Why does research require ethical approval?

As part of good Research Governance, research requires ethical approval.   This is:

• to protect the rights and welfare of participants and minimise the risk of physical and mental discomfort, harm and danger from research procedures
• to protect your rights as a researcher to carry out legitimate investigations, as well as the reputation of Anglia Ruskin University for research conducted by it's students and staff
• to minimise the potential for claims of negligence made against you, Anglia Ruskin University and any collaborating individual or organisation
• because increasingly external funding bodies and refereed journals require a statement of ethical practice in applications for research funds and as a precondition of publication
• to avoid the likelihood of problems occurring during the course of the research

A consideration of research ethics is also likely to influence the research design and the two should be considered at the same time.  A proper consideration of research ethics should strengthen your research design.

All research at Anglia Ruskin University needs Stage 1 of ethical approval

Stage 1 is the ethics review checklist.  All researchers must complete this.  This will tell you if you need to seek further ethical approval. 

Even if you do not require further ethical approval, you need to submit the checklist, signed and dated, to your Faculty Research Ethics Panel (FREP) Administrator prior to starting your research.  You may also require other permissions e.g. written permission from organisations where you are carrying the research out and it is your responsibility to check this.

What to do if you need to seek further ethical approval at Anglia Ruskin University?

Research requires ethical approval if it involves:

• human participants (including observation, questionnaires and telephone interviews)
• accessing personal, sensitive or confidential data
• human tissue or samples (including blood, saliva and urine)
• participants who are 16 years and over who lack capacity to consent and therefore fall under the Mental Capacity Act (2005)
• NHS patients, staff or premises or Social Care settings.

If you are carrying out research that does not fall into any of the above categories, but that you and/or your supervisor feel presents significant ethical issues (e.g. it has political or social significance), you are strongly advised to submit your application for ethical review.

What if I don’t need ethical approval?

You are still required to submit the Ethics Review Checklist to your Faculty Research Ethics Panel (FREP) Administrator, confirming that you don’t need ethical approval.  There may also be ethical issues that you need to consider, even if formal approval is not required.  You may also require other permissions e.g. written permission from organisations where you are carrying the research out.

How do I apply for ethical approval?

There is a Faculty Research Ethics Panel (FREP) in each faculty and a central research ethics committee (Research Ethics Subcommittee or RESC).  The FREPs deal with the review of research projects and RESC deals with policy and procedure.

In the first instance, please contact your Faculty Research Ethics Panel (FREP) Administrator, in order that he/she can advise on what approval you need to obtain.

For further information about applying for ethical approval at Anglia Ruskin University, please see:

• Guidelines for Applying for Ethical Approval at Anglia Ruskin University
• Question-specific Advice for Applying for Ethical Approval

You will also find the application form and example participant information sheet and consent form here

What if I need Criminal Records Bureau (CRB) Clearance?

If you need Criminal Records Bureau (CRB) Clearance, you need to apply for this at the earliest opportunity.  Further information regarding the procedure for this is in the Guidelines for Applying for Ethical Approval.  If you are carrying out research overseas, you need to obtain the equivalent of CRB clearance for that country, if required.  For further information, please see the CRB website

Research, Development and Commercial Services (RDCS) run research ethics training sessions and you may find it useful to attend one of these.  For further information please see: http://www.anglia.ac.uk/researchtraining

Research involving human tissue or samples

If your research involves human tissue or samples, you need to ensure that you are complying with the Human Tissue Act (2004).  Please see the Human Tissue Authority website

You also need to let Matt.Bristow@anglia.ac.uk know of all proposed research involving human tissue or samples, as he is the designated individual on our licence from the Human Tissue Authority.  You will also need to ensure that you attend training run by Matt prior to starting your research.

Matt can also advise on the approval that you will require.  Research that falls under the Human Tissue Act (2004) needs to be reviewed by an NHS REC (even if it does not involve the NHS), if it is not covered by the terms of our licence.  University research ethics committees are not authorised to review studies that fall under the Human Tissue Act, other than those falling within the remit of any licence that they hold.

To apply to an NHS REC, please see:
NHS National Research Ethics Service

Research involving people 16 years and over who do not have the capacity to consent

For research involving people over the age of 16 years who lack capacity to consent, you need to comply with the Mental Capacity Act (2005).  University research ethics committees are not authorised to review studies that fall under the Act.  Research that falls under the Act can only be reviewed by an NHS REC or the Social Care Research Ethics Committee.

To apply for approval from an NHS REC, please see:
NHS National Research Ethics Service

To apply for approval from the Social Care Research Ethics Committee, please see:
Social Care Research Ethics Committee

What do I need to submit for research involving animals?

All researchers conducting studies involving animals must submit an Animal Ethics Checklist to the relevant FREP or their delegated panels before commencing their research and complete a full ethics application form, if so directed.  The checklist can be found on the Faculty of Science and Technology website

Under current regulations, research involving procedures which require a Home Office Licence under the Animals (Scientific Procedures) Act 1986 (A(SP)A is not conducted on Anglia Ruskin University premises. The University does not hold a Home Office Site Licence to carry out work under A(SP)A,1986.

Feedback

If you have any comments about the Research Ethics web pages, please send details in an email to Beverley Pascoe

           

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