You are here

  1. Home
  2. Governance
  3. Ethics
  4. Human Research
  5. Human Research Ethics Review Process

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 academic 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.

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 your project (e.g. a consent form, participant information sheet, or questionnaire) should also be provided.

Further guidance can be found on the Informed Consent page.

Please see below for templates for consent forms, participant information sheets and other documents, which you can adapt for your study. You should complete these before beginning your online ethics project application. You will be prompted to attach them when you reach the supporting document question.

Templates

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.

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 if you are surveying more than 30 OU staff, or the Student Research Project Panel.

If your research involves the collection or processing of personal data it will need to be registered with Data Protection.

Research Data Management concerns the management, preservation and sharing of any research data which are collected, created or used during the course of your research. By creating a Data Management Plan, managing data responsibly throughout their lifecycle and wherever possible by sharing research data in a trusted data repository.

Additional information

Privacy Notice – Applicants submitting an ethics application

Information provided in application forms is stored in the online Research Ethics Application System.

All data will be managed and held securely by The Open University and Infonetica Ltd. Data will only be shared with HREC members as part of the research ethics review process. Occasionally, and only where relevant, applications are discussed with other OU research review panels, e.g. the Student Research Project Panel and the Staff Survey Project Panel, predominately to avoid delays where applications are being made simultaneously.

Any sensitive personal data disclosed as part of a research ethics application, will be stored securely and only shared as above. If such data is volunteered but then needs to be withdrawn, the researcher should email the Human Research Ethics team. Researchers are also able to delete submissions made to the Research Ethics Application System. More information about the collection and use of data is available in our Student privacy notice and Staff, workers and applicants privacy notice (internal link only).