Draft Framework for Internally Delegated Authority for Low Risk Research Ethics Applications

Appendix 1:Low risk projects and proportionate review for projects within Language & Communication Science (LCS) and Optometry ONLY.

A full application to the SHS Research Ethics Committee (SHS REC) may not be necessary for low risk research projects involving routine practices and procedures with individuals who are not considered vulnerable. Such projects may be dealt with at a divisional level, where an appropriate structure for taking these decisions exists.

Currently, this policy applies only to the Divisions of Language & Communication Science and Optometry within SHS, and is effective from 1st September 2012.

Detailed guidance on research ethics and forms, and links to University research ethics policy and guidance can be found on the SHS REC website:

In order to determine whether a full application for ethical approval needs to be made to the SHS REC or Senate REC you should review the sections below.

Projects for approval at School Level

You must make a full application to the SHS REC (or Senate REC or another duly authorised REC – see notes) if you answer “Yes” to any of the following questions. If you are in any doubt as to whether the answer is “Yes” or “No” you should speak to your divisional research ethics lead (Dr Rachel-Anne Knight, LCS and Prof Ron Douglas, Optometry) alternatively you may speak to Dr Nick Drey, Chair SHS REC. You should also refer to Appendix 1 for specific divisional guidance.

If all the questions are answered “No” then the ethical approval can be managed by your divisional procedure for signing off low risk projects.

Does the study involve participants who are vulnerable or unable to give informed consent; or in a dependant position to the researcher, for example, but not limited to: children who are unable to assent, people with learning difficulties, people with mental health problems, your own patients or clients, people in care facilities, over-researched groups, and people you have a line management responsibility for? (You may need NRES approval if the participants fall under the provisions of the Mental Capacity Act 2005)

Will participants be asked to take part in the study without their consent or knowledge at the time of recruitment, or will any sort of deception be involved? This might include covert observation of people in non-public spaces or data collection in social networking media, for example. (Senate REC approval will be needed).

Is there a risk that the highly sensitive nature of a research topic might lead to disclosures from participants concerning their own involvement in illegal activities or other activities that represent a risk to themselves or others for example, but not limited to, safeguarding issues, sexual activity, drug use or professional misconduct? (Senate REC approval may be needed, discuss with Chair SHS REC)

Could the study induce psychological stress or anxiety, produce humiliation or cause harm or other negative consequences beyond the risks encountered in everyday normal life?

Will the researcher be exposed to any dangers or risks beyond those encountered in their everyday normal life?

Is any part of the research to take part in another country outside of England and Wales? (Senate REC approval will be needed for countries cover by FCO travel warnings)

Are drugs, placebos or other substances, for example, but not limited to, foodstuffs or vitamins, be administered to study participants or will the study involve invasive, intrusive or potentially harmful procedures of any kind. These may include for example, but not limited to, electrical stimulation, heat, cold or bruising. (Senate REC approval will be needed)

Are you going to deviate from the example study information sheet and consent form on City University London Senate REC guidance web pages?

If you have answered No to these questions then your application can be considered by the proportionate review process (see below).

Projects for approval at Divisional Level

Local divisional structures within LCS & Optometry can deal with research ethics applications that constitute low risk according to the screening questions above. This will include applications from undergraduates, postgraduates (MSc and PhD) and staff.

Applicants to the “low risk” process are required to use the Application for Approval of Research Involving Human Participantsand the Research Registration Form (EC3) and to use the templates for study information sheets and consent forms that are available on the Senate REC Web Pages.

SHS REC reserves the right to review and amend any application and decision made through the Framework for Internally Delegated Authority for Low Risk Research Ethics Applications.

Structure & Reporting Requirements for Divisional Low Risk Ethics Structures

It is up to individual Divisions how they wish to constitute their low risk research ethics review. It could involve a committee, a virtual committee (applications dealt with by email) or sign off from two individuals. It is preferable that at least one person involved in the process sits on SSH REC and can report to this committee.

Divisional low risk research ethics approvals must be notified to SHS REC (Alison Welton) in summary on a quarterly basis for the financial year- 1st April to 31st March. Research Registration Forms (EC3) for all applications considered must form part of this quarterly report. A short annual report should be provided after 31st March, summarising the applications and actions taken and also describing the divisional process for low risk ethical approvals.

In order to obtain indemnity letters a summary of applications from each meeting, with names, needs to be provided to Alison Welton, who can issue a summary indemnity letter covering the projects.

Ethical approval and indemnity lasts for one year, divisional low risk ethics structures may extend this annually if the project details remain unchanged.

Minor amendments may also be considered at divisional level, as long as the answer to all the screening questions remains “No”.

Any breach of the ethical conditions, data protection or safeguarding issues must immediately be reported to SHS REC. Safeguarding issues must also be immediately raised with Chris Barnes(University Safeguarding Lead: Ext 5998, ).

School of Health Sciences Research Ethics Committee - 29th October 2013 - N Drey