Common use of Research Practice Clause in Contracts

Research Practice. 3.1. The Lead Applicant Institution and Lead Applicant shall ensure the Research; 3.1.1. is primarily relevant to the BactiVac Network and is compliant with ODA rules and regulations as set out by the OECD (guidance can be found at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/files/legacy/international/gcrfodaguidance-pdf/); or 3.1.2. is primarily relevant to the BactiVac Network and demonstrates strong industry engagement; or 3.1.3. is primarily relevant to the BactiVac Network and is aligned to UK Health. 3.2. Prior to the commencement of the Research, the Lead Applicant and the Lead Applicant Institution will obtain any and all licences, consents and approvals (including ethical approval) necessary for the conduct of the Research and will continue to hold such licences, consents and approvals during the Duration. 3.3. Where any part of the Research is to be conducted outside the UK such legal and regulatory requirements, and such licences and approvals should include those applicable in the additional countries involved. 3.4. The Lead Applicant Institution must ensure that the requirements under the UK Policy Framework for Health and Social Care Research (or equivalent) are met for managing, monitoring and for research involving NHS patients, their organs, tissues or data and the necessary arrangement are in place with partner organisations. Where it also accepts the responsibilities of a Sponsor, (as defined in the UK Policy Framework for Health and Social Care Research), it must also ensure that the requirements of Sponsors are met. 3.5. The Lead Applicant Institution shall be responsible for managing and monitoring statutory requirements for which it accepts responsibility, for example, in relation to legislation of clinical trials, use of human organs, tissues and data. 3.6. For clinical studies involving human participants and/or patients, appropriate consent must be obtained. When collaborating with other laboratories, or where animal facilities are provided by third parties, researchers and the local ethics committee in the UK should satisfy themselves that welfare standards consistent with the principles of UK legislation (e.g. the Animals (Scientific Procedures) Act 1986) and set out in the guidance document 'Responsibility in the use of animals in bioscience research' (available at ▇▇▇.▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇) are applied and maintained. 3.7. The Lead Applicant Institution is expected, wherever possible, to adopt procedures and techniques which avoids the use of animals and, where this is not possible, to use the minimum number of animals consistent with obtaining valid results as humanely as possible, in particular; 3.7.1. the least sentient species with the appropriate physiology is used; 3.7.2. the number of animals used is the minimum sufficient to provide adequate statistical power to answer the questions posed; 3.7.3. the severity of procedures performed on animals is kept to a minimum. Experiments should be kept as short as possible; and 3.7.4. appropriate anaesthesia, analgesia and humane endpoints should be used to minimise any pain and suffering. 3.8. MRC supports a central repository of mouse strains - the MRC mouse Frozen Embryo and Sperm Archive (FESA) at the Mammalian Genetics Unit, ▇▇▇▇▇▇▇. The Lead Applicant is expected to contact FESA to highlight mouse strains engineered, or characterised using MRC funds, and are encouraged to deposit these strains with the archive. Depositors retain ownership of strains and there is currently no charge for depositing strains to make them freely available to the academic community. 3.9. Where research involves human stem cell lines (both embryonic and adult), Lead Applicants must: 3.9.1. Abide by the UK Code of Practice for the use of Human Stem Cell lines (▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/publications/browse/code-of-practice-for-stem-cell-lines/); 3.9.2. Ensure that they hold all relevant licenses, accreditations and approvals from, and abide by the Codes of Practice issued by, but not limited to, the Human Fertilisation and Embryology Authority (HFEA; see AC10), the Human Tissue Authority (HTA; see AC12), the Health Research Authority (HRA; for research ethics, gene therapy and confidentiality; see AC6, AC7, AC8), the Medicines and Healthcare products Regulatory Agency (MHRA; see AC6, AC7, AC8), the EU Tissue and Cells Directive (where applicable). 3.10. In the case of research involving human embryonic stem cells: 3.10.1. Deposit a sample of every human embryonic stem cell line derived with MRC funding in the UK Stem Cell Bank; applications to deposit or access banked stem cell lines must be approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines (▇▇▇.▇▇▇.▇▇.▇▇/▇▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇▇▇▇▇/▇▇-▇▇▇▇-▇▇▇▇-▇▇▇▇-▇▇▇▇▇▇▇▇- committee/). 3.10.2. Not pass samples of human embryonic stem cell lines to third parties other than those approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines and/or the HFEA. 3.10.3. Not take human embryonic stem cell lines out of the UK unless approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines and/or the HFEA. 3.10.4. Scientists from overseas wishing to conduct human embryonic stem cell research in the UK as visiting workers must provide a written statement from their home institution, outlining that as the employer of the visiting worker they take on the responsibilities of ensuring their employee works to and complies with the requirements of the UK Governance landscape, set out in the UK Code of Practice. 3.10.5. Send copies of publications to the UK Stem Cell Bank, and agree that the UK Stem Cell Bank may post summaries of published results on their web site. 3.10.6. Assist the MRC and the UK Stem Cell Bank, on request, with public engagement activities. 