Health, safety and ethical approval
Requirements around research ethics, the ethical approval process and health and safety.
Students undertaking master's dissertations and other master's research projects need to appreciate that any project that collects data on/from human participants will involve ethical considerations. Often, ethical considerations can be handled straightforwardly, for instance by gaining informed consent and informing participants about the right to withdraw. Some types of research raise additional ethical considerations, such as working with children (i.e. persons under the age of 18) or gathering data on sensitive topics. Indeed, Masters dissertations can involve quite complex ethical issues.
For these reasons, master's students have a responsibility to ensure that they are aware of and comply with the University's requirements for research ethics.
The first stage is to complete the Ethics Decision Tool - ideally this should be completed with your supervisor. If this is not possible while completing the form, take screenshots of the pages (a print function for the Ethics Decision tool is currently under development) to discuss with your supervisor. It is really important that you answer the questions accurately so that you reach you the correct outcome for your project. Your supervisor will email the PG office after the discussion to let them know whether you need ethical review or not.
Please note that completing and gaining approval from your supervisor does not provide ethical approval for your project. The purpose of the form is to help you to identify whether your project raises ethical issues and therefore requires further ethical review. Most PG projects should not involve more than minimal risk.
If you do not need further ethical review you can proceed with your dissertation/ project.
If the Ethics Decision tool determined that you require ethical approval then you need to log on to the online Ethical Review Manager to create a new ethics application and have it reviewed and approved so you can start your research. Without ethical approval, you cannot start your research.
It is recommended that you read the School’s guidance document before logging on to the ERM. You will find full guidance documents and training videos on how to complete the application on the ERM site.
It is really important that applicants read the guidance notes BEFORE logging into ERM and discuss their project with their supervisor to decide which route of review is most appropriate.
Within the ERM there are two main routes for obtaining ethical approval for your research project the first set of questions as well as the Soss Guidance Notes will determine which route you need to follow via the ERM.
1. SoSS Research Ethics Template
SoSS can provide ethical approval for research projects that comply with the terms and conditions of a predefined template. The template has been approved for use by the University Research Ethics Committee (UREC). The template covers research involving non-vulnerable adults giving informed consent. It covers research that involves more than minimal risk but does not cover research that involves serious risk. The University Research Ethics Committee (UREC) should review research that involves serious risk. The template can be used for research projects conducted by students only.
2. University Research Ethics Committee (UREC)
UREC reviews research projects that fall outside the scope of the Social Sciences template and/or require full ethical review. You will need to obtain UREC review and approval for your project if the research involves serious risk. Examples include (but are not limited to) research that:
- Involves vulnerable participants (e.g. children)
- Might cause participants harm or distress/discomfort
- Poses significant risk to participants’ personal, social or economic well-being
- Involves research conducted without participants’ consent
- Involves physically invasive procedures (e.g. administering drugs, physiological measurement)
- Involves fieldwork in potentially dangerous locations
This is not an exhaustive list of the types of research that require UREC review. For further detail, please see the information on StaffNet: Which Type of Ethics Approval is Required?
3. NHS Research Ethics Committee (NHS REC)
Projects involving NHS patients/users typically requires review by an NHS REC. Some types of research using data from NHS staff may also require NHS REC review. However, guidance, issued by the Health Departments and effective from 1 September 2011, state that research involving NHS staff recruited as research participants by virtue of their professional role does not require NHS REC review. The Ethics Decision Tool will determine whether you need to submit an application to an NHS Research Ethics Committee.
The University provides further guidance on what types of research require ethical approval.
The ERM requires you to answer a series of questions about your research project. Your answers determine whether or not your research meets the template’s terms for low to moderate risk research.
You will be guided through the questions and help bubbles will appear to the right of each question. These will contain guidance notes to help you in answering the questions. If certain responses indicate that your research does not meet the template's terms, then the template will refer you to the University Research Ethics Committee. If your responses indicate that your project fits the template's terms, then your project can be approved under the template arrangement.
The template only covers research that:
- Involves only participants who are non-vulnerable adults who are able to give informed consent.
