All research projects undertaken at Northern Health must involve a Northern Health employee. To ensure oversight, safety, and ethical integrity, all research conducted at Northern Health must have a designated Northern Health Principal Investigator (PI). In most circumstances, the PI must be a paid employee of Northern Health.
This PI must be:
- A credentialed researcher (by satisfying the minimum requirements listed on the Table below)
- An individual with appropriate qualifications and experience to carry out the proposed research
Principal Investigator Responsibilities –What Must You Do as a Principal Investigator?
The PI holds overall responsibility for the safe, ethical conduct of the research project at Northern Health.
Responsibilities include (but not limited to):
- Submission of ethics and governance documents to the relevant regulatory bodies.
- Maintaining ongoing communication with the reviewing Human Research Ethics Committee and Research Development and Governance Unit (RDGU).
- Compliance with the requirements outlined in:
- Ethics and Governance Approval documentation.
- Research Agreements or collaborative arrangements.
- Funding and grant documentation.
- Safety and Incident Reports.
The PI is able to delegate research activities only to qualified team members, and each individual’s delegated tasks must be listed on the project’s delegation log.
Noting the following conditions:
- Research activities cannot begin until both the team member and the PI have signed and dated the delegation log, ensuring that all tasks are within the scope of the individual’s practice.
- The PI understands that all delegated individuals must remain qualified and properly trained throughout the duration of the project.
- The PI is responsible for regularly reviewing the delegation log and ensuring it is updated to reflect any changes in responsibilities or staff changes.
For additional information about the role and responsibilities for Principal Investigators (PIs) conducting single and multi-site research –please find a summary here. For training and educational resources for PIs –visit Researcher Training and Credentialing or ACTEC.
Eligibility Criteria –Can You Be a Principal Investigator at Northern Health?
| Quality Assurance Pathway | Non-HREC Pathway | External HREC Review & NH Governance Pathway | |
| Paid employee of Northern Health* | ✔︎ | ✔︎ | ✔︎ |
| Have expertise in the discipline relevant to the project | ✔︎ | ✔︎ | ✔︎ |
| Accept responsibility for the conduct of this research project according to the principles of theNational Statement on Ethical Conduct in Research (NHMRC, 2023) | ✔︎ | ✔︎ | ✔︎ |
| Familiar with theAustralian Code for the Responsible Conduct of Research | ✔︎ | ✔︎ | ✔︎ |
| Familiar with theNational Clinical Trials Governance Framework (NCTGF) requirements for Principal Investigators | Recommended | Recommended | ✔︎ |
| Familiar with all Northern Health SOPs related to research: • Research Policy • Research Governance SOP • Research –Standard Operating Procedure for Clinical Trials | ✔︎ | ✔︎ | ✔︎ |
| Current Good Clinical Practice (GCP) Certificate (within 3 years) | Recommended | Recommended | ✔︎ |
| Current AHPRA certificate (if applicable) | ✔︎ | ✔︎ | ✔︎ |
*Exceptions may be provided following approval from the Research Executive Committee. However, at minimum, there must be a NH paid employee listed as an associate investigator.
Ineligible to be listed as a Northern Health Principal Investigator:
- Students
- Registrars
- Junior Hospital Medical
Important to note: Being listed as a Principal Investigator on an ethics or governance application, reflects your governance and oversight responsibilities. It does not necessarily equate to being listed as a first or senior author on resulting publications.
