University Ethics Committee (UEC)Frequently asked questions

Often the length of time it takes to complete the form depends upon how well developed your thinking about the project itself is. If you have a fully developed project proposal completing the form may only take a few hours, but if you have not thought through all the ethical issues about your project it may take a few days to complete the form and all other paperwork.

Once you have completed the form, you need to obtain the Head of Department signature which you need to organise with your Department Secretary.

If the project is within the remit of the UEC the form should reach the UEC manager on or before the deadline date (all dates are advertised on the UEC website). The UEC manager will usually contact you within a few days of the UEC meeting. Often a few amendments are necessary which can be approved by the Chair of the UEC in between UEC meetings, and usually within a few days of the amendment being sent to the UEC manager.

Arrangements for the Departmental Ethics Committee (DEC) vary between Departments and you should ask your Department Secretary for advice about your local DEC.

The UEC managers if given time can provide feedback on completed forms, but there is no resource to help investigators complete the form. You can also ask colleagues, supervisors and your local DEC members for help with the form. There is a lot of guidance and information on the form itself, in the Code of Practice and on the ethics website. Read all available information first.

The sponsor is the organisation with overall responsibility for the design, conduct and management of the project and is usually Strathclyde University. If you think a third party should be the sponsor of your project you should discuss this with Louise McKean in Research and Knowledge Exchange Services (RKES).

You can discuss funding opportunities with the Business Development team at RKES.

Most funders are content for investigators to obtain ethics approval for a project once funding is granted. You should mention the need for ethics approval in your funding application and include your time to obtain ethics in your staff costs.

Contact your Department Secretary to ask about the procedure within your Department.

If the project is within the remit of the DEC your Department Secretary should be able to explain your local procedure to refer applications to your DEC. If the project is within the remit of the UEC the form with all supporting paperwork should be sent to RKES on or before the UEC deadline. The deadline dates are advertised on the ethics website.

The overall responsibility for the project including completing the ethics form rests with the Chief Investigator (CI). But the form can be completed by a student or researcher or by a group of people.

The CI usually will be the senior academic leading the project or for a student project the student’s supervisor. The CI must be an Ordinance 16 staff member. The only exception is for PhD students who may be a CI with their academic supervisor listed as ‘other Strathclyde investigator’.

If you are involved in the investigation as a University staff member or student your Strathclyde email and phone contact details should be given. Mobile phone numbers can also be used as a telephone contact point.

Best practice is to keep all digital project data on University PCs and all hard copies in locked storage in the University. However sometimes using portable devices is unavoidable. Why you need to use a portable device should be explained in your application form and you should set out all the precautions you will take to keep the data safe, for example using encryption, password protection and secure transportation methods. There is full advice on data storage in Section D of the Code of Practice.

If your employer is involved in the project their details should be on the form with an explanation of their role in the project.

If the co investigator is involved in the study as a student then they should be in section 2 as 'Other Strathclyde Investigator' but their role, their employer and any involvement of that employer should be spelt out in the application.

At Strathclyde we are content to accept ethics approval from other institutions so long as the institution has robust appropriate ethics procedures in place. Strathclyde will still want a copy of the other institution’s application form and approval. Discuss this with your course coordinator.

You need to carry out appropriate inquiries into your area of research to ensure you are aware of and can comply with all relevant legislation and guidelines. If you have any doubts you should discuss this with your course coordinator and/or your academic supervisor.

Unsound research is unethical and so the ethics committee reserves the right to ask questions about methodology if the research project has not been subject to independent review. Often the committee is not given sufficient information in the first draft of the application and so needs to ask these questions to be satisfied the investigators have thought of all issues.

The committee does not wish to read pages and pages of detail and references, but the committee needs enough detail so as to be able to fully understand the project. For example, explain what techniques are being used and why, use clear terminology and explain any acronyms/abbreviations. The form should be clearly understandable to a lay member of the committee.

It would be good practice to have permission from third parties, but if permission has not been finalised an application could be submitted with an explanation and with confirmation of permission being given to the Committee when it is granted. Ethics approval may be granted subject to permissions being obtained and the Committee being informed.

You must list all research venues including the countries in your application. You must comply with the laws applicable to each and every country the investigation is carried out. In addition your academic department must consider any health and safety issues and you must ensure you have appropriate travel insurance cover through the University if you are travelling to another country to conduct your project. The University has particular concerns about academic supervision of students overseas and the ethics committee may ask questions about that supervision if you do not provide sufficient detail in your application.

