Ongoing Monitoring and Reporting
After receiving approval to conduct a study, investigators must inform COUHES if there are changes in the protocol that impact human subjects, or if adverse reaction risks are noted.
Changes in Protocol
If protocol is modified after a study has been approved by COUHES, investigators must obtain COUHES approval for any changes that may affect the rights of human subjects. These include, but are not limited to, changes that may impact discomfort or risks associated with study procedures, change in study personnel, the amount of time required by subjects, confidentiality of data, the privacy of subjects, or other rights.
Investigators must complete the Application for changes to an approved protocol.
If the change is minor and involves no more than minimal risk to subjects then an expedited review may be performed. All other changes are subject to a full COUHES Committee review
Investigators are not required to contact COUHES if changes in protocol are restricted to methods of data analysis or other points that do not alter requirements of or interactions with human subjects.
Adverse Reactions, Injuries, or Unanticipated Risks
All serious or unexpected adverse reactions or injuries, including those that result in a subject dropping out of an experiment or requiring medical attention, must be reported to COUHES, orally or by e-mail, within 48 hours. All other adverse events should be reported within 10 working days of occurrence.
Investigators must report all adverse events using the Adverse event reporting form.
COUHES must also be informed if, during the conduct of a study, any unanticipated risks to subjects are noted.