Excluded are: NHS patients, children under 18, adults with learning difficulties, adults who have a terminal illness, adults with mental illness, adults with dementia, adults in care homes, adults or children in emergency situations, prisoners or criminals, young offenders, users of illegal drugs or illegal substances
- Will obtain informed consent from all participants;
- Does not involve physically invasive procedures;
- Does not involve activities that pose a significant risk of causing physical harm or more than mild discomfort;
- Does not involve activities that pose a significant risk of causing psychological stress or anxiety;
- Does not require participants to take part in activities that pose a significant risk of having an adverse effect on their personal well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness) or economic well-being (e.g. employment, employability, professional standing);
- Does not involve collecting or revealing data that enables individuals, groups or organizations to be identified in such a way that they could experience significant negative effects on their personal, social or economic well-being;
- Does not involve activities that pose a significant risk of harming the researcher(s).
Once you have submitted the application and supporting documentation e,g. participant information forms, informed consent, any adverts, risk assessment your supervisor(s) will be informed and they will then screen the application and may query elements of the application. Once they are satisfied with your application they will then sign it off.
Your application will then be reviewed by a School Reviewer who is trained in reviewing ethics applications, again they may come back to you and query elements of the application or ask for adjustments.
Your application and supporting documents will then be reviewed by an authorised SoSS signatory for research ethics. Once reviewed successfully, you will then receive notification of ethical approval, including an approval reference number.
Safety and risk assessment
The SoSS research ethics template requires you to make a risk assessment of your project. The School's generic risk assessment documents are listed below. If your project does not fall within these generic risk assessments you will have to complete a full risk assessment form, with guidance from your supervisor, outlining the specific risks you anticipate and the measures you plan to take to address them. Submit this risk assessment with your application as an attachment to your application in the ERM. If one of the generic templates fits your project in most, but not all, respects, you can use the full risk assessment form to state which generic assessment mainly applies and to then specify the risks associated with your project that fall outside the generic assessment, and the measures you plan to take to address them.
- SoSS Generic Risk Assessment A
- SoSS Generic Risk Assessment B
- SoSS Generic Risk Assessment C
- Full Risk Assessment
- Health & Safety in Fieldwork
- Guidance on Lone Working - If you are going to work alone, you should think about associated risks to the researcher and sensible safeguards for those risks
- Research Data Management Policy - Ethics approval involves issues of data management (what you will do with your data to secure them and protect them)
If your research project is of a type that needs ethical review and approval from the University Research Ethics Committee, you can read guidance and apply online:
The UREC application is submitted via the ERM.
- Complete the application online and upload documents and appendices (e.g. participant information sheets, consent forms and recruitment advertisements). Templates for participant information sheets and consent forms are available on StaffNet above
- The completed form will be pre-screened by a research ethics signatory authorised on behalf of the School. The purpose of pre-screening is to check if the project necessitates UREC approval and ensure that all applications are completed appropriately. The school signatory will aim to review your application within 10 working days.
Once completed, the signatory will sign-off your application and submit it directly via the ERM, for subsequent review at the next available UREC meeting (applicants will be copied into the email confirming receipt of submission).
The Research Ethics Office will email you to confirm the details of your review.
About UREC review
The University currently has five research ethics committees, with one committee meeting taking place every week. However, to target a specific committee date, you must submit your completed application(including all accompanying information) at least three weeks in advance of this date. Dates of forthcoming UREC meetings are listed. Once UREC has received your application they will write to you to confirm the date/time of the committee meeting at which your application will be discussed. Applicants usually attend this meeting to clarify any uncertain points and/or agree on amendments.
The outcomes of UREC review are:
- Favourable ethical opinion
- Provisional favourable ethical opinion, subject to minor specified amendments
- Provisional favourable ethical opinion, subject to specified amendments, clarifications, etc to be approved by the chair or a sub-committee
- Requirement to submit an amended application
- Unfavourable ethical opinion with no recommendations about re-submission (a decision which is very rarely given)
The Committee will write to you to confirm the outcomes of the meeting, including notifications of approval and confirmation of any insurance arrangements.
To contact the University Research Ethics Office, please email firstname.lastname@example.org.
To ensure that your proposed research project is covered by University insurance, particularly if your research raises significant ethical issues (e.g. involving vulnerable groups), please see the information on insurance on the University's Research Governance pages.
For those whose research is ethically reviewed and approved directly by the Senate Committee (UREC), insurance cover is automatically arranged. The insurance office is interested in studies which are defined as including invasive techniques, physical testing or psychological intervention. Definitions of these terms are provided in ERM and studies will be sent to the Insurance Office if these techniques are used on those under the age of 5, on pregnant women or are being conducted outside of the UK.