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