Frequently Asked Questions
This page has been set up as a resource for researchers. It aims to provide answers to some of the most frequently asked questions about the Research Ethics Committee system. If you have a query which you feel is not covered, please contact: email@example.com
No. To find out about NHS procedures please visit our guidance which includes links to the relevant NHS contacts.
The NHS issues guidance on when review by an NHS REC is required. For detailed guidance visit the National Research Ethics Service (NRES) website.
No as long as the data is non-sensitive and fully anonymous (i.e. there is no possibility of the further use of data leading to the identification of individuals).
The following research would normally be considered as involving MORE than minimal risk and would require ethical approval:
- Research involving vulnerable groups.
- Research involving sensitive topics - for example participants' sexual behaviour, their illegal or political behaviour, their experience of violence, their abuse or exploitation, their mental health, or their gender or ethnic status.
- Research involving groups where permission of a gatekeeper is normally required for initial access to members - for example, ethnic or cultural groups, native peoples or indigenous communities.
- Research involving deception or which is conducted without participants' full and informed consent at the time the study is carried out.
- Research involving access to records of personal or confidential information, including genetic or other biological information, concerning identifiable individuals.
- Research which could induce psychological stress, anxiety or humiliation or cause more than minimal pain.
- Research involving intrusive interventions - for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not encounter such interventions, which may cause them to reveal information which causes concern, in the course of their everyday life.
In order to download the application form, you will need to do the following:
- register your personal details within the ethics database if this is your first application (Registration Form);
- register your project details within the ethics database at which point you will be issued with a unique project ID number;
- once a project ID has been issued, the application form and guidelines will be available for download.
Also, please refer to the Procedures page of the ethics website which takes you through the application process.
As always, if you have any specific questions or difficulties, please do not hesitate to contact the Administrator of the Committee.
Applications recommended by the researcher's Head of Department for review by Chair's action based on the criteria of minimal risk as defined below allows for the expedited review of the application when:
- there are no contentious issues such as genetic research on illegal substances;
- no invasive procedures are involved such as the administration of pharmacological agents;
- participants are not children or other vulnerable groups such as prisoners;
- the research does not put the investigators at risk.
The Committee will endeavour to convey decisions to the applicant within a week of the meeting, unless there are queries to made of the applicant, or a need for an outside opinion.
Yes, only if the project is submitted for Chair's action otherwise the researcher will have to wait until the next meeting of the Committee. Our guiding principle is to promote and create an ethically sound research culture at UCL and not to place obstacles or delays in the way of researchers so we will do our best to accommodate the researcher within reason.
If you are doing long term research in multiple stages it is recommended that you consider submitting separate applications for each stage. This will ensure that you can start the earlier stages and will not have to amend the approval as the research changes and develops - it will also make the review simpler to complete. If you cannot do this you must bear in mind that you will need to submit a request for a modification to your project whenever changes are needed.
All participants need to be given adequate information about the study so that they can make an informed decision about whether to participate.
A template Information Sheet is provided to help you in preparing the information you are going to give to participants, however, this is provided to help you - not to prescribe the way you inform participants about your study.
The advantage of a written Information Sheet is that you and your participants have a record of all the relevant information about the study. In most cases this is supplementary to, rather than replacing, a discussion between the researcher and the potential participant. For some participants such as very young children, a written information sheet is not appropriate (although for children, their guardian should receive written information about the study). For other participants the information may be presented in a letter or email rather than as an 'Information Sheet'.
The important thing is that your participants have adequate information about why, how, when, with who, and where the study is taking place.
For studies involving children, consent from a guardian will be needed (in addition to the child's assent to participate).
For studies involving individuals aged 16 or over, who do not have the capacity to consent to participate in the proposed study, approval by an NHS Research Ethics Committee is required. Please note that it is illegal to undertake research with individuals over 16 who lack the capacity to consent to take part in your research unless you have approval from an NHS REC.
No. Self-completion questionnaires do not require the completion of consent form as submission of the completed questionnaire implies consent to participate (you should make this clear in your Information Sheet).
If the participants cannot read or write, how can they give their consent to participate in the research?
