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Human Research

Does your research require an ethics review?

The OU research ethics review process has two entry points depending on the level of risk linked to your research proposal.

  1.  HREC Project Registration and Risk Checklist - Researcher's should complete the checklist and if they judge their research has elements of risk, continue directly to  2. the full HREC review process.

If it is still not clear, the completed checklist should be sent to Research-REC-Review@open.ac.uk so your research proposal can be assessed by the HREC Chair, and you should receive a response within 7 working days as to whether a full ethics review will be required.  Points to note:

  • Research defined as being a service evaluation may not require ethics review and if you are unsure, please use the Health Research Authority (HRA) decision tool to determine if your proposed study would be categorised as research.
     
  • When planning their research, researchers should assess their research using the HREC checklist as some academic publishers may not publish research involving humans where it has not received an ethics review, or an explanation as to why a review was not necessary - Elsevier Ethics guidelines for journal publication
     
  • Research involving OU students may require agreement from the Student Research Project Panel
     
  • However, if you judge that your research has ethics implications or is of a sensitive nature, you can bypass the initial checklist stage and go directly to the full HREC review process.
     
  • If you are bidding for external funding, a formal ethics review is usually not required until funding has been awarded (see Bidding for external funding - Awards Management System below). To ensure that you are using the latest verion of forms and guidance please always download documents from this website rather than use an older version. 

The review process covers all OU research which involves collecting data or biological samples from human participants and it is essential that an assessment or review of ethics issues takes place before any potential participants are contacted.

The review process is part of the HREC remit to scrutinise and advise on ethical considerations relating to any research carried out by, and for the Open University, which involves investigations with humans or human materials. Information on OU governance is available to OU staff and if information is required externally, please send a mail to Research-REC-Review@open.ac.uk.

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External ethics review, research collaborations and Health Research Authority review

Where there is an existing external ethics review or the OU is not the lead in a research project, it is not necessary to seek a full HREC ethics review. However, the HREC would need to see a copy of the external application, for example:

External ethics review

Where the research has begun at another university and been agreed via an external research ethics review, HREC needs to see a copy of the full external application and the approval so it can be assessed by the HREC Chair to ensure compliance with HREC governance, and so we have a full record of the research. 

External collaborations where the OU is not the lead

Usually, an ethics review would be sought from the lead body and as above, the HREC would need to receive a copy of the full application for assessment. Occasionally researchers request an HREC review where the OU is not the lead, e.g.

  • the research is being carried out by a partner institution, but a major part of the work involving participants is being carried out by OU researchers
  • the other institution does not have an ethics review process in place

Health Research Authority (HRA) / Integrated Research Applications System (IRAS) review

Where researchers are applying to the Health Research Authority via the Integrated Research Applications System, HREC would need to receive a draft copy of the IRAS application in advance, as the HREC needs to agree it on behalf of the OU sponsor - PVC (Research and Academic Strategy), prior to IRAS submission - see FAQ 3 for full details.

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Bidding for external funding - Awards Management System (AMS) 

If you are bidding for funding using the Awards Management System (AMS), and the funder does not specifically require an ethics review at bid stage, you can adapt and insert research ethics standard text. This will assure the funder of the OU ethics review process which will be followed once funding is awarded. If you think a more formal ethics assessment will support your bid, please email Research-REC-Review and we can discuss what support is required. Once funding has been awarded, it is important that the HREC is contacted as soon as possible so the research can be assessed as to whether an ethics review will be required. There is guidance on the AMS SharePoint site, from your faculty research administrator, or Research-REC-Review@open.ac.uk.

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Research ethics applications - collection and use of data

To meet internal governance and highlight OU research, a list of all projects considered by the HREC (either by HREC checklist or proforma) with HREC reference number, Faculty/dept. and HREC decision date, are made available here.

Information provided as part of a research ethics applications, e.g. from research students and staff, is stored so the HREC has an accurate record. All data is managed and held securely by the Research Ethics Administrative Team and only shared with HREC members as part of the research ethics review process. Occasionally, and only where relevant, applications are discussed with like OU research review panels, e.g. the Student Research Project Panel (SRPP) and Staff Survey Project Panel (SSPP), predominately to avoid delays where applications are being made in tandem.

If, as part of a research ethics application sensitive personal data is disclosed, it will be stored securely and only shared as above. If such data is volunteered but then needs to be withdrawn, the researcher should email Research-REC-Review@open.ac.uk. More information is available in our Student privacy notice and Staff, workers and applicants privacy notice

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