3.11. The Lead Applicant Institution assumes full responsibility for staff funded from the Grant and, in consequence, accepts all duties owed to all and responsibilities for these staff, including without limitation, their terms and conditions of employment and their training and supervision, arising from the employer/employee relationship. The Lead Applicant Institution is responsible for ensuring that a safe working environment is provided for all individuals associated with the Research. 3.12. The Lead Applicant Institution shall ensure that it has in place, throughout the Duration, procedures for the identification and management of potential conflicts of interest in connection with the Research. The Lead Applicant Institution shall notify UoB of any conflicts of interest that arise and will keep UoB informed of any actions taken in relation to such issues. 3.13. The Lead Applicant Institution will promptly notify UoB of any incident connected to the Research (which the Lead Applicant Institution at its reasonable discretion considers relevant to UoB’s rights and interests in the Research), and will keep UoB promptly informed of any developments connected to such incident. 3.14. The Lead Applicant Institution and the Lead Applicant will conduct the Research in accordance with the principles set out in the Concordat to Support Research Integrity policy ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇/highereducation/Pages/Theconcordattosupportresearchintegrity.aspx and the Research Councils UK Code of Conduct and Policy on the Governance of Good Research Conduct (2009) and any subsequent amendments. The Lead Applicant Institution must on request provide information on its management of research integrity and ethics in response to the UKRI’s assurance questions, as described at: ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/about-us/policies-and-standards/research-integrity/. 3.15. The Lead Applicant Institution and the Lead Applicant are expected to adopt the principles, standards and good practice; 3.15.1. for the management of research staff set out in the 2008 Concordat to Support the Career Development of Researchers; and 3.15.2. good practice for public engagement with research set out in the 2010 Concordat for Engaging the Public with Research. 3.16. The Lead Applicant Institution will ensure that full details of any other third party funding or in kind contribution granted to it in connection with the Research will be included in the Application Form, or, if obtained subsequently to UoB’s acceptance of the Application Form, that it promptly notifies UoB in writing, with full details of such funding.

Research Practice. 3.1. The Lead Applicant Institution and Lead Applicant shall ensure the Research; 3.1.1. is primarily relevant to the BactiVac Network and is compliant with ODA rules and regulations as set out by the OECD (guidance can be found at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/files/legacy/international/gcrfodaguidance-pdf/); or 3.1.2. is primarily relevant to the BactiVac Network and demonstrates strong industry engagement; or 3.1.3. is primarily relevant to the BactiVac Network and is aligned to UK Health. 3.2. The Lead Applicant and Lead Applicant Institution shall ensure the Grant is used solely for the delivery of the Research and must not, without the prior written consent of UoB make any material changes to the Research. 3.3. Prior to the commencement of the Research, the Lead Applicant and the Lead Applicant Institution will obtain any and all licences, consents and approvals (including ethical approval) necessary for the conduct of the Research and will continue to hold such licences, consents and approvals during the Duration. 3.33.4. Where any part of the Research is to be conducted outside the UK such legal and regulatory requirements, and such licences and approvals should include those applicable in the additional countries involved. 3.43.5. The Lead Applicant Institution must ensure that the requirements under the UK Policy Framework for Health and Social Care Research (or equivalent) are met for managing, monitoring and for research involving NHS patients, their organs, tissues or data and the necessary arrangement are in place with partner organisations. Where it also accepts the responsibilities of a Sponsor, (as defined in the UK Policy Framework for Health and Social Care Research), it must also ensure that the requirements of Sponsors are met. 3.53.6. The Lead Applicant Institution shall be responsible for managing and monitoring statutory requirements for which it accepts responsibility, for example, in relation to legislation of clinical trials, use of human organs, tissues and data. 3.63.7. For clinical studies involving human participants and/or patients, appropriate consent must be obtained. When collaborating with other laboratories, or where animal facilities are provided by third parties, researchers and the local ethics committee in the UK should satisfy themselves that welfare standards consistent with the principles of UK legislation (e.g. the Animals (Scientific Procedures) Act 1986) and set out in the guidance document 'Responsibility in the use of animals in bioscience research' (available at ▇▇▇.▇▇▇▇▇.▇▇▇.▇▇/▇▇▇▇▇▇▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇) are applied and maintained. 