NWU Office for Research Support – Ethics Committee
E-mail: [email protected]
INFORMATION GUIDE FOR THE
NWU ETHICS APPLICATION FORM
Application for Approval for Scientific Projects
with Human Participants, Biological Samples of
Human Origin or Vertebrates
Version 1.01 (May 2008)
Table of Contents
1.
GENERAL ORIENTATION ON ETHICS APPLICATIONS ................................................................... 1
1.1
1.2
1.3
1.4
2
PROJECTS REQUIRING ETHICAL APPROVAL .................................................................................................. 1
REASONS FOR ETHICAL APPROVAL .............................................................................................................. 1
GENERAL ETHICS GUIDELINES ..................................................................................................................... 2
TERMINOLOGY, CONCEPTS & PRINCIPLES .................................................................................................... 3
THE ETHICS APPLICATION PROCESS.................................................................................................. 4
2.1
2.2
GENERAL INSTRUCTIONS FOR APPLICANTS .................................................................................................. 4
RESULT, APPEAL & CONDITIONS AND RULES ............................................................................................... 5
CREDITS .................................................................................................................................................................. 6
Information Guide for the NWU Ethics Application Form
1. General Orientation on Ethics Applications
1.1 Projects Requiring Ethical Approval
Any study or research project for the purpose of research or education1 in which (1) people
are involved and any form of study / survey / interaction / interference / intervention done with /
on the people and their lives or information obtained directly from the people (excluding where
mere public observations are made without any interaction2) or where (2) existing, stored
biological material or matter of human origin that was collected for another project or for
diagnosis, is used or in which (3) vertebrate animal subjects (including animal foetuses from
50% of the gestation period) are involved, must receive ethical approval from the Ethics
Committee.
Examples of projects for which ethical approval is required, whether or not it is for the purpose
of research, education, policy studies or management, include where any:
• information is obtained in any manner from/about people or communities (e.g.
questionnaires and surveys, the measuring of physical, physiological, psychosocial and
socio-economic parameters, etc.),
• experimental interventions with people or animals (e.g. the administration, modification or
withholding of drugs, food, exercise, activities, medical and/or psychosocial
interferences/therapies, etc.),
• experimental analysis is done on biological fluids, tissue samples or swabs of human origin
(even if it comes from a tissue bank or other source and even if the researcher and coworkers never come into contact with subjects3).
• retrospective studies making use of patient files or other archives with personal, privileged
information about individuals.
• researchers or lecturers take part in projects that are registered with ethics committees of
other parties/institutions and in which the North-West University is involved directly or
indirectly (in which case the Ethics Committee of the North-West University is to be notified
of the project in writing, provided with a protocol, and approval be given that this project
may be linked to the North-West University).
1.2 Reasons for Ethical Approval
Ethical approval for protection
The primary goal of ethical approval is the protection of (1) the participants (subjects) or
animal subjects, (2) the project team (e.g. researchers) and (3) the employer. Ethical
screening is a quality control measure that monitors whether the actions were ethically
responsible and legal and whether all appropriate safety measures were in place. Ethical
approval does not attempt to stymie research or undermine it unnecessarily, but merely to
assist the project leader in managing responsible conduct.
1 It must be noted that ethical approval for projects for the purpose of both research (acquisition of new knowledge) and
education (e.g. a project where learners / students must do a study simply for the learning experience) is necessary. So e.g.,
even when learners only have to do a small study / survey / interaction / interference / intervention with / on each other or other
learners for a small project or practical described in the study guide, it’s necessary that the lecturer obtains prior ethical
approval for that project as educational activity of a certain module or course.
2 Where observations are simply made in public, without any interaction with people (e.g. when the researcher goes and sits in a
public area and observes how people behave, without interacting directly with any person), ethical approval is not necessary.
3 There are several exceptions, e.g. the use of standard tissue culture lines from tissue banks, for which general informed
permission already exists.
