MRC - Ethical Information

MRC - Ethical Information

MRC - Ethical Information

The Ethical Information section is comprised of 6 mandatory sections.

  1. Human Participation (page 1 - 2)
  2. Animal Research (page 3)
  3. Animal Species (pages 4 – 6)
  4. Genetic and Biological Risk (page 7 – 8)
  5. Implications (page 9)
  6. Approvals (page 9)

Applicants are required to answer specific ethical questions within sections 1-6. It should be noted that ‘Yes’ responses to questions within sections 1, 2, 3, 5 & 6, will require details and justification of any specific usage (within the expandable table provided). As a guide, each narrative table box should not exceed 4,000 characters, however the expectation is that all applicants will keep their justification as brief as possible.

Further guidance is available here:

  1. Human Participation:

Please circle your (Yes / No) answer below.

If you select ‘Yes’ for any response, please describe the following:

  • The planned participant/ sample numbers
  • How the numbers were chosen
  • How they are sufficient to produce a robust result
  • The feasibility of recruiting sufficient participants/ collecting sufficient samples
  • How consent will be obtained and whether relevant information will be fed back to participants
  • How data/ samples will be anonymised or why anonymisation is not appropriate

For further information see:

5, GC 2 Research Governance, Research Ethics, Use of Animals in Research etc.)

Questions to be answered:

  1. Would the project involve the use of human participants (including healthy volunteers)?

Yes / No

If you have answered ‘Yes’ to question 1, please answer question a. below. If you have answered ‘No’ please go to question 2 on page 2.

  1. If human participants (including healthy volunteers) are to be involved, is it planned that there will be an equal number of males and females?

Yes / No

  1. Would the project involve the use of human tissues?

Yes /No

  1. Would the project involve the use of biological samples?

Yes / No

  1. Would the project involve the administration of drugs, chemical agents or vaccines to humans?

Yes/ No

  1. Will personal information be used?

Yes/ No

If have indicated ‘Yes’ (to question 5), please answer a, b & c below.

  1. Will the information be anonymised and unlinked?

Yes/ No

  1. Or will it be anonymised and linked?

Yes/ No

  1. Will the research participants be identifiable?

Yes/ No

  1. If the answer to any of the above questions ( 1 to 5 of Human Participation), is 'Yes', justify: the involvement of human participants, the numbers (and sexes) involved; and/or the nature and quantity of human material to be used:
  1. Animal Research:

Please circle your answers below.

  1. Would the project involve the use of vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act?

Yes/ No

  1. If yes, what would be the maximum severity of the procedures?

Mild or non-recovery/ Moderate / Severe

Please provide details of any areas which are Moderate or Severe:

  1. Animal Species

Please circle your answers to all 5 animal species question below (please note that question 5 is on page 6):

  1. Does the proposed research involve the use of non-human primates?

Yes / No

  1. Does the proposed research involve the use of dogs?

Yes / No

  1. Does the proposed research involve the use of cats?

Yes / No

  1. Does the proposed research involve the use of equidae?

Yes / No

Please note, if you have answered ‘Yes’ to any of the above questions, please provide supporting information to fully justify any use of the four animal species detailed above:

NC3Rs Primate Guidelines (please note that this is only applicable if you have selected ‘Yes’ to the use of non-human primates): Do the facilities and practices and the proposed research comply with the principles set out in the NC3Rs Guidelines 'Primate accommodation, care and use' ( If not, please explain why.

Statistical Advice: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.

Source of Animals:From where will the non-human primates be sourced?

Will it be necessary to transport the non-human primates (i.e. from breeding facility and within the university environment)? If so, indicate approximate journey times and the measures that will be taken to minimise the potential stress during transport.

Husbandry:Will single housing of the non-human primates be necessary at any time? If so, please provide details in terms of the justification for single housing, its duration, and what additional resources will be provided to the animals to minimise the impact on animal welfare.

Procedures:Describe the experimental procedures involved and how any pain, suffering, distress and/or lasting harm will be minimised. Have the procedures been recently reviewed by the NVS, NACWO and ERP?

Will any of the experimental procedures involve restraint? What alternatives have been considered? Describe the nature of the restraint, its duration and frequency, and what will be done to avoid distress?

Will any of the experimental procedures involve food and/or water control? If so, justify why this is necessary and outline what alternatives have been considered.

Staff Experience:What prior experience and training in non-human primate use, care and welfare do staff members named in the application have? What provision is made for continuing professional development in these areas?

Will any of the staff involved require specific training for any of the procedures concerned? Please provide details of the training needed and where it will be undertaken.

Advances:Do you envisage any advances arising from the research that might lead to replacement, refinement or reduction of the use of non-human primates? If so, what might they be, and how do you propose to disseminate such findings?

  1. Please also circle any other species of animals that are to be used in the proposed research:

FishRabbitAmphibianCowReptilePigBirdSheep

RatPoultryMouseGuinea PigOther Rodent

Other Animal

If you have circled any of the other species of animals detailed above (Fish, Rabbit etc), please supply supporting information in the box below to fully justify their use:

  1. Genetic and Biological Risk

Please circle your (Yes / No) answer below.

  1. Would the project involve the production and/or use of genetically modified animals?

Yes / No

If ‘Yes’, please answer questions a, b & c below. If you have answered ‘No’, please go to question 2.

  1. Will the genetic modification be used as an experimental tool, e.g., to study the function of a gene in a genetically modified organism?

Yes/ No

  1. And will the research involve the release of genetically modified organisms?

Yes / No

  1. And will the research be aimed at the ultimate development of commercial or industrial genetically modified products or processes?

Yes / No

  1. Would the project involve the production and/or use of genetically modified plants?

Yes / No

If ‘Yes’, please answer questions a, b & c below. If you have answered ‘No’, please go to question 3.

  1. will the genetic modification be used as an experimental tool, e.g., to study the function of a gene in a genetically modified organism?

Yes / No

  1. And will the research involve the release of genetically modified organisms?

Yes / No

  1. And will the research be aimed at the ultimate development of commercial or industrial genetically modified products or processes?

Yes / No

  1. Would the project involve the production and/or use of genetically modified microbes?

Yes / No

If you have indicated ‘Yes’, please answer questions a, b & c below.

  1. Will the genetic modification be used as an experimental tool, e.g., to study the function of a gene in a genetically modified organism?

Yes / No

  1. And will the research involve the release of genetically modified organisms?

Yes / No

  1. And will the research be aimed at the ultimate development of commercial or industrial genetically modified products or processes?

Yes / No

  1. Implications
  1. Are there ethical implications arising from the proposed research?

Please circle your answer.

Yes / No

If you have answered ‘Yes’, Provide details of what they are and how they would be addressed:

  1. Approvals

Please circle your (Yes / No / Not Required) answers below.

Have the following necessary approvals been given by:

  1. The Regional Multicentre Research Ethics Committee (MREC) or Local Research Ethics Committee (LREC)?

Yes / No / Not Required

  1. The Human Fertilisation and Embryology Authority?

Yes / No / Not Required

  1. The Home Office (in relation to personal and project licences, and certificates of designation)?

Yes / No / Not Required

  1. The Gene Therapy Advisory Committee?

Yes / No / Not Required

  1. The UK Xenotransplantation Interim Regulatory Authority?

Yes / No / Not Required

  1. Administration of Radioactive Substances Advisory Committee (ARSAC)?

Yes / No / Not Required

  1. Other bodies as appropriate? (Please specify)

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