Maintaining privacy is a fundamental requirement of conducting research.
Access and use of MH medical records including the EMR for research must be in accordance with legislation, laws, guidelines, MH policy, HREC and MH governance approvals and any other applicable requirements.
EMR Privacy Statement
“Accessing identified patient information from health services other than your own for research purposes is not permitted. Precinct polices regarding appropriate access MUST be followed. Identified patient information must ONLY EVER be accessed after governance authorisation or quality assurance (QA) approval from the appropriate health service.”
Golden rules
- Accessing identified patient information from health services other than your own for research purposes is NOT permitted.
- Precinct polices regarding appropriate access MUST be followed:
- Connecting Care Program - Parkville EMR: Appropriate Use for Research
- Process for Parkville EMR: Access for External Monitors Inspectors & Auditors
- Identified patient information must ONLY EVER be accessed after governance authorisation or quality assurance (QA) approval from the appropriate health service.
- Principal investigators are responsible for ensuring all members of the research team are aware of and abide by the all requirements of the protocol and research conduct including access and use of patient information and privacy.
- You must have a MH appointment (paid or honorary) to access medical records, including the EMR. This also applies to student researchers.
- External monitors may be given access to medical records in accordance with precinct and MH policies including:
- Process for Parkville EMR: Access for External Monitors Inspectors & Auditors
- Do not share login details.
- Do not access identifiable records for research for patients that are not in your study.
- Do not release patient information unless in accordance with the HREC approved protocol and AFTER governance authorisation (note, the reviewing HREC must be accredited by the NHMRC for single ethics review under the National Mutual Acceptance (NMA) scheme).
- Provide the RMH privacy brochure 'How the Royal Melbourne Hospital is protecting your privacy' to participants for studies that access, collect and/or use personal and/or medical information
Information for participants
For studies that access, collect and/or use personal and/or medical information, participants should be provided a copy of the privacy brochure 'How the Royal Melbourne Hospital is protecting your privacy' along with the research study or clinical trial information. The brochure can also be accessed via iPolicy.
References
- Australian Code for the Responsible Conduct of Research (2018)
- National Statement on Ethical Conduct in Human Research (2018)
- Public Records Act 1973 (Vic)
- Privacy and Data Protection Act 2014
- Privacy Act 1988 (Cth)
- Health Records Act 2001 (Vic) - Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1 (e) (iii) & 2.2 (g) (iii) - Office of the Health Services Commissioner (Victoria) February 2002 (Vic)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - annotated with TGA comments
- MH Research policy
- MH Research Integrity Guideline
- Connecting Care Program - Parkville EMR: Appropriate Use for Research
- Process for Parkville EMR: Access for External Monitors Inspectors & Auditors