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Human Research Ethics review process

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.

What is HREC?

This is the first of three short video clips about research ethics review at The Open University. It is primarily aimed at OU staff and students, but our principles and practices may be of interest to a wider audience.

The Open University's Human Research Ethics Committee, which we usually call HREC, provides a service to all staff and postgraduate students. HREC must be consulted about any research carried out in the University's name which involves human participants.

This is because ethical principles are very important at The Open University and must underpin our approach to all research. Ethical research practice is enshrined in the University's Code of Practice for Research, a Code which sets the standards expected of all OU researchers. HREC operates on the basis that the OU's reputation for high standards is maintained, whilst enabling researchers to carry out their projects.

As in other institutions, researchers at the OU carry out studies which may involve gathering or accessing data that can touch upon difficult and sensitive areas. In all research settings we aim to protect research participants from unnecessary harm or distress. We also aim to protect researchers from any potential dangers and remind them of The Open University's highly prized reputation for an ethical approach.

Why apply?

This is the second of three short video clips about research ethics review at The Open University. Whilst we aim for high quality, ground breaking research at the Open University, this can never be at the expense of an ethical approach. This means that in all cases the potential harm to participants must be considered.

In order to prevent causing unnecessary harm, most universities have ethics committees to which you make applications, detailing your methods, approach and safeguards.

Here at the OU we have a committee comprised of around 20 people who oversee all research involving human participants.

About half of the Committee are members of OU staff - usually academics but not always - and about half are 'external' members, who have a wide-range of expertise. These people give their time for free and provide an invaluable, independent service, to The Open University for which we are very grateful.

This means that even if your study might appear low risk, if you are gathering data from people, whether in person or via the internet, you need to consult us, especially if you intend to publish your findings.

We argue that an early application to the Ethics Committee can improve the rigour of your study, providing an insight you may not have considered. Also, you should note, that any project not provided with HREC favourable opinion will not be covered by The Open University's insurance policies.

The Open University's HREC offers a number of other beneficial advantages to your project.

We can offer informal advice before you submit your proposal.

We can provide insight as to how you should write your consent forms and information sheets.

And finally, it's free!

Seriously, very few journals, publishers, examiners or funders will now accept a study which does not have a substantive explanation of how ethical issues were considered.

The Open University's HREC works on a principle of 'enabling' good research to be conducted safely, fairly and in the best interests of individuals and society.

Members are elected on the basis that they have a wealth of knowledge, understanding and experience and are willing to give up their own research time to help others.

We hope you find the process helpful, rather than daunting or frustrating.

How to apply

This is the third of three short video clips about research ethics review at The Open University.

The Open University's HREC system is designed to enable good research, not to act as a brake on innovative and imaginative projects. Many applicants comment that the Committee has helped them to clarify issues and improve their study's approach and implementation.

The application process is electronic and involves a triage system. This allows us to speed up the process by filtering the high, low and medium risk projects.

Some low risk projects can be dealt with fairly speedily by Chair's action, whereas other have to go to the full Committee for review.

Each application that goes to the Committee is seen by an internal and external member. Following their written review the Chair will make a decision. This can take up to a month in total so we urge people to apply as soon as they can, so as not to delay the start date of their project.

Once the Committee members are satisfied that all questions have been covered, you will receive an email confirming that you have received a 'favourable opinion' and you are good to go.

Human 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.

Supporting documents

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.


Further considerations

The links in this section are internal only.

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 gathered, the Data Protection team (internal link only). Personal and sensitive data might include: signed consent forms, contact details, any audio/video recordings and other forms of data gathering relating to protected characteristics.

You will need to follow the Data Protection principles (internal link only) for any personal data processing. The Data Protection team have a Data Protection assessment form (internal link only) which will help you prepare your Information Asset Register (IAR) entry, which, once approved, should be lodged at Faculty level with your Information Governance Liaison Officer (IGLO).

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.

Checking your insurance cover

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.

Information Security requirements

Information Security approvals for use of third-party software

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,

Note: If your project is higher risk and you have been required to submit a DPIA (Data Protection Impact Assessment) to the Data Protection team, you will be advised when you receive a response back if you need to also submit a Business Impact Assessment Form (BIAF) to the Information Security team. However, if you were not required to submit a DPIA, and only register your data collection on the IAR, you should ensure you check (internal link only) whether any third-party software you propose to use is included on the InfoSec list of approved tools. If not, you should submit a BIAF. 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).

Additional information