3.73.8. The Lead Applicant Institution is expected, wherever possible, to adopt procedures and techniques which avoids the use of animals and, where this is not possible, to use the minimum number of animals consistent with obtaining valid results as humanely as possible, in particular; 3.7.13.8.1. the least sentient species with the appropriate physiology is used; 3.7.23.8.2. the number of animals used is the minimum sufficient to provide adequate statistical power to answer the questions posed; 3.7.33.8.3. the severity of procedures performed on animals is kept to a minimum. Experiments should be kept as short as possible; and 3.7.43.8.4. appropriate anaesthesia, analgesia and humane endpoints should be used to minimise any pain and suffering. 3.83.9. MRC supports a central repository of mouse strains - the MRC mouse Frozen Embryo and Sperm Archive (FESA) at the Mammalian Genetics Unit, ▇▇▇▇▇▇▇. The Lead Applicant is expected to contact FESA to highlight mouse strains engineered, or characterised using MRC funds, and are encouraged to deposit these strains with the archive. Depositors retain ownership of strains and there is currently no charge for depositing strains to make them freely available to the academic community. 3.93.10. Where research involves human stem cell lines (both embryonic and adult), Lead Applicants must: 3.9.13.10.1. Abide by the UK Code of Practice for the use of Human Stem Cell lines (▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/publications/browse/code-of-practice-for-stem-cell-lines/); 3.9.23.10.2. Ensure that they hold all relevant licenses, accreditations and approvals from, and abide by the Codes of Practice issued by, but not limited to, the Human Fertilisation and Embryology Authority (HFEA; see AC10), the Human Tissue Authority (HTA; see AC12), the Health Research Authority (HRA; for research ethics, gene therapy and confidentiality; see AC6, AC7, AC8), the Medicines and Healthcare products Regulatory Agency (MHRA; see AC6, AC7, AC8), the EU Tissue and Cells Directive (where applicable). 3.103.11. In the case of research involving human embryonic stem cells: 3.10.13.11.1. Deposit a sample of every human embryonic stem cell line derived with MRC funding in the UK Stem Cell Bank; applications to deposit or access banked stem cell lines must be approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines (▇▇▇.▇▇▇.▇▇.▇▇/▇▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇▇-▇▇▇-▇▇▇▇▇▇▇▇▇▇▇/▇▇-▇▇▇▇-▇▇▇▇-▇▇▇▇-▇▇▇▇▇▇▇▇- committee/). 3.10.23.11.2. Not pass samples of human embryonic stem cell lines to third parties other than those approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines and/or the HFEA. 3.10.33.11.3. Not take human embryonic stem cell lines out of the UK unless approved by the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines and/or the HFEA. 3.10.43.11.4. Scientists from overseas wishing to conduct human embryonic stem cell research in the UK as visiting workers must provide a written statement from their home institution, outlining that as the employer of the visiting worker they take on the responsibilities of ensuring their employee works to and complies with the requirements of the UK Governance landscape, set out in the UK Code of Practice. 3.10.53.11.5. Send copies of publications to the UK Stem Cell Bank, and agree that the UK Stem Cell Bank may post summaries of published results on their web site. 3.10.63.11.6. Assist the MRC and the UK Stem Cell Bank, on request, with public engagement activities. 3.113.12. The Lead Applicant Institution assumes full responsibility for staff funded from the Grant and, in consequence, accepts all duties owed to all and responsibilities for these staff, including without limitation, their terms and conditions of employment and their training and supervision, arising from the employer/employee relationship. The Lead Applicant Institution is responsible for ensuring that a safe working environment is provided for all individuals associated with the Research. 3.12. The Lead Applicant Institution shall ensure that it has in place, throughout the Duration, procedures for the identification and management of potential conflicts of interest in connection with the Research. The Lead Applicant Institution shall notify UoB of any conflicts of interest that arise and will keep UoB informed of any actions taken in relation to such issues. 3.13. The Lead Applicant Institution will promptly notify UoB of any incident connected to the Research (which the Lead Applicant Institution at its reasonable discretion considers relevant to UoB’s rights and interests in the Research), and will keep UoB promptly informed of any developments connected to such incident. 3.14. The Lead Applicant Institution and the Lead Applicant will conduct the Research in accordance with the principles set out in the Concordat to Support Research Integrity policy ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇/highereducation/Pages/Theconcordattosupportresearchintegrity.aspx and the Research Councils UK Code of Conduct and Policy on the Governance of Good Research Conduct (2009) and any subsequent amendments. The Lead Applicant Institution must on request provide information on its management of research integrity and ethics in response to the UKRI’s assurance questions, as described at: ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/about-us/policies-and-standards/research-integrity/. 3.15. The Lead Applicant Institution and the Lead Applicant are expected to adopt the principles, standards and good practice; 3.15.1. for the management of research staff set out in the 2008 Concordat to Support the Career Development of Researchers; and 3.15.2. good practice for public engagement with research set out in the 2010 Concordat for Engaging the Public with Research. 3.16. The Lead Applicant Institution will ensure that full details of any other third party funding or in kind contribution granted to it in connection with the Research will be included in the Application Form, or, if obtained subsequently to UoB’s acceptance of the Application Form, that it promptly notifies UoB in writing, with full details of such funding.