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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.

 

 

 

 

Face to Face Research with Human Participants

It remains the case that using online methods to gather data brings advantages for staff and students undertaking research at the current time. Advice on using online methods can be found below.  Online data collection methods can save time, cost, and avoid any pauses or changes to the research should a Covid-19 wave result in additional social distancing or safety measures.

Update: 10 December 2021

Northumbria University is mandating the use of face coverings whilst moving through buildings and where 2m social distancing or 1m+, with further risk mitigation (such as the use of screen), cannot be maintained (unless exempt).  This requirement applies in research environments, including those where face-to-face research methods with study participants are deployed. In-person studies with human participants can still proceed provided that the research is conducted in a covid-secure way and appropriate risk assessments and ethical approvals are in place. Those seeking ethical approval for projects that do involve in- person studies with participants can find further details at our research ethics and integrity webpages. The newly updated guidance around the use of face coverings means that risk assessments for approved projects must be reviewed and revised as necessary, and new controls may be required.

The University has a Covid-19 Information page with further information, notification forms and copies of the overarching risk assessments which form the basis for project-specific risk assessments.  Risk assessments are a dynamic tool to ensure that safety considerations are addressed and mitigated on an ongoing basis. As such changes to a study’s risk assessment will not require an amendment on the ethics online system. However, the Study Lead or Principal Investigator must ensure that safety measures are adapted as appropriate and communicated to study participants.  In the case of UGT/ PGT/ PGR, Supervisors must ensure that students are aware of the latest guidance and that risk assessments and safety measures pertaining to projects are reviewed and up to date.

Please ensure that research participants  are aware of current requirements to wear a face covering when transiting through building and ensure they’re aware of any requirements for a face covering during the research. Research participants should also be reminded not to attend campus if they have symptoms of Covid-19 (a high temperature, a new continuous cough or a loss or change to their sense of smell or taste) or have tested positive/need to self-isolate. Research participants should also be encouraged to take a lateral flow test in the 24 hour period prior to attending campus or participating in the research study.

If a research participant subsequently informs you that they have tested positive for Covid-19 within 72 hours of being on campus, or participating in the study, please contact CRHealthandSafety@northumbria.ac.uk for advice and guidance.

We have an established process for staff and PGRs to apply for face-to-face research with human participants using the ethics online system. Additionally, undergraduate and postgraduate taught students may now also undertake face to face research with human participants, within the scope 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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