Â鶹´«Ã½ÊÓƵÍøÕ¾

All research (unless exempted) conducted with living human participants and the collection and/or study of data derived from living human participants undertaken by Â鶹´«Ã½ÊÓƵÍøÕ¾ students and staff (to include honorary staff, affiliate academics and visiting researchers) on Â鶹´«Ã½ÊÓƵÍøÕ¾ premises or elsewhere, requires ethical approval to ensure that the research conforms with general ethical principles and standards.Ìý Ethical approval must be obtained before the commencement of data collection.

Do I need ethical approval?

You can find more information about exemptions on the Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Service ·É±ð²ú²õ¾±³Ù±ð.ÌýIt is important to note that if your study is exempt from Â鶹´«Ã½ÊÓƵÍøÕ¾ ethical review this does not mean it is automatically exempt from external ethical review (see below).

Where to obtain ethics approval from?

Ethical approval should be sought through one of the following routes depending on the nature of the research. Remember that ethics approval cannot be granted retrospectively so make sure you obtain one, if needed, before you start data collection. If you are not sure, seek advice.

Â鶹´«Ã½ÊÓƵÍøÕ¾ ethics review

There are two routes to ethical approval at Â鶹´«Ã½ÊÓƵÍøÕ¾:Ìý

• Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Committee -The Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Committee (Â鶹´«Ã½ÊÓƵÍøÕ¾ REC) is the central Â鶹´«Ã½ÊÓƵÍøÕ¾ research ethics committee and is responsible for reviewing most (non-NHS) ethics applications across Â鶹´«Ã½ÊÓƵÍøÕ¾, including all high-risk applications.
• Â鶹´«Ã½ÊÓƵÍøÕ¾ local Ethics Committee -There are a number of faculties/departments that have their own ethics systems and committees in place and it is important that you understand what your local arrangement is when planning your application.

To find out more information see Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Service.

Human Tissue Act 2004

Under the studies involving relevant material derived from human remains that are from people who died less than 100 years ago, must be stored on a licensed premises unless ethical approval has been granted by a 'recognised' ethics committee. ÌýUniversity ethics committees are not 'recognised' ethics committees and so researchers will usually need to apply to an NHS ethics committee via the IRAS system.Ìý Researchers seeking to access samples from a Biobank that has been granted generic ethical approval, provided the study meets their conditions of approval, the study will be considered to have ethical approval.

The Human Tissue Authority provide helpful , and Code E: Research has helpful guidance for researchers including a flowchart showing consent and licensing requirements.

Researchers storing samples under a human tissue license do not need to apply to a 'recognised' ethics committee for ethical approval.Ìý However, Â鶹´«Ã½ÊÓƵÍøÕ¾ researchers will still require ethical approval for the research and therefore will need to apply to the Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Committee (or Â鶹´«Ã½ÊÓƵÍøÕ¾ Local Research Ethics Committee).ÌýÌý This is because at Â鶹´«Ã½ÊÓƵÍøÕ¾ all research (unless exempted) requires ethical approval.

• Â鶹´«Ã½ÊÓƵÍøÕ¾ Research
• Ethics ServiceÌý
• Â鶹´«Ã½ÊÓƵÍøÕ¾ Human Tissue Biobank

Non-relevant material

Studies involving samples (i.e. serum, DNA etc) that are not classed as relevant material do not need to be stored under a HTA licence. In other words, researchers do not require a HTA storage licence under the HT Act 2004, if their research i) involves acellular material only (i.e. serum or DNA) or ii) if the cellular material (i.e. blood) is rendered acellular immediately and only serum is stored for research.Ìý

Studies involving prospective recruitment of participants and collection of relevant material (i.e. blood samples etc.) may need to be approved by a 'recognised' ethics committee. Studies that do not involve prospective recruitment and only involve existing acellular material can be ethically approved through the Â鶹´«Ã½ÊÓƵÍøÕ¾ ethics system as mentioned previously.Ìý

In summary there are three options for ethical approval depending on your study:

• A 'recognised' ethics committee (generally NHS ethical approval) - all studies falling under the remit of the HT Act 2004 (relevant material) unless stored under the governance of a HTA storage license
• A Biobank ethics committee - for studies applying to use samples from a Biobank with generic ethical approval
• A Â鶹´«Ã½ÊÓƵÍøÕ¾ Research Ethics Committee - for all studies that are not covered by ethical approval from a 'recognised' ethics committee or Biobank

For more information on requirements related to holding human remains more than 100 years old see ‘Museums, heritage and cultural collections’ pages.

External ethics review

Some research requires ethical review via an external ethics committee and cannot be reviewed by university committees:Ìý

• NHS Research Ethics Review: any research that involves NHS patients and carers, invasive research involving prisoners or adults lacking capacity, a Clinical Trial of an Investigational Medicinal Product or human tissue (see above). Guidance is available on the website including a checklist and .
• Social Care Research Ethics Committee (SCREC): ethical approval is required through for social care research projects funded by the Department of Health.
• Ministry of Defence Research Ethics Committee (MoDREC): ethical approval is required through for research involving human participants either undertaken, funded, or sponsored by MOD in order to meet nationally and internationally accepted ethical standards.

Collaborative research within UK

For Â鶹´«Ã½ÊÓƵÍøÕ¾ staff or student researchers involved as co-researchers on a project led by a Principal Investigator (PI) from another UK university and ethics approval has been granted by that institution (with the Â鶹´«Ã½ÊÓƵÍøÕ¾ co-researcher named on the application along with an account of their role on the project), provided that a UK university is the sponsor for the project (taking responsibility for the whole study), then additional ethical approval through the Â鶹´«Ã½ÊÓƵÍøÕ¾ REC will not be required.
The co-researcher must ensure that the PI gains ethical approval from his/her own institution before the commencement of data collection as well as local ethics/research permission if the study is based overseas.

Overseas researchÌý

All research with human participants or using human data is expected to follow ethical requirements conforming to UK’s and the study country(ies) regulations. This means that you might need to obtain more than one ethics approval: here in UK and locally in the country where research will be carried out.
Guidance on overseas research is available on the Overseas Research webpage.Ìý

After ApprovalÌý

It is expected that all members of the research team will be aware of what the formal ethical approval covers as well as any terms and conditions of approval, which includes the date approval expires, as well as the process regarding applying for modifications to ethical approval or extensions. ÌýTo assist them in assessing the proposed changes, many committees request that a revised version of the approved application and/or attached documents also be submitted.Ìý

For more information see ‘Responsibilities after ethical approval’