How the ​Surgical Clinical Research Unit can help

Research projects can be supported by the team from HSCRU and may include the following:

  • Research idea development and advice

  • Protocol development

  • Assistance and advice with research ethics and governance for projects.

  • Access and assistance with RedCap database for approved projects

  • Advice and assistance with preparation of abstracts and manuscripts for presentations and publications.

Research Ethics and Governance

All research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007). Research may include a variety of projects ranging from audits, surveys, cohort studies, randomised trials and basic science projects. Projects may include current or past patients or staff (surveys of practice as an example), or healthy volunteers. 

In addition, all human research that takes place in NSW Public Health Organisations, or that requires support from a NSW Public Health Organisation in the form of access to participants, tissue or data requires site authorisation. Department heads review each project and approve the project and then full site authorisation is provided by the Chief Executive HNELHD or their delegate before commencement.

Projects may require addition approval from the University of Newcastle Research Ethics Committee and other safety approvals or animal ethics approval if the project involves the University of Newcastle and/or the Hunter Medical Research Institute. Please discuss with the research team if this may be required.

Any randomised trial will need to be added to a nationaly recognised clinical trial registry. Please discuss this with staff also.

Any drug trials require additional regulatory processes to be gone through, and this needs to be discussed with the research unit.

 

Research Ethics and Governance Information System (REGIS)

The Research Ethics and Governance Information System (REGIS) is the system is used by researchers in NSW and the ACT to develop and submit both research ethics and site assessment applications for single-site and multi-site research conducted at public health organisations NSW and ACT. Research offices, including Human Research Ethics Committee Executive Officers and Research Governance Officers, members and expert reviewers, and Department Heads use the system to process, review and manage research projects throughout the study. Users need to register with REGIS to gain access in order to complete applications.

For projects that are considered low or negligible risk such as retrospective audits please discuss with the HSCRU staff as an alternate pathway to waiver of ethics approval may be possible, but is determined on a case by case basis.

For projects that may involve private hospitals as well please check with the HSCRU staff for information on this process.