Ethical Information

 

Contents:

AHRC - Specific Requirements

Please indicate whether there are any ethical implications arising from the proposed research activities.  For example, does the research involve human participants?  Does it require travel to countries where the safety of project participants might be in jeopardy? Could the research result in damage to the natural environment?  If the project involves public engagement in the research, has consideration been given to ensuring appropriate equality and diversity of engagement?

 

If there are ethical implications, you should give brief details of what they are and how you intend to address them.

 

You are also asked to indicate whether your HEI has a policy on good conduct in research, in line with the requirements of the Research Councils.

 

If the answer is Yes, please indicate where this can be accessed (e.g. website address).

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BBSRC - Specific Requirements

 

Each section of the ethical classification must be completed.

 

Human participation: state whether the proposed research will involve human participation and answer the questions as appropriate.

 

Animal research: The provisions of the Animals (Scientific Procedures) Act 1986 must be observed. Institutions and award-holders are responsible for ensuring that all appropriate personal and project licences required under the Act have been granted by the Home Office. All BBSRC awards are made on the absolute condition that no work which is controlled by the Act will begin until the necessary licences have been obtained. If the proposed research will involve the use of animals covered by the Act, indicate the severity of the procedure; if 'moderate' or 'severe', provide details of the experiments in the space provided. Please refer to the BBSRC Grants Guide Animal Use section for full details.

 

If your project involves the use of animals overseas, please read our guidance and submit a signed statement (uploaded as a Letter of Support to the Je-S application) from both UK and overseas PIs that:

·         they will adhere to all relevant national and local regulatory systems in the UK and overseas.

·         they will follow the guidelines laid out in the www.nc3rs.org.uk/responsibility-use-animals-bioscience-research document and ensure that work is carried out to UK standards.

·         before initiation of the proposed research work, appropriate approvals from institutional and/or central animal ethics committees will be obtained for experimental protocols to be adopted in their projects. [Successful proposals may be expected to provide copies of these permissions before funding is released.]

·         details where the animal research will take place (UK or overseas) and through which funder the resources are being sought.

 

If the research involves the use of rodents overseas rather than in the UK, please also complete the “Additional questions on the use of rodents overseas“ form (see www.ukri.org/funding/how-to-apply/), and attach as a letter of support in Je-S

 

Genetic and biological risk:If the research will involve the use of genetically modified organisms, answer the questions as appropriate.

 

Approvals: If approval is required for the research, this must be sought and given prior to the research commencing. Provide details of the approval(s) sought and/or received in relation to this proposal.

 

Other issues: Applicants should consider the social context of the proposed research and indicate any issues that might arouse specific public interest or concern about the motivation for the research, its conduct or potential outcomes, which might not be fully covered in the other sections.

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ESRC

 

Applicants should use the Ethical Information section to demonstrate to reviewers that they have fully considered any ethical concerns that have been overlooked or not appropriately accounted for. Each section of the ethical information must be completed.

Human Participation

Research involving human participants must comply with all relevant legislation. All UKRI funding is granted on the absolute condition that researchers ensure that all relevant ethics committee approvals and regulatory requirements are met. For further information, please see www.ukri.org/funding/information-for-award-holders/grant-terms-and-conditions/  (RGC 2. Research Governance, Research Ethics, Use of Animals in Research etc.)

Please read each of the five questions relating to the possible use of Human Participation as part of your proposal. These five questions require the applicant to indicate their ‘Yes’ or ‘No response by selecting the indicator to adjacent to either yes or no. Please note that a ‘Yes’ response to either the first or fifth question, will require the applicant to complete further ‘Yes’ or ‘No’ responses to the sub questions detailed.
Applicants indicating a ‘Yes’ to any of the Human Participation questions, are required to fully justify each ‘Yes’ response within the narrative text field* (at the bottom of the page), to demonstrate (to the EPSRC and reviewers) that any ethical issues and experiments concerning human participation, including the use of samples covered by the Human Tissue Act, or other biological samples in the project have been fully justified/considered.

o   A ‘Yes’ response to the first question, will also require the applicant to answer a subsequent question by indicating either a ‘Yes’ or ‘No’ response. If the applicant indicates ‘Yes’, to this further question, please outline the planned requirement to have an equal number of male and female participants within the narrative text field*.

o   Yes to the first further questions (Fifth question), confirming that the participants personal information will be anonymised and unlinked, please outline how the data/samples will be anonymised and unlinked.

o   Indicating ‘Yes’ to the final further question will require the applicant to describe how research participants will be identifiable.