You must comply with the laws applicable to the country you are taking the data from and with the laws applicable to the country you are processing the data in. If you are collecting and processing the data in the UK you must comply with the UK DPA. Full information about this must be included in your ethics application.

The answer to this question will depend upon your project and you should read the Code of Practice for full information. In addition to the issue of obtaining consent/assent from the children, parents, those with parental responsibility etc, you should also consider whether you will need consent to access the children, for example from a school or an institution.

Consent is the agreement needed for the participant to participate in the project. Assent is expressing a willingness to be involved in the project but not giving the required full consent. In Scotland for children between the ages of 12 and 16 with sufficient maturity and understanding they may give consent on their own behalf to participate in the project but their parents may assent to their involvement in the project to show that the parents are content with the children’s participation.

The answer to this question will depend upon your project and you should read the Code of Practice for full information. In general if you have no reason to suspect a potential participant has impaired cognitive ability there would not be any need to check this. But if you are dealing with a group of people who might include such people then an appropriately qualified and experienced person might be required to determine whether any proposed participant whose cognitive ability is impaired may lack capacity to consent.

Full information is in the Code of Practice. As a general rule it is good practice to send a letter to a participant's GP or other medical advisor when the project may have a potential impact on the mental or physical health of the participant. The participant must agree to the sending of the letter.

This depends upon the circumstances. You must avoid any suggestion of coercion and ensure you are obtaining contact details legitimately. The best forms of recruitment are less direct and allow participants to approach you if they are interested; for example a poster outlining information about the project and giving contact details for the researcher put in a place where likely participants will see.

Yes provided you have obtained email addresses appropriately.

Your email should provide sufficient information for a participant to decide if they are interested, although not as much information as the participant information sheet.

Payment refers to any inducement given to potential participants to encourage them to participate in the investigation. You should detail any benefits to participants from participating in the form, for example if participants are transported to the venue, detail where to and from transportation is provided. The committee must consider whether this inducement is correct in the circumstances and properly recorded. Please provide details of any prizes, money or any other incentive.

A small, appropriate inducement that is unlikely to sway someone's judgement is probably ethical.

Full information about obtaining consent is set out in the Code of Practice. As a general rule consent forms should be separate and obtained prior to the participant's participation in the project. However with a simple questionnaire completion can be taken as consent to participant in the project. Care should be taken with any personal data on the questionnaire.

The participant information sheet must be separate and should be retained by the participant for their future reference.

You should only refer to this if you have arranged with the University to offer such cover. In the vast majority of cases this is not appropriate and not offered.

The Code of Practice sets out the remit of Strathclyde’s ethics procedure. If your project is service evaluation it does not require ethics approval. In some cases you may still wish to obtain ethics approval for a service evaluation and this can be arranged.

The Code of Practice sets out the full remit of the UEC. If your project does not fall into one of the categories set out then it can be considered by your DEC. In some circumstances a DEC may have special permission from the UEC to consider projects that otherwise would fall into the remit of the UEC. Your DEC will have details of such permissions. In other cases although a DEC is allowed to consider your project it may feel it doesn’t have sufficient expertise or experience to do so and ask for your project to be referred to the UEC. The involvement of children in your project does not automatically mean the project must be considered by the UEC. Your DEC and the UEC managers can provide advice about the UEC remit.

Your Department Secretary will have details of your DEC.

In general investigators do not attend UEC or DEC meetings.

If your project is particularly complex you can offer to attend the UEC meeting that considers it, and in unusual cases the UEC will ask if you wish to attend. The UEC manager can advise.

This depends upon the circumstances but causing emotional anxiety probably is harm.

Touching the skin of the participant would not normally be considered invasive, but if you must break the skin to obtain the sample that is invasive. The feelings of the participant would be relevant to this.

Activity which causes sweating and or an increase in blood pressure, heartbeat or respiration.

Skin, hair, saliva, blood etc.

If your part of the project is carried out in England and/or Wales then you will need to comply with all relevant legislation there. If your part of the project is carried out solely in Scotland then you do not need to comply with other legislation but you should ensure you collaborators are aware of the relevant legislation and be satisfied that they are complying with it. Information about the Human Tissue (England and Wales) Act is in the Code of Practice.

