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Research Ethics & Governance Information System

Key dates

  • 19-OCT

    Biannual round table

  • 12-NOV

    HREC Chairs and Executive Officers annual meeting

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The Research Ethics and Governance Information System (REGIS) will support ethics and governance management of human research projects within all NSW public health organisations.

REGIS is a joint initiative between eHealth and the Office for Health and Medical Research. It is already being used by most NSW sites for local single-site research projects. Canberra based F1 Solutions have been contracted to build REGIS on their OmniEthics platform. Guided by ongoing stakeholder feedback, the REGIS team is progressively working with F1 solutions on the system build.

For more information and regular monthly updates on the REGIS transition, please visit the REGIS website.

Clinical trial risk category: REGIS Project Registration Question B8

In REGIS, the applicant completing Project Registration is asked to assign an overall risk category for all clinical trials (question B8).  This page provides additional guidance for the completion of that question, and for the use of the information for the HREC and institution.

International risk assessment guidance from the Office of Economic Cooperation and Development recommends an overall risk category is assigned to clinical trials. This categorisation is based on the:

  • potential risks of the use of the investigational product/device in the trial relative to standard of care for the clinical condition
  • level of clinical experience with the intervention

OHMR has expanded the scope of the risk assessment to all interventional trials.  Risks should be assessed relative to the standard of care and the level of clinical experience with the intervention rather than the patients’ underlying illness or the recognised adverse effects of the intervention.

By assigning each trial with a pragmatic risk category, the institution can use this information to plan an appropriate level of oversight (e.g. to inform a trial audit plan).  In addition, collection of these data will enable the institution to build an overall risk profile based on the clinical trials that it conducts.

Risk types for drug trials

Risk type Drug Trials
Type A: Risk comparable to standard medical care
Trials involving a drug entered onto the Australian Register of Therapeutic Goods (ARTG) if:
  • The use is within the conditions of its marketing approval, or
  • It involves off-label use of a registered drug, if this off-label use is established practice and supported by sufficient published evidence and/or guidelines (for example in paediatrics or oncology).
Type B: Risk associated with modified use of an existing product/intervention
Trials involving a drug entered onto the ARTG if:
  • Such products are used for a new indication (different patient population/disease group) or;
  • Substantial dosage modifications are made or;
  • They are used in combinations for which interactions are suspected.
Trials involving a drug not entered onto the ARTG if:
  • The active substance is part of a drug that is entered onto the ARTG.
Type C: Risk associated with use of an unlicensed product/novel intervention Trials involving a drug not entered onto the ARTG.

Risk types for device trials

Risk types Device trials
Type A: Risk comparable to standard medical care Trials involving a medical device used within the terms of its marketing approval if knowledge derived from controlled trials already exists.
Type B: Risk associated with modified use of an existing product/intervention
Trials involving a medical device used:
  • Outside the terms of its marketing approval or;
  • Within the terms of its marketing approval, but no knowledge from controlled trials exists.

A Type A grading may be justified if there is extensive use/clinical experience with the therapeutic good and no reason to suspect a different safety profile in the trial population.

Type C: Risk associated with use of an unlicensed product/novel intervention
Trials involving a medical device not entered onto the ARTG.
A grading other than ‘TYPE C’ may be justified for therapeutic goods not on the ARTG but which have been approved in other jurisdictions and for which there is extensive clinical data.

Risk types for interventional trials

Risk types Interventional trials
Type A: Risk comparable to standard medical care The use of an established intervention in line with local or national protocols.
Type B: Risk associated with modified use of an existing product/intervention Risk associated with modified use of an established intervention.
Type C: Risk associated with use of an unlicensed product/novel intervention Risk associated with the use of a new/novel intervention and/or where no knowledge from prior studies exists.

Guidelines: completing research team information in REGIS for the NSW SSA and HREA

Applicants for ethical and governance review in NSW can enter research team member details, such as contact, study role, and employment information, in three places in the Research Ethics and Governance Information System (REGIS): at Project Registration, on the Human Research Ethics Application (HREA), and on the NSW Site Specific Assessment (SSA) application.

These guidelines explain which research team members should be listed where, based on which information needs to be seen and reviewed by the Human Research Ethics Committee (HREC) on an ethics application, versus the governance officer (on an SSA application).

Key definitions

For all applications in REGIS and in forthcoming NSW Health policy document revisions, the following terminology applies:

The Coordinating Principal Investigator (CPI) is, in relation to research conducted at a single site, the investigator for that site; or, in relation to research conducted at more than one site, the individual, whether or not they are an investigator at any particular site, who takes primary responsibility for the conduct of the research.

A Principal Investigator (PI) is the person responsible, either individually or as a leader of the researchers at a site, for the conduct of research at that site. In a single site research project or when a project does not require the appointment of a NSW Health PI, the CPI may also be the PI.