 

No specialist characters and symbols (e.g. mathematical symbols) because these may not transfer successfully to other computer systems.

 

Please note that typing into a text box is not detectable by the system and is regarded as system inactivity. Please remember to save text regularly.

 

 **Select the “Save” option from the top of the screen, which will save any ‘Yes’ ‘No’ indications and (where applicable) narrative text input into the Je-S proposal.

 

Animal research

 

The provisions of the Animals (Scientific Procedures) Act 1986 must be observed. All UKRI awards are made on the absolute condition that no work which is controlled by the Act will begin until the necessary licences have been obtained. All work supported by UKRI award must comply with the principles described in “Responsibility in the use of animals in bioscience research: expectations of the major research council and charitable funding bodies” available here:  www.nc3rs.org.uk/responsibility-use-animals-bioscience-research.

 

Please indicate your answer ‘Yes’ or ‘No’ response to the first questions relating to the project involving the use of  vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act.  Please note that all proposals involving animal use must tick ‘Yes’ and complete this section, irrespective of whether funding for the animals is requested as part of the proposal.

 

If the project will involve the use of vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act, answer the further question confirming (what would be) the maximum severity of the procedures used, by selecting the appropriate indicator.

 

Should the applicant indicate that the maximum severity of the procedures will be either ‘Moderate’ or ‘Severe’, applicants/researchers are required to give details of any procedures categorised as moderate or severe in order that the assessment of the proposal can balance the importance of the potential scientific advancement to the welfare of the animals. This further information should be detailed within the narrative text field* provided. When you have detailed the required information within the field, please Select the “Save” option at the top of the screen, which will save the information you have input to the Je-S proposal form**.

 

If the applicant has selected the maximum severity of the procedure as ‘Mild or non-recovery’, the applicant should select the ‘Save’ option from the top of the page, which will then save the indicated responses.

 

Should your project not 

 

 

 

 

·         they will follow the guidelines laid out in the www.nc3rs.org.uk/responsibility-use-animals-bioscience-research document and ensure that work is carried out to UK standards.

·         before initiation of the proposed research work, appropriate approvals from institutional and/or central animal ethics committees will be obtained for experimental protocols to be adopted in their projects. [Successful proposals may be expected to provide copies of these permissions before funding is released.]

·         details where the animal research will take place (UK or overseas) and through which funder the resources are being sought.

 

If the research involves the use of rodents overseas rather than in the UK, please also complete the “Additional questions on the use of rodents overseas“ form (see www.ukri.org/funding/how-to-apply/), and attach as a letter of support in Je-S.

 

Genetic and biological risk

Please read each of the three questions relating to the proposals possible implications of genetic and biological risk. These three questions require the applicant to indicate their ‘Yes’ or ‘No response by selecting the indicator adjacent to either yes or no. Please note that a ‘Yes’ response to either the first, second or third questions, will require the applicant to further indicate the applicants ‘Yes’ or ‘No’ responses to the subsequent questions related to either questions one, two or three.

After the applicant has indicated their response to each question, select the “Save” option from the top of the screen, which will save the yes and no selections indicated to the Je-S proposal form**.

Approvals

The ‘Approvals’ section, lists six approvals potentially required by applicants.

Applicants are required to indicate their ‘Yes’. ‘No’ or ‘Not Required’ response to each of the six questions, indicating if the necessary approvals have been given or by selecting ‘Not required’ to confirm that approval it is not required for the project.

