Form for the Ethical Committee

Formulieren

To obtain ethics approval from the DEC the proposed project must first be written, clearly and in detail, on an official form provided by the ethics committee. This is completed by the BPRC project co-ordinator in close co-operation with his/her external collaborators. It is then submitted to the DEC, which meets on a monthly basis to review the proposals.

Considerable thought goes into the planning of every experiment. To have an idea of the questions that the DEC considers, below you will find a list of some of the questions that must be answered on every form:

  • Title of experiment.
  • Names of investigators and their qualifications.
  • Personnel responsible for the animal care and experimental techniques.
  • Proposed start and end dates for the research (studies lasting more than one year are re-evaluated after one year).
  • The scientific significance of the planned research (what is the aim of the research and how will it contribute to an improved scientific understanding of the problem).
  • A description by the researchers of why they believe this research to be ethically justified (this will include the social significance; for example how many people die from the disease being studied each year).
  • Applied significance (what is the potential benefit of the research ; for instance the prevention or cure of a specific disease in humans).
  • An explanation of why there are no alternatives to the use of animals in this research.
  • An explanation of why only non-human primates are suitable for the planned experiment (why can't the research be done using other animals, for example, mice or rats).
  • An explanation of how it is planned to reduce the number of animals used to the minimum (including the use of in vitro culture techniques so far as possible).
  • An explanation of how techniques will be refined to cause as little stress to the animals as possible.
  • A precise description of the animals to be used (which species, what origin, how many animals, what age, what sex).
  • A precise experimental design including all experimental procedures and the justification for the use of these procedures.
  • A careful (statistical) analysis of how many animals are required to obtain a clear answer to the research question.
  • A description of the location of the experiment.
  • A description of the required housing and diet of the animals.
  • A description of the frequency with which the animals will be monitored during the experiment, and the observations to be made.
  • An estimation of the discomfort the animals will experience during the research.
  • An explanation of the phased decision-making strategy to be followed (go/no-go scenarios) (for example in an experiment to see whether a new vaccine works against a disease, the animals in the experiment would only be tested by infecting them with the disease-causing organisms if there was already proof that the vaccine had induced a satisfactory immune response).
  • Humane end points (the definition of criteria for animal well being that, in cases where these are not met, will immediately lead to the stopping of the study for that particular animal).
  • Limitation of the re-use of animals for research (optimised to balance the number of animals bred and kept for research and the limitation of total discomfort for each animal).