Guidance on Applying for Proportionate UREC Review
Proportionate UREC Review
Proportionate UREC review is available to those researchers (staff and students) conducting low risk projects which are defined as adhering to the Proportionate UREC criteria outlined below.
**Denotes mandatory criteria that must be met in order to qualify for Proportionate UREC review. If your study does not meet these mandatory criteria you will need to apply for full UREC review, where appropriate.
If your research involves an activity falling within one of the conditional criteria beginning with “If” then it must meet the requirements of that criterion or criteria to be considered for Proportionate UREC Review.
Participants and Consent
- **Involves only participants who are non-vulnerable adults able to give informed consent or, if children/ young people are involved, they must be in an educational setting/accredited organisation and have the opportunity to assent with parental/guardian opt-in consent also provided.
Data Collection and Experimental Procedures
- **Does not involve physically invasive procedures (please note physically invasive refers to any test in which the skin of the participant is broken, or an implement is inserted into any opening of the human body, or involves the taking of body samples such as saliva, hair, urine, faeces, sputum, blood, skin, nails, or taking biopsies of any form for any purpose, or any form of scanning such as DEXTA scans, untrasound scans, MRI, fMRI, CT or PET scanning).
- **Does not involve activities that pose a significant risk of causing physical harm or more than mild discomfort.
- **Does not involve activities that pose a significant risk of causing psychological stress or anxiety.
- **Does not require participants to take part in activities that pose a significant risk of having an adverse effect on their personal well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness) or economic well-being (e.g. employment, employability, professional standing).
Sensitivity of Topic or Data
- **Does not involve collecting or revealing data that enables individuals, groups or organisations to be identified in such a way that they could experience negative effects on their personal, social or economic well-being.
- **Does not require research participants to provide personal and sensitive information likely to lead to significant levels of distress (ie research must only involve topics that are either not contentious or sensitive at all, or where a reasonable person would agree the topic is of legitimate interest and may result in distress only in rare instances).
- If topics being researched are of a sensitive nature, they are not personal to the participants.
- If using video recording or other images captured by the researcher and/or research study participants, the researcher is able to guarantee controlled access to authorised viewing.
- If researching professional practice, participants are in professional roles and the research is conducted in their work setting. It would also be acceptable to conduct these interviews via telephone or Skype as long as the content of the interviews is focused on professional practice and non-sensitive topics. Please note that in this instance, participants will be responsible for ensuring appropriate privacy arrangements.
- If conducting observations, they will be on ordinary, non-sensitive behaviours.
Location of Data Collection
- **Will be conducted inside the EU or in one of the 3 non-EU EEA member countries.
- **Will be carried out within normal working hours or at a time convenient to participants.
- If conducting observations they will be located in a public space or the clearly public areas of a building (e.g. the high street, the University campus, the entrance hall of a town hall).
Human Tissue Specific Criteria (if applicable)
- Research involving relevant material, limited to the secondary use of anonymised tissue samples, previously collected with consent for use in research.
- Research involving the analysis of DNA (or RNA), or using the results of DNA analysis from bodily materials, including extraction of DNA (RNA) from acellular materials where the samples have been anonymised, previously collected and with specific consent for DNA (or RNA) analysis in research.
- Research involving the use of tissue samples that comprise existing holdings that were collected before September 2006.
All applications to the Proportionate UERC Committee will still require a pre-screen check from a designated Ethics Signatory, a process which may take up to 10 working days. To apply for UREC Proportionate Review, researchers will need to create an application in the ERM online system and select the appropriate option for Question A5. Please note that the Proportionate UREC Committee or designated Ethics Signatory reserve the right to escalate an application to full UREC review should it be found to be high risk and not adhere to the criteria as outlined above.
If your application proceeds to Proportionate UREC Review you will not be required to attend a Committee meeting as all reviews are conducted electronically via the ERM system. After your Ethics Signatory has approved your application it will be sent out for review by the Proportionate Committee who will then communicate their decision to you within 10 working days. If revisions are required to your application or supporting documentation, these must be made within 5 working days of receiving them and resubmitted to the Committee for final approval.
If you have any queries regarding this process please contact your designated Ethics Signatory or email firstname.lastname@example.org