Information Guide for the NWU Ethics Application Form
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Ethical approval is compulsory
Ethical approval is not optional, but compulsory, and no project may be initiated before this
approval has been received. Approval must comply with the requirements of all authorities
under which the project team falls (e.g. the country’s laws, employer, professional councils,
etc.) and, where requirements differ, the strictest requirement applies. All relevant approval
must already have been obtained (inter alia, an allocated ethics number) before any project
may commence. Without the necessary ethical approval any project is illegal and furthermore
there is NO protection from the employer (e.g. from the North-West University). The project
leader may then also be prosecuted and is personally legally responsible for any problems
that may arise and claims that may be instituted. Ethically responsible use (according to
international convention) and ethical approval is also a prerequisite for most grant applications
and for publication in all good, accredited international scientific journals. Furthermore, any
person has the right to request to see and study the original data of published results in order
to verify the accuracy and validity thereof.
The project leader is personally responsible
The ethical justifiability of any project remains the responsibility of the project leader, who
must himself/herself be au fait with the ethical implications of any project and must manage it
responsibly. The Ethics Committee offers the researcher and lecturer a service in order to
facilitate the obtaining of the necessary ethical approval from the North-West University (and
in line with international guidelines), and does not simply lay down unnecessary aggravating
rules. Evaluators of the Ethics Committee are all volunteers who kindly and without any
compensation assist the applicants with the ethical evaluation and approval.
The
responsibility remains with the researcher to ensure that the necessary ethical approval is
obtained and that the necessary selection panels are provided with the necessary information
for assessment in a friendly, understandable and accessible way. The application form is
designed to make it as clear and easy as possible for both the applicants and evaluators to act
ethically justifiably and to meet the requirements.
1.3 General Ethics Guidelines
General ethics guidelines and more specifically as applicable to research in the health
sciences, are summarised in electronic books that are available on the Medical Research
Council’s Website [Web link]:
• Book 1: Guidelines on Ethics in Medical Research: General Principles. [Web link]
• Book 2: Guidelines on Ethics in Reproductive Biology and Genetic Research. [Web link]
• Book 3: Guidelines on Ethics in the Use of Animals in Research. [Web link]
• Book 4: Guidelines on Ethics in the Use of Biohazards and Radiation. [Web link]
• Book 5: Guidelines on Ethics in HIV Vaccine Trials. [Web link]
Principles for human participants:
Book 1 above discusses the four basic principles on which the medical ethic rests, viz:
“autonomy (respect for the person - a notion of human dignity), beneficence (benefit to the
research participant), non-maleficence (absence of harm to the research participant) and
justice (notably distributive justice - equal distribution of risks and benefits between
communities)”
Principles for animal subjects:
Book 3 above discusses the three basic principles of Russell and Burch on which the animal
research ethic rests, viz: “replacement (of sentient animals with non-sentient research models
or systems), reduction (of the number of animals to smallest number necessary for valid data
and by optimal design) and refinement (of sourcing, care and experimental procedures to
minimise distress, within experimental boundaries)”
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1.4 Terminology, Concepts & Principles
The following explanations may help the applicant (project leader) to gain clarity on the use of
terms in this application form. It also explains certain concepts and principles that apply:
• Participant (subject):
Human subjects in studies / experiments are rather called participants in the current ethical
paradigm, thereby indicating equal partnership.
• Project team, project leader, project supervisor, co-workers, assistants and field workers:
The “project leader” is a researcher or lecturer who accepts final, overall responsibility for
the management of the total project (from beginning to end), is thoroughly familiar with the
theoretical substructure and practical / experimental background of the project, manages
the process of data collection, data handling, data processing and data archiving, as well
as co-ordinating all activities of the research team. Where the project leader is not
physically present or consistently available and where supervision of the research activities
is necessary, or where the project leader is relatively inexperienced (e.g. junior
researchers), a “project supervisor” may assist the project leader. All other researchers who
are actively involved in the project are co-workers. Other helpers who are not involved in
the capacity of a researcher are assistants or field workers. These persons are usually
trained and accompanied by researchers to assist especially with the collection and
processing of data. All these persons who together are involved with the planning and
execution of the study / research project are called the project team.
