If you are planning to carry out OU research that involves collecting data or biological samples from human participants, it is essential that an assessment or review of ethics issues takes place before any potential participants are contacted. The first stage is to complete the HREC Project Registration and Risk Checklist, and return it to the Research-REC-Review@open.ac.uk so your research can be assessed and you should receive a response within 7 working days as to whether a full ethics review will be required. Points to note:
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@CResearch-REC-Review@open.ac.uk.
Where a research project requires an external high level research ethics review, the researcher can submit a HREC Project Registration and Risk checklist to register the research, then once the application has been externally reviewed and completed, copies of all documents should be sent to Research-REC-Review@open.ac.uk so there is a full record of the research. However, researchers applying to the Health Research Authority (HRA) via the Integrated Research Applications System should send a draft copy of the IRAS application in advance as the HREC submits on behalf of the OU sponsor - PVC (Research and Academic Strategy). See FAQ 3 for full details.
Where OU researchers are collaborating with external partners and the OU is not the lead, an ethics review would usually be sought from the lead institution. As above, a copy of the application and review would need to be sent to the HREC for assessment by the HREC Chair to ensure compliance with HREC research ethics review. Occasionally, researchers request a HREC review where the OU is not the lead, in addition to, or instead of, the lead institution review HREC can provide this. For example:
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 nsert 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.
Both the OU Student Privacy notice and staff, workers and applicants privacy notice include information on the personal data we collect from students and staff. Information collected as part of a research ethics application - from both research students and staff, is held securely and only shared with HREC members as part of the research ethics review process which is co-ordinated by members of the Research Ethics Administrative Team. Occasionally, to avoid delays and support OU research, applications are discussed with other relevant OU staff e.g. the Staff Research Project Panel and the Student Research Project Panel, particularly if applications are being made in tandem. If, as part of a research ethics application, a research student or researcher discloses sensitive personal data, it will be stored securely and shared as outlined above.