Required approvals do not need to have been obtained before submitting a proposal, but must be given prior to the research commencing. In this instance ‘No’ should be indicated and an explanation of the expected timeframe to obtain the approval given in the ‘other issues’ section.  (Please note: If the scheme or call does not contain an ‘other issues’ section, please include this information within the ‘Justification for Resources’ attachment.)

Please indicate your ‘Yes’, ‘No’ or ‘Not Required’ response to the six questions asking if the necessary approvals have been given by:

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

2.   The Human Fertilisation and Embryology Authority?

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

4.   The Gene Therapy Advisory Committee?

5.   The UK Xenotransplantation Interim Regulatory Authority?

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

When the applicant has indicated their responses, they should select the “Save” option from the top of the screen, which will save the indications provided, to the Je-S proposal form**.

Other approvals not listed: Should the applicant proposal involve another (unlisted) ‘Body’ (including other Authorities, Committees, licences, Certificates required etc.),

Examples:

 

Details of these other approval(s) sought and/or received in relation to the proposal, should be provided by selecting the underlined ‘Add New Body’ option at the bottom of the page.

Following your selection of ‘Add New Body’, please type the name of the body (limited to a maximum of 30 characters) and then indicate either ‘Yes’ or ‘No’, to confirm if approval has been given. Select the “Save” option from the top of the screen, which will save the details to the Je-S proposal form**.

Repeat the ‘Add New Body’ process, to add additional approving bodies to the application.

Other issues: Applicants should consider the social context of the proposed research and indicate any issues that might arouse specific public interest or concern about the motivation for the research, its conduct or potential outcomes, which might not be fully covered in the other sections.  (Please note on some EPSRC schemes and calls this section is called ‘Implications’).

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MRC, NC3Rs & UKRI - Specific Requirements

Applicants should use the Ethical Information section to demonstrate to reviewers that they have fully considered any ethical issues concerning the material they intend to use, the nature and choice, current public perceptions and attitudes towards the subject matter or research area. Each section of the ethical information must be completed.

Further guidance for MRC and NRC3Rs applicants is available here:

MRC guidance for applicants: www.mrc.ac.uk/funding/guidance-for-applicants/

NC3Rs applicant handbook: www.nc3rs.org.uk/funding

Human Participation

Research involving human participants must comply with all relevant legislation. All UKRI funding is granted on the absolute condition that researchers ensure that all relevant ethics committee approvals and regulatory requirements are met. For further information, please see: www.ukri.org/funding/information-for-award-holders/grant-terms-and-conditions/ (RGC 2 Research Governance, Research Ethics, Use of Animals in Research etc.)

Please read each of the five questions relating to the possible use of Human Participation as part of your proposal. These five questions require the applicant to indicate their ‘Yes’ or ‘No response by selecting the indicator to adjacent to either yes or no. Please note that a ‘Yes’ response to either the first or fifth question, will require the applicant to complete further ‘Yes’ or ‘No’ responses to the sub questions detailed.

Applicants indicating a ‘Yes’ to any of the Human Participation questions, are required to fully justify each ‘Yes’ response within the narrative text field* (at the bottom of the page), to demonstrate (to the MRC and reviewers) that any ethical issues and experiments concerning human participation, including the use of samples covered by the Human Tissue Act, or other biological samples in the project have been fully justified/considered.

o   A ‘Yes’ response to the first question, will also require the applicant to answer a subsequent question by indicating either a ‘Yes’ or ‘No’ response. If the applicant indicates ‘Yes’, to this further question, please outline the planned requirement to have an equal number of male and female participants within the narrative text field*.

o   Yes to the first further questions (Fifth question), confirming that the participants personal information will be anonymised and unlinked, please outline how the data/samples will be anonymised and unlinked.

o   Yes to the second further questions (Fifth question), confirming that the participants personal information will be anonymised and linked, please outline how the data/samples will be anonymised and linked within the narrative text field*.

o   Please note: If you indicate a ‘No’ to both first and second further questions, regarding anonymisation (both linked and unlinked), please justify why anonymisation is not appropriate for your proposal within the narrative text field*.

o   Indicating ‘Yes’ to the final further question will require the applicant to describe how research participants will be identifiable.

