What do I need to do?
This section is not a substitute for reading and understanding the Guidance Notes, but as a procedural guide.
In the first instance, however, it is suggested that researchers ask themselves the following questions:
Is it research on human subjects, human samples or human personal data?
If it involves human data, are those data in the public domain? Do they relate to deceased persons?
Guidance is provided on the following areas:
Two difficult issues: consent to research with children and research involving human cells.
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.
Definition
Research - is designed and conducted to generate new knowledge.
Service evaluations - are designed to answer the question “What standard does this service achieve?”.
Audits - are designed to find out whether the quality of a service meets a defined standard.
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 considerations and 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?
For applications to be submitted to UREC, you will need to prepare an Application form, a Data Management Plan (DMP), 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 .
The University Research Ethics Committee has prepared a standard , which a number of Schools have implemented. The Ethics Application form along with the Data Management Plan addresses the requirements outlined in the guidance. You should consult your School research ethics contact for more information. For researchers in Schools without a School Research Ethics Committee who making an application to the University level Committee, the UREC application form and Data Management Plan should be completed and submitted in line with the guidance documentation.
The Research Ethics can be downloaded here. The Data Management Plan can be downloaded from this webpage.
And the template participant information sheet and consent form here.
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 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 (Abbe Davy) or your School Research Ethics contact (). If your research does not fall within the Exceptions Procedure, the documentation needs to come to the University Committee, via Abbe Davy (email: urec@reading.ac.uk)
Data Protection and Research
Personal data used for research purposes must be used in accordance with the General Data Protection Regulation (GDPR) 2016 and Data Protection Act (DPA) 2018.
The above legislation sets out specific obligations for:
- Informing participants about how their data will be used, shared and retained, as well as their rights
- Minimising the use of personally identifiable data wherever possible
- Having in place safeguards to protect the data of research participants
All research using human subjects, human samples (however obtained) or human personal data to be undertaken in the University, or under the auspices of the University, however funded, cannot be carried out without the approval of the University's Research Ethics Committee.
Heads of School are responsible for having procedures in place within their School that identify and review all projects that might fall within the Research Ethics Committee's terms of reference, as described in . However, the Research Ethics Committee will not consider the data protection aspects of a project so the following data protection guidance notes have been prepared to help researchers to deal with data protection issues. These should be read in conjunction with the University's guidance on Research ethics and the Quality Assurance in Research website.
Resources
Data Protection for researchers
Detailed information on Data Protection law and requirements for research activities
Data protection checklist for researchers
A step by step guide for ensuring your research meets data protection requirements
An example consent form for researchers to ensure data protection requirements are met
Data protection for Participant Information Sheets
Information that we are required by law to provide to research participants under Article 13/14 of the GDPR. This can be added into sheets or included as an extra page.
Find out if you need to complete a data protection impact assessment before starting a new research project.
Data Management Plan
When planning research, specifically research which will involve data collected from research participants, consideration needs to be given to how research data will be collected, used, stored, shared and disposed of. Further information is provided on the webpage linked to below, and as is the Data Management Planning template.
The Data Management Planning template should be completed and submitted as part of all applications submitted to UREC.
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.
- Contact the Research & Ethics Committee by email on urec@reading.ac.uk