Research Governance Audits
The SPHPM audit process can be summarised in the following diagram:
A Self-Audit Tool has been designed to help research personnel reflect on their research conduct and comply with guidelines for responsible conduct. It is SPHPM policy that a Self-Audit be completed annually for each project.
Self-Audit requests are sent to a coordinator / investigator for each project annually. An email will be sent explaining that the Self-Audit must be completed by the designated due date. If the audit is not received, the Research Goverance team will follow up with the study investigator.
Research Governance Auditors regularly conduct short audits of a range of research projects including low risk review projects. This involves meeting with researchers to:
+ Examine relevant documentation including protocol, signed consent forms, completed Case Report Forms, data spreadsheets, correspondence and HREC approval certificates
+ Check on the arrangements to protect privacy and confidentiality of participant data
+ Check data storage and security
Short Audits for Completed Projects
Short audits may be conducted at any stage of the project including after its completion. Auditing completed projects ensures any potential problems with data retention/records are rectified. For the purposes of the short audit, any project that is considered ‘open’ by MUHREC is subject to audit by the RGC.
Short Audit Process
The Research Governance Auditor (RGA) will contact researchers to request a copy of the following documents to prepare for the short audit
+ Study protocol
+ Original ethics application and approval OR request to be exempt from ethical review and approval
+ Any amendments and related HREC approvals (if applicable)
After assessment of these documents the Research Governance Auditor will arrange a mutually convenient time to conduct the short audit. Researchers will be provided with a list of prospective questions and a short audit procedure. The audit process usually takes around one to two hours.
Within a fortnight of completion of the audit, researchers will receive by email, an audit report including a summary of the main findings and a list of items that require action in order to comply with guidelines for good research practice. The researcher then has 7 days to:
a. Provide a response to the short audit report for consideration by the Research Governance Sub-Committee (optional)
b. Complete the Principal Investigator/Supervisor certification (compulsory)
c. Researchers are expected to action recommendations identified in the Short Audit within a reasonable timeframe specified by the RGA.
If the outcomes are deemed satisfactory the audit will be considered closed. If the outcomes are not satisfactory the researcher may need to discuss the issues with the Research Governance Officer, who can assist with resolving specific issues.
Occasionally, a Long Audit is required if the results of the short audit indicate a need for a detailed examination of the project. This may take two or three days and can be spread over several sessions if necessary. Researchers will be informed if a long audit is to take place.
Common Problem Areas
Issues frequently identified during audits of research projects include: compliance with privacy and confidentiality requirements; inadequate safe storage of data and access by key researchers, lack of protocol, changes to research methodology and recruitment without seeking ethics approval and failure to submit annual, or in the case of completed studies, final reports.
For more information, queries and complaints
Please contact Marina Skiba, SPHPM Research Governance Officer: firstname.lastname@example.org.