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Securing an amendment

You do not have to submit an amendment if the only change to the project is moving from face to face interactions to remote interaction providing your project meets the requirements detailed below.

  • You use the University’s preferred platform of Microsoft Teams for interviews, or you use a telephone
  • Online data collection is secure - please refer to the guidance here
  • Working in a remote manner does not constitute a substantial change. A substantial change to a research project is one that alters the potential risk or harm to participants. For example, if your research deals with sensitive issues you will need to submit an amendment. This is because (i) you may be less readily able detect stress in the participant or refer them to support services (ii) securing a confidential space may be more difficult in a ‘lockdown’ scenario.

Any member of staff who is unsure whether an amendment is required should consult their Department Ethics Lead. Any student who is unsure about how to proceed should consult their Supervisor.

 

 

 

 

Pausing your research

If you need to pause your research, you need to notify all participants that you have recruited to the study whether the study has commenced or not.  Communications with participants who have already been engaged in the study should be as comprehensive as possible and enable any planned debriefing etc. You do not need to submit an amendment in order to pause your study.

 

 

 

Doctoral students

If you are a student with time constraints around conducting your research and cannot conduct remote participant interactions, you should change your research to involve secondary data analysis where possible. You should discuss your approach with your supervisor.

If you are a final year PGR student you may apply for an amendment.

 

 

 

 

Re-starting research with human participants for staff and PGR students

If you are a member of staff or PGR student you may, in exceptional circumstances, apply to undertake research with human participants. Please note that this is not yet applicable to undergraduate or postgraduate taught students. The process for this is set out here.

For new applications, please use the Ethics Online System

For an amendment to an existing ethics application please use this form.

Please contact ethicssupport@northumbria.ac.uk if you have any queries.

 

 

Remote working and data protection

Please refer to the guidance here

 

 

Sources of useful information

 

Internet mediated research

For further information from Research and Innovation Services click here (internal link)

 

 

 

Additional information from external agencies for undertaking research during the COVID -19 pandemic

National Institute for Health Research (NIHR) 

This guidance from the Department of Health and Social Care provides information on the impact on COVID-19 on research funded or supported by NIHR.

NHS Health Research Authority (HRA) 

This guidance relates to Research Ethics Committee (REC) and NHS arrangements. As the situation is still evolving, please check back at the link for updates. 

Examples of substantial and non-substantial amendments can be found here.

With effect from 25 March 2020, the HRA has stopped reviewing applications for individual undergraduate and master’s student projects from now until further notice. Click here for further details which relates to health and social care research projects conducted by undergraduate and master’s students.

HRA have changed how they operate to prioritise COVID-19 related research. They have also published guidance to support sponsors, sites and researchers during this time.

Recruiting patients to COVID-19 clinical trials

CMOs and NHSE Medical Directors have produced this letter regarding the recruitment of patients to COVID-19 clinical trials.

Medical Research Council (MRC)

Please check here for updates relating to COVID-19 guidance.

Support and guidance for those conducting research with human participants, their tissues or data can be found here.

Medicines and Healthcare products Regulatory Agency (MHRA) 

This guidance relates to the management of clinical trials. 

Human Tissue Authority (HTA)

The HTA has produced guidance and key information to support professionals working at HTA licensed establishments.

Nuffield Council on Bioethics

Nuffield Council on Bioethics has produced this guidance.

UKRI COVID-19 support for researchers and innovators

UKRI have produced this helpful guidance.

UKRIO

UKRIO Recommended Checklist for Research Communities During the COVID-19 Pandemic for both existing and new research

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