An Associate Investigator (AI) is any individual member of the team at the study site, designated and supervised by the site PI, to perform significant study-related procedures and/or to make important study-related decisions.

Who is responsible for reviewing which team listings?

The National Statement, the NHMRC Research Governance Handbook, and current NSW Health research ethics and governance policy recognise the need for human research to be “conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research,” (NS 1.1), and that the institution and the reviewing HREC have responsibility for ensuring these requirements.

For clinical trials conducted under Good Clinical Practice, and other research conducted per GCP principles, the investigator is responsible for ensuring that study teams are “qualified by education, training, and experience,” and that they have “an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial.” The sponsor is also responsible for selecting qualified investigators/institutions with adequate resources. In effect, these are clearly shared responsibilities.

However, since the implementation of single ethical review in NSW and the expansion of the National Mutual Acceptance (NMA) scheme from clinical trials to all research, HRECs are no longer necessarily located within the institution where the research will be conducted. Furthermore, for clinical trials, the research site isn’t always the study sponsor. Thus, there is some duplication of the review of study team listings by the reviewing HREC, the RGO on behalf of the institution hosting the study, and the “institution-as-sponsor.”

Draft NSW Health policy states that PHOs are expected to develop an effective research governance framework that, among other recommendations:

  • enables all checks and approvals to be undertaken without duplication or unnecessary delay; and
  • clarifies the roles and responsibilities of all stakeholders.

As early adopters of single ethical review, Australia and the UK have had to delineate all aspects of the ethics and governance roles, and are setting examples world-wide for multi-centre research reviewed by a single ethics committee.

Applicant guidelines: listing research team members

For all new applications entered into REGIS, regardless of the number of sites:

At Project Registration and on the HREA
The applicant is to list the people outlined in table 1 at Project Registration – these details will be pre-populated into the HREA (if required). The CPI and each site PI must have a REGIS account and profile in order to proceed past project registration.

Important: Associate Investigators and other team members at the site are to be listed on the SSA only; not at Project Registration.

If the CPI wishes for additional contacts to have access to the study at the project level, those people should create profiles in REGIS, and the CPI should share the project with them. Table 1 also shows which role to select from the drop-down in HREA question 1.9.1, for which people.

Table 1: Study team members to list in Project Registration and on the HREA in REGIS

Team member role Where to list in Project Registration Where to list on the HREA HREA Q1.9.10 drop down selection
Coordinating Principal Investigator details Part D Q1.9.1 – Q1.9.13 (pre-populated from registration) Co-ordinating Principal Investigator
Site names and Principal Investigator details Part C Q1.9.1 – Q1.9.13; M6.2.1.2.6 if applicable Principal Investigator
Details about key members of the study management group/ CPI’s team Do not include at Project Registration Do not include at Project Registration. No need to include on Project Registration

On the NSW SSA(s)
The applicant is to list the people outlined in table 2. These people need not have a REGIS account and profile. The applicant does not list members of the CPI’s project management team on the SSA unless they also meet the definition of one of roles in table 2.

Table 2: Study team members to list on the NSW Health SSA in REGIS (Part B)

Team member role SSA B2 project team member role drop-down selection
Coordinating Principal Investigator details N/A; pre-populated from project registration
Site names and Principal Investigator details N/A; pre-populated from project registration
Other site-level administrative contact for the project at this site to receive copies of notification and other correspondence (optional) N/A; separate fields provided
Associate Investigator details Associate Investigator
Details about any other research personnel requiring physical access to the site who are not NSW Health staff at that site/location (This is used by the research office to determine whether any additional human resources/workforce checks are required.) Investigator/Researcher (label to change in future version of REGIS SSA)

NSW research office guidelines: who reviews which team members?

These guidelines are an extension of the roles and responsibilities established by the Australia-wide Clinical Trials Project Reference Group (CTPRG); formerly, the Clinical Trials Jurisdictional Working Group (CTJWG) (see figure 1). For NSW HRECs and sites, per the Matrix of Shared Responsibilities:

The HREC

  • Assesses the suitability of the CPI and key members of the study management group. This includes whether the CPI and if applicable, key members of the CPI’s team have sufficient expertise to undertake all research activities, including, where relevant, GCP training.
  • Examples of study management group roles include protocol co-authors, study statistician, and members of the study advisory committee.
  • Is aware of the number and type of sites covered by the ethics approval and the name of the PIs at those sites.

The Research Governance Officer/Public Health Organisation

  • Must be satisfied that HoDs have assessed whether the local PI and their study team have the necessary training and experience to undertake their role as described in the protocol/project description.
  • Does not need to assess the study management group (unless they are the study sponsor and have reviewed this; for example, by reviewing the HREA, as part of the sponsor operational activities).

