Access to patient records for research at NALHN
It is a SA Health directive that patient records can only be accessed for research purposes after the patient has given consent. Only SA Health staff legitimately involved in patient care (primary purpose) can access patient records. Only when the patient has consented to their records being accessed for research (secondary purpose) can SA Health staff, who are not directly involved in the patient care, access patient records in order to see if they are suitable to participate in a research project. Further consent is then required for the patient to actually participate in a project.
It is therefore critical for researchers to provide fully detailed information in the protocol, Ethics application, and Site-Specific Assessment (SSA) on how potential study participants are being identified and recruited. Provide as much detail as you can to cover such questions as:
- How is the treating team referring patients to the research team, and what is the process of obtaining patient consent to access their records? Who is obtaining consent?
- Have patients already given consent to access their records for screening (eg on admission, or as part of a follow up study?)
- Who will be accessing patient records, when, and why?
- What patient databases are you accessing, and what approvals have you received from the relevant Data Managers/Data Custodians
The Healthcare Act and NHMRC guidelines recognise that in some instances, it is necessary to disclose personal information to researchers provided that the research methodology has been approved by an ethics committee.
Therefore in addition to the standard HREC and SSA application, a researcher must
- Specifically state that they are requesting a waiver of consent to access patient records
- Address ALL of the criteria outlined in section 2.3.10 of the National Statement on Ethical Conduct in Human Research
The more detailed the information in the protocol and SSA, will make it easier the HREC and RGO to assess an application.