• Professional supervisor:
Some interventions with people or animals require supervision by an appropriate registered
professional person, such as a medical doctor, nurse, psychologist, pharmacist or
veterinary surgeon, for example. Sometimes more than one type of supervisor is
necessary, e.g. a medical doctor, a psychologist and a pharmacist. Where supervision is
compulsory by law, such a person must be able to act impartially. This person may
therefore not be directly involved in the research as a researcher, but must look after the
well-being of the participants (subjects) or animal subjects professionally, independently
from the impact on the project. The “professional supervisor” must not be confused with the
“project supervisor”.
Examples of where a professional supervisor is necessary include:
-
A medical doctor where patients are examined and monitored medically.
-
A medical doctor where unregistered medication is used or where medication is used
for another indication than that for which it’s registered.
-
A psychologist where psychotherapeutic interventions are investigated.
-
A pharmacist where scheduled medicines are kept and distributed.
-
A nurse where blood samples are drawn.
-
A veterinary surgeon where animal subjects are given anaesthetics, and/or surgical
operations are performed4.
-
A qualified scientist (who is competent, appropriately registered with the Council of
Natural Science Professions (SACNASP) and where the necessary authorisation is
obtained from the Veterinary Council (SAVC)) where certain procedures are carried out
on animal subjects.
4 New legislation is now very strict w.r.t. the actions belonging to a veterinary surgeon and which may not be carried out by
another unqualified person. Some of this action may be carried out under supervision of a veterinary surgeon by a veterinary
technologist or, with the necessary registration and permission, by a qualified scientist (see following paragraph).
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• Project, study, research, experiment, trial and training:
Different disciplines use terminology differently and you can interpret it as appropriate
within your discipline. In this application form “project” refers to any form of scientific study
for the purpose of research or training. “Research” refers specifically to a scientific study
with the purpose of providing new data / information / knowledge. An “experiment” is a very
specifically planned scientific study that controls certain variables and attempts to
determine the influence of specific factors on variables. Some disciplines in science do not
do experiments and therefore use broader terminology such as “study / investigation”. A
“trial” or “clinical trial” refers to an experiment in which humans are involved. A project for
“training” implies that it is not aimed at the collection of new information (research), but
rather the training of undergraduate and postgraduate students (e.g. laboratory practicals,
small studies or interventions as specified in study guides, etc.).
• Full / final study vs. pilot study:
In some cases pioneering work is done in research and there are no clear guidelines for the
boundaries of the variables within which to work, or the validity of a test instrument is
unknown, or the number of participants needed to obtain valid data is unknown. In such
instances it is necessary to first do a pilot study with a limited number of participants in
order to determine the guidelines. From the results of the pilot study it is then determined
exactly how the full (final) study will be done. Since the pilot study can have a real influence
on how the full (final) study will be done, no ethical approval can be given beforehand for
the full (final) project (the Ethics Committee may not and will not issue a proverbial “blank
cheque” for ethical approval). It is therefore necessary to apply first for the pilot study
separately, to finalise it and then plan the full (final) study thoroughly based on the results
of the pilot study. Only then can an application be made for ethical approval of the full (final)
project in a second application.
• Authorisation, consent, proxy consent and assent
”Authorisation” is given by authority (e.g. the Department of Health or the Medicines Control
Council) to execute certain scientific projects or actions. A legally competent person who is
legally authorised to act on that person’s behalf (e.g. an adult who understand the
implications and consequences) may give “consent” to participate in a scientific project.
When a person is unable to give consent (e.g. during coma, or a minor or a person that is
not mentally competent), a legally competent person (e.g. a spouse or close relative of the
person in the coma, or the legal parent or guardian of a child) may give “proxy consent” in
the participant’s best interest. The latter may only be given by the legally competent
person and not by a doctor, hospital manager, institution manager, etc. When proxy
consent is given, the minor must still give free “assent” and proxy consent can never
override refusal for assent by the minor. Free withdrawal after any consent, proxy consent
or assent should always be respected and guaranteed, with immediate effect and without
any negative consequences or penalty to the person(s) who withdraw.
