What do I need to do?
This section is not a substitute for reading and understanding the Guidance Notes, but as a procedural guide. A more detailed FAQs document can be accessed here
In the first instance, however, it is suggested that researchers ask themselves the following questions:
Is it research?
It is not research if the activity is carried out solely for the purpose of teaching and learning, or if it constitutes Clinical or Social work practice or audit. With regard to the latter two categories, see the Annex E in the Guidance Notes (PDF-299kb).
If the activity is not research then it does not require ethical approval. However, appropriate procedures must be in place for the people involved to give their consent to the activity.
Is it research on human subjects, human samples or human personal data?
If the answer to this question is "yes" then the research requires ethical approval, subject to the following questions:
If it involves human data, are those data in the public domain? Do they relate to deceased persons?
If the answer to either of these questions is "yes", there is no need to obtain ethical approval.
If the answer to both these questions is "no", then ethical approval is needed.
What documentation do I need?
You will need to prepare a Project Submission Form, an Information Sheet for participants, and a Consent Form. The details of what is required for these documents is given in Section 5 of the Guidance Notes (PDF-299kb).
A number of Schools have standard application forms, which address the requirements outlined in the guidance. You should consult your research ethics contact for more information. For researchers in Schools without such forms and who are making an application to the University level Committee, the Committee has produced a generic template application, which can be downloaded here, and adapted accordingly. The tempate includes the project submission form, outline consent form (as also provided below), information sheet and recruitment poster.
UREC template application form
Samples of the Project Submission Form and the Consent Form are given in
Annex B (PDF-122kb) and Annex C (PDF-86kb) of the Guidance Notes respectively. Word versions of the Project Submission Form and Consent Form are also available for download.
If your project involves the taking of blood samples, you should also refer to the information sheet and consent form for the taking of blood samples - Annex D1 (PDF-83kb)
You may find it useful to use a 'Health & Lifestyle' questionnaire as part of your study - Example Questionnaires (PDF-115kb) for male and female participants can be tailored for your use.
To whom do I submit the documentation, i.e. is my project eligible for ethical approval by my Head of School, or should I apply to the Research Ethics Committee itself?
The "Exceptions Procedure" set out in Section 6 of the Guidance Notes (PDF-299kb) explains when ethical approval can be obtained "in-house" from your Head of School. If you are unsure, please contact the University Research Ethics Committee Secretary (Nathan Helsby) or your School Research Ethics contact (School Research Ethics contacts). If your research does not fall within the Exceptions Procedure, the documentation needs to come to the University Committee, via Nathan Helsby (email: n.e.helsby@reading.ac.uk)
Two difficult issues:
Consent to research with children
The difficulty here is in assessing who should give consent. The following link provides some additional notes: Consent to Research with Children (PDF-113kb)
Research on material which consists of or includes human cells
Such research is regulated by the Human Tissue Act 2004 (PDF-125kb) and is subject to requirements for consent and for licensing. If in doubt as to whether or not the Act applies to your research, you are welcome to discuss the matter with the Chair of the Research Ethics Committee.