Experiments and Investigations

 

The proposed experiments/investigations within any ‘Yes’ responses should be outlined, MRC require the 'Reproducibility and Statistical Design' annex to the Case for Support to be completed with information relating to the experimental design, statistical analyses and justification of methods.  

Further guidance is available here: www.mrc.ac.uk/funding/guidance-for-applicants/ and MRC Case for Support

The information should cover:

 

Duplication of information across the Je-S proposal form and Case for Support is not required.

 

If you have indicated a ‘No’ response to all the human participation questions, please select the indicator adjacent to ‘No’ and then Select the “Save” option from the top of the screen, which will save the no responses the Je-S proposal**.

 

Please note that typing into a text box is not detectable by the system and is regarded as system inactivity. Please remember to save text regularly.

 

**Select the “Save” option from the top of the screen, which will save any ‘Yes’ ‘No’ indications and (where applicable) narrative text input into the Je-S proposal. 

 

Animal research

 

The provisions of the Animals (Scientific Procedures) Act 1986 (amended 2012) must be observed. All UKRI (including NC3Rs) awards are made on the absolute condition that no work which is controlled by the Act will begin until the necessary licences have been obtained. All work supported by UKRI award must comply with the principles described in “Responsibility in the use of animals in bioscience research: expectations of the major research council and charitable funding bodies” available here: www.nc3rs.org.uk/responsibility-use-animals-bioscience-research.

 

Please indicate your answer ‘Yes’ or ‘No’ response to the first questions relating to the project involving the use of  vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act.  Please note that all proposals involving animal use must tick ‘Yes’ and complete this section, irrespective of whether funding for the animals is requested as part of the proposal.

 

If the project will involve the use of vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act, answer the further question confirming (what would be) the maximum prospective severity of the procedures used, by selecting the appropriate indicator.

 

Should the applicant indicate that the maximum severity of the procedures will be either ‘Moderate’ or ‘Severe’ (in accordance with the maximum prospective severity rating in the Home Office licence under which the work will be carried out), applicants/researchers are required to give details of any procedures categorised as moderate or severe in order that the assessment of the proposal can balance the importance of the potential scientific advancement with the welfare cost to the animals. This further information should be detailed within the narrative text field* provided. When you have detailed the required information within the field, please Select the “Save” option at the top of the screen, which will save the information you have input to the Je-S proposal form**.

 

If the applicant has selected the maximum severity of the procedure as ‘Mild or non-recovery’, the applicant should select the ‘Save’ option from the top of the page, which will then save the indicated responses.

 

Should your project not involve the use of vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act, please indicate a ‘No’ response to the first question and select the “Save” option from the top of the screen, which will save the ‘No’ response to the Je-S proposal form**.

 

Animal Species

 

The provisions of the Animals (Scientific Procedures) Act 1986 must be observed. All UKRI awards are made on the absolute condition that no work which is controlled by the Act will begin until the necessary licences have been obtained. All work supported by UKRI award must comply with the principles described in “Responsibility in the use of animals in bioscience research: expectations of the major research council and charitable funding bodies” available here: www.nc3rs.org.uk/responsibility-use-animals-bioscience-research .

This section must be completed for all proposals involving animal use, irrespective of whether funding for the animals is requested as part of the proposal and should be indicated within this Animal Species section of the Je-S proposal form.

Please indicate your response to the four ‘Yes’ and ‘No’ questions regarding the research project involving animal use and then select the species of animals to be used in the proposed research project, from the detailed list of animals.  If more than one species of animal is to be used in the proposed research project, you must also include these.

If you have indicated four ‘No’ responses and not indicated any other species of animals are to be used on the project, please select the “Save” option from the top of the screen, which will save the four ‘No’ responses indicated to the Je-S proposal form** and complete the section.

If you have stated ‘Yes’ to any of the four yes/no questions (at the top of the page), and/or checked any boxes indicating the use of other animal species, you will be required to select and complete the ‘Supporting Information’ section (at the bottom of the page). Please note: The MRC encourages applicants who propose the use of animal experiments as part of their proposal to detail the methodological and experimental design aspects of proposals (including figures/tables where appropriate) in the optional one-page reproducibility and statistical design annex' . Please see the MRC’s guidance for applicants for more information.

