Annex E – template form Use of animals and/or human participants

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Annex E
Use of animals and/or human participants – template form
If you are using animals and/or human participants in your research under the Atmospheric Pollution and
Human Health in an Indian Megacity call, please ensure you complete the form below and follow the guidance
in sections 8.2 and 8.3 of the MRC Guidance for Applicants and Award Holders 2015
(http://www.mrc.ac.uk/documents/pdf/guidance-for-applicants-and-award-holders/). Please ensure that you
read to the end of the form and complete all sections of relevance. It is expected that boxes are completed
extensively as this information will be assessed.
Animal Costs
Animal
Species
Type and
Microbiological
Quality
Genetically
Altered?
No.
Purchased
Average
Cost per
Animal (£)
No.
Bred
Average
Cost per
Animal
(£)
Maintenan
ce duration
(weeks)
Weekly
Maintenanc
e costs per
Species (£)
Total Cost
£
Total £
0
Human Participation
Would the project involve the use of human subjects?
If yes, would equal numbers of males and females be used?
Would the project involve the use of human tissue?
Would the project involve the use of biological samples?
Would the project involve the administration of drugs, chemical agents or vaccines
to humans?
Will personal information be used?
If yes, will the information be anonymised and unlinked?
Or will it be anonymised and linked?
Will the research participants be identifiable?
Please provide details of any areas of substantial or moderate severity:
Animal Research
Would the project involve the use of vertebrate animals or other organisms
covered by the Animals (Scientific Procedures) Act?
If yes, what would be the severity of the procedures?
Yes
Yes
Yes
Yes
No
No
No
No
Yes No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No

Mild

Moderate
Substantial 
Please provide details of any areas of substantial or moderate severity:
Animal Species
Does the proposed research involve the use of non-human primates?
Does the proposed research involve the use of dogs?
Does the proposed research involve the use of cats?
Does the proposed research involve the use of equidae?
Yes
Yes
Yes
Yes
No
No
No
No
Please select any other species of animals that are to be used in the proposed research.
Fish
Rabbit
Amphibian
Cow
Reptile
Pig
Bird
Sheep
Rat
Poultry
Mouse
Other Rodent
Guinea Pig
Species:
Statistical Analysis
Experimental Design and Statistical Framework: Please justify your use of the species proposed and describe the
experimental design, including any plans to reduce bias such as blinding or randomisation if appropriate. A justification of
the proposed sample size must be given along with details of the planned statistical analyses. Power calculations must be
included in this section if appropriate.
Genetic and Biological Risk
Would the project involve the production and/or use of genetically modified animals?
If yes, will the genetic modification be used as an experimental tool, e.g., to study the
function of a gene in a genetically modified organism?
And will the research involve the release of genetically modified organisms?
And will the research be aimed at the ultimate development of commercial or
industrial genetically modified products or processes?
Would the project involve the production and/or use of genetically modified plants?
If yes, will the genetic modification be used as an experimental tool, e.g., to study the
function of a gene in a genetically modified organism?
And will the research involve the release of genetically modified organisms?
And will the research be aimed at the ultimate development of commercial or
industrial genetically modified products or processes?
Would the project involve the production and/or use of genetically modified
microbes?
If yes, will the genetic modification be used as an experimental tool, e.g., to study the
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
function of a gene in a genetically modified organism?
And will the research involve the release of genetically modified organisms?
And will the research be aimed at the ultimate development of commercial or
industrial genetically modified products or processes?
 Yes
 No
 Yes
 No
Implications (mandatory)
Are there ethical implications arising from the
proposed research?
Provide details of what they are and how they would be addressed [up to 1000 characters]
Approvals
Have the following necessary approvals been given by:
The Regional Multicentre Research Ethics Committee
(MREC) or Local Research Ethics Committee (LREC)?
Yes No
The Human Fertilisation and Embryology Authority?
Yes No
The Home Office (in relation to personal and project
licences, and certificates of designation)?
Yes No
The Gene Therapy Advisory Committee?
Yes No
The UK Xenotransplantation Interim Regulatory Authority?
Yes No
Administration of Radioactive Substances Advisory
Committee (ARSAC)?
Other bodies as appropriate? Please specify.
Yes No
Not
required
Not
required
Not
required
Not
required
Not
required
Not
required
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