Per forthcoming NSW policy clarifications, NSW PHOs may verify, through the declarations of relevant department heads and the PI involved in the research, that the investigators at the PHO have the necessary skills, training and experience to undertake their role.

What's new in the new NSW Site Specific Assessment form?

In early 2018, an updated NSW Site Specific Assessment form (SSA) was introduced in the Research Ethics and Governance System (REGIS).

This form facilitates a more streamlined and targeted SSA process, for the applicant, Heads of Departments (HoDs), and the Research Office.

The summary table below provides an overview of all changes, compared to the NSW SSA form that is in Online Forms.

Forthcoming policy changes reflected in new SSA form

While some of the changes to the SSA  – such as the ability to reduce duplication of answers already provided within the Human Research Ethics Application (HREA) – have been necessary to support REGIS, many of the changes reflect forthcoming policy updates.

Important:  All policy documents will be updated to reflect these changes. In the meantime, applicants should accept any policy-related changes in the REGIS SSA form rather than current policy.

Key SSA changes and rationale

  • Part B: Project team
  • Part C: Departments and services
  • Other

 

Summary of all SSA form changes

For a summary of what’s new in the NSW SSA form in REGIS compared to the NSW SSA form that is in Online Forms, download the summary or review the table below.

 

Section New SSA Old SSA
Navigation
  • 7 sections always visible on left-hand side
  • Sections labelled by section title, and show what’s complete or requires more information
  • Navigable by page number only
  • Section overview not visible when working inside the form
Part A: Project-wide information
  • All completed at Project Registration, and pre-populated into each related SSA, including site names.
  • Only Project title, summary and HREC name pre-populated from the National Ethics Application Form (NEAF)
Part B: Project team
  • Applicant completes remaining information about the Principal Investigator (PI) entered at Project Registration, and completes remaining information about – and adds any additional – site team members.
  • Allows for entry of Associate Investigators (AIs), other research personnel requiring physical access to the site who are not NSW Health staff at that site, and administrative contact.
  • Collects student information, and requires supervisor declaration.
  • Does not collect training information; has fields for project role and expertise
  • Required re-entry of PI’s information
  • Allowed for entry of AI’s and a contact person
  • Did not collect student information at the SSA level
  • Collected a list of researcher-required training; had four fields for qualifications, experience, expertise and role
Part C: Departments and services
  • Department, and Head of Department (HoD) name and email address prepopulated from pre-set, updateable list provided by Research Office and uploaded into system
  • Each HoD must have a REGIS account before SSA form can be submitted. New field provided for each PI to state support required from HoD (e.g. personnel, services, facilities, equipment) which is populated onto each relevant declaration.
  • Department information entered into separate “time and resources” table and “departments and services involved” table
  • HoDs did not require system account for SSA form to be completed in system; declarations of support often collected external to system
Part D: recruitment, records, tissue and data
  • Non-clinical trials: free text field for proposed number of participants. Clinical trials: minimum and maximum enrolment numbers collected for NSW metrics program
  • Categories of people recruited not asked, as available elsewhere.
  • Two new fields for, if applicable, number of medical records proposed for review, and number of tissue samples proposed to access
  • One free-text field for proposed number of participants
  • Asked about categories of people to be recruited
  • No fields about medical records or tissue samples
Part E: site costing and funding
  • Both funding and cost information collected, with real-time in-system calculation of difference between the two.
  • Non-financial costs and estimated dollar value collected, and included in calculations
  • Six funding types available (commercial, donations/ bequests, grants, non-commercial, other external and internal department)
  • Only funding information collected; no costing information collected
  • No in-system calculations provided
  • Amount units varied (e.g. per year or per participant)
Part F: attachments – site specific documents
  • Site-specific attachments uploaded as part of SSA. No duplicative checklist provided. PIs encouraged to refer to required lists per policy and site requirements.
  • Fields provided for document type and title, wherein investigator may enter date and version.
  • Although SSA provided a yes/no checklist that recommended required attachments, documents were uploaded under a separate tab and were not linked to the checklist
  • Fields provided for document type, version, date and description
Part G: declarations
  • Only the PI completes a declaration, upon electronic submission of the application
  • HoDs, including Authority for Data Provision, receive email notification upon SSA completion, and confirm or qualify their support by logging into the system
  • HoD information pre-populated from Part C
  • Declarations generated inside SSA form for PI, all AIs, and HoDs
  • Declarations could be made electronically within system or collected via email or web signature and included as attachments
  • No pre-population from Department tables to declarations
Other differences
  • Anticipated start and finish dates requested. For clinical trials, requires identification of an AI who will act as substitute for the PI when available.
  • The “complete SSA” button automatically sends application to HoDs for their review.
  • The “complete SSA” button automatically sends application to HoDs for their review
  • Generation of a submission code did not electronically submit the form; PIs needed to send a PDF of the form via email or post

Updated 1 month ago