RESEARCH ETHICS COMMITTEE

HEALTH AND WELLNESS SCIENCES

APPLICATION FOR ETHICAL CLEARANCE FOR THE USE OF ANIMALS

APPLICATION NO.

The application (HWS-REC 4.3) to the Health and Applied Sciences Research Ethics Committee (HWS-REC) follows approval of the research proposal by the Faculty Research Committee.

Documents required for application to HWS-REC:

CPUT application (HWS-REC 4.1)

Research proposal

Consent form

Budget/funding information

Evidence of all other Research Ethics applications/approval for the study.

Evidence of approval for this proposal (scientific merit and investigator qualification) from the Faculty Research Committee (FRC).

Evidence of Qualification registered for if student researcher involved for qualification purposes.

The HWS-REC must receive three hard copies of this application form, all relevant accompanying documentation (i.e. consent forms, questionnaire, instruments, data collection sheets, etc.) and your research proposal.

For submission details see end of document

Title of Experiment:

DECLARATION BY INVESTIGATOR

NB: Undergraduate and honours students may not sign this declaration.

1.I am suitably qualified and, if appropriate, authorised under the Veterinary and Para-veterinary Professions Act 1982 to perform or supervise the procedure proposed.

2.The experiment is likely to advance biological knowledge,. As REC we deal with ethics in research and not for teaching. This includes human involvement so should not be different for animals, I think.

3.The work does not to my knowledge unnecessarily repeat other experiments.

4.The experiment has been designed so as not to be wasteful of animals.

5.The experiment has been designed to minimise discomfort, stress or distress in the animals.

6.Having carefully considered all possible alternatives, I am satisfied that it is impossible to attain the objectives in any other way.

7.I shall comply with any restrictions or modifications required by the Ethics Committee.

8.I agree that at any time during the experiment to provide the Animal Ethics Committee with an annual progress report about the work, when requested to do so.

Signature:
Name: (in capitals)
University Department:
Date:

SECTION A

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1.Please classify this application (mark with one X only).

(a) Fundamental research: / YES / NO
(b) Development of products for animal medicine: / YES / NO
(c) Education and Training: / Graduate: / Undergraduate; Course code:
Demonstration: / Laboratory Exercise: / Students will OR / Will not be handling animals:
Supervised by:

2.Has the specific research project been reviewed for scientific merit by the Faculty Research Committee?

Yes / By whom:
No / Explain why not:
  1. Has this application been submitted or will it be submitted for ethical review by any other ethics committee(s)?

(If your answer is yes, please provide details, including the status of pending applications and a list of all institutions involved.)

4.Expected duration of project

From ………………………….. to ……………………..………….

5.Please give details of your current status in the box below:

5a. Applicant

Name: / Qualifications:
Univ. Dept: / Tel No:
E-mail: / Fax No:
Staff No: / Student No:1

1 Please enter student number if you are currently registered for a higher degree at the University

5b. Principal investigator (if not applicant).

Name: / Qualifications:
Dept: / Organisation:
E-mail: / Tel No:

5c. Co-workers

Please list in the table below the names, qualifications and duties of co-workers involved in this project. The names of persons responsible for performing the surgery and administering the anaesthetic should be clearly indicated.

Name /

Organisation

/ Qualification /

Specific Duties

/ Tel No. /

Regis-

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1 Please indicate if any researchers or co-workers for this protocol are registered with the Health Professions Council of South Africa (HPCSA), the South African Veterinary Council (SAVC) or the Natural Scientists Council (NSC):

6.Should any permits be required for this project, please list.

Relevant authority / Application date / Status

SECTION B:

DETAILS OF THE EXPERIMENT

  1. Background

(An introductory statement should describe in terms comprehensible to a lay person the basis of the experiment or teaching exercise and the potential significance of the project. In particular this section should clarify how this work builds on previously published studies. Key references should be cited and then listed.)

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  1. Rationale for use of vertebrate animals

(Justify the use of animals, the choice of species, the numbers to be used and if there is limited availability, or large numbers are to be used, provide additional rationale for their selection and numbers. State also which non-animal models were considered and on what grounds they were rejected.)

3.Statement of specific objective/s/hypotheses:

(The major specific objective is to be stated briefly and clearly, eg "For teaching basic mammalian anatomy", or “To determine the effect of sunlight on plasma vitamin D concentration".)

4.Potential benefits of the research / teaching exercise:

(These are required to aid the reviewing committee in performing a harm/benefit assessment.)

SECTION C:

1.Animals

a. Please indicate the animals required in the table below

Species / Strain (if applicable) / Gender / Age/Body Mass / Total number of animals required

b.Briefly describe how the animals will be caged and what provisions have been made for their physical and psychological wellbeing i.e. comfort, socialisation, behavioural needs and enrichment of their cage environment:

  1. Can standard (in the case of laboratory and domestic animals) or appropriate (in the case of wild animals) husbandry procedures be followed, including twice daily inspections?

Yes / No Please delete which is not applicable

If “Yes”, list the responsible person(s)

If “No”, please explain briefly.

