SOPs are to be included as part of the research ethics application when the research involves:
- equipment or devices that have been created and/or built by the researchers to collect bio-metric or physiological data, or
- commercially produced equipment or devices that have been modified by the researchers, or are being used differently from the manufacturer's directions/terms of use, where there is the possibility of injury, harm, or discomfort to participants, or
- creation of a bio-bank or bio-repository, or
- a controlled act as outlined by the Regulated Health Professions Act of Ontario; or
- any other use of equipment or devices where the study procedure includes the possibility of injury, harm, or discomfort to a participant (e.g., EEG cap and gel, EMG/ECG electrodes, TMS, tDCS, etc.)
If the above criteria do not apply to your equipment or device and/or study procedure, then an alternative to an SOP can be provided.
- In place of an SOP, provide information from the manufacturer (e.g., user manual) as supplementary information with your ethics application.
- If information from the manufacturer is not available contact Research Ethics for a supplementary appendix to complete and submit with your application.
SOPs may also be useful in situations where differences in protocol execution across members of the research team may negatively affect data reliability and integrity. They may also be beneficial in situations where consistency of process is required to minimize risk to researchers or participants.
SOPs are written by the research team and the originals kept in their possession. Sharing of SOPs among researchers is encouraged.
Network of Networks (N2) SOPs
N2 SOPs are available to Waterloo researchers conducting biomedical and clinical research. Contact Research Ethics for a copy by indicating the SOP# and Title.
Table of Contents for N2 SOPs (PDF)
Table of Contents for Biorepository and Clinical Trials SOPs (PDF)
Other samples also available:
- Archival Tissue Tracker
- Blood collection Sheet
- Collection and Processing Log
- Equipment Maintenance Log
- Freezer Storage Log
- Shipping Tracker
- Specimen Tracker
- Training Log
Research Ethics Board approved standard SOPs