Where any biological sample is taken from a participant the consent from the participant should include that the material becomes the property of the University. Further information on this is in the Code of Practice.

The Committee would expect the investigator to have considered the issue on the basis of what would a reasonable person (or a typical potential participant) think. Reactions from participants in past or similar studies would be relevant as would comment from disinterested colleagues.

For the purposes of determining whether a project is within the remit of the UEC, a project that administers vitamins and food supplements will be within the remit of the UEC. The vitamins, liquid and food additives etc do not need to have a pharmaceutical purpose.

A project where substances are applied to the skin for research purposes would be within the remit of the UEC.

For the purposes of determining whether a project is within the remit of the UEC the UEC would expect the investigator to have considered the issue of whether the information was highly personal, intimate or private from the point of view of the potential participant. Commercially sensitive information would not normally be considered of a personal nature.

For the purposes of determining whether a project is within the remit of the UEC, the UEC would not normally consider non English speakers vulnerable. But if the potential participants or the project falls within any of the other categories the UEC might consider the participants vulnerable for that reason and the project would be within the remit of the UEC.

For the purposes of determining whether a project is within the remit of the UEC, the UEC would not normally consider children vulnerable. But if the potential participants or the project falls within any of the other categories the UEC might consider the participants vulnerable for that reason and the project would be within the remit of the UEC.

If the collaborator’s ethics procedures are suitably robust Strathclyde will probably accept the ethics approval from your collaborator but Strathclyde will want copies of the ethics application and approval.

If you obtain ethics approval from Strathclyde then all investigators including external collaborations must follow the approved ethics application and Strathclyde’s usual procedure. If you have ethics approval from your collaborator’s institution you should follow the procedure of that institution. If you have any concerns about the appropriateness of the institution’s procedure you should discuss the issue with the ethics committee.

The answer to this question will depend upon the circumstances of your project. If you have obtained the biological tissue from an NHS bio-bank with all appropriate consents and paperwork (usually including a Material Transfer Agreement (MTA)) then you will not need NHS ethics approval but you may need Strathclyde ethics approval if you are working with the material at Strathclyde. This approval might be obtained from your DEC.

If your project involves the NHS in any way you may need NHS ethics approval, which is obtained through the IRAS system and can be accessed at Integrated Research Application System (IRAS). For example if your project using data held by the NHS, recruits via the NHS or any NHS staff, asks questions of any NHS staff or patients, or requires access to NHS facilities, then you will need NHS approval. Obtaining NHS approval usually takes a few months and requires significant effort and paperwork. Help can be obtained from the NHS and the UEC managers. As a starting point you should look at the IRAS website and complete the online training.

In addition to NHS ethics approval you will require NHS R&D approval. You should contact the R&D office of the NHS Health Board you wish to work within as soon as possible to get advice about your project. The UEC managers can help you make contact with the NHS R&D offices. If during your project you will have a direct impact upon the care of NHS patients then you will also require an honorary contract with the NHS. This is obtained via the Research Passports system.

Strathclyde does not carry out an additional ethical review of your project if it has NHS approval. But we do require a copy of the NHS ethics paperwork so we can confirm the project is appropriate from the University’s point of view with respect to insurance, sponsorship and ethics. This confirmation is usually obtained very quickly. Once you have NHS approval you should talk to the UEC managers. Usually you have already spoken to them to obtain sponsorship information for the NHS application form.

Once you have ethics approval and confirmation of sponsorship and insurance cover (which usually occurs at the same time) then you can start the project. If your project is within the remit of the UEC you must provide an annual report and a final report to the UEC. Ask your DEC about reporting requirements if your project is within the remit of your DEC. Your must carry out the project as you have set out in your ethics application form. If you wish to change the project you should discuss that with the UEC managers or your DEC (depending upon which committee approved the project).

If any problems arise during the project, for example a complaint from a participant, an unexpected event or a change to the project, you should stop the project and contact the UEC or DEC (depending upon which committee approved your project) immediately.

The participants in the pilot study needed to know this and consent to their data being used again in the larger study.

• Purpose of investigation.
• Possible results.
• Data storage.

Adequate dissemination may prevent the same research being done elsewhere, unnecessarily, at potential risk to participants.