Note: The activities listed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to participants.
1. Whether a study qualifies as minimal risk or not is a decision taken by OxTREC and not the applicant. OxTREC therefore reserves the right to request a full application at any time.
2. Indicative criteria for minimal risk studies are as follows:
- The risk and magnitude of possible harms associated with these studies must be no greater than those of daily living activities of the volunteers
- Includes most questionnaires or interviews which would not distress the volunteers and will remain confidential
- Does not include a drug or medical device
- May allow non-invasive or minimally invasive specimens or tests (eg urine/stool/saliva samples; nasal/throat/rectal/vaginal swabs in adults)
- May allow use of specimens collected for routine health purposes
- May include venous blood sampling from healthy adults up to a maximum volume of 1ml/kg in 8 weeks
3. For such studies please complete the OxTREC minimal risk application form:
Please also submit the following supporting documents:
Please note that, for minimal risk studies only, it is no longer necessary to submit a protocol with your application.
All study documentation should have a version number and date on each page of the document (header or footer).
4. The application form and supporting documentation should be emailed to the OxTREC secretariat.
5. Minimal risk applications can be approved at any time and the study can then be started. The full committee will be informed at the following meeting.
A FULL APPLICATION is required for all other studies.