2.Is this a pilot study?Yes / No Please delete which is not applicable

  1. Experimental Design

(Describe how the animals will be allocated to experimental and control groups and how the experimental treatments will be assigned to each group, where applicable.)

  1. Summary of manipulations and management involved in this protocol: check as appropriate and wherever YES is the answer, please provide full details in the space provided below, continue on additional pages if necessary. Include description of sequence of manipulations where procedures are combined.

NO / YES
A. / RESTRAINT (chemical or physical method and duration)
B. / NON-INVASIVE PROCEDURES (method, duration, frequency, time interval between procedures, expected clinical effects)
C. / INVASIVE PROCEDURES (method, duration, frequency, time interval between
procedures, expected clinical effects)
D. / DEPRIVATION (type, duration, frequency)
E. / ADMINISTRATION OF CHEMICALS/BIOLOGICALS (agents, dose ranges, routes, schedule, expected clinical effects)
F. / ANESTHESIA
Inhalation: / Halothane: / Isoflurane: / Other:
Injection: / Drug: / Dose/route:
Drug: / Dose/route:
Local/regional: / Drug: / Dose/site:
Fluid therapy: / Drug: / Dose/route:
Administered by (name):
G. / NEUROMUSCULAR BLOCKING AGENTS (purpose, type):
H. / SPECIAL MANAGEMENT (diet, sedation, antibiotics, special nursing, analgesics,
tranquillisers, etc.
To be provided by:
I. / DEATH (justify and provide brief description of and reference for procedure)
J. / OTHER (additional information not included above):
Details of answers above (A flow diagram may be used but should not replace important details):

5.Pain and/or distress expected (check):

When /
Level
During restraint/handling / Nil / Low / Moderate / High / N/A
During procedure / Nil / Low / Moderate / High / N/A
Immediately post-operation / Nil / Low / Moderate / High / N/A
During convalescence / Nil / Low / Moderate / High / N/A
Over long term / Nil / Low / Moderate / High / N/A
Other: / Nil / Low / Moderate / High / N/A
Description of “other”:
Justify any distress or pain
expected:

6.Measures to alleviate pain and/or distress:

NONE / If selecting this option you MUST provide a detailed scientific justification.
YES, analgesics; as follows / Agent / Route / Dosage / Time span
Before procedure
During procedure
Immediately after procedure
Long-term
As necessary
Agents to be administered by:
YES, other measures (i.e. management, etc.):
  1. Reduction of number of animals to a minimum to achieve scientific objective

(Describe how the data from the study will be analysed statistically and justify the number of animals which have been requested.)

  1. Protocol end points

(Give the endpoints of data collection in experiments or procedures that may cause animals to become ill, lose weight, become distressed and experience pain. Justify these in terms of the needs of the experiment in order that it may attain its objectives. Also state at which point interventions to avoid death will be taken.)

9.Hazardous materials and organisms

a.If any of the following materials are to be used in living animals, mark with an ‘X’:

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Radioactive isotopes / Infectious organisms
Carcinogens / Tumour Cells
Teratogens / Tissue, serum or other biological material

Mutagens

/

Transgenics

Toxins

/ Other

Pesticides

/ None

b.What precautionswill be taken with the materials, live/dead animals, their tissues, and body fluids?

c.Are appropriate facilities for the use of these materials/organisms in place?

d.How will exposure of people, animals and the environment to these materials/organisms be minimized?

10.a.Drug administration

Please list in the table below the name/s and qualification/s of the person/s responsible for drug handling/administration and who will be using the drugs listed in Section 4 and 6.

Name / Qualification / Telephone No.

b.Drugs.

If any Schedule 3 - 7 substances in terms of the Medicines and Related Substances Control Act, Act 101 of 1965, i.e. analgesics, tranquilizers, anaesthetics, antibiotics etc, will be used please give the name and qualification(s) of the person who is legally authorised to use or supervise the use of these substances.

Name / Qualification(s) / Signature

c.Side-Effects

Please given any known adverse effects for the drugs listed in 4 and 6.

11.Post-operative care

Can appropriate veterinary care be given to animals in this experiment?

Yes / No Please delete which is not applicable

If "No", explain briefly.

12.Ultimate fate of the animals (please tick one)

Euthanasia

/ Justify:

Return to stock

/ Justify:

Return to source

/ Justify:

13.Please provide any information not mentioned in this form that should be considered in the ethical clearance of this project:

SECTION D

Declaration by Head of Department/Programme or designated deputy

(i)This application is submitted with my approval and I am satisfied that the investigator is competent to undertake or supervise this research or teaching project.

(ii)I have examined the project protocol and consider it to be scientifically sound.

(iii)I believe that there are no alternative methodologies which exclude the use of animals and which would be likely to produce a satisfactory outcome.

Signature (Head or Designated Deputy):...... ……………......

Date:...... ……......

Submit electronic version of completed application form to:

Miss Oelfah Daniels

Sumit:

2 hardcopies of completed application form HWS-REC 4.3

2 copies of research/project proposal

Evidence of Faculty Research Committee approval

Evidence of applications/approval from any other Ethics Committees

To:

Ms O Daniels

Research Ethics Committee

Faculty of Health and Wellness

Bellville Campus

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