Please note: The MRC encourages applicants who propose the use of animal experiments to detail the methodological and experimental design aspects of their proposals. This information may be provided within the one-page reproducibility and statistical design annex'  (which can include figures/tables where appropriate) or, without duplication, within the ‘supporting information’ section as below.

For guidance on how to use the reproducibility and statistical design annex', please see MRC’s guidance for applicants.

 

Completing the ‘Supporting Information’ section:

Supporting Information supplied by the applicant must include the following:

Please note: MRC require the 'Reproducibility and Statistical Design' annex to the Case for Support to be completed with information relating to the experimental design, statistical analyses and justification of methods. Further guidance is available here: www.mrc.ac.uk/funding/guidance-for-applicants/

For NC3Rs, and Experimental Design and Methodology' appendix to the Case for Support is optional but strongly encouraged for the proposals involving animals or novel/complex experimental designs. Further guidance is available here: www.nc3rs.org.uk/funding

 

Use of animals overseas 

If your project involves the use of animals overseas, please read our guidance (see www.mrc.ac.uk/funding/guidance-for-applicants/4-proposals-involving-animal-use/) and submit a signed statement (uploaded as a Letter of Support to the Je-S application) from both UK and overseas PIs that:

·         they will adhere to all relevant national and local regulatory systems in the UK and overseas.

·         they will follow the guidelines laid out in the www.nc3rs.org.uk/responsibility-use-animals-bioscience-research document and ensure that work is carried out to UK standards.

·         before initiation of the proposed research work, appropriate approvals from institutional and/or central animal ethics committees will be obtained for experimental protocols to be adopted in their projects. [Successful proposals may be expected to provide copies of these permissions before funding is released.]

·         details where the animal research will take place (UK or overseas) and through which funder the resources are being sought.

If the research involves the use of rodents overseas rather than in the UK, please also complete the “Additional questions on the use of rodents overseas“ form (see www.mrc.ac.uk/funding/guidance-for-applicants/4-proposals-involving-animal-use/), and attach as a letter of support in Je-S.

 

Genetic and biological risk

Please read each of the three questions relating to the proposals possible implications of genetic and biological risk. These three questions require the applicant to indicate their ‘Yes’ or ‘No response by selecting the indicator adjacent to either yes or no. Please note that a ‘Yes’ response to either the first, second or third questions, will require the applicant to further indicate the applicants ‘Yes’ or ‘No’ responses to the subsequent questions related to either questions one, two or three.

After the applicant has indicated their response to each question, select the “Save” option from the top of the screen, which will save the yes and no selections indicated to the Je-S proposal form**.

Implications

Please indicate your ‘Yes’ or ‘No’ response to the single question, which asks if there are ethical implications arising from the proposed research.

If the answer is ‘No’ please select the indicator adjacent to ‘No’ and select the “Save” option from the top of the screen, which will save the response indicated to the Je-S proposal form**.

If the applicant indicates a ‘Yes’ to the ethical implications question, they should use the narrative text field* provided to summarise any social and/or ethical implications of the work proposed and any issues that might arouse specific public interest or concern about the motivation for the research, its conduct or potential outcomes, which might not be fully covered in the other sections. Please note that this text box allows a maximum of 1000 character including spaces and returns.

Please note: Applicants should refer to the MRC guidance for applicants and to any call-specific information for further detailed guidance on the ethical considerations that should be described here, particularly with regard to research in lower and middle income countries (LMICs).   Approvals

The ‘Approvals’ section, lists six approvals potentially required by applicants.

Applicants are required to indicate their ‘Yes’. ‘No’ or ‘Not Required’ response to each of the six questions, indicating if the necessary approvals have been given or by selecting ‘Not required’ to confirm that approval  is not required for the project.

