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Safety Advice on Research Grant or
CULATR Applications

Research Proposals

Policy on Safety Approval for Research Proposals including flow diagrams for various scenarios.
Checklists to aid the risk assessment process for the submission of grants can be found on the research services website:-

 


CULATR Applications

In section 11k (i) and (ii) of the standard CULATR application form the applicant is asked if hazardous materials (including infectious agents) will be used and whether the safety office has been consulted on any safety measures to be adopted. If the applicant ticks one of the hazards the CULATR panel will expect to see documentation that the Safety Office has been consulted. If there is no evidence the application will be returned without approval.

In order to facilitate the approval process it is recommended that the applicant obtains advice from the Safety Office before submission to CULATR. We will endeavour to reply within 48hours but in some circumstances this may not be possible. Please be sure full details of the experimental procedures and reagents are included as this will avoid the Safety Office asking for more details.

Common Applications

A standard reply in response to a CULATR application, involving a simple xeno-transplantation model, using immune deficient or standard rodents as a cancer model:-

Although this type of experiment is relatively safe it is worth pointing out that there is a risk associated with accidental self injection of the transformed cell lines. However even if accidental inoculation does occur it is likely that the cell lines would be rejected due to mismatched HLA (assuming none of the cell lines were derived from the individuals doing the work). There is one report in the literature [1] of a tumour which grew in a laboratory worker accidentally inoculated with cells of a human tumour cell line and cancers have been transferred between people during transplantation [2]. Although the growth of tumour cells from a different person is unlikely in healthy individuals, anyone with a compromised immune system is at greater risk. Injections should therefore be carried out to minimise the risk of a needlestick injury.


Consequently it is prudent to adopt, as a minimum, the standard precautions for protecting staff when handling animals and to implement a stringent sharps policy. (i.e. a stringent sharps policy should include measures such as not manually re-sheathing, bending or breaking needles prior to disposal; needles must not be passed by hand between staff, must be disposed of a the site of use directly to a sharps bin without removal from any syringe barrel and the sharps disposal container must be no more than 3/4 full).

 

[1] Gugel EA, Sanders ME. Needle-stick transmission of human colonic adenocarcinoma. New Engl J Med 315: 1487, 1986.
[2] Southam CM. Homotransplantation of human cell lines. Bull NY Acad Med 34: 416-423, 1958.

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