Monitoring Research Projects

Research » Post Ethics & Governance Approval » Monitoring Research Projects

Monitoring Research Projects

The HREC monitors approved projects to ensure compliance with the protocol and relevant legislation and guidelines as per HREC approval. The NH HREC mechanisms for monitoring are as follows:

1. Annual Reports (including DSMB reports and multi-site approvals)
An annual report must be submitted to the NH HREC by the PI (or delegate) at the anniversary of the NH HREC approval date or as per Lead HREC requirements. The annual report is submitted on the approved Department of Health & Human Services approved Site Report Form.

Annual reports not received within 4 weeks of the anniversary due date may result in the ethical and governance suspension of the research project.

2. Final Reports (including multi-site approvals)
A final report must be submitted to the RGO by the PI (or delegate) at the completion of a research project or if the project is discontinued or abandoned. The final report is submitted on the approved HREC Final Report Form.

3. Safety Reports
The HREC monitors approved research projects via the safety reports.

4. Protocol Deviation/Violation
Protocol deviation/violation reports must be sent to the NH Ethics/RGO if the deviation/violation occurred at a NH site and impacts on a patient’s safety or the overall conduct of the trial.

5. Monitoring & Auditing visits
The Research Governance Office may conduct on site monitoring and auditing. The purpose of the auditing program is to review how research is conducted, and to detect, correct and prevent potential and existing problems.

The objectives of the auditing program are:

a)   to ensure research is conducted ethically, safely, legally and in compliance with the protocol; conditions of HREC approval and institutional policies & procedures.
b)   to raise awareness of requirements and promote researchers' accountability.
c)   to ensure that the conduct of research does not compromise the integrity of the results.

All ongoing human research projects conducted at Northern Health sites with ethics approval are eligible to be audited, including clinical trials, observational studies, clinical audit activities and public health research projects.

The RGO may recommend that safety issues are logged in Riskman as a near miss or incident, escalation to the NH HREC and/or suspend the project at NH.

Click on this link to download the standard templates for self-audit accepted by NH Office of Research & Ethics