Particular difficulties may arise when consent needs to be recorded in illiterate populations. The application of safeguards to protect such participants from possible exploitation is illustrated by the trial of vaccines for leprosy in Point 1.1 (obtained from the Nuffield Council on Bioethics website which contains some excellent information on issues surrounding the obtaining of informed consent):
Towards an appropriate consent process: research into leprosy in Venezuela
In one study of a vaccine against leprosy carried out in rural Venezuela, researchers and prospective participants had no previous experience of an informed consent procedure. A process was designed in which the principal researcher visited communities where the research was to be conducted and explained it to community leaders. Following the approval of the community leaders, the research was explained to the community, followed by a question and answer session.
One to two months later members of the Ministry of Health visited the communities and asked individual participants if they understood what the research was about and whether or not they wished to participate. As many participants were not literate, their decision was recorded by a government worker, or in the presence of such a worker, without any of the researchers being present. Individual decisions were recorded and each participant either signed a form or gave a fingerprint.
Information sheets and consent forms must be designed to assist participants to make informed choices. We recommend that the information provided should be accurate, concise, clear, simple, specific to the proposed research and appropriate for the social and cultural context in which it is being given. Where it is inappropriate for consent to be recorded in writing, genuine consent must be obtained verbally. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated, include consideration of an appropriate process for witnessing the consent.
Are there special rules if I am researching people that I already know (e.g. my students or people in my own workplace)?
Yes. Whenever there is a pre-existing relationship between researcher and potential participant it is the researcher's responsibility to ensure that steps are taken to counteract any feelings of obligation potential volunteers might have, and also to make it clear to them that they will not benefit from their participation nor suffer as a result of choosing not to take part.
You must consider and demonstrate clearly to the committee:
- How you are going to communicate clearly to your potential research participants that there is no pressure to participate.
- What additional arrangements you intend to put in place to ensure that this is the case.
- What additional practical arrangements you intend to put in place to ensure that those who do agree to participate can change their mind at any point without having to give a reason, even after they have participated in the research activities.
Written evidence of permission (on letterhead or via a organisation's email) should always be obtained by the researcher unless there are justifiable circumstances why this is not possible/necessary. These might include where the individual participant is senior enough within their organisation that their own consent can also be taken as evidence of permission from the organisation, or where the security or safety of the participant/organisation would be compromised by this. In such circumstances a real and substantive justification must be given and this will be considered on a case by case basis by the committee.
Formal risk assessment is the responsibility of your department and you will need to be aware of what your department's requirements are. If the conduct of research puts participants and/or researchers at risk then the ethics committee will be looking for assurances that appropriate risk assessment has been undertaken and risks are being managed effectively. This will not normally require the submission of a risk assessment form but the Committee may request this if they feel the information will assist them in assessing whether the risks to participants and researchers are warranted. It is important that the reviewers are able to gauge the risks presented from the information you provide them with in your application so that they can reach an informed decision about the ethics of the project.
Your participants will need to be told that you intend to record them and should be free to decline this aspect of the research unless participation isn't possible without you recording them (in which case they will not be able to participate). You should your state your intention to record participants in your Information Sheet and may wish to seek explicit consent for recordings in the consent form. You must delete all recordings following completion of the research unless you have explicit consent from your research participants to keep the recordings for future use.
Please refer to the Human Tissue Authority guidance on what constitutes relevant material for the purposes of the Human Tissue Act 2004.
The Human Tissue Authority publish a full list of licensed establishments. Please find below a list of UCL licensed premises as of June 2011.
|Licensing Number||Licensed Premises||Sector||Corp Licence Holder|
|11025||Wolfson Cellular And Gene Therapy Unit||Human Application||UCL Hospital NHS Foundation Trust|
|11059||Institute of Ophthalmology||Human Application||Anatomy|
|12055||Royal Free and University College Medical School||Research||UCL|
|12120||UCL, Department of Anatomy & Developmental Biology||Anatomy||UCL|
|12177||UCL Institute of Ophthalmology||Research||UCL|
|12189||University College London||Research||UCL|
|12198||UCL Institute of Neurology||Research||UCL|
|12220||Institute of Child Health||Research||UCL|
|12277||Eastman Dental Institute||Research||UCL|
|22611||University College Hospital||Human Application||UCL Hospital NHS Foundation Trust|
For the purposes of an application to the UCL REC your sponsor is the organisation who takes responsibility for the initiation, management and financing of the study or project. This is not the same as a funder. If you are a staff member or a student member your sponsor will normally be UCL (and if it is not you will need to explain why you are submitting for review by a College body if the College isn't responsible). Research can have more than one sponsor and, in such cases, you must outline what responsibilities are being taken on by each sponsor.