Required approvals do not need to have been obtained before submitting a proposal, but must be given prior to the research commencing. In this instance ‘No’ should be indicated and an explanation of the expected timeframe to obtain the approval given in the ‘Implications’ section.

Please indicate your ‘Yes’, ‘No’ or ‘Not Required’ response to the six questions asking if the necessary approvals have been given by:

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

2.      The Human Fertilisation and Embryology Authority?

3.      The Home Office (in relation to personal and project licences, and establishment licence (prior to 2012 establishment licence was previously referred to as 'certificates of designation')?

4.      The Gene Therapy Advisory Committee?

5.      The UK Xenotransplantation Interim Regulatory Authority? (applicants should indicate 'Not required' as this authority has ceased to exist)

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

When the applicant has indicated their responses, they should select the “Save” option from the top of the screen, which will save the indications provided, to the Je-S proposal form**.

Other approvals not listed: Should the applicant proposal involve another (unlisted) ‘Body’ (including other Authorities, Committees, licences, Certificates required etc.),

Examples:

Details of these other approval(s) sought and/or received in relation to the proposal, should be provided by selecting the underlined ‘Add New Body’ option at the bottom of the page.

 

Following your selection of ‘Add New Body’, please type the name of the body (limited to a maximum of 30 characters) and then indicate either ‘Yes’ or ‘No’, to confirm if approval has been given. Select the “Save” option from the top of the screen, which will save the details to the Je-S proposal form**.

Repeat the ‘Add New Body’ process, to add additional approving bodies to the proposal.

 

Honorary Clinical Contract and Clinical Details (Fellowship Proposals only)


Applicants for non-clinical fellowships (Career Development Awards & Senior Non-Clinical fellowship), are not required to complete the Honorary Clinical Contract and Clinical Details section and therefore it is not included in the forms for these schemes.

 

Applicants wishing to apply for any other MRC fellowship (Clinical fellowships or Strategic skills fellowships), should follow the below guidance when completing the Honorary Clinical Contract and Clinical Details Je-S section:

 

Please indicate your ‘Yes’ or ‘No’ response to the first question asking “would an Honorary Clinical Contract be sought?”

 

Applicants who are not clinically qualified should answer ‘No’ to the first question and enter ‘NA’ or ‘0’ in the following narrative text box and zero in the required fields E.G. ‘0’ (zero), where percentages/numbers are requested by MRC).

 

All clinically qualified applicants (including doctors, nurses, midwives, and allied health professionals)  indicating a ‘Yes’ response, must complete the (first/top) narrative text field explaining how they plan to maintain their clinical skills during the tenure of the award, also ensuring that they detail what level of Honorary Clinical Contract they will be seeking.

 

All clinically qualified applicants (including doctors, nurses, midwives, and allied health professionals) who’ve answered ‘No’ to the first question asking “would an Honorary Clinical Contract be sought?”, must outline their reasons for not seeking a Honorary Clinical Contract and detail how they plan to maintain their clinical skills during the tenure of the fellowship within the (second/bottom), narrative text box provided.

 

Applicants are also required to detail the number of ‘Clinical Sessions/Programme Activities’ they are planning to undertake during the duration of the Fellowship. Please note, if the planned number of Clinical Sessions/PAs is none, then the clinical applicant should detail ‘0’ (zero), within the box provided.

 

Clinical applicants are required to indicate the percentage of their time they propose to spend on clinical work (including higher specialist training) from 0-100 (maximum) and what percentage of that time will be directly relevant to the applicants research project.

 

*This (narrative text) field must be completed using:

No more than 4000 characters, including spaces, tabs and character returns (2 characters).

Only the standard Je-S character set should be used.

No specialist characters and symbols (e.g. mathematical symbols) because these may not transfer successfully to other computer systems.

Please note that typing into a text box is not detectable by the system and is regarded as system inactivity. Please remember to save text regularly.

**Select the “Save” option from the top of the screen, which will save the information input into the Je-S proposal. 

 

UKRI Future Leaders Fellowships

Check the Call Guidance documentation to determine whether there are specific UKRI specific requirements which would override the information above.  

 

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