, blood components, waste products, hair or nail clippings, including those from deceased or living people.
Health Information
Health information includes information:
The gathering and use of health information requires the researcher to consult either the Health and Disability Privacy Information Act or the Privacy Act.
Information Sheet
This sheet fully informs research participants about the research they are invited to participate in, using appropriate language. For example, an information sheet for children will differ significantly from one for teachers. It should include an appropriately worded invitation to participate in the research project. (please refer to Appendices D and D1)
Informed Consent
A person's voluntary agreement, based on adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure.
Institutional Research
Institutional Research is the planning, coordination, collection, organisation, compiling and dissemination of information concerning the characteristics and performance of the institution.
The purpose of Institutional Research is to provide objective, systematic and thorough research that supports the institution's enrolment goals, planning, policy formation and decision making.
"Broadly, 'institutional research' is viewed as a range of activities involving the collection, analysis and interpretation of information descriptive of an institution and its activities, including its students and staff, programmes, management and operations. The findings of such 'institutional research' can assist institutional leaders (in both academic and administrative domains) through informing their planning and decision making."
Zimmer, B; JIR, Vol.4 No.1, May 1995, pg.74, "Achieving quality within funding constraints: the potential contribution of institutional research"
Institutional Research:
(Acknowledgement is made to the Australasian Association for Institutional Research (AAIR) for this information.)
Koha
The general usage and contemporary application of the concept of Koha is as follows:
"It is the offering and presentation of a gift or reward for some work or duty that has been performed by a person, party, group or organisation. It also incurs a mutual obligation"
It involves the three entities the koha, the donor and the recipient. Certain duties and expectations are inherent in the koha concept. The main principle of the koha involves a mutual understanding between the donor and recipient. This in turn leads to an undertaking between the two parties. (This understanding and undertaking is often not written).
Finally, the notion of koha includes an obligation between both parties to adhere to certain procedures.
When a koha (gift or present) is offered or presented to a person, group or organisation implicit in the offering and receipt of the koha is the notion that at some later date (Time can be specified or is unspecified) some reciprocal arrangement will be made. It could be the return, or compensation of a koha.
The koha may be offered in several ways:
If the amount of money or donations given as koha in acknowledgment of duties performed is in excess of actual expenses incurred then that koha is liable for tax. Researchers may wish to refer to the booklet, "Payments and gifts in the Maori community", on the Inland Revenue Website.
Please also refer to the definition of payment.
Lay Person
A lay person is defined in the National Standard as a person who is not currently, nor has recently been:
In educational settings, the term is defined more broadly to refer primarily to the last of the criteria specified above.
Minimal Risk
Risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
Paper Approval
Ethics approval must be sought for taught papers which include a student research component. In this case, the teacher needs to submit an ethics application which explains the types of research being proposed by students and the parameters within which all the research will fall, using Form EA6 (Appendix L). Approval can be given for three years. The Teacher must supply AUTEC with a short report of all student projects and their titles at the end of each year using Form EA7 (Appendix M). Any student project deviating from the original paper approval must be submitted to AUTEC as a separate application.
Payment
The offering of payment or inducements to potential participants is a practice not normally approved by AUTEC, Such instances need to be identified and justified in the application. Small gifts after the completion of the project and/or compensation for expenses incurred in participation may be offered. Please also refer to the definition of Koha.
Public Domain
This refers to information which is openly (and often freely) available to all members of the public, through libraries, publication, the media and/or the internet.
Participants
A participant is any person involved in a research or teaching situation as an experimental subject, as an example of some human characteristic or condition, as a recipient of any physical, psychological, behavioural or social intervention or manipulation, or as a provider of information. Though recognising the variety of descriptions of such persons in different research areas and disciplines, e.g. 'subjects', 'clients', 'patients', 'consumers', 'informants', AUTEC uses the term 'participants' for simplicity and as a reminder of the power differentials inherent in research relationships.
Primary Data
This is information collected directly from "the field", including research participants themselves. Primary data will usually need to be analysed or "treated" in a particular way in order that conclusions or interpretations can be deduced.
Remuneration
Please refer to the definition of payment.
Research
In this document, unless specified otherwise, the term 'research' refers to any investigative activity undertaken by members of the University within, or outside, AUT. This includes any University research, including contract research. Student research, either independent thesis research or as part of course requirements, is also included.
Risk
The function of the magnitude of a harm or injury (physical, psychological, social or economic) and the probability of its occurrence as a result of participation in innovative practices or research studies. Both the probability and magnitude of possible harm may vary from minimal to significant.
Secondary Data
This usually refers to information and knowledge gained through information already in the public domain e.g. through books, journal articles, statistics etc.
Staff Research
This is research undertaken by staff under the auspices of AUT as part of their employment.
Staff as Student Research
This is research engaged in by AUT staff members while studying as formally enrolled students themselves. They may be enrolled at AUT or at another New Zealand or overseas institution.
Student Research
This is research engaged in by students enrolled at AUT. The research may be part of a taught module (usually covered by AUTEC paper approval) or an independent research project (dissertation or thesis).
Teaching
"Teaching refers to any activity which is undertaken by an academic staff member to facilitate learning as part of any course of study prescribed by AUT, and which involves human participants."
Therapeutic Trials
The research physician's intent to provide some benefit to improving a participant's condition (for example, prolongation of life, shrinkage of a tumour, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the consumer's condition as well as assessing the safety and pharmacology of a drug.
All research which is deemed to fall under the category of a therapeutic trial must be submitted to a Regional Ethics Committee for ethical review.
Verified Translation
This is a translation (a text converted into another language or languages) by a properly qualified and certified individual. Ideally, this person should be accredited to the equivalent of at least NAATI (National Association of the Accreditation of Translators and Interpreters) Level Three.
Voluntary
Free of coercion, duress, or undue inducement; used in the health and disability care and research contexts to refer to a consumer's or participant's decision to receive health or disability care or to participate (or continue to participate) in a research activity.
View the contact details for faculty representatives, research ethics advisor and AUTEC.