Research and Data Protection
The following are some of the frequently asked questions we have received about the Data Protection Act 1998 ("DPA") with particular emphasis, but not limited to research. However this list is by no means exhaustive:
All research projects using personal data must be registered with the data protection team before the data is collected. This includes projects approved by the Joint Research Office.
Form 2 should be used to register most projects. For those approved by the Joint Research Office Form 9 should be used. Both forms can be downloaded at http://www.ucl.ac.uk/finance/legal_services/data_protection/index.php.
They should be completed electronically and sent to firstname.lastname@example.org with copies of any information sheets and consent forms that you are using.
Please note that data protection registration numbers will not be issued when you submit an application form in person to the data protection team.
Applications for data protection registration are normally dealt within five working days. Therefore, please ensure you allow plenty of time when submitting your form. This is especially important if you are applying for ethics approval.
Projects using anonymised data do not have to be registered with the data protection team and you do not have to worry about compliance with the Act.
Data is only truly anonymised if it is impossible to identify subjects from that information and, if relevant, any other information that UCL holds. For example, if you have a list of research subjects and anonymise it by giving each one a number, but keep a list of the numbers with the names of the subjects, the information has not been anonymised. In this case, it is personal data, and the project must be registered with the data protection team.
My research project is exempt from approval by the UCL Ethics Committee, do I still need to register it with the Data Protection Officer?
Exemption from approval by the UCL ethics Committee does not mean that the research project is also exempt from registration with the UCL Data Protection Officer. Please visit the Research and Data Protection web page for further information.
Paper records containing personal data should be locked away when not in use, and never left on the desk when you are away from it or overnight.
When working from home you should ensure family members and visitors cannot view the personal data you are working with. You should also consider the appropriateness of public spaces for working on personal data, for example trains or cafes.
Use the university's shared drives to store and access the personal data. These are backed up overnight and this will ensure that only those individuals who need to use the information will have access to it. No data should be held on PC hard drives.
Use remote access facilities to access personal data and avoid transporting it on portable devices or using third party hosting providers. Portable devices and media are defined as: laptops, USB flash drives, portable hard drives, CDs and DVDs and other portable media.
The UCL Computer Security Team has published guidance on the storage of data on portable devices and media which is available at the UCL Computer Security Team web page.
You should avoid sending personal data by email. If you need to use email to send personal data you should encrypt it first. Further information on encryption is available at http://www.ucl.ac.uk/isd/common/cst/good_practice/encrypt
Principle 5 of the DPA states that information should be kept for no longer than is necessary. All records should be retained or disposed of according to retention schedules and appraisal guidelines established by the Records Management Programme.
It is good practice to conduct a regular review of the personal data that you hold. You should consider deleting any personal data that you no longer need. Information that you do not need regular access to, but needs to be retained should be archived.
Further advice and guidance on retention periods and the Records Management Services, please contact the Records Office by email.
Principle 8 of the DPA states that personal data shall not be transfered to a country or territory outside the European Economic Area (EEA) unless that country or territory ensures an adequate level of protection for the rights and freedoms of data subjects in relation to the processing of personal data.
Personal data can be transferred with the consent of the data subject. It is recommended that consent is sought at the point of collection where there will be a requirement to transfer data overseas.
These are currently:
The following countries are deemed to have adequate levels of protection for personal data:
Isle of Man
Safe Harbor is a policy agreement established between the United States of America (USA) and the European Union (EU), to regulate the way that USA companies handle personal data it receives.
Under this agreement, the USA recipient of personal data undertakes to handle such data by complying with the seven Safe Harbor principles, meeting with the EU data protection legislation.
As with any data transfer, security of the data is of up most importance and you should seek assurance from the data protection team, as to whether the country you intend to transfer data to provides adequate levels of protection.
For more information on data protection and research at UCL please visit the Reseach and Data Protection web page.
Further information on the DPA is also available from the Information Commissioner's Office website.