The Human Research Ethics Committee (HREC) provides a mechanism for assuring the ethical integrity of research carried out by OU staff and directly registered postgraduate research students. An ethics review by HREC is required for research projects which involve the collection of data or biological samples from human participants.
The following videos explain the role of HREC and outline the research ethics review process.
Please note this guidance and the Research Ethics Application System is for use by OU staff and OU postgraduate research students only.
Undergraduate and postgraduate taught students, undertaking a research project, should consult their tutor or module team for guidance as to any module level ethics review process they will need to follow. All students are welcome to use the HREC consent form and information sheet templates, if useful.
Ethics project applications being made to HREC should be completed using the research ethics application system. The review process has two points of entry as previously, but you will automatically be directed to the appropriate process depending on how you respond to the questions in the ethics project application form. All applicants should complete the main application form.
Your application will be marked for the HREC chairing team’s attention so they can assess if a full ethics review will be needed, and you should normally receive a reply in the next sevenbworking days. Notification of revisions and decision letters will be sent to your OU email and can also be accessed through the online ethics system. If a full ethics review is required, you wll be notified by email. Then this can take up to three working weeks, once it has been sent to the HREC panel.
It is essential that no potential participants should be approached until you have received a response on whether a full HREC review will be required, and once the review is complete, a formal HREC favourable opinion.
Please expect that you are likely to be asked for some clarifications or queries and time will be needed to enter into dialogue with the HREC towards the award of a favourable opinion for your study.
If you do have any queries in the meantime, please contact the Human Research Ethics team.
In some circumstances you may need to complete an ethics project application in the Research Ethics Application System. Please see the guidance provided on the What needs HREC review page.
You will still need to complete an ethics project application in the Research Ethics Application System but will also need to attach a copy of the ethics favourable opinion from the lead institution. You will be asked whether the OU is the lead during the online project application process and will be guided through the appropriate questions if your answer no.
You will still need to complete an ethics project application in the Research Ethics Application System. You will be asked whether your research involves NHS patients during the online project application process and will be guided through the appropriate questions if you answer yes. Further guidance on research involving NHS patients can be found on the Health and social care research page.
You will still need to complete an ethics project application in the Research Ethics Application System. You will be asked whether you are applying for pre-bid funding during the online project application process and will be guided through the appropriate questions if you answer yes. Further guidance can be found on the Bids for external funding page.
We are hosting monthly Research Approval Advice Drop-ins, in partnership with Information Rights (Data Protection), the Student Research Project Panel (SRPP) and the Library Research Support team, on the third Tuesday of every month from 11am-12pm. If you need any advice or want to speak to us about our approval processes, please join us!
Find the dates and links to the next drop-in sessions (internal link only)
When submitting an Ethics project application, supporting documentation related to the stage of your project (e.g. gatekeeper communications, consent forms, participant information, and research tools, eg questionnaire or interview protocol) should also be provided.
We welcome multi-stage applications to embrace participatory and iterative research designs. In your first application, please set the scene for the overall project and explain how many stages of application you intend to submit and the scale of each stage eg which research methods will be included in each stage. This could mean that the initial stage can be reviewed more quickly (within seven days) than more complex later stages of your applications (which might need to go out to the HREC panel), which should be submitted as revisions. You will keep the same project application code throughout.
Please see below for templates for consent forms, participant information sheets and other documents, which outline the key information which should be communicated. These should be adapted for gatekeepers, participants and their context eg. for age-appropriateness or professional/practitioner settings. Assent of children and young people and competency to offer consent should be included in projects, if relevant. You should complete these before beginning your online ethics project application. These will rely on you being confident with your research data management and, in particular your identification of personal data and how this will be collected, stored, transferred and destroyed, as this information should be communicated with potential participants. You will be prompted to attach them when you reach the supporting document question.
Further guidance on completing supporting documents can be found on the Informed Consent page.
It is essential that you do not advertise for, or attempt to recruit, potential participants until you have received a formal response from HREC. The ethics review must take place before the data collection phase of the project commences.
The HREC reference number should be included in any documents designed for participants, so it is clear that the research project adheres to OU ethics review processes. Logos on all research documents must comply with the current OU brand guidelines on the Asset Bank (internal iink only).
If you are carrying out research overseas and will not be conducting your data collection in English, an English translation of all paperwork should be provided.
If your research involves collecting data from OU staff or students you will need to obtain approval from either the Staff Survey Project Panel (internal link only) if you are approaching more than 30 OU staff, or the Student Research Project Panel (internal link only) if planning to involve students in research and scholarship about their educational experience. Please submit these applications in parallel to the HREC application. It is a good idea to copy and paste text which is needed on both HREC and SRPP forms.
Further information on planning to engage in educational research with students at the Open University can be found on The Researcher's Journey Landing Page (internal link only).
On this landing page you can find a calendar of events, which include monthly Research Approval Advice Drop-In sessions. All the teams, not only associated with research with students, supporting research project approval are represented in these drop-ins, These take place on TEAMS on the third Tuesday of every month from 11:00 to 12:00.
We recommend as you develop your application to HREC (SRPP and/or SSPP) you consult the Library Research Support team (using their resources or directly) to develop your research data management plan and, for any personal data to be collected or used, the Data Protection team (internal link only). Personal and sensitive data might include: signed consent forms, contact details, any audio/video recordings and anything else linked to a name or ID, or where a participant could be identified from contextual data, even if anonymistion is planned.
You will need to follow the Data Protection principles (internal link only) for any personal data processing, please follow the instructions outlined on the Data Protection by Design (internal link only) page.
More broadly, Research Data Management concerns the management, preservation and sharing of all research data which are collected, created or used during the course of your research. Creating a Data Management Plan helps manage data responsibly throughout a project’s lifecycle. Wherever possible, sharing research data should be done using a trusted data repository.
HREC do not need to see your research data management plan or IAR entry but the contents of them will affect your participant facing documentation and application to HREC.
Please review the insurance cover for your study. You can find information about insurance cover for Open University researchers at the Finance and Business Services webpage (internal link only). Please direct any specific enquiries about types and levels of cover offered for research work at the University to the Insurance Team.
If using third party software to collect data from human participants (i.e., any software not created in-house at the OU), you may now need to submit an application to the Open University Information Security (InfoSec) team in order to check that the software complies with their standards for data security. Please see further guidance and information (internal link only), including a list of currently approved tools for OU researchers to use for data collection,
You will need to complete a BIAF regardless of whether you are collecting personal or completely anonymous/non-personal data (if the tool is not already on the InfoSec approved list).