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. To do this you should complete the HREC Project Registration and Risk Checklist, and return it to the Research-REC-Review mailbox. The HREC Chair will then assess whether an ethics review will be required (this may take up to 7 working days). Points to note:
Research defined as being a service evaluation may not require ethics review and if you are unsure, please use the Human Research Authority (HRA) decision tool to determine if your proposed study would be categorised as research.
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 have not already done so, refer to the OU Ethics Principles for Research involving Human Participants. If you are bidding for external funding formal ethics review it is not usually required until funding has been awarded (see Awards Management System - bidding for external funding below). To ensure that you are using the latest verion of forms and guidance please always download documents from the websire and not use previously saved versions.
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 contact Carmel Collins - Research Ethics Manager.
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 to the HREC in advance, as the HREC submits on behalf of the OU sponsor - PVC (Research and Academic Strategy). See FAQ 3 for full details.
Similarly 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 assessing by the HREC Chair and another committee member to ensure HREC governance is being met. Where the OU is not the lead, if for any reason the researcher requires a HREC review in addition to, or instead of, the lead institution review, that is possible and can be necessary, 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 insert some research ethics standard text into the bid (scroll down to Research Ethics standard text for bids). The text can be adapted as necessary, and by including a version of it in the bid should assure the funder that the OU has an ethics review process which will be followed once funding is awarded. If for any reason you would like the HREC Chair or Deputy Chair, to assess the section on ethics, please email Research-REC-Review. Once funding has been awarded, it is important that the HREC is contacted as soon as possible so an assessment can be made as to whether an ethics review will be required. There is guidance on the AMS SharePoint site or from your faculty research administrator, or Carmel Collins, HREC Secretary.
Where an ethics application is related to a bid (pre and post award), researchers and administrators can set up a SharePoint library for each ethics application within AMS where the relevant documents can be stored, and a link sent to Research-REC-Review with the application.