2 The Ethics Application Process
2.1 General Instructions for Applicants
The following general principles apply:
• The latest version of this form, as available on the PUK Website [Web link], must be used.
This form will shortly be made available in Web format, however, after which the system will automatically
generate an individualised ethics application form for you, with only the necessary sections that you must
complete, on the basis of the answers you provided in Section 1.
• The responsibility rests and remains with the applicant (project leader) to present the
application as comprehensively, clearly and in as evaluator-friendly a manner as possible
and to ensure that all ethical aspects are addressed.
• How to complete:
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- The form must be completed electronically (typed in Microsoft Office Word).
- All applicants complete Sections 1, 2, 3, 7 & 8.
- In addition, applicants must complete those parts of Sections 4, 5, 6 & 9 that apply to
their project (see table of contents).
- All relevant parts must be completed in full on the ethics application form itself. Mere
reference to a research proposal is unacceptable and applications that do not meet this
requirement will be not be evaluated, but returned.
-
This form has been designed to allow typing and editing only in those parts that
needs to be filled in, marked with dark red text on grey shadowed backgrounds.
Complete the form by (1) typing in text areas prompting “Type here”, “0” or “°”, (2)
tick-marking appropriate tick boxes (e.g. ) and (3) selecting options from the
dropdown lists (e.g. - select - ).
-
You may move between grey areas to be filled in by using the “Tab” key on your
keyboard, or forward in the document by scrolling down and then select the
appropriate grey areas to be filled in.
-
You may select the whole “Type here” phrase in text areas and begin typing over
the red text, or “copy & paste” the relevant text from an existing research proposal
and adapt as necessary. Please be aware of not copying text blindly, without
ensuring that it reads correctly within the new context of the question in the
application form.
-
As parts are filled in on the form, it is logical and acceptable that information shifts
down and the page layout adjusts accordingly.
- The pages with declarations and signatures (see Error! Reference source not
found.) must be printed out and signed and sent on to the Office of the Director:
Research Support (Box 116, PUK, North-West University, Potchefstroom, 2520) by
ordinary / internal post. As soon as this form is made available shortly in Web format and electronic
verification is possible, printouts and signatures will be eliminated.
• The fully completed form must be sent by e-mail to the Office of the Director: Research
Support at [email protected] at least six (6) weeks before the planned commencement of
the project.
2.2 Result, Appeal & Conditions and Rules
Result
The result of the application will be communicated to the project leader by e-mail and in the
case of final approval (with allocated ethics authorisation number), the project leader will
also be provided with it in writing.
Appeal
If you want to appeal against the result, you can motivate it in writing or you can also
request that a conversation with the evaluation panel be organised to clarify the
problems/obscurities. The procedure is described in the constitution of the Ethics
Committee.
Conditions and Rules
Any project is approved for a maximum of 5 years, whereupon application for approval for
continuation with the project must be made again. The project leader of an approved
project must:
1. make sure that the project is managed ethically justifiably from start to finish;
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2. make sure that the approved protocol is adhered to precisely and, where any
amendments to the protocol are required, first apply to the ethics committee for approval
of the amendment before it is implemented;
3. report any problems or complications experienced during the project without delay to the
ethics committee;
4. report annually (or as determined by the ethics committee) to the ethics committee on the
prescribed forms on the progress and all ethical aspects of the project;
5. on termination of the project, report to the ethics committee on the prescribed forms on
the outcome of the project, as well as all ethical aspects of the project;
6. ensure that all raw data is stored safely and remains in the possession of the North-West
University.
Credits
Compiled on request of the NWU Ethics Committee by Prof Christiaan B Brink (PhD)
Advisory panel: Prof Hester Klopper, Dr Alan MacLeod, Prof Nico Malan, Dr Douw van der
Nest, Dr Francois van der Westhuizen, Prof Marié Wissing
Other credits: Many individuals contributed in various ways to formulate, develop and compile
previous ethics application forms of the University, of which excerpts were used to formulate
some of the contents of the current ethics application form.
©Copyright 2007, North-West University, all rights retained
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